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Diampa
Empagliflozin
Diampa
Empagliflozin
Indications
Type 2 DM
Indication detailsView
Empagliflozin is indicated in:
- As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
- To reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease.
Therapeutic classView
Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors
PharmacologyView
Empagliflozin is a sodium glucose co-transporter-2 (SGLT-2) inhibitor. SGLT2 co-transporters are responsible for reabsorption of glucose from the glomerular filtrate in the kidney. The glucuretic effect resulting from SGLT2 inhibition reduces renal absorption and lowers the renal threshold for glucose, resulting in increased glucose excretion. Additionally, it contributes to reduced hyperglycaemia, assists weight loss, and reduces blood pressure.
DosageView
The recommended dose of Empagliflozin is 10 mg once daily, taken in the morning, with or without food. In patients tolerating Empagliflozin, the dose may be increased to 25 mg once daily. In patients with volume depletion, correcting this condition prior to initiation of Empagliflozin is recommended.
Side effectsView
The most common adverse reactions associated with Empagliflozin are urinary tract infections and female genital mycotic infections. Others common side effects includes dehydration, hypotension, weakness, dizziness and increased thirstiness.
ContraindicationsView
Empagliflozin is contraindicated in patients with history of serious hypersensitivity reaction to Empagliflozin or any of its ingredients, severe renal impairment, end-stage renal disease, or dialysis.
PrecautionsView
Assessment of renal function is recommended prior to initiation of Empagliflozin and periodically thereafter. Empagliflozin should not initiated in patients with an eGFR less than 45 ml/min/1.73 m2. No dose adjustment is needed in patients with an eGFR greater than or equal to 45 ml/min/1.73 m2.
InteractionsView
Diuretics: Co-administration of Empagliflozin with diuretics resulted in increased urine volume.
Insulin or Insulin Secretagogues: Co-administration of Empagliflozin with insulin or insulin secretagogues increases the risk for hypoglycemia.
Positive Urine Glucose Test: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glycemic control.
Interference with 1,5-anhydroglucitol (1,5-AG) Assay: Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.
Insulin or Insulin Secretagogues: Co-administration of Empagliflozin with insulin or insulin secretagogues increases the risk for hypoglycemia.
Positive Urine Glucose Test: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glycemic control.
Interference with 1,5-anhydroglucitol (1,5-AG) Assay: Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.
Pregnancy & lactationView
There are no adequate and well-controlled studies of Empagliflozin in pregnant women. Empagliflozin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if Empagliflozin is excreted in human milk. It is not recommended when breastfeeding.
Overdose effectsView
In the event of an overdose with Empagliflozin the usual supportive measures (e.g., remove unabsorbed material from the gastrointestinal tract, perform clinical monitoring, and institute supportive treatment) should be employed. Removal of Empagliflozin by hemodialysis has not been studied.
StorageView
Keep in a cool & dry place (below 30° C), protected from light & moisture. Keep out of the reach of children.
Diampa M
Empagliflozin + Metformin Hydrochloride
Diampa M
Empagliflozin + Metformin Hydrochloride
Indications
Type 2 DM
Indication detailsView
This tablet is indicated for the treatment of adults with type 2 diabetes mellitus as an adjunct to diet and exercise:
- In patients insufficiently controlled on their maximally tolerated dose of Metformin alone
- In combination with other medicinal products for the treatment of diabetes, in patients insufficiently controlled with Metformin and these medicinal products
- In patients already being treated with the combination of Empagliflozin and Metformin as separate tablets.
Therapeutic classView
Combination Oral hypoglycemic preparations
PharmacologyView
Empagliflozin is an inhibitor of Sodium-Glucose Co-Transporter 2 (SGLT2). SGLT2 is the predominant transporter, responsible for reabsorption of glucose from the kidney back into the circulation. By inhibiting SGLT2, Empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose and thereby increases urinary glucose excretion.
Metformin Hydrochloride is a biguanide type oral antihyperglycemic drug, used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. It does not produce hypoglycemia. Metformin Hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
Metformin Hydrochloride is a biguanide type oral antihyperglycemic drug, used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. It does not produce hypoglycemia. Metformin Hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.
DosageView
The dosage should be individualized based on effectiveness and tolerability. Take this combination twice daily with meals. Dose escalation should be gradual to reduce the gastrointestinal side effects due to Metformin Hydrochloride. Maximum recommended daily dose of Metformin Hydrochloride is 2000 mg and Empagliflozin is 25 mg.
Recommended individualized starting dose:
Pediatric patients under 18 years of age: Safety and effectiveness in pediatric patients under 18 years of age have not been established.
Recommended individualized starting dose:
- In patients on Metformin Hydrochloride, switch to this combination containing Empagliflozin 5 mg with a similar total daily dose of Metformin Hydrochloride.
- In patients on Empagliflozin, switch to this combination containing Metformin Hydrochloride 500 mg with a similar total daily dose of Empagliflozin.
- In patients already treated with Empagliflozin and Metformin Hydrochloride separately switch to this combination containing the same total daily doses of each component.
- In patients with volume depletion not previously treated with Empagliflozin, correct this condition before initiating this combination.
Pediatric patients under 18 years of age: Safety and effectiveness in pediatric patients under 18 years of age have not been established.
Side effectsView
Most common adverse reactions associated with Empagliflozin (5% or greater incidence) were urinary tract infection and female genital mycotic infections. Most common adverse reactions associated with Metformin (>5%) are diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia, and headache. The following important adverse reactions are given below:
- Very common: Hypoglycemia (when used with sulphonylurea or insulin), Gastrointestinal symptoms
- Common: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection. Urinary tract infection (including pyelonephritis and urosepsis), thirst, taste disturbance, pruritus (generalised), rash, Increased urination, serum lipids increased
- Uncommon: Volume depletion, urticaria, dysuria, blood creatinine increased/Glomerular filtration rate decreased, Haematocrit increased
- Rare: Diabetic ketoacidosis.
ContraindicationsView
- Hypersensitivity to Empagliflozin and Metformin
- Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis)
- Diabetic pre-coma
- Severe renal failure (GFR <30 ml/min)
- Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock
- Disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic disease) such as: decompensated heart failure, respiratory failure, recent myocardial infarction, shock
- Hepatic impairment, acute alcohol intoxication, alcoholism
PrecautionsView
Lactic Acidosis: Postmarketing cases of Metformin Hydrochloride-associated lactic acidosis. If lactic acidosis is suspected, general supportive measures should be instituted promptly in a hospital setting, along with immediate discontinuation of this combination.
Hypotension: Before initiating this combination assess and correct volume status in patients with renal impairment, the elderly, in patients with low systolic blood pressure, and in patients on diuretics. Monitor for signs and symptoms of hypotension after initiating therapy and increase monitoring in clinical situations where volume contraction is expected.
Ketoacidosis: Before initiating this combination assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue this combination, evaluate and treat promptly.
Acute kidney injury & impairment in renal function: Consider temporarily discontinuing this combination in settings of reduced oral intake or fluid losses. If acute kidney injury occurs, discontinue this combination promptly and institute treatment.
Urosepsis, Pyelonephritis, Fournier’s gangrene & Genital mycotic infections: Treatment with SGLT2 inhibitors increases the risk for urinary tract infections. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated.
Hypoglycemia: Consider lowering the dose of insulin secretagogue or insulin to reduce the risk of hypoglycemia when initiating this combination.
Vitamin B12 Deficiency: Metformin Hydrochloride may lower vitamin B12 levels. Monitor hematologic parameters annually.
Increased LDL-C: Monitor and treat as appropriate.
Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with this combination.
Hypotension: Before initiating this combination assess and correct volume status in patients with renal impairment, the elderly, in patients with low systolic blood pressure, and in patients on diuretics. Monitor for signs and symptoms of hypotension after initiating therapy and increase monitoring in clinical situations where volume contraction is expected.
Ketoacidosis: Before initiating this combination assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue this combination, evaluate and treat promptly.
Acute kidney injury & impairment in renal function: Consider temporarily discontinuing this combination in settings of reduced oral intake or fluid losses. If acute kidney injury occurs, discontinue this combination promptly and institute treatment.
Urosepsis, Pyelonephritis, Fournier’s gangrene & Genital mycotic infections: Treatment with SGLT2 inhibitors increases the risk for urinary tract infections. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated.
Hypoglycemia: Consider lowering the dose of insulin secretagogue or insulin to reduce the risk of hypoglycemia when initiating this combination.
Vitamin B12 Deficiency: Metformin Hydrochloride may lower vitamin B12 levels. Monitor hematologic parameters annually.
Increased LDL-C: Monitor and treat as appropriate.
Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with this combination.
InteractionsView
Diuretics: Co-administration of Empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.
Insulin or Insulin Secretagogues: Co-administration of Empagliflozin with insulin or insulin secretagogues increases the risk for hypoglycemia.
Positive Urine Glucose Test: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.
Drugs that Reduce Metformin Clearance: Drugs that reduce Metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine) may increase the accumulation of Metformin.
Carbonic Anhydrase Inhibitors: Carbonic anhydrase inhibitors may increase risk of lactic acidosis.
Drugs Affecting Glycemic Control: Thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid produce hoperglycemia. When such drugs are administered to a patient receiving Empagliflozin and Metformin combination, the patient should be closely observed to maintain adequate glycemic control. When such drugs are withdrawn from a patient receiving Empagliflozin and Metformin combination, the patient should be observed closely for hypoglycemia.
Alcohol: Alcohol can potentiate the effect of Metformin on lactate metabolism. Warn patients against excessive alcohol intake.
Insulin or Insulin Secretagogues: Co-administration of Empagliflozin with insulin or insulin secretagogues increases the risk for hypoglycemia.
Positive Urine Glucose Test: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.
Drugs that Reduce Metformin Clearance: Drugs that reduce Metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine) may increase the accumulation of Metformin.
Carbonic Anhydrase Inhibitors: Carbonic anhydrase inhibitors may increase risk of lactic acidosis.
Drugs Affecting Glycemic Control: Thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid produce hoperglycemia. When such drugs are administered to a patient receiving Empagliflozin and Metformin combination, the patient should be closely observed to maintain adequate glycemic control. When such drugs are withdrawn from a patient receiving Empagliflozin and Metformin combination, the patient should be observed closely for hypoglycemia.
Alcohol: Alcohol can potentiate the effect of Metformin on lactate metabolism. Warn patients against excessive alcohol intake.
Pregnancy & lactationView
Advise females of the potential risk to a fetus especially during the second and third trimesters. This is not recommended when breastfeeding.
Overdose effectsView
In controlled clinical studies single doses of up to 800 mg Empagliflozin (equivalent to 32-times the highest recommended daily dose) in healthy volunteers and multiple daily doses of up to 100 mg Empagliflozin (equivalent to 4-times the highest recommended daily dose) in patients with type 2 diabetes did not show any toxicity. Hypoglycaemia has not been seen with Metformin doses of up to 85 g, although lactic acidosis has occurred in such circumstances. Lactic acidosis is a medical emergency and must be treated in hospital. In the event of an overdose, treatment should be initiated as appropriate to the patient's clinical status. The most effective method to remove lactate and Metformin is haemodialysis. The removal of Empagliflozin by haemodialysis has not been studied
StorageView
Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.
Dianak
Cholera Saline
Dianak
Cholera Saline
Indications
Vomiting
Indication detailsView
Cholera Saline contains different electrolytes which are usually depleted in various conditions e.g. diarrhoea, vomiting, profuse sweating etc. So, this saline is indicated in cholera, also in diarrhoea, vomiting, fluid loss, to replenish and restore the normal electrolyte balance of the body.
Therapeutic classView
Intravenous fluid preparations
DosageView
The volume and rate of infusion of Cholera Saline depends upon the requirements of the patient and the judgement of the physician. It usually varies with age, weight and clinical condition of the patient.
AdministrationView
Administration Procedure:
- Check infusion set and infusion solution prior to use
- Pull moderately to tear off the protective cover of the Eurohead
- Hold lightly the Eurohead but not the bag
- Open the flow regulator fully and hold the giving set on the top white area, but not the membrane venting region
- Insert the spike of the administration set to the Eurohead and fit the connector of the administration set firmly to the needle
- Gradually allow the fluid to flow down to the needle tip and close
- Remove the protective cover of the needle
- Locate the venipuncture site and clean the site with an antiseptic solution, and then insert the needle
- Securely tape the puncture site
- Securely tape the wings and tubing
- Start infusion while adjusting drip speed
Side effectsView
- Severe burning, pain, or swelling around the IV needle;
- Warmth, redness, oozing, or bleeding where the IV was placed;
- fever, ongoing cough.
PrecautionsView
Since Cholera Saline contains different electrolytes, it should be infused with caution in patients where electrolyte imbalance may cause detrimental effects, e.g. in pregnancy, renal impairment, heart failure, pulmonary congestion, head injury etc. or in patients receiving potassium sparing diuretics.
StorageView
Should be stored at controlled room temperature.
Dianide
Nitazoxanide
Dianide
Nitazoxanide
Indications
Giardiasis
Indication detailsView
Nitazoxanide is indicated for the treatment of diarrhea caused by Cryptosporidium parvum, Giardia lamblia and Entamoeba histolytica.
Therapeutic classView
Anti-diarrhoeal Antiprotozoal
PharmacologyView
Nitazoxanide is a synthetic antiprotozoal agent for oral administration. The antiprotozoal activity of Nitazoxanide is believed to be interference with the Pyruvate Ferredoxin Oxido Reductase (PFOR) enzyme-dependant electron transfer reaction. This reaction is essential for anaerobic energy metabolism of the protozoa. Nitazoxanide and its metabolites, tizoxanid are active in vitro in inhibiting the growth of sporozoites and oocyst of Cryptosporidium parvum and trophozoites of Giardia lamblia.
DosageView
Age 1-3 years: 1 tea-spoonfull or 5 ml suspension every 12 hours for 3 days.
Age 4-11 years: 2 tea-spoonfulls or 10 ml suspension every 12 hours for 3 days.
Age 12 years or above: 5 tea-spoonfulls (25 ml) suspension or 1 tablet every 12 hours for 3 days.
It is recommended to be administered with food.
Age 4-11 years: 2 tea-spoonfulls or 10 ml suspension every 12 hours for 3 days.
Age 12 years or above: 5 tea-spoonfulls (25 ml) suspension or 1 tablet every 12 hours for 3 days.
It is recommended to be administered with food.
Side effectsView
The most frequent side effects, reported by Nitazoxanide are abdominal pain, vomiting and headache. These side effects are typically mild and transient in nature. Very rare side effects include- nausea, anorexia, flatulence, increased appetite, enlarged salivary glands, increased creatinine & SGPT level, pruritus, rhinitis, sweating, dizziness, discolored urine etc.
ContraindicationsView
It is contraindicated in patients with known hypersensitivity to Nitazoxanide or any components of the preparation.
PrecautionsView
Nitazoxanide must be administered with caution to patients with hepatic & biliary disease and to patients with renal disease.
InteractionsView
It is highly bound to plasma protein. Therefore, caution should be exercised when administering Nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic index.
Pregnancy & lactationView
US FDA pregnancy category of Nitazoxanide is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nitazoxanide have been shown to be excreted in human milk. So, caution should be exercised when Nitazoxanide is administered during lactation.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Dianide
Nitazoxanide
Dianide
Nitazoxanide
Indications
Giardiasis
Indication detailsView
Nitazoxanide is indicated for the treatment of diarrhea caused by Cryptosporidium parvum, Giardia lamblia and Entamoeba histolytica.
Therapeutic classView
Anti-diarrhoeal Antiprotozoal
PharmacologyView
Nitazoxanide is a synthetic antiprotozoal agent for oral administration. The antiprotozoal activity of Nitazoxanide is believed to be interference with the Pyruvate Ferredoxin Oxido Reductase (PFOR) enzyme-dependant electron transfer reaction. This reaction is essential for anaerobic energy metabolism of the protozoa. Nitazoxanide and its metabolites, tizoxanid are active in vitro in inhibiting the growth of sporozoites and oocyst of Cryptosporidium parvum and trophozoites of Giardia lamblia.
DosageView
Age 1-3 years: 1 tea-spoonfull or 5 ml suspension every 12 hours for 3 days.
Age 4-11 years: 2 tea-spoonfulls or 10 ml suspension every 12 hours for 3 days.
Age 12 years or above: 5 tea-spoonfulls (25 ml) suspension or 1 tablet every 12 hours for 3 days.
It is recommended to be administered with food.
Age 4-11 years: 2 tea-spoonfulls or 10 ml suspension every 12 hours for 3 days.
Age 12 years or above: 5 tea-spoonfulls (25 ml) suspension or 1 tablet every 12 hours for 3 days.
It is recommended to be administered with food.
Side effectsView
The most frequent side effects, reported by Nitazoxanide are abdominal pain, vomiting and headache. These side effects are typically mild and transient in nature. Very rare side effects include- nausea, anorexia, flatulence, increased appetite, enlarged salivary glands, increased creatinine & SGPT level, pruritus, rhinitis, sweating, dizziness, discolored urine etc.
ContraindicationsView
It is contraindicated in patients with known hypersensitivity to Nitazoxanide or any components of the preparation.
PrecautionsView
Nitazoxanide must be administered with caution to patients with hepatic & biliary disease and to patients with renal disease.
InteractionsView
It is highly bound to plasma protein. Therefore, caution should be exercised when administering Nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic index.
Pregnancy & lactationView
US FDA pregnancy category of Nitazoxanide is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nitazoxanide have been shown to be excreted in human milk. So, caution should be exercised when Nitazoxanide is administered during lactation.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Dianorm
Repaglinide
Dianorm
Repaglinide
Indications
Type 2 DM
Indication detailsView
Repaglinide is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with type 2 diabetes mellitus (NIDDM) whose hyperglycemia cannot be controlled satisfactorily by diet and exercise alone. It is also indicated for use in combination with Metformin to lower blood glucose in patients whose hyperglycemia cannot be controlled by exercise, diet, and either Repaglinide or Metformin alone.
Therapeutic classView
Meglitinide Analogues
PharmacologyView
Repaglinide binds to specific receptors in the cell membrane leading to the closure of ATP dependent K+ channels and the depolarisation of cell membrane. This in turn, leads to Ca++ influx, increased intracellular Ca++ and the stimulation of insulin secretion.
DosageView
- For patients not previously treated or whose HbA1c is <8%, the starting dose should be 0.5 mg before each meal.
- For patients previously treated with blood glucose-lowering drugs and whose HbA1c is >8%, the initial dose is 1 or 2 mg before each meal.
- Repaglinide should be taken immediately or up to 30 minutes before each meal.
- Dosage should be adjusted according to response at intervals of 1-2 weeks; up to 4 mg may be given as a single-dose, maximum 16 mg daily.
Side effectsView
The most common side effects of Repaglinide are hypoglycemia and related symptoms. Others include upper respiratory tract infections, diarrhea, constipation, nausea and vomiting. Hypersensitivity reactions include rashes and urticaria.
ContraindicationsView
Repaglinide is contraindicated in patients with:
- Diabetic ketoacidosis, with or without coma.
- Type 1 diabetes mellitus and
- Known hypersensitivity to the drug or its inactive ingredients.
PrecautionsView
Insulin should be substituted during concurrent illness (such as myocardial infarction, coma, infection, and trauma) and during surgery. All oral blood glucose-lowering drugs are capable of producing hypoglycemia. Repaglinide should be administered with meals to lessen the risk of hypoglycemia.
InteractionsView
The dose of Repaglinide may need to be adjusted, if taken with other medications. The possible interactions of Repaglinide with other drugs are:
- Inhibitors of the cytochrome P450 enzyme system (azole antifungals and macrolides) may lead to lower Repaglinide clearance and longer half life.
- Inducers of the cytochrome P450 enzyme system (Rifampin, Phenobarbital, Carbamazepine, Troglitazone, etc.) may accelerate Repaglinide metabolism and shorten its effect.
- Cimetidine has no significant effect on Repaglinide absorption or clearance.
- Repaglinide has no significant effect on Digoxin, Theophyllin, or Warfarin.
- Highly protein bound drugs (e.g., NSAIDs) may increase the plasma level of unbound Repaglinide and potentiate its glucose lowering effect. Thus, co-administration of these drugs with Repaglinide may increase the risk of hypoglycaemia.
- The risk of hypoglycaemia may also be increased when hypoglycaemic agents are co-administered with certain drugs such as salicylates, sulphonamides, Chloramphenicol, coumarins, Probenecid, monoamine oxidase (MAO) inhibitors, and adrenergic blockers.
Pregnancy & lactationView
Safety in pregnant women has not been established. Repaglinide should be used during pregnancy only if it is clearly needed. It is not known whether Repaglinide is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Repaglinide, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.
Overdose effectsView
Patients receiving up to 80 mg of Repaglinide developed few adverse effects other than lowering of blood glucose. Hypoglycemia did not occur when meals were given with these high doses. Severe hypoglycemic reactions with coma, seizure or other neurological impairment occur infrequently.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Diapac
Iohexol
Diapac
Iohexol
Indications
Radiographic contrast medium for diagnostic procedures
Indication detailsView
Iohexol is an X-ray contrast medium for use in adults and children for cardioangiography, arteriography, urography, phlebography and CT-enhancement. Lumbar, thoracic, cervical myelography and computed tomography of the basal cisterns, following subarachnoid injection. It is also indicated for arthrography, endoscopic retrograde pancreatography (ERP), endoscopic retrograde cholangiopancreatography (ERCP), herniography, hysterosalpingography, sialography and studies of the gastrointestinal tract when the use of barium sulphate is unsatisfactory, undesirable or contraindicated.
The dosage varies depending on the type of examination, age, weight, cardiac output and general condition of the patient and the technique used. Usually the same iodine concentration and volume is used as with other iodinated X-ray contrast media in current use. Adequate hydration should be assured before and after administration as for other contrast media.
The dosage varies depending on the type of examination, age, weight, cardiac output and general condition of the patient and the technique used. Usually the same iodine concentration and volume is used as with other iodinated X-ray contrast media in current use. Adequate hydration should be assured before and after administration as for other contrast media.
Therapeutic classView
Contrast medium for diagnostic procedures
PharmacologyView
Iohexol provides opacification of blood vessels and permits radiographic visualisation until sufficient haemodilution occurs or sufficient contrast medium has left the site of injection. Being a non-ionic compound, Iohexol yields solutions of lower osmolality than the conventional ionic contrast media. Intravenous or intra-arterial injection of Iohexol causes less pain and sensation of heat than conventional ionic media with similar iodine content. Iohexol solutions cause less cardiac and vascular disturbances on intravascular injection. The transit time of Iohexol through the coronary vascular system is slightly increased compared with conventional ionic contrast media, probably due to the increased viscosity of Iohexol at comparable iodine concentrations. The period of maximal opacification of the renal vessels may begin as early as 30 seconds after IV injection. Urograms become apparent in about 1 to 3 minutes with optimal contrast occurring between 5 to 15 minutes. In nephropathic conditions, particularly when excretory capacity has been altered, the rate of excretion may vary unpredictably, and opacification may be delayed after injection. Severe renal impairment may result in a lack of diagnostic opacification of the collecting system. The initial concentration and volume of the medium, in conjunction with appropriate patient manipulation and the volume of CSF into which the medium is placed, will determine the extent of diagnostic contrast that can be achieved. Following subarachnoid injection, Iohexol will continue to provide good diagnostic contrast by conventional radiography for at least 30 minutes. Slow diffusion of Iohexol takes place throughout the CSF as well as transfer into the circulation. At approximately 1 hour, contrast of diagnostic quality will not usually be available for conventional myelography. However, sufficient contrast for CT myelography will be available for several hours. If CT myelography is to follow, it should be deferred for several hours to allow the degree of contrast to decrease. Following lumbar subarachnoid placement, irrespective of the position in which the patient is later maintained, slow upward diffusion of Iohexol takes place throughout the CSF. CSF contrast enhancement for CT scanning may be expected in the thoracic region in about 1 hour, in the cervical region in about 2 hours and in the basal cisterns in 3 to 4 hours after administration into the lumbar subarachnoid space.
DosageView
Injection As iohexol soln containing 6-350 mg iodine/mL: Dose and strength used depends on the procedure and route of administration.
Peripheral arteriography:
Contrast-enhanced computerized tomography:
Contrast-enhanced computerized tomography of the abdomen:
Injection-
Angiocardiography:- Adult: Ventriculography: 350 mg iodine/ml: 30-60 ml, usual: 40 ml, may be repeated as necessary. If with selective coronary arteriography: max 250 ml. Selective coronary arteriography: 350 mg iodine/ml: 3-14 ml per inj, usual: 5 ml. Aortic root and arch study when used alone: 350 mg iodine/ml: 20-75 ml, usual 50 ml. Multiple procedures: 350 mg iodine/ml: max 250 ml.
- Child: Ventriculography: 350 mg iodine/ml: 1-1.5 ml/kg, usual: 1.25 ml/kg; 300 mg iodine/ml: 1.5-2 ml/kg, usual 1.75 ml/kg. Max: 5 ml/kg; 350 mg iodine/ml: 250 ml; 300 mg iodine/ml: 291 ml. Pulmonary angiography: 350 mg iodine/ml: 1 ml/kg. Multiple procedures: Max: 5 ml/kg; 350 mg iodine/ml: 250 ml; 300 mg iodine/ml: 291 ml.
- Adult: Use 300 or 350 mg iodine/ml solution, single inj. Aorta: 50-80 ml; major branches: 30-60 ml; renal arteries: 5-15 ml. Repeat as necessary. Max: 300 mg iodine/ml: 291 ml; 350 mg iodine/ml: 250 ml.
- Child: Use 350 mg iodine/ml solution: 1 ml/kg, single dose. Max: 5 ml/kg up to 250 ml.
- Adult: Use diluted solutions using sterile water for inj to concentrations of 50-100 mg iodine/ml. Usual volume: 50 mg iodine/ml solution: 50-600 ml; 100 mg iodine/ml: 50-300 ml.
- Child: Children: Use diluted solutions using sterile water for inj to concentrations of 50-100 mg iodine/ml: 50-300 ml.
- Adult: 240 mg iodine/ml: 15-20 ml; 300 mg iodine/ml: 15-20 ml.
- Adult: Knee: 240 mg iodine/ml: 5-15 ml; 300 mg iodine/ml: 5-15 ml; 350 mg iodine/ml: 5-10 ml. Shoulder: 240 mg iodine/ml: 3 ml; 300 mg iodine/ml: 10 ml. Temporomandibular: 300 mg iodine/ml: 0.5-1 ml. Lower volumes are recommended for double-contrast examinations; higher volumes are recommended fro single-contrast examinations.
- Adult: 240 mg iodine/ml: 50 ml.
- Adult: Use 300 or 350 mg iodine/ml solution: 200-350 mg iodine/kg.
- Child: Use 300 mg iodine/ml solution: 0.5-3 ml/kg, usual: 1-1.5 ml/kg; max: 3 ml/kg.
- Adult: Use 240 mg iodine/ml: 10-50 ml.
Intra-arterial-
Peripheral arteriography:- Adult: Aortofemoral runoffs: 350 mg iodine/ml: 20-70 ml; 300 mg iodine/ml: 30-90 ml. Selective arteriograms (femoral/iliac): 350 mg iodine/ml: 10-30 ml; 300 mg iodine/ml: 10-60 ml. Venography (per leg): 240 mg iodine/ml: 20-150 ml; 300 mg iodine/ml: 40-100 ml.
- Adult: Use 300 mg iodine/ml solution: Common carotid artery: 6-12 ml; internal carotid artery: 8-10 ml; external carotid artery: 6-9 ml; vertebral artery: 6-10 ml.
- Adult: Use 140 mg iodine/ml solution: Aorta: 20-45 ml at 8-20 ml/sec; carotid: 5-10 ml at 3-6 ml/sec; femoral: 9-20 ml at 3-6 ml/sec; vertebral: 4-10 ml at 2-8 ml/sec; renal: 6-12 ml at 3-6 ml/sec; other branches of the aorta (includes subclavian, axillary, innominate and iliac): 8-25 ml at 3-10 ml/sec.
Intrathecal-
Contrast-enhanced computerized tomography:- Adult: Lumbar (via lumbar inj): 180 mg iodine/ml: 10-17 ml; 240 mg iodine/ml: 7-12.5 ml. Thoracic (via lumbar or cervical inj): 240 mg iodine/ml: 6-12.5 ml; 300 mg iodine/ml: 6-10 ml. Cervical (via lumbar inj): 240 mg iodine/ml: 6-12.5 ml; 300 mg iodine/ml solution: 6-10 ml. Cervical (via C1-2 inj): 180 mg iodine/ml: 7-10 ml; 240 mg iodine/ml: 6-12.5 ml; 300 mg iodine/ml: 4-10 ml. Total columnar (via lumbar inj): 240 mg iodine/ml: 6-12.5 ml; 300 mg iodine/ml: 6-10 ml.
- Child: Use 180 mg iodine/ml solution. 0-<3 mth: 240 ml; 3-<36 mth: 4-8 ml; 3-<7 yr: 5-10 ml; 7-<13 yr: 5-12 ml; 13-18 yr: 6-15 ml.
Intravenous-
Contrast-enhanced computerized tomography of the abdomen:- Adult: In conjunction with dilute oral admin, use 300 mg iodine/ml solution: 100-150 ml. The oral dose is administered 20-40 min prior to IV dose and image acquisition.
- Child: In conjunction with dilute oral admin, use 240 or 300 mg iodine/ml solution: 1-2 ml/kg; max 3 ml/kg. The oral dose is administered 30-60 min prior to IV dose and image acquisition.
- Adult: 350 mg iodine/ml: 30-50 ml, as a bolus at 7.5-30 ml/second using a pressure injector, usually for 3 or more inj; max: 250 ml.
- Adult: Head imaging by inj: 300 mg iodine/ml: 70-150 ml; 350 mg iodine/ml: 80 ml. Head imaging by infusion: 240 mg iodine/ml: 120-250 ml. Body imaging by inj: 300 mg iodine/ml: 50-200 ml; 350 mg iodine/ml: 60-100 ml.
- Child: Head imaging: 240 or 300 mg iodine/ml: 1-2 ml/kg. Max: 28 g iodine with 240 mg iodine/ml solution or 35 g iodine with 300 mg iodine/ml solution.
AdministrationView
Dose and strength used depends on the procedure and route of administration.
Side effectsView
Flushing or a sensation of heat; pain, extravasation, thrombophlebitis at the inj site; nausea, vomiting, headache, and dizziness; urticaria, pruritus, pallor, sweating, metallic taste, weakness, coughing, rhinitis, sneezing, lachrymation, visual disturbances; hypotension, tachycardia, bradycardia, transient ECG abnormalities, haemodynamic disturbances; dyspnoea, bronchospasm, angioedema, severe urticaria; convulsions, paraesthesia, paralysis; acute renal failure; thromboembolism, disseminated intravascular coagulation, thrombocytopenia; hyperthyroidism, thyroid storm thyrotoxicosis.
ContraindicationsView
Manifest thyrotoxicosis. History of serious reaction to Iohexol.
PrecautionsView
A positive history of allergy, asthma, or untoward reactions to iodinated contrast media indicates a need for special caution. Premedication with corticosteroids or histamine H1 and H2 antagonists might be considered in these cases. The risk of serious reactions in connection with use of Iohexol is regarded as minor. However, iodinated contrast media may provoke anaphylactoid reactions or other manifestations of hypersensitivity. A course of action should therefore be planned in advance, with necessary drugs and equipment available for immediate treatment, should a serious reaction occur. It is advisable always to use an indwelling cannula or catheter for quick intravenous access throughout the entire X-ray procedure. Non-ionic contrast media have less effect on the coagulation system in vitro, compared to ionic contrast media. When performing vascular catheterisation procedures one should pay meticulous attention to the angiographic technique and flush the catheter frequently (e.g.: with heparinised saline) so as to minimise the risk of procedure-related thrombosis and embolism. Adequate hydration should be assured before and after contrast media administration. This applies especially to patients with multiple myeloma, diabetes mellitus, renal dysfunction, as well as to infants, small children and elderly patients. Young infants (age < 1 year) and especially neonates are susceptible to electrolyte disturbance and haemodynamic alterations. Care should also be taken in patients with serious cardiac disease and pulmonary hypertension as they may develop haemodynamic changes or arrhythmias. Patients with acute cerebral pathology, tumours or a history of epilepsy are predisposed for seizures and merit particular care. Also alcoholics and drug addicts have an increased risk for seizures and neurological reactions. A few patients have experienced a temporary hearing loss or even deafness after myelography, which is believed to be due to a drop in spinal fluid pressure by the lumbar puncture per se. To prevent acute renal failure following contrast media administration, special care should be exercised in patients with pre-existing renal impairment and diabetes mellitus as they are at risk. Patients with paraproteinemias (myelomatosis and Waldenström's macroglobulinemia) are also at risk
InteractionsView
Use of contrast media may result in a transient impairment of renal function and this may precipitate lactic acidosis in diabetics who are taking metformin (see Warnings and Precautions). Patients treated with interleukin-2 less than two weeks previously have been associated with an increased risk for delayed reactions (flu-like symptoms or skin reactions). All iodinated contrast media may interfere with tests on thyroid function, thus the iodine binding capacity of the thyroid may be reduced for up to several weeks. High concentrations of contrast media in serum and urine can interfere with laboratory tests for bilirubin, proteins or inorganic substances (e.g. iron, copper, calcium and phosphate). These substances should therefore not be assayed on the day of examination.
Pregnancy & lactationView
Use in Pregnancy: The safety of Iohexol for use in human pregnancy has not been established. An evaluation of experimental animal studies does not indicate direct or indirect harmful effects with respect to reproduction, development of the embryo or foetus, the course of gestation and peri- and postnatal development. Since whenever possible, radiation exposure should be avoided during pregnancy, the benefits of an X-ray examination, with or without contrast media, should be carefully weighed against the possible risk. Iohexol should not be used in pregnancy unless the benefit outweighs the risk and it is considered essential by the physician.
Use during Lactation: Breast feeding may be continued normally when iodinated contrast media are given to the mother.
Use during Lactation: Breast feeding may be continued normally when iodinated contrast media are given to the mother.
Overdose effectsView
Preclinical data indicate a high safety margin for Iohexol and no fixed upper dose level has been established for routine intravascular use. Symptomatic overdosing is unlikely in patients with normal renal function unless the patient has received an excess of 2000 mg I/kg body-weight over a limited period of time. The duration of the procedure is important for the renal tolerability of high doses of contrast media (t½ ~ 2 hours). Accidental overdosing is most likely following complex angiographic procedures in children, particularly when multiple injections of contrast medium with high-concentration are given. In cases of overdose, any resulting water or electrolyte imbalance must be corrected. Renal function should be monitored for the next 3 days. If needed, haemodialysis may be used for clearance of excessive contrast medium. There is no specific antidote.
ReconstitutionView
Like all parenteral products, Iohexol should be inspected visually for particulate matter, discoloration and the integrity of the container prior to use. The product should be drawn into the syringe immediately before use. Vials are intended for single use only, any unused portions must be discarded. The 500 ml contrast medium bottles should only be used in connection with auto injectors/pumps approved for this volume. A single piercing procedure should be used. The line running from the auto injector/pump to the patient must be exchanged after each patient. Any unused portions of the contrast medium remaining in the bottle and all connecting tubes must be discarded at the end of the day. When convenient, smaller bottles can also be used. Instructions from the manufacturer of the auto injector/pump must be followed.
StorageView
Store at room temperature below 30° C and protect from light and secondary X-rays. The product in glass vials and bottles may be stored at 37° C for up to 3 months prior to use.Do not freeze.
Diapamiro
Iopamidol
Diapamiro
Iopamidol
Indications
Radiographic contrast medium for diagnostic procedures
Indication detailsView
Neuroradiology: Lumber myelography, thoraco-cervical myelography
Angiography: Cerebral angiography, selective coronary angiography, left ventriculography, aortography, angiocadiography, selective visceral arteriography, peripheral arteriography, digital subtraction angiography, venography, urography
Other diagnostic procedures: Contrast enhancement in CT scanning, arthrography, fistulography.
Angiography: Cerebral angiography, selective coronary angiography, left ventriculography, aortography, angiocadiography, selective visceral arteriography, peripheral arteriography, digital subtraction angiography, venography, urography
Other diagnostic procedures: Contrast enhancement in CT scanning, arthrography, fistulography.
Therapeutic classView
Contrast medium for diagnostic procedures
PharmacologyView
Iopamidol, an organic Iodine compound and used as a non-ionic water soluble radiographic contrast medium. Iopamidol blocks X-rays as they pass through the body, thereby allowing body structures not containing Iodine to be visualized. The degree of opacity produced by Iopamidol is directly proportional to the total amount of the iodinated contrast agent in the path of the X-rays. The visualization of body structures is dependent upon the distribution and elimination of Iopamidol.
DosageView
Adult dosage:
Selective coronary arteriography: Iopamidol 370, 4-8 ml/artery
Peripheral arteriography: Iopamidol 370, 20-50 ml
Venography: Iopamidol 370, 24-60 ml
Angiocardiography: Iopamidol 370, 30-80 ml
Left ventriculography: Iopamidol 370, 30-80 ml
Percutaneous transfemoral or renal arteriography: Iopamidol 370, 30 ml
Selective renal arteriography: Iopamidol 370, 5-10 ml
Hepatic angiography: Iopamidol 370, 70 ml
Coeliac angiography: Iopamidol 370, 40-70 ml
Superior mesenteric angiography: Iopamidol 370, 25-50 ml
Inferior mesenteric angiography: Iopamidol 370, 5-30 ml
Digital subtraction angiography: 30-50 ml (10-20 ml/sec) of Iopamidol 370, IV 25 ml (left ventricle), 2-5 ml (coronary arteries) ,15 ml/sec. of Iopamidol 370 i.a for cardiac imaging
- Neurology: Lumber myelography: Iopamidol 370, 6-13 ml,
- Thoraco-cervical myelography: Iopamidol 370, 6-13 ml.
- Urography: Iopamidol 370, 40-80 ml IV up to 1.5 ml/kg in severe renal disease.
- Usual Dose: 1-2.5 ml/kg
- Other Diagnostic Procedure: Contrast enhancement in CT scanning: Iopamidol 370, 0.5-2.0 ml/kg
Selective coronary arteriography: Iopamidol 370, 4-8 ml/artery
Peripheral arteriography: Iopamidol 370, 20-50 ml
Venography: Iopamidol 370, 24-60 ml
Angiocardiography: Iopamidol 370, 30-80 ml
Left ventriculography: Iopamidol 370, 30-80 ml
Percutaneous transfemoral or renal arteriography: Iopamidol 370, 30 ml
Selective renal arteriography: Iopamidol 370, 5-10 ml
Hepatic angiography: Iopamidol 370, 70 ml
Coeliac angiography: Iopamidol 370, 40-70 ml
Superior mesenteric angiography: Iopamidol 370, 25-50 ml
Inferior mesenteric angiography: Iopamidol 370, 5-30 ml
Digital subtraction angiography: 30-50 ml (10-20 ml/sec) of Iopamidol 370, IV 25 ml (left ventricle), 2-5 ml (coronary arteries) ,15 ml/sec. of Iopamidol 370 i.a for cardiac imaging
AdministrationView
NEURORADIOLOGY-
Lumber myelography: A slow sub-arachnoid injection is made through a fine lumber puncture needle into one of the lower interspinous spaces (L3-L4 or L4-L5). Optimum contrast appears immediately after injections and films should be obtained promptly.
Thoraco-cervical myelography: Following a slow sub-arachnoid injection the patient should be turned on his/her side and tilted 10o-20o head down under fluoroscopic control. In this manner it is possible to control movement of the contrast medium column into the dorsal region.
If the cervical region is to be examined, the contrast medium should be run into the cervical region first, before the examination of the dorsal areas where it is progressively diluted. Iopamidol 300/370 may also be injected sub-occipitally or by lateral puncture technique .Care should be taken to ensure that the contrast medium does not move intracranially. It is generally recommended that in intrathecal use the patient should remain with a raised bed head and be kept well hydrated; following hydration it is preferable that the patient be allowed to be ambulatory .
ANGIOGRAPHY-
Cerebral angiography: Any current technique is suitable for radiological visualization of the cerebral vasculature with Iopamidol 370/300 injection. Carotid and vertebral angiography, performed by catheterization or percutaneous injection techniques, require rapid injection which, if necessary, may be repeated.
Peripheral arteriography and venography: Percutaneous injection into the appropriate blood vessel is used for visualization of peripheral arteries and veins.
Angiocardiography, left ventriculography, selective coronary arteriography: Iopamidol 370/300 injection may be administered by rapid injection through a catheter into a suitable peripheral artery or vein. It can also be introduced under pressure through a cardiac catheter in to any of the heart chambers, or injected into large vessel for immediate visualization. The contrast medium may also be administered during selective catheterization of the coronary arteries.
Aortography: The contrast medium may be introduced directly or by intra-arterial injection for visualization of the aorta and its main branches.
Selective visceral angiography: Visualization can be achieved by selective catheterization and injection into the hepatic, coeliac or mesenteric arteries.
Digital subtraction angiography: For cardiac imaging the contrast medium may be administered intra-arterially by selective catheterization to provide substrated images. Iopamidol 370/300 injected intravenously either centrally or peripherally is also recommended for use this modality.
UROGRAPHY-
The contrast medium injected intravenously and rapidly eliminated through the kidneys. In patients with severe renal failure, high dose urography should be used.
OTHER DIAGNOSTIC PROCEDURES-
Arthrography: Visualization of joint cavities and articular surfaces can be achieved either single or double contrast examination.
Contrast enhancement in CT scanning: Contrast enhancement for brain scans can be achieved between one and three minutes after i.v. injection. Iopamidol 370/300 are also be used for total body scanning examinations after i.v.administration as a bolus, as a drip infusion or by combination of the two methods.
Lumber myelography: A slow sub-arachnoid injection is made through a fine lumber puncture needle into one of the lower interspinous spaces (L3-L4 or L4-L5). Optimum contrast appears immediately after injections and films should be obtained promptly.
Thoraco-cervical myelography: Following a slow sub-arachnoid injection the patient should be turned on his/her side and tilted 10o-20o head down under fluoroscopic control. In this manner it is possible to control movement of the contrast medium column into the dorsal region.
If the cervical region is to be examined, the contrast medium should be run into the cervical region first, before the examination of the dorsal areas where it is progressively diluted. Iopamidol 300/370 may also be injected sub-occipitally or by lateral puncture technique .Care should be taken to ensure that the contrast medium does not move intracranially. It is generally recommended that in intrathecal use the patient should remain with a raised bed head and be kept well hydrated; following hydration it is preferable that the patient be allowed to be ambulatory .
ANGIOGRAPHY-
Cerebral angiography: Any current technique is suitable for radiological visualization of the cerebral vasculature with Iopamidol 370/300 injection. Carotid and vertebral angiography, performed by catheterization or percutaneous injection techniques, require rapid injection which, if necessary, may be repeated.
Peripheral arteriography and venography: Percutaneous injection into the appropriate blood vessel is used for visualization of peripheral arteries and veins.
Angiocardiography, left ventriculography, selective coronary arteriography: Iopamidol 370/300 injection may be administered by rapid injection through a catheter into a suitable peripheral artery or vein. It can also be introduced under pressure through a cardiac catheter in to any of the heart chambers, or injected into large vessel for immediate visualization. The contrast medium may also be administered during selective catheterization of the coronary arteries.
Aortography: The contrast medium may be introduced directly or by intra-arterial injection for visualization of the aorta and its main branches.
Selective visceral angiography: Visualization can be achieved by selective catheterization and injection into the hepatic, coeliac or mesenteric arteries.
Digital subtraction angiography: For cardiac imaging the contrast medium may be administered intra-arterially by selective catheterization to provide substrated images. Iopamidol 370/300 injected intravenously either centrally or peripherally is also recommended for use this modality.
UROGRAPHY-
The contrast medium injected intravenously and rapidly eliminated through the kidneys. In patients with severe renal failure, high dose urography should be used.
OTHER DIAGNOSTIC PROCEDURES-
Arthrography: Visualization of joint cavities and articular surfaces can be achieved either single or double contrast examination.
Contrast enhancement in CT scanning: Contrast enhancement for brain scans can be achieved between one and three minutes after i.v. injection. Iopamidol 370/300 are also be used for total body scanning examinations after i.v.administration as a bolus, as a drip infusion or by combination of the two methods.
Side effectsView
Common side effects are arrhythmias, arterial spasm, flushing, vasodilatation, angina, cardiopulmonary arrest; dizziness, confusion, paraesthesia, visual disturbances, seizure, paralysis, coma, temporary amnesia; inj site pain, pallor, periorbital and facial oedema; coughing, sneezing, rhinitis, asthma, apnoea, laryngeal oedema, chest tightness; watery itchy eyes, lachrymation, conjunctivitis; muscle spasm, involuntary leg movement; tremors, malaise; severe retching and choking, abdominal pain; urogenital pain, haematuria.
ContraindicationsView
There are no definite or absolute contraindications to the use of Amidol, with the possible exception of waldenstrom's macroglobulinemia, multiple myeloma and severe liver and kidney disease.
PrecautionsView
May inhibit blood coagulation. Multiple myeloma or other paraproteinaemia. Sickle-cell disease. Known or suspected phaeochromocytoma (monitor closely). Hyperthyroidism. Ensure adequate hydration. History of a previous sensitivity to a contrast medium, sensitivity to iodine, bronchial asthma, hay fever and food allergy. Monitor patients with CHF. Avoid angiography in patients with homocystinuria. Severe arterial or venous disease. Severe renal impairment, combined renal and hepatic disease or anuria, especially when large doses are used. Pregnancy and lactation.
InteractionsView
Iopamidol may interfere with thyroid function. Biguanide compete for excretion in the kidneys with contrast media and this could lead to reduction in kidney function. Patient taking Metformin or other Biguanides should therefore not take any doses of Metformin for 48 hours before or 48 hours after the X-ray examination.
Pregnancy & lactationView
Iopamidol injection should be administered in pregnancy only if the procedure is considered essential by the physician.
Overdose effectsView
Treatments of an overdose is directed toward the support of all vital functions and prompt institution of symptomatic therapy.
StorageView
Store at 20-25° C
Diapiotab
Pioglitazone
Diapiotab
Pioglitazone
Indications
Type 2 DM
Indication detailsView
Pioglitazone is indicated as an adjunct to diet and exercise to improve glycaemic control in patients with type II diabetes (NIDDM). Pioglitazone is indicated for monotherapy and also indicated for use in combination with sulphonylurea, Metformin or Insulin when diet and exercise plus the single agent does not result in adequate glycaemic control.
Therapeutic classView
Thiazolidinedione Group
PharmacologyView
Pioglitazone is a preparation of Pioglitazone which is a member of the newest class of oral antidiabetic agent called thiazolidinediones. It depends on the presence of Insulin for its mechanism of action. Pioglitazone decreases Insulin resistance in the periphery and in the liver, resulting in increased Insulin dependent glucose disposal and decreased hepatic glucose output. It also improves abnormality in lipid metabolism by activating peroxisome proliferator activated receptor gamma (PPAR-γ).
DosageView
Pioglitazone can be taken once daily without regard to meals. The management of antidiabetic therapy should be individualized. Pioglitazone monotherapy may be initiated at 15 mg or 30 mg once daily dosages in patients not adequately controlled with diet and exercise alone. For patients who respond inadequately to the initial dose of Pioglitazone, the dose can be increased up to 45 mg once daily. For patients not responding adequately to monotherapy, combination therapy should be considered.
Maximum recommended daily dose of Pioglitazone should not exceed 45 mg since doses higher than 45 mg have not been studied in placebo controlled clinical studies. Besides, no placebo controlled clinical studies of more than 30 mg once daily have been conducted in combination therapy.
Maximum recommended daily dose of Pioglitazone should not exceed 45 mg since doses higher than 45 mg have not been studied in placebo controlled clinical studies. Besides, no placebo controlled clinical studies of more than 30 mg once daily have been conducted in combination therapy.
Side effectsView
The overall incidence and types of adverse events reported in placebo controlled clinical trials of Pioglitazone monotherapy at doses of 7.5 mg, 15 mg, 30 mg or 45 mg once daily are upper respiratory tract infection (13.2%), headache (9.1%), sinusitis (6.3%), myalgia (5.4%), tooth disorder (5.3%), and pharyngitis (5.1%).
ContraindicationsView
Pioglitazone is contraindicated in patients with known hypersensitivity to any of its components.
PrecautionsView
Pioglitazone exerts its antihyperglycaemic effect only in the presence of Insulin. Therefore, it should not be used in Type 1 diabetes or for the treatment of diabetic ketoacidosis. Pioglitazone should be used with caution in case of combination antidiabetic therapy and hepatic insufficiency. Liver enzyme should be monitored regularly.
InteractionsView
Administration of thiazolidinediones with an oral contraceptive containing ethinyl oestradiol and norethindrone reduces the plasma concentration of both hormones by approximately 30% which could result in loss of contraception.
Pregnancy & lactationView
Pregnancy: There are no adequate and well controlled studies in pregnant women. Pioglitazone should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Lactation: It is not known whether Pioglitazone is secreted in human milk. As many drugs are excreted in human milk, it should not be administered to a lactating women.
Lactation: It is not known whether Pioglitazone is secreted in human milk. As many drugs are excreted in human milk, it should not be administered to a lactating women.
StorageView
Store at 25° C.
Diapiotab
Pioglitazone
Diapiotab
Pioglitazone
Indications
Type 2 DM
Indication detailsView
Pioglitazone is indicated as an adjunct to diet and exercise to improve glycaemic control in patients with type II diabetes (NIDDM). Pioglitazone is indicated for monotherapy and also indicated for use in combination with sulphonylurea, Metformin or Insulin when diet and exercise plus the single agent does not result in adequate glycaemic control.
Therapeutic classView
Thiazolidinedione Group
PharmacologyView
Pioglitazone is a preparation of Pioglitazone which is a member of the newest class of oral antidiabetic agent called thiazolidinediones. It depends on the presence of Insulin for its mechanism of action. Pioglitazone decreases Insulin resistance in the periphery and in the liver, resulting in increased Insulin dependent glucose disposal and decreased hepatic glucose output. It also improves abnormality in lipid metabolism by activating peroxisome proliferator activated receptor gamma (PPAR-γ).
DosageView
Pioglitazone can be taken once daily without regard to meals. The management of antidiabetic therapy should be individualized. Pioglitazone monotherapy may be initiated at 15 mg or 30 mg once daily dosages in patients not adequately controlled with diet and exercise alone. For patients who respond inadequately to the initial dose of Pioglitazone, the dose can be increased up to 45 mg once daily. For patients not responding adequately to monotherapy, combination therapy should be considered.
Maximum recommended daily dose of Pioglitazone should not exceed 45 mg since doses higher than 45 mg have not been studied in placebo controlled clinical studies. Besides, no placebo controlled clinical studies of more than 30 mg once daily have been conducted in combination therapy.
Maximum recommended daily dose of Pioglitazone should not exceed 45 mg since doses higher than 45 mg have not been studied in placebo controlled clinical studies. Besides, no placebo controlled clinical studies of more than 30 mg once daily have been conducted in combination therapy.
Side effectsView
The overall incidence and types of adverse events reported in placebo controlled clinical trials of Pioglitazone monotherapy at doses of 7.5 mg, 15 mg, 30 mg or 45 mg once daily are upper respiratory tract infection (13.2%), headache (9.1%), sinusitis (6.3%), myalgia (5.4%), tooth disorder (5.3%), and pharyngitis (5.1%).
ContraindicationsView
Pioglitazone is contraindicated in patients with known hypersensitivity to any of its components.
PrecautionsView
Pioglitazone exerts its antihyperglycaemic effect only in the presence of Insulin. Therefore, it should not be used in Type 1 diabetes or for the treatment of diabetic ketoacidosis. Pioglitazone should be used with caution in case of combination antidiabetic therapy and hepatic insufficiency. Liver enzyme should be monitored regularly.
InteractionsView
Administration of thiazolidinediones with an oral contraceptive containing ethinyl oestradiol and norethindrone reduces the plasma concentration of both hormones by approximately 30% which could result in loss of contraception.
Pregnancy & lactationView
Pregnancy: There are no adequate and well controlled studies in pregnant women. Pioglitazone should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Lactation: It is not known whether Pioglitazone is secreted in human milk. As many drugs are excreted in human milk, it should not be administered to a lactating women.
Lactation: It is not known whether Pioglitazone is secreted in human milk. As many drugs are excreted in human milk, it should not be administered to a lactating women.
StorageView
Store at 25° C.
Diapizi
Glipizide
Diapizi
Glipizide
Indications
Type 2 DM
Indication detailsView
Glipizide is indicated as an adjunct to diet for the control of hyperglycaemia and its associated symptomatology in the treatment of non-insulin-dependent diabetes mellitus (NIDDM type II) when diet modification has not been proved effective on its own. In certain patients who are receiving insulin, the concurrent use of Glipizide would allow a reduction in the daily dose of insulin.
Use of Glipizide must be viewed by both the physician and patient as a treatment in addition to diet and not as a substitute for diet or as a convenient mechanism for avoiding dietary restraint. Furthermore, short term administration may be required if diet control alone results in transient control of blood glucose level.
During maintenance, if satisfactory lowering of blood glucose is no longer achieved, use of Glipizide should be discontinued.
Use of Glipizide must be viewed by both the physician and patient as a treatment in addition to diet and not as a substitute for diet or as a convenient mechanism for avoiding dietary restraint. Furthermore, short term administration may be required if diet control alone results in transient control of blood glucose level.
During maintenance, if satisfactory lowering of blood glucose is no longer achieved, use of Glipizide should be discontinued.
Therapeutic classView
Sulfonylureas
PharmacologyView
Glipizide lowers blood glucose by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells. The extrapancreatic effects of Glipizide are increase in insulin sensitivity and decrease in hepatic glucose production.
DosageView
Like any other oral hypoglycaemic agent, dosage of Glipizide is not fixed and may be adjusted through periodic monitoring of blood glucose level. Short term administration of Glipizide may be sufficient during periods of transient loss of control of blood glucose in patients, usually controlled well on diet.
In general, Glipizide should be given approximately 30 minutes before a meal to achieve the maximum reduction in postprandial hyperglycaemia.
Patients receiving insulin: Many stable non-insulin-dependent diabetic patients receiving Insulin may be safely placed on Glipizide if the physician decides to do so.
Patients receiving other oral hypoglycaemic agents: As with other sulphonylurea, no transition period is necessary while transferring patients to Glipizide. Patients should be observed carefully for any possible hypoglycaemic effect due to overlapping of drug effects.
Pediatric Use: Safety and effectiveness in children have not been established.
In general, Glipizide should be given approximately 30 minutes before a meal to achieve the maximum reduction in postprandial hyperglycaemia.
- Initial dose: The recommended starting dose is 5 mg, given before breakfast. Geriatric patients or those with liver disease may be started on 2.5 mg.
- Dosage adjustments: Dosage adjustment may be done at intervals of several days by an increment of 2.5-5 mg, as determined by blood glucose response. If response to a single dose is not satisfactory, dividing that dose might prove effective. The maximum recommended once daily dose is 15 mg. Doses above 15 mg should ordinarily be divided and given before meals of adequate calorie content. The maximum recommended total daily dose is 40 mg.
- Maintenance: Some patients may be effectively controlled on a once daily regimen, while others show better response with divided dosing. Total daily dose above 30 mg have been safely given on bid basis to long term patients. Patients can usually be stabilized on a dosage ranging from 2.5 to 30 mg daily.
Patients receiving insulin: Many stable non-insulin-dependent diabetic patients receiving Insulin may be safely placed on Glipizide if the physician decides to do so.
Patients receiving other oral hypoglycaemic agents: As with other sulphonylurea, no transition period is necessary while transferring patients to Glipizide. Patients should be observed carefully for any possible hypoglycaemic effect due to overlapping of drug effects.
Pediatric Use: Safety and effectiveness in children have not been established.
Side effectsView
The majority of side effects have been dose related, transient, and responded to dose reduction or withdrawal of the medication.
Gastrointestinal: Gastrointestinal complaints were reported with the following approximate incidences like nausea, diarrhoea, constipation and gastralgia. They appear to be dose related and usually disappear on division or reduction of dosage. Cholestatic jaundice may occur rarely with these kind of drugs and Glipizide should be discontinued if this occurs.
Dermatological: Allergic skin reactions including erythema, morbilliform or maculopapular eruption, urticaria, pruritus and eczema have been reported. They frequently disappear with continued therapy. However, if they persist, the drug should be discontinued.
Haematologic: Leucopenia, agranulocytosis, thrombocytopenia, haemolytic anaemia, aplastic anaemia and pancytopenia have been reported with sulphonylureas.
Metabolic: Hepatic porphyria and disulphiram like reactions have been reported with sulphonylurea.
Endocrine reactions: Cases of hyponatraemia and the syndrome of inappropriate antidiuretic hormone (SIADH) secretion have been reported with this and other sulphonylureas.
Miscellaneous: Dizziness, drowsiness and headache have been reported in patients treated with Glipizide. They are usually transient and seldom require discontinuation of therapy.
Gastrointestinal: Gastrointestinal complaints were reported with the following approximate incidences like nausea, diarrhoea, constipation and gastralgia. They appear to be dose related and usually disappear on division or reduction of dosage. Cholestatic jaundice may occur rarely with these kind of drugs and Glipizide should be discontinued if this occurs.
Dermatological: Allergic skin reactions including erythema, morbilliform or maculopapular eruption, urticaria, pruritus and eczema have been reported. They frequently disappear with continued therapy. However, if they persist, the drug should be discontinued.
Haematologic: Leucopenia, agranulocytosis, thrombocytopenia, haemolytic anaemia, aplastic anaemia and pancytopenia have been reported with sulphonylureas.
Metabolic: Hepatic porphyria and disulphiram like reactions have been reported with sulphonylurea.
Endocrine reactions: Cases of hyponatraemia and the syndrome of inappropriate antidiuretic hormone (SIADH) secretion have been reported with this and other sulphonylureas.
Miscellaneous: Dizziness, drowsiness and headache have been reported in patients treated with Glipizide. They are usually transient and seldom require discontinuation of therapy.
ContraindicationsView
Glipizide is contraindicated in the following conditions :
- Patients who are hypersensitive to Glipizide or any component of the product
- Juvenile onset diabetes
- Severe or unstable ‘brittle’ diabetes
- Diabetes complicated by ketosis and acidosis, major surgery, severe sepsis or severe trauma
- Severe renal, hepatic or thyroid impairment, co-existent renal and hepatic disease
PrecautionsView
Hypoglycaemia: All sulphonylurea drugs are capable of producing severe hypoglycaemia. Proper patient selection, dosage and instructions are important to avoid hypoglycaemic episodes. Renal or hepatic insufficiency may cause elevated blood levels of Glipizide and the latter may also diminis gluconeogenic capacity, both of which increase the risk of serious hypoglycaemic reactions. Elderly, debilitated or malnourished patients and those with adrenal or pituitary insufficiency are particularly susceptible to the hypoglycaemic actions of glucose lowering drugs. Patients should be instructed to take their meals regularly and not to exercise excessively without additional calorie intake.
Renal and hepatic disease: The metabolism and excretion of Glipizide may be slowed in patients with impaired renal and/or hepatic function. These patients may suffer from prolonged hypoglycaemia and appropriate measures should be instituted.
Loss of control on blood glucose: When a patient stabilized on any antidiabetic regimen is exposed to stress such as fever, trauma, infection or surgery, a loss of control on blood glucose may occur. At that time it may be necessary to discontinue Glipizide and administer Insulin.
The effectiveness of any oral hypoglycaemic drug including Glipizide, in lowering blood glucose to a desired level, decreases in many patients over a period of time, which may be due to secondary failure, i.e., progression of the severity of the diabetes or diminished responsiveness to the drug.
Renal and hepatic disease: The metabolism and excretion of Glipizide may be slowed in patients with impaired renal and/or hepatic function. These patients may suffer from prolonged hypoglycaemia and appropriate measures should be instituted.
Loss of control on blood glucose: When a patient stabilized on any antidiabetic regimen is exposed to stress such as fever, trauma, infection or surgery, a loss of control on blood glucose may occur. At that time it may be necessary to discontinue Glipizide and administer Insulin.
The effectiveness of any oral hypoglycaemic drug including Glipizide, in lowering blood glucose to a desired level, decreases in many patients over a period of time, which may be due to secondary failure, i.e., progression of the severity of the diabetes or diminished responsiveness to the drug.
InteractionsView
The hypoglycaemic action of sulphonylurea may be potentiated by certain drugs including non-steroidal anti inflammatory agents and other drugs that are highly protein bound e.g., Salicylates, Sulphonamides, Chloramphenicol, Probenecid, Coumarins, Monoamine Oxidase Inhibitors, and β adrenergic blocking agents. When such drugs are administered to a patient receiving Glipizide, the patients should be observed closely for hypoglycaemia. When such drugs are withdrawn from a patient receiving Glipizide, the patient should be observed closely for loss of control on blood glucose.
Certain drugs tend to produce hyperglycaemia and may lead to loss of control on blood glucose. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, oestrogens, oral contraceptives, Phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs and Isoniazid. When such drugs are administered to or withdrawn from a patient receiving Glipizide, the patient should be closely observed for loss of control on blood glucose. Diabetic control may be altered also in patients treated with cyclophosphamide.
Certain drugs tend to produce hyperglycaemia and may lead to loss of control on blood glucose. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, oestrogens, oral contraceptives, Phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs and Isoniazid. When such drugs are administered to or withdrawn from a patient receiving Glipizide, the patient should be closely observed for loss of control on blood glucose. Diabetic control may be altered also in patients treated with cyclophosphamide.
Pregnancy & lactationView
Pregnancy: Glipizide should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. Prolonged severe hypoglycaemia (4-10 days) has been reported in neonates born to mothers who were receiving sulphonylurea (e.g., Glipizide) at the time of delivery. So, if Glipizide is used during pregnancy, it should be discontinued at least one month before the expected delivery date.
Lactation: Although it is not known whether Glipizide is excreted in human milk, some sulphonylurea drugs are known to be so. Breast feeding is not therefore recommended while taking this medication.
Lactation: Although it is not known whether Glipizide is excreted in human milk, some sulphonylurea drugs are known to be so. Breast feeding is not therefore recommended while taking this medication.
StorageView
The tablets should be protected from moisture and humidity and stored at room temperature (below 30° C).
Diapizi
Glipizide
Diapizi
Glipizide
Indications
Type 2 DM
Indication detailsView
Glipizide is indicated as an adjunct to diet for the control of hyperglycaemia and its associated symptomatology in the treatment of non-insulin-dependent diabetes mellitus (NIDDM type II) when diet modification has not been proved effective on its own. In certain patients who are receiving insulin, the concurrent use of Glipizide would allow a reduction in the daily dose of insulin.
Use of Glipizide must be viewed by both the physician and patient as a treatment in addition to diet and not as a substitute for diet or as a convenient mechanism for avoiding dietary restraint. Furthermore, short term administration may be required if diet control alone results in transient control of blood glucose level.
During maintenance, if satisfactory lowering of blood glucose is no longer achieved, use of Glipizide should be discontinued.
Use of Glipizide must be viewed by both the physician and patient as a treatment in addition to diet and not as a substitute for diet or as a convenient mechanism for avoiding dietary restraint. Furthermore, short term administration may be required if diet control alone results in transient control of blood glucose level.
During maintenance, if satisfactory lowering of blood glucose is no longer achieved, use of Glipizide should be discontinued.
Therapeutic classView
Sulfonylureas
PharmacologyView
Glipizide lowers blood glucose by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells. The extrapancreatic effects of Glipizide are increase in insulin sensitivity and decrease in hepatic glucose production.
DosageView
Like any other oral hypoglycaemic agent, dosage of Glipizide is not fixed and may be adjusted through periodic monitoring of blood glucose level. Short term administration of Glipizide may be sufficient during periods of transient loss of control of blood glucose in patients, usually controlled well on diet.
In general, Glipizide should be given approximately 30 minutes before a meal to achieve the maximum reduction in postprandial hyperglycaemia.
Patients receiving insulin: Many stable non-insulin-dependent diabetic patients receiving Insulin may be safely placed on Glipizide if the physician decides to do so.
Patients receiving other oral hypoglycaemic agents: As with other sulphonylurea, no transition period is necessary while transferring patients to Glipizide. Patients should be observed carefully for any possible hypoglycaemic effect due to overlapping of drug effects.
Pediatric Use: Safety and effectiveness in children have not been established.
In general, Glipizide should be given approximately 30 minutes before a meal to achieve the maximum reduction in postprandial hyperglycaemia.
- Initial dose: The recommended starting dose is 5 mg, given before breakfast. Geriatric patients or those with liver disease may be started on 2.5 mg.
- Dosage adjustments: Dosage adjustment may be done at intervals of several days by an increment of 2.5-5 mg, as determined by blood glucose response. If response to a single dose is not satisfactory, dividing that dose might prove effective. The maximum recommended once daily dose is 15 mg. Doses above 15 mg should ordinarily be divided and given before meals of adequate calorie content. The maximum recommended total daily dose is 40 mg.
- Maintenance: Some patients may be effectively controlled on a once daily regimen, while others show better response with divided dosing. Total daily dose above 30 mg have been safely given on bid basis to long term patients. Patients can usually be stabilized on a dosage ranging from 2.5 to 30 mg daily.
Patients receiving insulin: Many stable non-insulin-dependent diabetic patients receiving Insulin may be safely placed on Glipizide if the physician decides to do so.
Patients receiving other oral hypoglycaemic agents: As with other sulphonylurea, no transition period is necessary while transferring patients to Glipizide. Patients should be observed carefully for any possible hypoglycaemic effect due to overlapping of drug effects.
Pediatric Use: Safety and effectiveness in children have not been established.
Side effectsView
The majority of side effects have been dose related, transient, and responded to dose reduction or withdrawal of the medication.
Gastrointestinal: Gastrointestinal complaints were reported with the following approximate incidences like nausea, diarrhoea, constipation and gastralgia. They appear to be dose related and usually disappear on division or reduction of dosage. Cholestatic jaundice may occur rarely with these kind of drugs and Glipizide should be discontinued if this occurs.
Dermatological: Allergic skin reactions including erythema, morbilliform or maculopapular eruption, urticaria, pruritus and eczema have been reported. They frequently disappear with continued therapy. However, if they persist, the drug should be discontinued.
Haematologic: Leucopenia, agranulocytosis, thrombocytopenia, haemolytic anaemia, aplastic anaemia and pancytopenia have been reported with sulphonylureas.
Metabolic: Hepatic porphyria and disulphiram like reactions have been reported with sulphonylurea.
Endocrine reactions: Cases of hyponatraemia and the syndrome of inappropriate antidiuretic hormone (SIADH) secretion have been reported with this and other sulphonylureas.
Miscellaneous: Dizziness, drowsiness and headache have been reported in patients treated with Glipizide. They are usually transient and seldom require discontinuation of therapy.
Gastrointestinal: Gastrointestinal complaints were reported with the following approximate incidences like nausea, diarrhoea, constipation and gastralgia. They appear to be dose related and usually disappear on division or reduction of dosage. Cholestatic jaundice may occur rarely with these kind of drugs and Glipizide should be discontinued if this occurs.
Dermatological: Allergic skin reactions including erythema, morbilliform or maculopapular eruption, urticaria, pruritus and eczema have been reported. They frequently disappear with continued therapy. However, if they persist, the drug should be discontinued.
Haematologic: Leucopenia, agranulocytosis, thrombocytopenia, haemolytic anaemia, aplastic anaemia and pancytopenia have been reported with sulphonylureas.
Metabolic: Hepatic porphyria and disulphiram like reactions have been reported with sulphonylurea.
Endocrine reactions: Cases of hyponatraemia and the syndrome of inappropriate antidiuretic hormone (SIADH) secretion have been reported with this and other sulphonylureas.
Miscellaneous: Dizziness, drowsiness and headache have been reported in patients treated with Glipizide. They are usually transient and seldom require discontinuation of therapy.
ContraindicationsView
Glipizide is contraindicated in the following conditions :
- Patients who are hypersensitive to Glipizide or any component of the product
- Juvenile onset diabetes
- Severe or unstable ‘brittle’ diabetes
- Diabetes complicated by ketosis and acidosis, major surgery, severe sepsis or severe trauma
- Severe renal, hepatic or thyroid impairment, co-existent renal and hepatic disease
PrecautionsView
Hypoglycaemia: All sulphonylurea drugs are capable of producing severe hypoglycaemia. Proper patient selection, dosage and instructions are important to avoid hypoglycaemic episodes. Renal or hepatic insufficiency may cause elevated blood levels of Glipizide and the latter may also diminis gluconeogenic capacity, both of which increase the risk of serious hypoglycaemic reactions. Elderly, debilitated or malnourished patients and those with adrenal or pituitary insufficiency are particularly susceptible to the hypoglycaemic actions of glucose lowering drugs. Patients should be instructed to take their meals regularly and not to exercise excessively without additional calorie intake.
Renal and hepatic disease: The metabolism and excretion of Glipizide may be slowed in patients with impaired renal and/or hepatic function. These patients may suffer from prolonged hypoglycaemia and appropriate measures should be instituted.
Loss of control on blood glucose: When a patient stabilized on any antidiabetic regimen is exposed to stress such as fever, trauma, infection or surgery, a loss of control on blood glucose may occur. At that time it may be necessary to discontinue Glipizide and administer Insulin.
The effectiveness of any oral hypoglycaemic drug including Glipizide, in lowering blood glucose to a desired level, decreases in many patients over a period of time, which may be due to secondary failure, i.e., progression of the severity of the diabetes or diminished responsiveness to the drug.
Renal and hepatic disease: The metabolism and excretion of Glipizide may be slowed in patients with impaired renal and/or hepatic function. These patients may suffer from prolonged hypoglycaemia and appropriate measures should be instituted.
Loss of control on blood glucose: When a patient stabilized on any antidiabetic regimen is exposed to stress such as fever, trauma, infection or surgery, a loss of control on blood glucose may occur. At that time it may be necessary to discontinue Glipizide and administer Insulin.
The effectiveness of any oral hypoglycaemic drug including Glipizide, in lowering blood glucose to a desired level, decreases in many patients over a period of time, which may be due to secondary failure, i.e., progression of the severity of the diabetes or diminished responsiveness to the drug.
InteractionsView
The hypoglycaemic action of sulphonylurea may be potentiated by certain drugs including non-steroidal anti inflammatory agents and other drugs that are highly protein bound e.g., Salicylates, Sulphonamides, Chloramphenicol, Probenecid, Coumarins, Monoamine Oxidase Inhibitors, and β adrenergic blocking agents. When such drugs are administered to a patient receiving Glipizide, the patients should be observed closely for hypoglycaemia. When such drugs are withdrawn from a patient receiving Glipizide, the patient should be observed closely for loss of control on blood glucose.
Certain drugs tend to produce hyperglycaemia and may lead to loss of control on blood glucose. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, oestrogens, oral contraceptives, Phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs and Isoniazid. When such drugs are administered to or withdrawn from a patient receiving Glipizide, the patient should be closely observed for loss of control on blood glucose. Diabetic control may be altered also in patients treated with cyclophosphamide.
Certain drugs tend to produce hyperglycaemia and may lead to loss of control on blood glucose. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, oestrogens, oral contraceptives, Phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs and Isoniazid. When such drugs are administered to or withdrawn from a patient receiving Glipizide, the patient should be closely observed for loss of control on blood glucose. Diabetic control may be altered also in patients treated with cyclophosphamide.
Pregnancy & lactationView
Pregnancy: Glipizide should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. Prolonged severe hypoglycaemia (4-10 days) has been reported in neonates born to mothers who were receiving sulphonylurea (e.g., Glipizide) at the time of delivery. So, if Glipizide is used during pregnancy, it should be discontinued at least one month before the expected delivery date.
Lactation: Although it is not known whether Glipizide is excreted in human milk, some sulphonylurea drugs are known to be so. Breast feeding is not therefore recommended while taking this medication.
Lactation: Although it is not known whether Glipizide is excreted in human milk, some sulphonylurea drugs are known to be so. Breast feeding is not therefore recommended while taking this medication.
StorageView
The tablets should be protected from moisture and humidity and stored at room temperature (below 30° C).
Diaplus
Glipizide
Diaplus
Glipizide
Indications
Type 2 DM
Indication detailsView
Glipizide is indicated as an adjunct to diet for the control of hyperglycaemia and its associated symptomatology in the treatment of non-insulin-dependent diabetes mellitus (NIDDM type II) when diet modification has not been proved effective on its own. In certain patients who are receiving insulin, the concurrent use of Glipizide would allow a reduction in the daily dose of insulin.
Use of Glipizide must be viewed by both the physician and patient as a treatment in addition to diet and not as a substitute for diet or as a convenient mechanism for avoiding dietary restraint. Furthermore, short term administration may be required if diet control alone results in transient control of blood glucose level.
During maintenance, if satisfactory lowering of blood glucose is no longer achieved, use of Glipizide should be discontinued.
Use of Glipizide must be viewed by both the physician and patient as a treatment in addition to diet and not as a substitute for diet or as a convenient mechanism for avoiding dietary restraint. Furthermore, short term administration may be required if diet control alone results in transient control of blood glucose level.
During maintenance, if satisfactory lowering of blood glucose is no longer achieved, use of Glipizide should be discontinued.
Therapeutic classView
Sulfonylureas
PharmacologyView
Glipizide lowers blood glucose by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells. The extrapancreatic effects of Glipizide are increase in insulin sensitivity and decrease in hepatic glucose production.
DosageView
Like any other oral hypoglycaemic agent, dosage of Glipizide is not fixed and may be adjusted through periodic monitoring of blood glucose level. Short term administration of Glipizide may be sufficient during periods of transient loss of control of blood glucose in patients, usually controlled well on diet.
In general, Glipizide should be given approximately 30 minutes before a meal to achieve the maximum reduction in postprandial hyperglycaemia.
Patients receiving insulin: Many stable non-insulin-dependent diabetic patients receiving Insulin may be safely placed on Glipizide if the physician decides to do so.
Patients receiving other oral hypoglycaemic agents: As with other sulphonylurea, no transition period is necessary while transferring patients to Glipizide. Patients should be observed carefully for any possible hypoglycaemic effect due to overlapping of drug effects.
Pediatric Use: Safety and effectiveness in children have not been established.
In general, Glipizide should be given approximately 30 minutes before a meal to achieve the maximum reduction in postprandial hyperglycaemia.
- Initial dose: The recommended starting dose is 5 mg, given before breakfast. Geriatric patients or those with liver disease may be started on 2.5 mg.
- Dosage adjustments: Dosage adjustment may be done at intervals of several days by an increment of 2.5-5 mg, as determined by blood glucose response. If response to a single dose is not satisfactory, dividing that dose might prove effective. The maximum recommended once daily dose is 15 mg. Doses above 15 mg should ordinarily be divided and given before meals of adequate calorie content. The maximum recommended total daily dose is 40 mg.
- Maintenance: Some patients may be effectively controlled on a once daily regimen, while others show better response with divided dosing. Total daily dose above 30 mg have been safely given on bid basis to long term patients. Patients can usually be stabilized on a dosage ranging from 2.5 to 30 mg daily.
Patients receiving insulin: Many stable non-insulin-dependent diabetic patients receiving Insulin may be safely placed on Glipizide if the physician decides to do so.
Patients receiving other oral hypoglycaemic agents: As with other sulphonylurea, no transition period is necessary while transferring patients to Glipizide. Patients should be observed carefully for any possible hypoglycaemic effect due to overlapping of drug effects.
Pediatric Use: Safety and effectiveness in children have not been established.
Side effectsView
The majority of side effects have been dose related, transient, and responded to dose reduction or withdrawal of the medication.
Gastrointestinal: Gastrointestinal complaints were reported with the following approximate incidences like nausea, diarrhoea, constipation and gastralgia. They appear to be dose related and usually disappear on division or reduction of dosage. Cholestatic jaundice may occur rarely with these kind of drugs and Glipizide should be discontinued if this occurs.
Dermatological: Allergic skin reactions including erythema, morbilliform or maculopapular eruption, urticaria, pruritus and eczema have been reported. They frequently disappear with continued therapy. However, if they persist, the drug should be discontinued.
Haematologic: Leucopenia, agranulocytosis, thrombocytopenia, haemolytic anaemia, aplastic anaemia and pancytopenia have been reported with sulphonylureas.
Metabolic: Hepatic porphyria and disulphiram like reactions have been reported with sulphonylurea.
Endocrine reactions: Cases of hyponatraemia and the syndrome of inappropriate antidiuretic hormone (SIADH) secretion have been reported with this and other sulphonylureas.
Miscellaneous: Dizziness, drowsiness and headache have been reported in patients treated with Glipizide. They are usually transient and seldom require discontinuation of therapy.
Gastrointestinal: Gastrointestinal complaints were reported with the following approximate incidences like nausea, diarrhoea, constipation and gastralgia. They appear to be dose related and usually disappear on division or reduction of dosage. Cholestatic jaundice may occur rarely with these kind of drugs and Glipizide should be discontinued if this occurs.
Dermatological: Allergic skin reactions including erythema, morbilliform or maculopapular eruption, urticaria, pruritus and eczema have been reported. They frequently disappear with continued therapy. However, if they persist, the drug should be discontinued.
Haematologic: Leucopenia, agranulocytosis, thrombocytopenia, haemolytic anaemia, aplastic anaemia and pancytopenia have been reported with sulphonylureas.
Metabolic: Hepatic porphyria and disulphiram like reactions have been reported with sulphonylurea.
Endocrine reactions: Cases of hyponatraemia and the syndrome of inappropriate antidiuretic hormone (SIADH) secretion have been reported with this and other sulphonylureas.
Miscellaneous: Dizziness, drowsiness and headache have been reported in patients treated with Glipizide. They are usually transient and seldom require discontinuation of therapy.
ContraindicationsView
Glipizide is contraindicated in the following conditions :
- Patients who are hypersensitive to Glipizide or any component of the product
- Juvenile onset diabetes
- Severe or unstable ‘brittle’ diabetes
- Diabetes complicated by ketosis and acidosis, major surgery, severe sepsis or severe trauma
- Severe renal, hepatic or thyroid impairment, co-existent renal and hepatic disease
PrecautionsView
Hypoglycaemia: All sulphonylurea drugs are capable of producing severe hypoglycaemia. Proper patient selection, dosage and instructions are important to avoid hypoglycaemic episodes. Renal or hepatic insufficiency may cause elevated blood levels of Glipizide and the latter may also diminis gluconeogenic capacity, both of which increase the risk of serious hypoglycaemic reactions. Elderly, debilitated or malnourished patients and those with adrenal or pituitary insufficiency are particularly susceptible to the hypoglycaemic actions of glucose lowering drugs. Patients should be instructed to take their meals regularly and not to exercise excessively without additional calorie intake.
Renal and hepatic disease: The metabolism and excretion of Glipizide may be slowed in patients with impaired renal and/or hepatic function. These patients may suffer from prolonged hypoglycaemia and appropriate measures should be instituted.
Loss of control on blood glucose: When a patient stabilized on any antidiabetic regimen is exposed to stress such as fever, trauma, infection or surgery, a loss of control on blood glucose may occur. At that time it may be necessary to discontinue Glipizide and administer Insulin.
The effectiveness of any oral hypoglycaemic drug including Glipizide, in lowering blood glucose to a desired level, decreases in many patients over a period of time, which may be due to secondary failure, i.e., progression of the severity of the diabetes or diminished responsiveness to the drug.
Renal and hepatic disease: The metabolism and excretion of Glipizide may be slowed in patients with impaired renal and/or hepatic function. These patients may suffer from prolonged hypoglycaemia and appropriate measures should be instituted.
Loss of control on blood glucose: When a patient stabilized on any antidiabetic regimen is exposed to stress such as fever, trauma, infection or surgery, a loss of control on blood glucose may occur. At that time it may be necessary to discontinue Glipizide and administer Insulin.
The effectiveness of any oral hypoglycaemic drug including Glipizide, in lowering blood glucose to a desired level, decreases in many patients over a period of time, which may be due to secondary failure, i.e., progression of the severity of the diabetes or diminished responsiveness to the drug.
InteractionsView
The hypoglycaemic action of sulphonylurea may be potentiated by certain drugs including non-steroidal anti inflammatory agents and other drugs that are highly protein bound e.g., Salicylates, Sulphonamides, Chloramphenicol, Probenecid, Coumarins, Monoamine Oxidase Inhibitors, and β adrenergic blocking agents. When such drugs are administered to a patient receiving Glipizide, the patients should be observed closely for hypoglycaemia. When such drugs are withdrawn from a patient receiving Glipizide, the patient should be observed closely for loss of control on blood glucose.
Certain drugs tend to produce hyperglycaemia and may lead to loss of control on blood glucose. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, oestrogens, oral contraceptives, Phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs and Isoniazid. When such drugs are administered to or withdrawn from a patient receiving Glipizide, the patient should be closely observed for loss of control on blood glucose. Diabetic control may be altered also in patients treated with cyclophosphamide.
Certain drugs tend to produce hyperglycaemia and may lead to loss of control on blood glucose. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, oestrogens, oral contraceptives, Phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs and Isoniazid. When such drugs are administered to or withdrawn from a patient receiving Glipizide, the patient should be closely observed for loss of control on blood glucose. Diabetic control may be altered also in patients treated with cyclophosphamide.
Pregnancy & lactationView
Pregnancy: Glipizide should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. Prolonged severe hypoglycaemia (4-10 days) has been reported in neonates born to mothers who were receiving sulphonylurea (e.g., Glipizide) at the time of delivery. So, if Glipizide is used during pregnancy, it should be discontinued at least one month before the expected delivery date.
Lactation: Although it is not known whether Glipizide is excreted in human milk, some sulphonylurea drugs are known to be so. Breast feeding is not therefore recommended while taking this medication.
Lactation: Although it is not known whether Glipizide is excreted in human milk, some sulphonylurea drugs are known to be so. Breast feeding is not therefore recommended while taking this medication.
StorageView
The tablets should be protected from moisture and humidity and stored at room temperature (below 30° C).
Diaplus XR
Glipizide
Diaplus XR
Glipizide
Indications
Type 2 DM
Indication detailsView
Glipizide is indicated as an adjunct to diet for the control of hyperglycaemia and its associated symptomatology in the treatment of non-insulin-dependent diabetes mellitus (NIDDM type II) when diet modification has not been proved effective on its own. In certain patients who are receiving insulin, the concurrent use of Glipizide would allow a reduction in the daily dose of insulin.
Use of Glipizide must be viewed by both the physician and patient as a treatment in addition to diet and not as a substitute for diet or as a convenient mechanism for avoiding dietary restraint. Furthermore, short term administration may be required if diet control alone results in transient control of blood glucose level.
During maintenance, if satisfactory lowering of blood glucose is no longer achieved, use of Glipizide should be discontinued.
Use of Glipizide must be viewed by both the physician and patient as a treatment in addition to diet and not as a substitute for diet or as a convenient mechanism for avoiding dietary restraint. Furthermore, short term administration may be required if diet control alone results in transient control of blood glucose level.
During maintenance, if satisfactory lowering of blood glucose is no longer achieved, use of Glipizide should be discontinued.
Therapeutic classView
Sulfonylureas
PharmacologyView
Glipizide lowers blood glucose by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells. The extrapancreatic effects of Glipizide are increase in insulin sensitivity and decrease in hepatic glucose production.
DosageView
Like any other oral hypoglycaemic agent, dosage of Glipizide is not fixed and may be adjusted through periodic monitoring of blood glucose level. Short term administration of Glipizide may be sufficient during periods of transient loss of control of blood glucose in patients, usually controlled well on diet.
In general, Glipizide should be given approximately 30 minutes before a meal to achieve the maximum reduction in postprandial hyperglycaemia.
Patients receiving insulin: Many stable non-insulin-dependent diabetic patients receiving Insulin may be safely placed on Glipizide if the physician decides to do so.
Patients receiving other oral hypoglycaemic agents: As with other sulphonylurea, no transition period is necessary while transferring patients to Glipizide. Patients should be observed carefully for any possible hypoglycaemic effect due to overlapping of drug effects.
Pediatric Use: Safety and effectiveness in children have not been established.
In general, Glipizide should be given approximately 30 minutes before a meal to achieve the maximum reduction in postprandial hyperglycaemia.
- Initial dose: The recommended starting dose is 5 mg, given before breakfast. Geriatric patients or those with liver disease may be started on 2.5 mg.
- Dosage adjustments: Dosage adjustment may be done at intervals of several days by an increment of 2.5-5 mg, as determined by blood glucose response. If response to a single dose is not satisfactory, dividing that dose might prove effective. The maximum recommended once daily dose is 15 mg. Doses above 15 mg should ordinarily be divided and given before meals of adequate calorie content. The maximum recommended total daily dose is 40 mg.
- Maintenance: Some patients may be effectively controlled on a once daily regimen, while others show better response with divided dosing. Total daily dose above 30 mg have been safely given on bid basis to long term patients. Patients can usually be stabilized on a dosage ranging from 2.5 to 30 mg daily.
Patients receiving insulin: Many stable non-insulin-dependent diabetic patients receiving Insulin may be safely placed on Glipizide if the physician decides to do so.
Patients receiving other oral hypoglycaemic agents: As with other sulphonylurea, no transition period is necessary while transferring patients to Glipizide. Patients should be observed carefully for any possible hypoglycaemic effect due to overlapping of drug effects.
Pediatric Use: Safety and effectiveness in children have not been established.
Side effectsView
The majority of side effects have been dose related, transient, and responded to dose reduction or withdrawal of the medication.
Gastrointestinal: Gastrointestinal complaints were reported with the following approximate incidences like nausea, diarrhoea, constipation and gastralgia. They appear to be dose related and usually disappear on division or reduction of dosage. Cholestatic jaundice may occur rarely with these kind of drugs and Glipizide should be discontinued if this occurs.
Dermatological: Allergic skin reactions including erythema, morbilliform or maculopapular eruption, urticaria, pruritus and eczema have been reported. They frequently disappear with continued therapy. However, if they persist, the drug should be discontinued.
Haematologic: Leucopenia, agranulocytosis, thrombocytopenia, haemolytic anaemia, aplastic anaemia and pancytopenia have been reported with sulphonylureas.
Metabolic: Hepatic porphyria and disulphiram like reactions have been reported with sulphonylurea.
Endocrine reactions: Cases of hyponatraemia and the syndrome of inappropriate antidiuretic hormone (SIADH) secretion have been reported with this and other sulphonylureas.
Miscellaneous: Dizziness, drowsiness and headache have been reported in patients treated with Glipizide. They are usually transient and seldom require discontinuation of therapy.
Gastrointestinal: Gastrointestinal complaints were reported with the following approximate incidences like nausea, diarrhoea, constipation and gastralgia. They appear to be dose related and usually disappear on division or reduction of dosage. Cholestatic jaundice may occur rarely with these kind of drugs and Glipizide should be discontinued if this occurs.
Dermatological: Allergic skin reactions including erythema, morbilliform or maculopapular eruption, urticaria, pruritus and eczema have been reported. They frequently disappear with continued therapy. However, if they persist, the drug should be discontinued.
Haematologic: Leucopenia, agranulocytosis, thrombocytopenia, haemolytic anaemia, aplastic anaemia and pancytopenia have been reported with sulphonylureas.
Metabolic: Hepatic porphyria and disulphiram like reactions have been reported with sulphonylurea.
Endocrine reactions: Cases of hyponatraemia and the syndrome of inappropriate antidiuretic hormone (SIADH) secretion have been reported with this and other sulphonylureas.
Miscellaneous: Dizziness, drowsiness and headache have been reported in patients treated with Glipizide. They are usually transient and seldom require discontinuation of therapy.
ContraindicationsView
Glipizide is contraindicated in the following conditions :
- Patients who are hypersensitive to Glipizide or any component of the product
- Juvenile onset diabetes
- Severe or unstable ‘brittle’ diabetes
- Diabetes complicated by ketosis and acidosis, major surgery, severe sepsis or severe trauma
- Severe renal, hepatic or thyroid impairment, co-existent renal and hepatic disease
PrecautionsView
Hypoglycaemia: All sulphonylurea drugs are capable of producing severe hypoglycaemia. Proper patient selection, dosage and instructions are important to avoid hypoglycaemic episodes. Renal or hepatic insufficiency may cause elevated blood levels of Glipizide and the latter may also diminis gluconeogenic capacity, both of which increase the risk of serious hypoglycaemic reactions. Elderly, debilitated or malnourished patients and those with adrenal or pituitary insufficiency are particularly susceptible to the hypoglycaemic actions of glucose lowering drugs. Patients should be instructed to take their meals regularly and not to exercise excessively without additional calorie intake.
Renal and hepatic disease: The metabolism and excretion of Glipizide may be slowed in patients with impaired renal and/or hepatic function. These patients may suffer from prolonged hypoglycaemia and appropriate measures should be instituted.
Loss of control on blood glucose: When a patient stabilized on any antidiabetic regimen is exposed to stress such as fever, trauma, infection or surgery, a loss of control on blood glucose may occur. At that time it may be necessary to discontinue Glipizide and administer Insulin.
The effectiveness of any oral hypoglycaemic drug including Glipizide, in lowering blood glucose to a desired level, decreases in many patients over a period of time, which may be due to secondary failure, i.e., progression of the severity of the diabetes or diminished responsiveness to the drug.
Renal and hepatic disease: The metabolism and excretion of Glipizide may be slowed in patients with impaired renal and/or hepatic function. These patients may suffer from prolonged hypoglycaemia and appropriate measures should be instituted.
Loss of control on blood glucose: When a patient stabilized on any antidiabetic regimen is exposed to stress such as fever, trauma, infection or surgery, a loss of control on blood glucose may occur. At that time it may be necessary to discontinue Glipizide and administer Insulin.
The effectiveness of any oral hypoglycaemic drug including Glipizide, in lowering blood glucose to a desired level, decreases in many patients over a period of time, which may be due to secondary failure, i.e., progression of the severity of the diabetes or diminished responsiveness to the drug.
InteractionsView
The hypoglycaemic action of sulphonylurea may be potentiated by certain drugs including non-steroidal anti inflammatory agents and other drugs that are highly protein bound e.g., Salicylates, Sulphonamides, Chloramphenicol, Probenecid, Coumarins, Monoamine Oxidase Inhibitors, and β adrenergic blocking agents. When such drugs are administered to a patient receiving Glipizide, the patients should be observed closely for hypoglycaemia. When such drugs are withdrawn from a patient receiving Glipizide, the patient should be observed closely for loss of control on blood glucose.
Certain drugs tend to produce hyperglycaemia and may lead to loss of control on blood glucose. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, oestrogens, oral contraceptives, Phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs and Isoniazid. When such drugs are administered to or withdrawn from a patient receiving Glipizide, the patient should be closely observed for loss of control on blood glucose. Diabetic control may be altered also in patients treated with cyclophosphamide.
Certain drugs tend to produce hyperglycaemia and may lead to loss of control on blood glucose. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, oestrogens, oral contraceptives, Phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs and Isoniazid. When such drugs are administered to or withdrawn from a patient receiving Glipizide, the patient should be closely observed for loss of control on blood glucose. Diabetic control may be altered also in patients treated with cyclophosphamide.
Pregnancy & lactationView
Pregnancy: Glipizide should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. Prolonged severe hypoglycaemia (4-10 days) has been reported in neonates born to mothers who were receiving sulphonylurea (e.g., Glipizide) at the time of delivery. So, if Glipizide is used during pregnancy, it should be discontinued at least one month before the expected delivery date.
Lactation: Although it is not known whether Glipizide is excreted in human milk, some sulphonylurea drugs are known to be so. Breast feeding is not therefore recommended while taking this medication.
Lactation: Although it is not known whether Glipizide is excreted in human milk, some sulphonylurea drugs are known to be so. Breast feeding is not therefore recommended while taking this medication.
StorageView
The tablets should be protected from moisture and humidity and stored at room temperature (below 30° C).
Diaprid
Gliclazide
Diaprid
Gliclazide
Indications
Type 2 DM
Indication detailsView
Gliclazide is a medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to the sulphonylurea group). Gliclazide is used in a certain form of diabetes (type 2 diabetes Mellitus) in adults, when diet, exercise and weight loss alone do not have an adequate effect on keeping blood sugar at the correct level.
Therapeutic classView
Sulfonylureas
PharmacologyView
Gliclazide is a second generation sulfonylurea drug that has hypoglycaemic and potentially useful hematological properties. It stimulates the release of insulin from pancreatic β-cells by facilitating Ca+2 transport across the β-cell membranes and decreases hepatic glucose output.
DosageView
Film-coated tablet: The usual initial dose is 40 to 80 mg daily. The dose can be increased up to 320 mg daily in divided doses when needed. The drug should be taken before meal. For children, Gliclazide is not used because it is contraindicated in juvenile-onset diabetes.
Modified release preparation: Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The dose is determined by the doctor, depending on your blood and possibly urine sugar levels. Change in external factors (weight reduction, lifestyle, stress) or improvements in the blood sugar control may require changed gliclazide doses.
The recommended daily dose is one to four tablets (maximum 120 mg) in a single intake at breakfast time. This depends on the response to treatment. Gliclazide MR tablet is for oral use. Take your tablet(s) with a glass of water at breakfast time (and preferably at the same time each day). Swallow your whole tablet(s) in one piece. Do not chew or crush. You must always eat a meal after taking your tablet(s).
If a combination therapy of gliclazide with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor a GLP-1 receptor agonist or insulin is initiated your doctor will determine the proper dose of each medicine individually for you. If you notice that your blood sugar levels are high although you are taking the medicine as prescribed, you should contact your doctor or pharmacist.
If you take more Gliclazide tablets than you should: If you take too many tablets, contact your doctor or the nearest hospital Accident & Emergency department immediately. The signs of overdose are those of low blood sugar (hypoglycaemia). The symptoms can be helped by taking sugar (4 to 6 lumps) or sugary drinks straight away, followed by a substantial snack or meal. If the patient is unconscious immediately inform a doctor and call the emergency services. The same should be done if somebody, (for instance a child), has taken the product unintentionally. Unconscious patients must not be given food or drink. It should be ensured that there is always a pre-informed person that can call a doctor in case of emergency.
If you forget to take Gliclazide tablet: It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Gliclazide MR tablet, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Gliclazide MR tablet: As the treatment for diabetes is usually lifelong, you should discuss with your doctor before stopping this medicinal product. Stopping could cause high blood sugar (hyperglycaemia) which increases the risk of developing complications of diabetes. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Modified release preparation: Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The dose is determined by the doctor, depending on your blood and possibly urine sugar levels. Change in external factors (weight reduction, lifestyle, stress) or improvements in the blood sugar control may require changed gliclazide doses.
The recommended daily dose is one to four tablets (maximum 120 mg) in a single intake at breakfast time. This depends on the response to treatment. Gliclazide MR tablet is for oral use. Take your tablet(s) with a glass of water at breakfast time (and preferably at the same time each day). Swallow your whole tablet(s) in one piece. Do not chew or crush. You must always eat a meal after taking your tablet(s).
If a combination therapy of gliclazide with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor a GLP-1 receptor agonist or insulin is initiated your doctor will determine the proper dose of each medicine individually for you. If you notice that your blood sugar levels are high although you are taking the medicine as prescribed, you should contact your doctor or pharmacist.
If you take more Gliclazide tablets than you should: If you take too many tablets, contact your doctor or the nearest hospital Accident & Emergency department immediately. The signs of overdose are those of low blood sugar (hypoglycaemia). The symptoms can be helped by taking sugar (4 to 6 lumps) or sugary drinks straight away, followed by a substantial snack or meal. If the patient is unconscious immediately inform a doctor and call the emergency services. The same should be done if somebody, (for instance a child), has taken the product unintentionally. Unconscious patients must not be given food or drink. It should be ensured that there is always a pre-informed person that can call a doctor in case of emergency.
If you forget to take Gliclazide tablet: It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Gliclazide MR tablet, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Gliclazide MR tablet: As the treatment for diabetes is usually lifelong, you should discuss with your doctor before stopping this medicinal product. Stopping could cause high blood sugar (hyperglycaemia) which increases the risk of developing complications of diabetes. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Side effectsView
Like all medicines, Gliclazide can cause side effects, although not everybody gets them. The most commonly observed side effect is low blood sugar (hypoglycaemia). If left untreated these symptoms could progress to drowsiness, loss of consciousness or possibly coma. If an episode of low blood sugar is severe or prolonged, even if it is temporarily controlled by eating sugar, you should seek immediate medical attention.
Liver disorders: There have been isolated reports of abnormal iiver function, which can cause yellow skin and eyes. If you get this, see your doctor immediately. The symptoms generally disappear if the medicine is stopped. Your doctor will decide whether to stop your treatment.
Skin disorders: Skin reactions such as rash, redness, itching, hives, blisters, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty) have been reported. Rash may progress to widespread blistering or peeling of the skin. If you develop this, stop taking, seek urgent advice from a doctor and tell him that you are taking this medicine. Exceptionally, signs of severe hypersensitivity reactions have been reported: initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature.
Blood disorders: Decrease in the number of cells in the blood (e.g. platelets, red and white blood cells) which may cause paleness, prolonged bleeding, bruising, sore throat and fever have been reported. These symptoms usually vanish when the treatment is discontinued.
Digestive disorders: Abdominal pain, nausea, vomiting, indigestion, diarrhoea, and constipation. These effects are reduced when Gliclazide is taken with a meal as recommended.
Eye disorders: Your vision may be affected for a short time especially at the start of treatment. This effect is due to changes in blood sugar levels.
As for another sulfonylurea, the following adverse events have been observed: cases of severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels, reduction in blood sodium (hyponatraemia), symptoms of liver impairment (for instance jaundice) which in most cases disappeared after withdrawal of the sulfonylurea, but may lead to life-threatening liver failure in isolated cases.
Reporting of side effects: If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.
Liver disorders: There have been isolated reports of abnormal iiver function, which can cause yellow skin and eyes. If you get this, see your doctor immediately. The symptoms generally disappear if the medicine is stopped. Your doctor will decide whether to stop your treatment.
Skin disorders: Skin reactions such as rash, redness, itching, hives, blisters, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty) have been reported. Rash may progress to widespread blistering or peeling of the skin. If you develop this, stop taking, seek urgent advice from a doctor and tell him that you are taking this medicine. Exceptionally, signs of severe hypersensitivity reactions have been reported: initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature.
Blood disorders: Decrease in the number of cells in the blood (e.g. platelets, red and white blood cells) which may cause paleness, prolonged bleeding, bruising, sore throat and fever have been reported. These symptoms usually vanish when the treatment is discontinued.
Digestive disorders: Abdominal pain, nausea, vomiting, indigestion, diarrhoea, and constipation. These effects are reduced when Gliclazide is taken with a meal as recommended.
Eye disorders: Your vision may be affected for a short time especially at the start of treatment. This effect is due to changes in blood sugar levels.
As for another sulfonylurea, the following adverse events have been observed: cases of severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels, reduction in blood sodium (hyponatraemia), symptoms of liver impairment (for instance jaundice) which in most cases disappeared after withdrawal of the sulfonylurea, but may lead to life-threatening liver failure in isolated cases.
Reporting of side effects: If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.
ContraindicationsView
Do not take Gliclazide:
- if you are allergic to gliclazide or to other medicines of the same group (sulfonylurea), or to other related medicines (hypoglycaemic sulfonamides)
- if you have insulin-dependent diabetes (type 1)
- if you have ketone bodies and sugar in your urine (this may mean you have diabetic ketoacidosis), a diabetic pre-coma or coma
- if you have severe kidney or liver disease
- if you are taking medicines to treat fungal infections
- if you are breastfeeding
PrecautionsView
Talk to your doctor before taking Gliclazide. You should observe the treatment plan prescribed by your doctor to achieve proper blood sugar levels. This means, apart from regular tablet intake, to observe the dietary regimen, have physical exercise and, where necessary, reduce weight During gliclazide treatment regular monitoring of your blood (and possibly urine) sugar level and also your glycated haemoglobin (HbA1c) is necessary. In the first few weeks of treatment, the risk of having reduced blood sugar levels (hypoglycaemia) may be increased. So particularly close medical monitoring is necessary.
Low blood sugar (Hypoglycaemia) may occur:
The following signs and symptoms may also occur: sweating, clammy skin, anxiety, fast or irregular heartbeat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris).
If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop convulsions, lose self-control, your breathing may be shallow and your heartbeat slowed down, you may become unconscious.
In most cases the symptoms of low blood sugar vanish very quickly when you consume .some form of sugar, (for instance, glucose tablets, sugar cubes, sweet juice, sweetened tea).
You should therefore always carry some form of sugar with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. Please contact your doctor or the nearest hospital if taking sugar does not help or if the symptoms recur.
Symptoms of low blood sugar may be absent, less obvious or develop very slowly or you are not aware in time that your blood sugar level has dropped. This may happen if you are an elderly patient taking certain medicines (for instance those acting on the central nervous system and beta-blockers).
If you are in stressful situations (e.g. accidents, surgical operations, fever etc.) your doctor may temporarily switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide has not yet sufficiently reduced the blood sugar when you have not complied with the treatment plan prescribed by your doctor if you take St. John’s Wort (Hypericum perforatum) preparations or in special stress situations. These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and reduced performance.
Blood glucose disturbances (low blood sugar and high bold sugar) can occur when Gliclazide is prescribed at the same time as medicines to a class of antibiotics called fluoroquinolone, especially in elderly patients. In this case, your doctor will remind you of the importance of monitoring your blood glucose.
If you have a family history of or know you have the hereditary condition glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormality of red blood cells), lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur. Contact your doctor before taking this medicinal product.
Gliclazide is not recommended for use in children due to lack of data.
Low blood sugar (Hypoglycaemia) may occur:
- if you take meals irregularly or skip meals altogether,
- if you are fasting
- if you are malnourished
- if you change your diet
- if you increase your physical activity and carbohydrate intake does not match this increase,
- if you drink alcohol, especially in combination with skipped meals,
- if you take other medicines or natural remedies at the same time,
- if you take too high doses of gliclazide,
- if you suffer from particular hormone-induced disorders (functional disorders of the thyroid gland, pituitary gland or adrenal cortex),
- if your kidney function or liver function is severely decreased.
The following signs and symptoms may also occur: sweating, clammy skin, anxiety, fast or irregular heartbeat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris).
If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop convulsions, lose self-control, your breathing may be shallow and your heartbeat slowed down, you may become unconscious.
In most cases the symptoms of low blood sugar vanish very quickly when you consume .some form of sugar, (for instance, glucose tablets, sugar cubes, sweet juice, sweetened tea).
You should therefore always carry some form of sugar with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. Please contact your doctor or the nearest hospital if taking sugar does not help or if the symptoms recur.
Symptoms of low blood sugar may be absent, less obvious or develop very slowly or you are not aware in time that your blood sugar level has dropped. This may happen if you are an elderly patient taking certain medicines (for instance those acting on the central nervous system and beta-blockers).
If you are in stressful situations (e.g. accidents, surgical operations, fever etc.) your doctor may temporarily switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide has not yet sufficiently reduced the blood sugar when you have not complied with the treatment plan prescribed by your doctor if you take St. John’s Wort (Hypericum perforatum) preparations or in special stress situations. These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and reduced performance.
Blood glucose disturbances (low blood sugar and high bold sugar) can occur when Gliclazide is prescribed at the same time as medicines to a class of antibiotics called fluoroquinolone, especially in elderly patients. In this case, your doctor will remind you of the importance of monitoring your blood glucose.
If you have a family history of or know you have the hereditary condition glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormality of red blood cells), lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur. Contact your doctor before taking this medicinal product.
Gliclazide is not recommended for use in children due to lack of data.
InteractionsView
Other medicines and Gliclazide: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
The blood sugar lowering effect of gliclazide may be strengthened and signs of low blood sugar levels may occur when one of the follow ng medicines is taken:
Gliclazide may increase the effects of medicines that reduce blood clotting (warfarin).
Consult your doctor before you start taking another medicinal product. If you go into hospital tell the medical staff you are taking gliclazide.
Gliclazide with food and drink: Gliclazide can be taken with food and non-alcoholic drinks. Drinking alcohol is not recommended as it can alter the control of your diabetes in an unpredictable manner.
Driving and using machines: Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycaemia), or too high (hyperglycaemia) or if you develop visual problems as a result of such conditions. Bear in mind that you could endanger yourself or others (for instance when driving a car or using machines). Please ask your doctor whether you can drive a car if you:
The blood sugar lowering effect of gliclazide may be strengthened and signs of low blood sugar levels may occur when one of the follow ng medicines is taken:
- other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists or insulin),
- antibiotics (sulphonamides, clarithromycin)
- medicines to treat high blood pressure or heart failure (beta-blockers. ACE-inhibitors such as captopril, or enalapril)
- medicines to treat fungal infections (miconazole, fluconazole)
- medicines to treat ulcers in the stomach or duodenum (H2 receptor antagonists),
- medicines to treat depression (monoamine oxidase inhibitors)
- painkiller or antirheumatics (phenylbutazone, ibuprofen)
- medicines containing alcohol
- medicines to treat disorders of the central nervous system (chlorpromazine)
- medicines reducing inflammation (corticosteroids)
- medicines to treat asthma or used during labour (intravenous salbutamol, ritodrine and terbutaline)
- medicines to treat breast disorders, heavy menstrual bleeding and endometriosis (danazol)
- St John's Wort- Hypericum perforatum- preparations
Gliclazide may increase the effects of medicines that reduce blood clotting (warfarin).
Consult your doctor before you start taking another medicinal product. If you go into hospital tell the medical staff you are taking gliclazide.
Gliclazide with food and drink: Gliclazide can be taken with food and non-alcoholic drinks. Drinking alcohol is not recommended as it can alter the control of your diabetes in an unpredictable manner.
Driving and using machines: Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycaemia), or too high (hyperglycaemia) or if you develop visual problems as a result of such conditions. Bear in mind that you could endanger yourself or others (for instance when driving a car or using machines). Please ask your doctor whether you can drive a car if you:
- have frequent episodes of low blood sugar (hypoglycaemia)
- have few or no warning signals of low blood sugar (hypoglycaemia)
Pregnancy & lactationView
Gliclazide is not recommended for use during pregnancy. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You must not take Gliclazide while you are breastfeeding.
StorageView
Keep out of the reach and sight of children. Do not use this medicine after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of that month. Store below 30°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Diapro
Gliclazide
Diapro
Gliclazide
Indications
Type 2 DM
Indication detailsView
Gliclazide is a medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to the sulphonylurea group). Gliclazide is used in a certain form of diabetes (type 2 diabetes Mellitus) in adults, when diet, exercise and weight loss alone do not have an adequate effect on keeping blood sugar at the correct level.
Therapeutic classView
Sulfonylureas
PharmacologyView
Gliclazide is a second generation sulfonylurea drug that has hypoglycaemic and potentially useful hematological properties. It stimulates the release of insulin from pancreatic β-cells by facilitating Ca+2 transport across the β-cell membranes and decreases hepatic glucose output.
DosageView
Film-coated tablet: The usual initial dose is 40 to 80 mg daily. The dose can be increased up to 320 mg daily in divided doses when needed. The drug should be taken before meal. For children, Gliclazide is not used because it is contraindicated in juvenile-onset diabetes.
Modified release preparation: Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The dose is determined by the doctor, depending on your blood and possibly urine sugar levels. Change in external factors (weight reduction, lifestyle, stress) or improvements in the blood sugar control may require changed gliclazide doses.
The recommended daily dose is one to four tablets (maximum 120 mg) in a single intake at breakfast time. This depends on the response to treatment. Gliclazide MR tablet is for oral use. Take your tablet(s) with a glass of water at breakfast time (and preferably at the same time each day). Swallow your whole tablet(s) in one piece. Do not chew or crush. You must always eat a meal after taking your tablet(s).
If a combination therapy of gliclazide with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor a GLP-1 receptor agonist or insulin is initiated your doctor will determine the proper dose of each medicine individually for you. If you notice that your blood sugar levels are high although you are taking the medicine as prescribed, you should contact your doctor or pharmacist.
If you take more Gliclazide tablets than you should: If you take too many tablets, contact your doctor or the nearest hospital Accident & Emergency department immediately. The signs of overdose are those of low blood sugar (hypoglycaemia). The symptoms can be helped by taking sugar (4 to 6 lumps) or sugary drinks straight away, followed by a substantial snack or meal. If the patient is unconscious immediately inform a doctor and call the emergency services. The same should be done if somebody, (for instance a child), has taken the product unintentionally. Unconscious patients must not be given food or drink. It should be ensured that there is always a pre-informed person that can call a doctor in case of emergency.
If you forget to take Gliclazide tablet: It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Gliclazide MR tablet, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Gliclazide MR tablet: As the treatment for diabetes is usually lifelong, you should discuss with your doctor before stopping this medicinal product. Stopping could cause high blood sugar (hyperglycaemia) which increases the risk of developing complications of diabetes. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Modified release preparation: Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The dose is determined by the doctor, depending on your blood and possibly urine sugar levels. Change in external factors (weight reduction, lifestyle, stress) or improvements in the blood sugar control may require changed gliclazide doses.
The recommended daily dose is one to four tablets (maximum 120 mg) in a single intake at breakfast time. This depends on the response to treatment. Gliclazide MR tablet is for oral use. Take your tablet(s) with a glass of water at breakfast time (and preferably at the same time each day). Swallow your whole tablet(s) in one piece. Do not chew or crush. You must always eat a meal after taking your tablet(s).
If a combination therapy of gliclazide with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor a GLP-1 receptor agonist or insulin is initiated your doctor will determine the proper dose of each medicine individually for you. If you notice that your blood sugar levels are high although you are taking the medicine as prescribed, you should contact your doctor or pharmacist.
If you take more Gliclazide tablets than you should: If you take too many tablets, contact your doctor or the nearest hospital Accident & Emergency department immediately. The signs of overdose are those of low blood sugar (hypoglycaemia). The symptoms can be helped by taking sugar (4 to 6 lumps) or sugary drinks straight away, followed by a substantial snack or meal. If the patient is unconscious immediately inform a doctor and call the emergency services. The same should be done if somebody, (for instance a child), has taken the product unintentionally. Unconscious patients must not be given food or drink. It should be ensured that there is always a pre-informed person that can call a doctor in case of emergency.
If you forget to take Gliclazide tablet: It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Gliclazide MR tablet, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Gliclazide MR tablet: As the treatment for diabetes is usually lifelong, you should discuss with your doctor before stopping this medicinal product. Stopping could cause high blood sugar (hyperglycaemia) which increases the risk of developing complications of diabetes. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Side effectsView
Like all medicines, Gliclazide can cause side effects, although not everybody gets them. The most commonly observed side effect is low blood sugar (hypoglycaemia). If left untreated these symptoms could progress to drowsiness, loss of consciousness or possibly coma. If an episode of low blood sugar is severe or prolonged, even if it is temporarily controlled by eating sugar, you should seek immediate medical attention.
Liver disorders: There have been isolated reports of abnormal iiver function, which can cause yellow skin and eyes. If you get this, see your doctor immediately. The symptoms generally disappear if the medicine is stopped. Your doctor will decide whether to stop your treatment.
Skin disorders: Skin reactions such as rash, redness, itching, hives, blisters, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty) have been reported. Rash may progress to widespread blistering or peeling of the skin. If you develop this, stop taking, seek urgent advice from a doctor and tell him that you are taking this medicine. Exceptionally, signs of severe hypersensitivity reactions have been reported: initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature.
Blood disorders: Decrease in the number of cells in the blood (e.g. platelets, red and white blood cells) which may cause paleness, prolonged bleeding, bruising, sore throat and fever have been reported. These symptoms usually vanish when the treatment is discontinued.
Digestive disorders: Abdominal pain, nausea, vomiting, indigestion, diarrhoea, and constipation. These effects are reduced when Gliclazide is taken with a meal as recommended.
Eye disorders: Your vision may be affected for a short time especially at the start of treatment. This effect is due to changes in blood sugar levels.
As for another sulfonylurea, the following adverse events have been observed: cases of severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels, reduction in blood sodium (hyponatraemia), symptoms of liver impairment (for instance jaundice) which in most cases disappeared after withdrawal of the sulfonylurea, but may lead to life-threatening liver failure in isolated cases.
Reporting of side effects: If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.
Liver disorders: There have been isolated reports of abnormal iiver function, which can cause yellow skin and eyes. If you get this, see your doctor immediately. The symptoms generally disappear if the medicine is stopped. Your doctor will decide whether to stop your treatment.
Skin disorders: Skin reactions such as rash, redness, itching, hives, blisters, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty) have been reported. Rash may progress to widespread blistering or peeling of the skin. If you develop this, stop taking, seek urgent advice from a doctor and tell him that you are taking this medicine. Exceptionally, signs of severe hypersensitivity reactions have been reported: initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature.
Blood disorders: Decrease in the number of cells in the blood (e.g. platelets, red and white blood cells) which may cause paleness, prolonged bleeding, bruising, sore throat and fever have been reported. These symptoms usually vanish when the treatment is discontinued.
Digestive disorders: Abdominal pain, nausea, vomiting, indigestion, diarrhoea, and constipation. These effects are reduced when Gliclazide is taken with a meal as recommended.
Eye disorders: Your vision may be affected for a short time especially at the start of treatment. This effect is due to changes in blood sugar levels.
As for another sulfonylurea, the following adverse events have been observed: cases of severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels, reduction in blood sodium (hyponatraemia), symptoms of liver impairment (for instance jaundice) which in most cases disappeared after withdrawal of the sulfonylurea, but may lead to life-threatening liver failure in isolated cases.
Reporting of side effects: If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.
ContraindicationsView
Do not take Gliclazide:
- if you are allergic to gliclazide or to other medicines of the same group (sulfonylurea), or to other related medicines (hypoglycaemic sulfonamides)
- if you have insulin-dependent diabetes (type 1)
- if you have ketone bodies and sugar in your urine (this may mean you have diabetic ketoacidosis), a diabetic pre-coma or coma
- if you have severe kidney or liver disease
- if you are taking medicines to treat fungal infections
- if you are breastfeeding
PrecautionsView
Talk to your doctor before taking Gliclazide. You should observe the treatment plan prescribed by your doctor to achieve proper blood sugar levels. This means, apart from regular tablet intake, to observe the dietary regimen, have physical exercise and, where necessary, reduce weight During gliclazide treatment regular monitoring of your blood (and possibly urine) sugar level and also your glycated haemoglobin (HbA1c) is necessary. In the first few weeks of treatment, the risk of having reduced blood sugar levels (hypoglycaemia) may be increased. So particularly close medical monitoring is necessary.
Low blood sugar (Hypoglycaemia) may occur:
The following signs and symptoms may also occur: sweating, clammy skin, anxiety, fast or irregular heartbeat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris).
If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop convulsions, lose self-control, your breathing may be shallow and your heartbeat slowed down, you may become unconscious.
In most cases the symptoms of low blood sugar vanish very quickly when you consume .some form of sugar, (for instance, glucose tablets, sugar cubes, sweet juice, sweetened tea).
You should therefore always carry some form of sugar with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. Please contact your doctor or the nearest hospital if taking sugar does not help or if the symptoms recur.
Symptoms of low blood sugar may be absent, less obvious or develop very slowly or you are not aware in time that your blood sugar level has dropped. This may happen if you are an elderly patient taking certain medicines (for instance those acting on the central nervous system and beta-blockers).
If you are in stressful situations (e.g. accidents, surgical operations, fever etc.) your doctor may temporarily switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide has not yet sufficiently reduced the blood sugar when you have not complied with the treatment plan prescribed by your doctor if you take St. John’s Wort (Hypericum perforatum) preparations or in special stress situations. These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and reduced performance.
Blood glucose disturbances (low blood sugar and high bold sugar) can occur when Gliclazide is prescribed at the same time as medicines to a class of antibiotics called fluoroquinolone, especially in elderly patients. In this case, your doctor will remind you of the importance of monitoring your blood glucose.
If you have a family history of or know you have the hereditary condition glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormality of red blood cells), lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur. Contact your doctor before taking this medicinal product.
Gliclazide is not recommended for use in children due to lack of data.
Low blood sugar (Hypoglycaemia) may occur:
- if you take meals irregularly or skip meals altogether,
- if you are fasting
- if you are malnourished
- if you change your diet
- if you increase your physical activity and carbohydrate intake does not match this increase,
- if you drink alcohol, especially in combination with skipped meals,
- if you take other medicines or natural remedies at the same time,
- if you take too high doses of gliclazide,
- if you suffer from particular hormone-induced disorders (functional disorders of the thyroid gland, pituitary gland or adrenal cortex),
- if your kidney function or liver function is severely decreased.
The following signs and symptoms may also occur: sweating, clammy skin, anxiety, fast or irregular heartbeat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris).
If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop convulsions, lose self-control, your breathing may be shallow and your heartbeat slowed down, you may become unconscious.
In most cases the symptoms of low blood sugar vanish very quickly when you consume .some form of sugar, (for instance, glucose tablets, sugar cubes, sweet juice, sweetened tea).
You should therefore always carry some form of sugar with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. Please contact your doctor or the nearest hospital if taking sugar does not help or if the symptoms recur.
Symptoms of low blood sugar may be absent, less obvious or develop very slowly or you are not aware in time that your blood sugar level has dropped. This may happen if you are an elderly patient taking certain medicines (for instance those acting on the central nervous system and beta-blockers).
If you are in stressful situations (e.g. accidents, surgical operations, fever etc.) your doctor may temporarily switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide has not yet sufficiently reduced the blood sugar when you have not complied with the treatment plan prescribed by your doctor if you take St. John’s Wort (Hypericum perforatum) preparations or in special stress situations. These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and reduced performance.
Blood glucose disturbances (low blood sugar and high bold sugar) can occur when Gliclazide is prescribed at the same time as medicines to a class of antibiotics called fluoroquinolone, especially in elderly patients. In this case, your doctor will remind you of the importance of monitoring your blood glucose.
If you have a family history of or know you have the hereditary condition glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormality of red blood cells), lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur. Contact your doctor before taking this medicinal product.
Gliclazide is not recommended for use in children due to lack of data.
InteractionsView
Other medicines and Gliclazide: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
The blood sugar lowering effect of gliclazide may be strengthened and signs of low blood sugar levels may occur when one of the follow ng medicines is taken:
Gliclazide may increase the effects of medicines that reduce blood clotting (warfarin).
Consult your doctor before you start taking another medicinal product. If you go into hospital tell the medical staff you are taking gliclazide.
Gliclazide with food and drink: Gliclazide can be taken with food and non-alcoholic drinks. Drinking alcohol is not recommended as it can alter the control of your diabetes in an unpredictable manner.
Driving and using machines: Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycaemia), or too high (hyperglycaemia) or if you develop visual problems as a result of such conditions. Bear in mind that you could endanger yourself or others (for instance when driving a car or using machines). Please ask your doctor whether you can drive a car if you:
The blood sugar lowering effect of gliclazide may be strengthened and signs of low blood sugar levels may occur when one of the follow ng medicines is taken:
- other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists or insulin),
- antibiotics (sulphonamides, clarithromycin)
- medicines to treat high blood pressure or heart failure (beta-blockers. ACE-inhibitors such as captopril, or enalapril)
- medicines to treat fungal infections (miconazole, fluconazole)
- medicines to treat ulcers in the stomach or duodenum (H2 receptor antagonists),
- medicines to treat depression (monoamine oxidase inhibitors)
- painkiller or antirheumatics (phenylbutazone, ibuprofen)
- medicines containing alcohol
- medicines to treat disorders of the central nervous system (chlorpromazine)
- medicines reducing inflammation (corticosteroids)
- medicines to treat asthma or used during labour (intravenous salbutamol, ritodrine and terbutaline)
- medicines to treat breast disorders, heavy menstrual bleeding and endometriosis (danazol)
- St John's Wort- Hypericum perforatum- preparations
Gliclazide may increase the effects of medicines that reduce blood clotting (warfarin).
Consult your doctor before you start taking another medicinal product. If you go into hospital tell the medical staff you are taking gliclazide.
Gliclazide with food and drink: Gliclazide can be taken with food and non-alcoholic drinks. Drinking alcohol is not recommended as it can alter the control of your diabetes in an unpredictable manner.
Driving and using machines: Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycaemia), or too high (hyperglycaemia) or if you develop visual problems as a result of such conditions. Bear in mind that you could endanger yourself or others (for instance when driving a car or using machines). Please ask your doctor whether you can drive a car if you:
- have frequent episodes of low blood sugar (hypoglycaemia)
- have few or no warning signals of low blood sugar (hypoglycaemia)
Pregnancy & lactationView
Gliclazide is not recommended for use during pregnancy. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You must not take Gliclazide while you are breastfeeding.
StorageView
Keep out of the reach and sight of children. Do not use this medicine after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of that month. Store below 30°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Diapro MR
Gliclazide
Diapro MR
Gliclazide
Indications
Type 2 DM
Indication detailsView
Gliclazide is a medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to the sulphonylurea group). Gliclazide is used in a certain form of diabetes (type 2 diabetes Mellitus) in adults, when diet, exercise and weight loss alone do not have an adequate effect on keeping blood sugar at the correct level.
Therapeutic classView
Sulfonylureas
PharmacologyView
Gliclazide is a second generation sulfonylurea drug that has hypoglycaemic and potentially useful hematological properties. It stimulates the release of insulin from pancreatic β-cells by facilitating Ca+2 transport across the β-cell membranes and decreases hepatic glucose output.
DosageView
Film-coated tablet: The usual initial dose is 40 to 80 mg daily. The dose can be increased up to 320 mg daily in divided doses when needed. The drug should be taken before meal. For children, Gliclazide is not used because it is contraindicated in juvenile-onset diabetes.
Modified release preparation: Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The dose is determined by the doctor, depending on your blood and possibly urine sugar levels. Change in external factors (weight reduction, lifestyle, stress) or improvements in the blood sugar control may require changed gliclazide doses.
The recommended daily dose is one to four tablets (maximum 120 mg) in a single intake at breakfast time. This depends on the response to treatment. Gliclazide MR tablet is for oral use. Take your tablet(s) with a glass of water at breakfast time (and preferably at the same time each day). Swallow your whole tablet(s) in one piece. Do not chew or crush. You must always eat a meal after taking your tablet(s).
If a combination therapy of gliclazide with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor a GLP-1 receptor agonist or insulin is initiated your doctor will determine the proper dose of each medicine individually for you. If you notice that your blood sugar levels are high although you are taking the medicine as prescribed, you should contact your doctor or pharmacist.
If you take more Gliclazide tablets than you should: If you take too many tablets, contact your doctor or the nearest hospital Accident & Emergency department immediately. The signs of overdose are those of low blood sugar (hypoglycaemia). The symptoms can be helped by taking sugar (4 to 6 lumps) or sugary drinks straight away, followed by a substantial snack or meal. If the patient is unconscious immediately inform a doctor and call the emergency services. The same should be done if somebody, (for instance a child), has taken the product unintentionally. Unconscious patients must not be given food or drink. It should be ensured that there is always a pre-informed person that can call a doctor in case of emergency.
If you forget to take Gliclazide tablet: It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Gliclazide MR tablet, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Gliclazide MR tablet: As the treatment for diabetes is usually lifelong, you should discuss with your doctor before stopping this medicinal product. Stopping could cause high blood sugar (hyperglycaemia) which increases the risk of developing complications of diabetes. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Modified release preparation: Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The dose is determined by the doctor, depending on your blood and possibly urine sugar levels. Change in external factors (weight reduction, lifestyle, stress) or improvements in the blood sugar control may require changed gliclazide doses.
The recommended daily dose is one to four tablets (maximum 120 mg) in a single intake at breakfast time. This depends on the response to treatment. Gliclazide MR tablet is for oral use. Take your tablet(s) with a glass of water at breakfast time (and preferably at the same time each day). Swallow your whole tablet(s) in one piece. Do not chew or crush. You must always eat a meal after taking your tablet(s).
If a combination therapy of gliclazide with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor a GLP-1 receptor agonist or insulin is initiated your doctor will determine the proper dose of each medicine individually for you. If you notice that your blood sugar levels are high although you are taking the medicine as prescribed, you should contact your doctor or pharmacist.
If you take more Gliclazide tablets than you should: If you take too many tablets, contact your doctor or the nearest hospital Accident & Emergency department immediately. The signs of overdose are those of low blood sugar (hypoglycaemia). The symptoms can be helped by taking sugar (4 to 6 lumps) or sugary drinks straight away, followed by a substantial snack or meal. If the patient is unconscious immediately inform a doctor and call the emergency services. The same should be done if somebody, (for instance a child), has taken the product unintentionally. Unconscious patients must not be given food or drink. It should be ensured that there is always a pre-informed person that can call a doctor in case of emergency.
If you forget to take Gliclazide tablet: It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Gliclazide MR tablet, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Gliclazide MR tablet: As the treatment for diabetes is usually lifelong, you should discuss with your doctor before stopping this medicinal product. Stopping could cause high blood sugar (hyperglycaemia) which increases the risk of developing complications of diabetes. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Side effectsView
Like all medicines, Gliclazide can cause side effects, although not everybody gets them. The most commonly observed side effect is low blood sugar (hypoglycaemia). If left untreated these symptoms could progress to drowsiness, loss of consciousness or possibly coma. If an episode of low blood sugar is severe or prolonged, even if it is temporarily controlled by eating sugar, you should seek immediate medical attention.
Liver disorders: There have been isolated reports of abnormal iiver function, which can cause yellow skin and eyes. If you get this, see your doctor immediately. The symptoms generally disappear if the medicine is stopped. Your doctor will decide whether to stop your treatment.
Skin disorders: Skin reactions such as rash, redness, itching, hives, blisters, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty) have been reported. Rash may progress to widespread blistering or peeling of the skin. If you develop this, stop taking, seek urgent advice from a doctor and tell him that you are taking this medicine. Exceptionally, signs of severe hypersensitivity reactions have been reported: initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature.
Blood disorders: Decrease in the number of cells in the blood (e.g. platelets, red and white blood cells) which may cause paleness, prolonged bleeding, bruising, sore throat and fever have been reported. These symptoms usually vanish when the treatment is discontinued.
Digestive disorders: Abdominal pain, nausea, vomiting, indigestion, diarrhoea, and constipation. These effects are reduced when Gliclazide is taken with a meal as recommended.
Eye disorders: Your vision may be affected for a short time especially at the start of treatment. This effect is due to changes in blood sugar levels.
As for another sulfonylurea, the following adverse events have been observed: cases of severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels, reduction in blood sodium (hyponatraemia), symptoms of liver impairment (for instance jaundice) which in most cases disappeared after withdrawal of the sulfonylurea, but may lead to life-threatening liver failure in isolated cases.
Reporting of side effects: If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.
Liver disorders: There have been isolated reports of abnormal iiver function, which can cause yellow skin and eyes. If you get this, see your doctor immediately. The symptoms generally disappear if the medicine is stopped. Your doctor will decide whether to stop your treatment.
Skin disorders: Skin reactions such as rash, redness, itching, hives, blisters, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty) have been reported. Rash may progress to widespread blistering or peeling of the skin. If you develop this, stop taking, seek urgent advice from a doctor and tell him that you are taking this medicine. Exceptionally, signs of severe hypersensitivity reactions have been reported: initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature.
Blood disorders: Decrease in the number of cells in the blood (e.g. platelets, red and white blood cells) which may cause paleness, prolonged bleeding, bruising, sore throat and fever have been reported. These symptoms usually vanish when the treatment is discontinued.
Digestive disorders: Abdominal pain, nausea, vomiting, indigestion, diarrhoea, and constipation. These effects are reduced when Gliclazide is taken with a meal as recommended.
Eye disorders: Your vision may be affected for a short time especially at the start of treatment. This effect is due to changes in blood sugar levels.
As for another sulfonylurea, the following adverse events have been observed: cases of severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels, reduction in blood sodium (hyponatraemia), symptoms of liver impairment (for instance jaundice) which in most cases disappeared after withdrawal of the sulfonylurea, but may lead to life-threatening liver failure in isolated cases.
Reporting of side effects: If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.
ContraindicationsView
Do not take Gliclazide:
- if you are allergic to gliclazide or to other medicines of the same group (sulfonylurea), or to other related medicines (hypoglycaemic sulfonamides)
- if you have insulin-dependent diabetes (type 1)
- if you have ketone bodies and sugar in your urine (this may mean you have diabetic ketoacidosis), a diabetic pre-coma or coma
- if you have severe kidney or liver disease
- if you are taking medicines to treat fungal infections
- if you are breastfeeding
PrecautionsView
Talk to your doctor before taking Gliclazide. You should observe the treatment plan prescribed by your doctor to achieve proper blood sugar levels. This means, apart from regular tablet intake, to observe the dietary regimen, have physical exercise and, where necessary, reduce weight During gliclazide treatment regular monitoring of your blood (and possibly urine) sugar level and also your glycated haemoglobin (HbA1c) is necessary. In the first few weeks of treatment, the risk of having reduced blood sugar levels (hypoglycaemia) may be increased. So particularly close medical monitoring is necessary.
Low blood sugar (Hypoglycaemia) may occur:
The following signs and symptoms may also occur: sweating, clammy skin, anxiety, fast or irregular heartbeat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris).
If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop convulsions, lose self-control, your breathing may be shallow and your heartbeat slowed down, you may become unconscious.
In most cases the symptoms of low blood sugar vanish very quickly when you consume .some form of sugar, (for instance, glucose tablets, sugar cubes, sweet juice, sweetened tea).
You should therefore always carry some form of sugar with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. Please contact your doctor or the nearest hospital if taking sugar does not help or if the symptoms recur.
Symptoms of low blood sugar may be absent, less obvious or develop very slowly or you are not aware in time that your blood sugar level has dropped. This may happen if you are an elderly patient taking certain medicines (for instance those acting on the central nervous system and beta-blockers).
If you are in stressful situations (e.g. accidents, surgical operations, fever etc.) your doctor may temporarily switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide has not yet sufficiently reduced the blood sugar when you have not complied with the treatment plan prescribed by your doctor if you take St. John’s Wort (Hypericum perforatum) preparations or in special stress situations. These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and reduced performance.
Blood glucose disturbances (low blood sugar and high bold sugar) can occur when Gliclazide is prescribed at the same time as medicines to a class of antibiotics called fluoroquinolone, especially in elderly patients. In this case, your doctor will remind you of the importance of monitoring your blood glucose.
If you have a family history of or know you have the hereditary condition glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormality of red blood cells), lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur. Contact your doctor before taking this medicinal product.
Gliclazide is not recommended for use in children due to lack of data.
Low blood sugar (Hypoglycaemia) may occur:
- if you take meals irregularly or skip meals altogether,
- if you are fasting
- if you are malnourished
- if you change your diet
- if you increase your physical activity and carbohydrate intake does not match this increase,
- if you drink alcohol, especially in combination with skipped meals,
- if you take other medicines or natural remedies at the same time,
- if you take too high doses of gliclazide,
- if you suffer from particular hormone-induced disorders (functional disorders of the thyroid gland, pituitary gland or adrenal cortex),
- if your kidney function or liver function is severely decreased.
The following signs and symptoms may also occur: sweating, clammy skin, anxiety, fast or irregular heartbeat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris).
If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop convulsions, lose self-control, your breathing may be shallow and your heartbeat slowed down, you may become unconscious.
In most cases the symptoms of low blood sugar vanish very quickly when you consume .some form of sugar, (for instance, glucose tablets, sugar cubes, sweet juice, sweetened tea).
You should therefore always carry some form of sugar with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. Please contact your doctor or the nearest hospital if taking sugar does not help or if the symptoms recur.
Symptoms of low blood sugar may be absent, less obvious or develop very slowly or you are not aware in time that your blood sugar level has dropped. This may happen if you are an elderly patient taking certain medicines (for instance those acting on the central nervous system and beta-blockers).
If you are in stressful situations (e.g. accidents, surgical operations, fever etc.) your doctor may temporarily switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide has not yet sufficiently reduced the blood sugar when you have not complied with the treatment plan prescribed by your doctor if you take St. John’s Wort (Hypericum perforatum) preparations or in special stress situations. These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and reduced performance.
Blood glucose disturbances (low blood sugar and high bold sugar) can occur when Gliclazide is prescribed at the same time as medicines to a class of antibiotics called fluoroquinolone, especially in elderly patients. In this case, your doctor will remind you of the importance of monitoring your blood glucose.
If you have a family history of or know you have the hereditary condition glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormality of red blood cells), lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur. Contact your doctor before taking this medicinal product.
Gliclazide is not recommended for use in children due to lack of data.
InteractionsView
Other medicines and Gliclazide: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
The blood sugar lowering effect of gliclazide may be strengthened and signs of low blood sugar levels may occur when one of the follow ng medicines is taken:
Gliclazide may increase the effects of medicines that reduce blood clotting (warfarin).
Consult your doctor before you start taking another medicinal product. If you go into hospital tell the medical staff you are taking gliclazide.
Gliclazide with food and drink: Gliclazide can be taken with food and non-alcoholic drinks. Drinking alcohol is not recommended as it can alter the control of your diabetes in an unpredictable manner.
Driving and using machines: Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycaemia), or too high (hyperglycaemia) or if you develop visual problems as a result of such conditions. Bear in mind that you could endanger yourself or others (for instance when driving a car or using machines). Please ask your doctor whether you can drive a car if you:
The blood sugar lowering effect of gliclazide may be strengthened and signs of low blood sugar levels may occur when one of the follow ng medicines is taken:
- other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists or insulin),
- antibiotics (sulphonamides, clarithromycin)
- medicines to treat high blood pressure or heart failure (beta-blockers. ACE-inhibitors such as captopril, or enalapril)
- medicines to treat fungal infections (miconazole, fluconazole)
- medicines to treat ulcers in the stomach or duodenum (H2 receptor antagonists),
- medicines to treat depression (monoamine oxidase inhibitors)
- painkiller or antirheumatics (phenylbutazone, ibuprofen)
- medicines containing alcohol
- medicines to treat disorders of the central nervous system (chlorpromazine)
- medicines reducing inflammation (corticosteroids)
- medicines to treat asthma or used during labour (intravenous salbutamol, ritodrine and terbutaline)
- medicines to treat breast disorders, heavy menstrual bleeding and endometriosis (danazol)
- St John's Wort- Hypericum perforatum- preparations
Gliclazide may increase the effects of medicines that reduce blood clotting (warfarin).
Consult your doctor before you start taking another medicinal product. If you go into hospital tell the medical staff you are taking gliclazide.
Gliclazide with food and drink: Gliclazide can be taken with food and non-alcoholic drinks. Drinking alcohol is not recommended as it can alter the control of your diabetes in an unpredictable manner.
Driving and using machines: Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycaemia), or too high (hyperglycaemia) or if you develop visual problems as a result of such conditions. Bear in mind that you could endanger yourself or others (for instance when driving a car or using machines). Please ask your doctor whether you can drive a car if you:
- have frequent episodes of low blood sugar (hypoglycaemia)
- have few or no warning signals of low blood sugar (hypoglycaemia)
Pregnancy & lactationView
Gliclazide is not recommended for use during pregnancy. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You must not take Gliclazide while you are breastfeeding.
StorageView
Keep out of the reach and sight of children. Do not use this medicine after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of that month. Store below 30°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Diapro MR
Gliclazide
Diapro MR
Gliclazide
Indications
Type 2 DM
Indication detailsView
Gliclazide is a medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to the sulphonylurea group). Gliclazide is used in a certain form of diabetes (type 2 diabetes Mellitus) in adults, when diet, exercise and weight loss alone do not have an adequate effect on keeping blood sugar at the correct level.
Therapeutic classView
Sulfonylureas
PharmacologyView
Gliclazide is a second generation sulfonylurea drug that has hypoglycaemic and potentially useful hematological properties. It stimulates the release of insulin from pancreatic β-cells by facilitating Ca+2 transport across the β-cell membranes and decreases hepatic glucose output.
DosageView
Film-coated tablet: The usual initial dose is 40 to 80 mg daily. The dose can be increased up to 320 mg daily in divided doses when needed. The drug should be taken before meal. For children, Gliclazide is not used because it is contraindicated in juvenile-onset diabetes.
Modified release preparation: Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The dose is determined by the doctor, depending on your blood and possibly urine sugar levels. Change in external factors (weight reduction, lifestyle, stress) or improvements in the blood sugar control may require changed gliclazide doses.
The recommended daily dose is one to four tablets (maximum 120 mg) in a single intake at breakfast time. This depends on the response to treatment. Gliclazide MR tablet is for oral use. Take your tablet(s) with a glass of water at breakfast time (and preferably at the same time each day). Swallow your whole tablet(s) in one piece. Do not chew or crush. You must always eat a meal after taking your tablet(s).
If a combination therapy of gliclazide with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor a GLP-1 receptor agonist or insulin is initiated your doctor will determine the proper dose of each medicine individually for you. If you notice that your blood sugar levels are high although you are taking the medicine as prescribed, you should contact your doctor or pharmacist.
If you take more Gliclazide tablets than you should: If you take too many tablets, contact your doctor or the nearest hospital Accident & Emergency department immediately. The signs of overdose are those of low blood sugar (hypoglycaemia). The symptoms can be helped by taking sugar (4 to 6 lumps) or sugary drinks straight away, followed by a substantial snack or meal. If the patient is unconscious immediately inform a doctor and call the emergency services. The same should be done if somebody, (for instance a child), has taken the product unintentionally. Unconscious patients must not be given food or drink. It should be ensured that there is always a pre-informed person that can call a doctor in case of emergency.
If you forget to take Gliclazide tablet: It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Gliclazide MR tablet, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Gliclazide MR tablet: As the treatment for diabetes is usually lifelong, you should discuss with your doctor before stopping this medicinal product. Stopping could cause high blood sugar (hyperglycaemia) which increases the risk of developing complications of diabetes. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Modified release preparation: Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The dose is determined by the doctor, depending on your blood and possibly urine sugar levels. Change in external factors (weight reduction, lifestyle, stress) or improvements in the blood sugar control may require changed gliclazide doses.
The recommended daily dose is one to four tablets (maximum 120 mg) in a single intake at breakfast time. This depends on the response to treatment. Gliclazide MR tablet is for oral use. Take your tablet(s) with a glass of water at breakfast time (and preferably at the same time each day). Swallow your whole tablet(s) in one piece. Do not chew or crush. You must always eat a meal after taking your tablet(s).
If a combination therapy of gliclazide with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor a GLP-1 receptor agonist or insulin is initiated your doctor will determine the proper dose of each medicine individually for you. If you notice that your blood sugar levels are high although you are taking the medicine as prescribed, you should contact your doctor or pharmacist.
If you take more Gliclazide tablets than you should: If you take too many tablets, contact your doctor or the nearest hospital Accident & Emergency department immediately. The signs of overdose are those of low blood sugar (hypoglycaemia). The symptoms can be helped by taking sugar (4 to 6 lumps) or sugary drinks straight away, followed by a substantial snack or meal. If the patient is unconscious immediately inform a doctor and call the emergency services. The same should be done if somebody, (for instance a child), has taken the product unintentionally. Unconscious patients must not be given food or drink. It should be ensured that there is always a pre-informed person that can call a doctor in case of emergency.
If you forget to take Gliclazide tablet: It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Gliclazide MR tablet, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Gliclazide MR tablet: As the treatment for diabetes is usually lifelong, you should discuss with your doctor before stopping this medicinal product. Stopping could cause high blood sugar (hyperglycaemia) which increases the risk of developing complications of diabetes. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Side effectsView
Like all medicines, Gliclazide can cause side effects, although not everybody gets them. The most commonly observed side effect is low blood sugar (hypoglycaemia). If left untreated these symptoms could progress to drowsiness, loss of consciousness or possibly coma. If an episode of low blood sugar is severe or prolonged, even if it is temporarily controlled by eating sugar, you should seek immediate medical attention.
Liver disorders: There have been isolated reports of abnormal iiver function, which can cause yellow skin and eyes. If you get this, see your doctor immediately. The symptoms generally disappear if the medicine is stopped. Your doctor will decide whether to stop your treatment.
Skin disorders: Skin reactions such as rash, redness, itching, hives, blisters, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty) have been reported. Rash may progress to widespread blistering or peeling of the skin. If you develop this, stop taking, seek urgent advice from a doctor and tell him that you are taking this medicine. Exceptionally, signs of severe hypersensitivity reactions have been reported: initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature.
Blood disorders: Decrease in the number of cells in the blood (e.g. platelets, red and white blood cells) which may cause paleness, prolonged bleeding, bruising, sore throat and fever have been reported. These symptoms usually vanish when the treatment is discontinued.
Digestive disorders: Abdominal pain, nausea, vomiting, indigestion, diarrhoea, and constipation. These effects are reduced when Gliclazide is taken with a meal as recommended.
Eye disorders: Your vision may be affected for a short time especially at the start of treatment. This effect is due to changes in blood sugar levels.
As for another sulfonylurea, the following adverse events have been observed: cases of severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels, reduction in blood sodium (hyponatraemia), symptoms of liver impairment (for instance jaundice) which in most cases disappeared after withdrawal of the sulfonylurea, but may lead to life-threatening liver failure in isolated cases.
Reporting of side effects: If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.
Liver disorders: There have been isolated reports of abnormal iiver function, which can cause yellow skin and eyes. If you get this, see your doctor immediately. The symptoms generally disappear if the medicine is stopped. Your doctor will decide whether to stop your treatment.
Skin disorders: Skin reactions such as rash, redness, itching, hives, blisters, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty) have been reported. Rash may progress to widespread blistering or peeling of the skin. If you develop this, stop taking, seek urgent advice from a doctor and tell him that you are taking this medicine. Exceptionally, signs of severe hypersensitivity reactions have been reported: initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature.
Blood disorders: Decrease in the number of cells in the blood (e.g. platelets, red and white blood cells) which may cause paleness, prolonged bleeding, bruising, sore throat and fever have been reported. These symptoms usually vanish when the treatment is discontinued.
Digestive disorders: Abdominal pain, nausea, vomiting, indigestion, diarrhoea, and constipation. These effects are reduced when Gliclazide is taken with a meal as recommended.
Eye disorders: Your vision may be affected for a short time especially at the start of treatment. This effect is due to changes in blood sugar levels.
As for another sulfonylurea, the following adverse events have been observed: cases of severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels, reduction in blood sodium (hyponatraemia), symptoms of liver impairment (for instance jaundice) which in most cases disappeared after withdrawal of the sulfonylurea, but may lead to life-threatening liver failure in isolated cases.
Reporting of side effects: If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.
ContraindicationsView
Do not take Gliclazide:
- if you are allergic to gliclazide or to other medicines of the same group (sulfonylurea), or to other related medicines (hypoglycaemic sulfonamides)
- if you have insulin-dependent diabetes (type 1)
- if you have ketone bodies and sugar in your urine (this may mean you have diabetic ketoacidosis), a diabetic pre-coma or coma
- if you have severe kidney or liver disease
- if you are taking medicines to treat fungal infections
- if you are breastfeeding
PrecautionsView
Talk to your doctor before taking Gliclazide. You should observe the treatment plan prescribed by your doctor to achieve proper blood sugar levels. This means, apart from regular tablet intake, to observe the dietary regimen, have physical exercise and, where necessary, reduce weight During gliclazide treatment regular monitoring of your blood (and possibly urine) sugar level and also your glycated haemoglobin (HbA1c) is necessary. In the first few weeks of treatment, the risk of having reduced blood sugar levels (hypoglycaemia) may be increased. So particularly close medical monitoring is necessary.
Low blood sugar (Hypoglycaemia) may occur:
The following signs and symptoms may also occur: sweating, clammy skin, anxiety, fast or irregular heartbeat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris).
If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop convulsions, lose self-control, your breathing may be shallow and your heartbeat slowed down, you may become unconscious.
In most cases the symptoms of low blood sugar vanish very quickly when you consume .some form of sugar, (for instance, glucose tablets, sugar cubes, sweet juice, sweetened tea).
You should therefore always carry some form of sugar with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. Please contact your doctor or the nearest hospital if taking sugar does not help or if the symptoms recur.
Symptoms of low blood sugar may be absent, less obvious or develop very slowly or you are not aware in time that your blood sugar level has dropped. This may happen if you are an elderly patient taking certain medicines (for instance those acting on the central nervous system and beta-blockers).
If you are in stressful situations (e.g. accidents, surgical operations, fever etc.) your doctor may temporarily switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide has not yet sufficiently reduced the blood sugar when you have not complied with the treatment plan prescribed by your doctor if you take St. John’s Wort (Hypericum perforatum) preparations or in special stress situations. These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and reduced performance.
Blood glucose disturbances (low blood sugar and high bold sugar) can occur when Gliclazide is prescribed at the same time as medicines to a class of antibiotics called fluoroquinolone, especially in elderly patients. In this case, your doctor will remind you of the importance of monitoring your blood glucose.
If you have a family history of or know you have the hereditary condition glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormality of red blood cells), lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur. Contact your doctor before taking this medicinal product.
Gliclazide is not recommended for use in children due to lack of data.
Low blood sugar (Hypoglycaemia) may occur:
- if you take meals irregularly or skip meals altogether,
- if you are fasting
- if you are malnourished
- if you change your diet
- if you increase your physical activity and carbohydrate intake does not match this increase,
- if you drink alcohol, especially in combination with skipped meals,
- if you take other medicines or natural remedies at the same time,
- if you take too high doses of gliclazide,
- if you suffer from particular hormone-induced disorders (functional disorders of the thyroid gland, pituitary gland or adrenal cortex),
- if your kidney function or liver function is severely decreased.
The following signs and symptoms may also occur: sweating, clammy skin, anxiety, fast or irregular heartbeat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris).
If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop convulsions, lose self-control, your breathing may be shallow and your heartbeat slowed down, you may become unconscious.
In most cases the symptoms of low blood sugar vanish very quickly when you consume .some form of sugar, (for instance, glucose tablets, sugar cubes, sweet juice, sweetened tea).
You should therefore always carry some form of sugar with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. Please contact your doctor or the nearest hospital if taking sugar does not help or if the symptoms recur.
Symptoms of low blood sugar may be absent, less obvious or develop very slowly or you are not aware in time that your blood sugar level has dropped. This may happen if you are an elderly patient taking certain medicines (for instance those acting on the central nervous system and beta-blockers).
If you are in stressful situations (e.g. accidents, surgical operations, fever etc.) your doctor may temporarily switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide has not yet sufficiently reduced the blood sugar when you have not complied with the treatment plan prescribed by your doctor if you take St. John’s Wort (Hypericum perforatum) preparations or in special stress situations. These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and reduced performance.
Blood glucose disturbances (low blood sugar and high bold sugar) can occur when Gliclazide is prescribed at the same time as medicines to a class of antibiotics called fluoroquinolone, especially in elderly patients. In this case, your doctor will remind you of the importance of monitoring your blood glucose.
If you have a family history of or know you have the hereditary condition glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormality of red blood cells), lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur. Contact your doctor before taking this medicinal product.
Gliclazide is not recommended for use in children due to lack of data.
InteractionsView
Other medicines and Gliclazide: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
The blood sugar lowering effect of gliclazide may be strengthened and signs of low blood sugar levels may occur when one of the follow ng medicines is taken:
Gliclazide may increase the effects of medicines that reduce blood clotting (warfarin).
Consult your doctor before you start taking another medicinal product. If you go into hospital tell the medical staff you are taking gliclazide.
Gliclazide with food and drink: Gliclazide can be taken with food and non-alcoholic drinks. Drinking alcohol is not recommended as it can alter the control of your diabetes in an unpredictable manner.
Driving and using machines: Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycaemia), or too high (hyperglycaemia) or if you develop visual problems as a result of such conditions. Bear in mind that you could endanger yourself or others (for instance when driving a car or using machines). Please ask your doctor whether you can drive a car if you:
The blood sugar lowering effect of gliclazide may be strengthened and signs of low blood sugar levels may occur when one of the follow ng medicines is taken:
- other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists or insulin),
- antibiotics (sulphonamides, clarithromycin)
- medicines to treat high blood pressure or heart failure (beta-blockers. ACE-inhibitors such as captopril, or enalapril)
- medicines to treat fungal infections (miconazole, fluconazole)
- medicines to treat ulcers in the stomach or duodenum (H2 receptor antagonists),
- medicines to treat depression (monoamine oxidase inhibitors)
- painkiller or antirheumatics (phenylbutazone, ibuprofen)
- medicines containing alcohol
- medicines to treat disorders of the central nervous system (chlorpromazine)
- medicines reducing inflammation (corticosteroids)
- medicines to treat asthma or used during labour (intravenous salbutamol, ritodrine and terbutaline)
- medicines to treat breast disorders, heavy menstrual bleeding and endometriosis (danazol)
- St John's Wort- Hypericum perforatum- preparations
Gliclazide may increase the effects of medicines that reduce blood clotting (warfarin).
Consult your doctor before you start taking another medicinal product. If you go into hospital tell the medical staff you are taking gliclazide.
Gliclazide with food and drink: Gliclazide can be taken with food and non-alcoholic drinks. Drinking alcohol is not recommended as it can alter the control of your diabetes in an unpredictable manner.
Driving and using machines: Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycaemia), or too high (hyperglycaemia) or if you develop visual problems as a result of such conditions. Bear in mind that you could endanger yourself or others (for instance when driving a car or using machines). Please ask your doctor whether you can drive a car if you:
- have frequent episodes of low blood sugar (hypoglycaemia)
- have few or no warning signals of low blood sugar (hypoglycaemia)
Pregnancy & lactationView
Gliclazide is not recommended for use during pregnancy. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You must not take Gliclazide while you are breastfeeding.
StorageView
Keep out of the reach and sight of children. Do not use this medicine after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of that month. Store below 30°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Diar
Nitazoxanide
Diar
Nitazoxanide
Indications
Giardiasis
Indication detailsView
Nitazoxanide is indicated for the treatment of diarrhea caused by Cryptosporidium parvum, Giardia lamblia and Entamoeba histolytica.
Therapeutic classView
Anti-diarrhoeal Antiprotozoal
PharmacologyView
Nitazoxanide is a synthetic antiprotozoal agent for oral administration. The antiprotozoal activity of Nitazoxanide is believed to be interference with the Pyruvate Ferredoxin Oxido Reductase (PFOR) enzyme-dependant electron transfer reaction. This reaction is essential for anaerobic energy metabolism of the protozoa. Nitazoxanide and its metabolites, tizoxanid are active in vitro in inhibiting the growth of sporozoites and oocyst of Cryptosporidium parvum and trophozoites of Giardia lamblia.
DosageView
Age 1-3 years: 1 tea-spoonfull or 5 ml suspension every 12 hours for 3 days.
Age 4-11 years: 2 tea-spoonfulls or 10 ml suspension every 12 hours for 3 days.
Age 12 years or above: 5 tea-spoonfulls (25 ml) suspension or 1 tablet every 12 hours for 3 days.
It is recommended to be administered with food.
Age 4-11 years: 2 tea-spoonfulls or 10 ml suspension every 12 hours for 3 days.
Age 12 years or above: 5 tea-spoonfulls (25 ml) suspension or 1 tablet every 12 hours for 3 days.
It is recommended to be administered with food.
Side effectsView
The most frequent side effects, reported by Nitazoxanide are abdominal pain, vomiting and headache. These side effects are typically mild and transient in nature. Very rare side effects include- nausea, anorexia, flatulence, increased appetite, enlarged salivary glands, increased creatinine & SGPT level, pruritus, rhinitis, sweating, dizziness, discolored urine etc.
ContraindicationsView
It is contraindicated in patients with known hypersensitivity to Nitazoxanide or any components of the preparation.
PrecautionsView
Nitazoxanide must be administered with caution to patients with hepatic & biliary disease and to patients with renal disease.
InteractionsView
It is highly bound to plasma protein. Therefore, caution should be exercised when administering Nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic index.
Pregnancy & lactationView
US FDA pregnancy category of Nitazoxanide is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nitazoxanide have been shown to be excreted in human milk. So, caution should be exercised when Nitazoxanide is administered during lactation.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Diar
Nitazoxanide
Diar
Nitazoxanide
Indications
Giardiasis
Indication detailsView
Nitazoxanide is indicated for the treatment of diarrhea caused by Cryptosporidium parvum, Giardia lamblia and Entamoeba histolytica.
Therapeutic classView
Anti-diarrhoeal Antiprotozoal
PharmacologyView
Nitazoxanide is a synthetic antiprotozoal agent for oral administration. The antiprotozoal activity of Nitazoxanide is believed to be interference with the Pyruvate Ferredoxin Oxido Reductase (PFOR) enzyme-dependant electron transfer reaction. This reaction is essential for anaerobic energy metabolism of the protozoa. Nitazoxanide and its metabolites, tizoxanid are active in vitro in inhibiting the growth of sporozoites and oocyst of Cryptosporidium parvum and trophozoites of Giardia lamblia.
DosageView
Age 1-3 years: 1 tea-spoonfull or 5 ml suspension every 12 hours for 3 days.
Age 4-11 years: 2 tea-spoonfulls or 10 ml suspension every 12 hours for 3 days.
Age 12 years or above: 5 tea-spoonfulls (25 ml) suspension or 1 tablet every 12 hours for 3 days.
It is recommended to be administered with food.
Age 4-11 years: 2 tea-spoonfulls or 10 ml suspension every 12 hours for 3 days.
Age 12 years or above: 5 tea-spoonfulls (25 ml) suspension or 1 tablet every 12 hours for 3 days.
It is recommended to be administered with food.
Side effectsView
The most frequent side effects, reported by Nitazoxanide are abdominal pain, vomiting and headache. These side effects are typically mild and transient in nature. Very rare side effects include- nausea, anorexia, flatulence, increased appetite, enlarged salivary glands, increased creatinine & SGPT level, pruritus, rhinitis, sweating, dizziness, discolored urine etc.
ContraindicationsView
It is contraindicated in patients with known hypersensitivity to Nitazoxanide or any components of the preparation.
PrecautionsView
Nitazoxanide must be administered with caution to patients with hepatic & biliary disease and to patients with renal disease.
InteractionsView
It is highly bound to plasma protein. Therefore, caution should be exercised when administering Nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic index.
Pregnancy & lactationView
US FDA pregnancy category of Nitazoxanide is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nitazoxanide have been shown to be excreted in human milk. So, caution should be exercised when Nitazoxanide is administered during lactation.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.