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Amuran
Ranitidine Hydrochloride
Amuran
Ranitidine Hydrochloride
Indications
Zollinger-Ellison syndrome
Indication detailsView
Ranitidine is indicated in:
- Treatment of active duodenal ulcer
- Benign gastric ulcer
- Treatment & prevention of ulcer associated with non-steroidal anti-inflammatory agent
- Post operative stress ulcer.
- Zollinger-Ellison Syndrome.
- Gastroesophageal reflux disease (GERD).
- Gastro-intestinal haemorrhage from stress ulcer in seriously ill patient.
- Recurrent haemorrhage in patients with bleeding peptic ulcer.
- Before general anesthesia in patient considered to be at risk of acid aspiration particulary obstetric patients.
Therapeutic classView
H2 receptor antagonist
PharmacologyView
Ranitidine competitively blocks histamine at H2-receptors of the gastric parietal cells which inhibits gastric acid secretion. It does not affect pepsin secretion, pentagastrin-stimulated intrinsic factor secretion or serum gastrin.
DosageView
Ranitidine Tablet & Syrup:
Duodenal and gastric ulcer: The usual dosage is 150 mg twice daily taken in the morning and evening or 300 mg as a single daily dose at night for 4 to 8 weeks.Reflux oesophagitis: 150 mg twice daily or 300 mg at bed time for up to 8 weeks.
Zollinger Ellison syndrome: 150 mg 3 times daily and increased if necessary up to 6 g daily in divided doses. Dosage should be continued as long as clinically indicated.
Episodic dyspepsia: 150 mg twice daily or 300 mg at bed time for up to 6 weeks.
Maintenance: 150 mg at night for preventing recurrences.
Child (peptic ulcer): 2-4 mg/kg twice daily, maximum 300 mg daily.
Ranitidine IV injection & IV Infusion:
Ranitidine injection may be given either as a slow (over a period of at least two minutes) intravenous injection of 50 mg, after dilution to a volume of 20 ml per 50 mg dose, which may be repeated every six to eight hours; or as an intermittent intravenous infusion at a rate of 25 mg per hour for two hours; the infusion may be repeated at six to eight hour intervals; or as an intramuscular injection of 50 mg (2 ml) every six to eight hours. In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, parenteral administration may be continued until oral feeding commences.In the prophylaxis of upper gastrointestinal haemorrhage from stress ulceration in seriously ill patient sapriming dose of 50 mg as low as intravenous injection followed by a continuous intravenous infusion of 0.125-0.250 mg/kg/hour may be preferred. In patients considered to be at risk of developing aspiration syndrome Ranitidine injection 50 mg may be given intramuscularly or by slow intravenous injection 45 to 60 minutes before induction of general anaesthesia.
Children: The recommended oral dose for the treatment of peptic ulcer in children is 2 mg/kg to 4 mg/kg twice daily to a maximum of 300 mg ranitidine per day. Safety and effectiveness of Ranitidine injection have not been established in case of children.
Side effectsView
Ranitidine is well tolerated and side effects are usually uncommon. Altered bowel habit, dizziness, rash, tiredness, reversible confusional states, headache, decreased blood counts, muscle or joint pain have rarely been reported.
ContraindicationsView
Patients hypersensitive to Ranitidine
PrecautionsView
Ranitidine should be given in reduced dosage to patients with impaired renal and hepatic function.
InteractionsView
Delayed absorption and increased peak serum concentration with propantheline bromide. Ranitidine minimally inhibits hepatic metabolism of coumarin anticoagulants, theophylline, diazepam and propanolol. May alter absorption of pH-dependent drugs (e.g. ketoconazole, midazolam, glipizide). May reduce bioavailability with antacids.
Pregnancy & lactationView
Pregnancy: Ranitidine crosses the placenta. But there is no evidence of impaired fertility or harm to the foetus due to Ranitidine. Like other drugs, Ranitidine should only be used during pregnancy if considered essential.
Lactation: Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.
Lactation: Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.
Pediatric usageView
Use in elderly patients: In clinical trial the ulcer healing rates have been found similar in patients age 65 and over with those in younger patients. Additionally, there was no difference in the incidence of adverse effects.
Overdose effectsView
Ranitidine is very specific in action and accordingly no particular problems are expected following overdosage with the drug. Symptomatic and supportive therapy should be given as appropriate. If required, the drug may be removed from the plasma by haemodiaiysis.
ReconstitutionView
Slow IV inj: Ranitidine 50 mg diluted to a concentration ≤2.5 mg/mL (e.g. total of 20 mL) with NaCl 0.9% inj or dextrose 5% or 10%, lactated Ringer's, Na bicarbonate 5% soln.
Intermittent slow IV infusion: Ranitidine 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Continuous IV infusion: Ranitidine 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Patients with Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Intermittent slow IV infusion: Ranitidine 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Continuous IV infusion: Ranitidine 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Patients with Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
StorageView
Store in a cool and dry place. protect from light.
Amynil
Glimepiride
Amynil
Glimepiride
Indications
Type 2 DM
Indication detailsView
Glimepiride is indicated in following conditions-
- Glimepiride is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with noninsulin dependent (Type II) diabetes mellitus (NIDDM) whose hyperglycaemia cannot be controlled by diet and exercise alone.
- Glimepiride may be used concomitantly with metformin when diet, exercise, and Glimepiride or metformin alone does not result in adequate glycaemic control.
- Glimepiride is also indicated for use in combination with insulin to lower blood glucose in patients whose hyperglycaemia cannot be controlled by diet and exercise in conjunction with an oral hypoglycaemic agent.
- Combined use of Glimepiride and insulin may increase the potential for hypoglycaemia.
Therapeutic classView
Sulfonylureas
PharmacologyView
Glimepiride is a sulfonylurea antidiabetic agent which decreases blood glucose concentration. The primary mechanism of action of Glimepiride appears to be dependent on stimulating the release of insulin from functioning pancreatic beta cells. Glimepiride acts in concert with glucose by improving the sensitivity of beta cells to physiological glucose stimulus, resulting in insulin secretion. In addition, extrapancreatic effects like reduction of basal hepatic glucose production, increased peripheral tissue sensitivity to insulin and glucose uptake may also play role in the activity of Glimepiride. In non-fasting diabetic patients, the hypoglycaemic action of a single dose of Glimepiride persists for 24 hours.
DosageView
In principle, the dosage of Glimepiride is governed by the desired blood sugar level. The dosage of Glimepiride must be the lowest which is sufficient to achieve the desired metabolic control. The initial and the maintenance doses are set based on the results of regular check of glucose in blood and urine. Monitoring of glucose levels in blood and urine also serves to detect either primary or secondary failure of therapy.
Initial dose and dose titration: the usual initial dose is 1 mg once daily, if necessary, the daily dose can be increased. Any increase can be based on regular blood sugar monitoring, and should be gradual, i.e., at intervals of 1 to 2 weeks, and carried out stepwise, as follows: 1 mg -> 2 mg -> 3 mg -> 4 mg -> 6 mg.
Dose in patients with well controlled diabetes: the usual dose range in patients with well controlled diabetes is 1 to 4 mg daily.
Distribution of doses: Timing and distribution of doses are decided by the physician, in consideration of the patient's current life-style. Normally, a single daily dose is sufficient. This should be taken immediately before a substantial breakfast or if none is taken immediately before the first main meal. It is very important not to skip meals after taking the drug.
Secondary dosage adjustment: As control of diabetes improves, sensitivity to insuiin increases; therefore, Glimepiride requirement may fall as treatment proceeds. To avoid hypoglycaemia, timely dose reduction or cessation of Glimepiride therapy must be considered. A dose adjustment must also be considered whenever the patient's weight or life-styie changes, or other factors arise which cause an increased susceptibility to hypo or hyperglycaemia.
Changeover from other oral antidiabetics to Glimepiride: There is no exact dosage relationship between Glimepiride and other oral blood sugar lowering agents. When substituting Glimepiride for other such agents, the initial daily dose is 1 mg; this applies even in changeover from maximum dose of other oral blood sugar lowering agents. Any dose increase should be in accordance with guideline given above in 'initial dose and dose titration'. Consideration must be given to the potency and duration of action of the previous blood sugar lowering agent. It may be necessary to interrupt treatment to avoid additive effects which would increase the risk of hypoglycaemia.
Initial dose and dose titration: the usual initial dose is 1 mg once daily, if necessary, the daily dose can be increased. Any increase can be based on regular blood sugar monitoring, and should be gradual, i.e., at intervals of 1 to 2 weeks, and carried out stepwise, as follows: 1 mg -> 2 mg -> 3 mg -> 4 mg -> 6 mg.
Dose in patients with well controlled diabetes: the usual dose range in patients with well controlled diabetes is 1 to 4 mg daily.
Distribution of doses: Timing and distribution of doses are decided by the physician, in consideration of the patient's current life-style. Normally, a single daily dose is sufficient. This should be taken immediately before a substantial breakfast or if none is taken immediately before the first main meal. It is very important not to skip meals after taking the drug.
Secondary dosage adjustment: As control of diabetes improves, sensitivity to insuiin increases; therefore, Glimepiride requirement may fall as treatment proceeds. To avoid hypoglycaemia, timely dose reduction or cessation of Glimepiride therapy must be considered. A dose adjustment must also be considered whenever the patient's weight or life-styie changes, or other factors arise which cause an increased susceptibility to hypo or hyperglycaemia.
Changeover from other oral antidiabetics to Glimepiride: There is no exact dosage relationship between Glimepiride and other oral blood sugar lowering agents. When substituting Glimepiride for other such agents, the initial daily dose is 1 mg; this applies even in changeover from maximum dose of other oral blood sugar lowering agents. Any dose increase should be in accordance with guideline given above in 'initial dose and dose titration'. Consideration must be given to the potency and duration of action of the previous blood sugar lowering agent. It may be necessary to interrupt treatment to avoid additive effects which would increase the risk of hypoglycaemia.
AdministrationView
Glimepiride tablet must be swallowed with sufficient amount of liquid.
Side effectsView
Hypoglycaemia, temporary visual impairment, nausea, vomiting, diarrhoea, abdominal pain, urticaria, fall in blood pressure.
ContraindicationsView
Glimepiride is not suitable for the treatment of insulin dependent (type I) diabetes mellitus, or for the treatment of diabetic ketoacidosis, nor for the treatment of diabetic coma. Glimepiride must not be used in patients hypersensitive to Glimepiride, other sulfonylureas, other sulfonamides, severe hepatic dysfunction, severe impairment of renal function and dialysis patients.
PrecautionsView
in the initial weeks of treatment, the risk of hypoglycaemia may be increased and necessitates careful monitoring. If such risk present it may be necessary to adjust the dosage of Glimepiride, Hypoglycaemia can almost be promptly controlled by immediate intake of carbohydrates (glucose or sugar).
InteractionsView
Based on experience with Glimepiride and known interactions for other sulfonylureas, the following interactions must be considered.
In addition to insulin and other oral antidiabetic agents, drugs which may potentiate the hypoglycaemic action of Glimepiride include: ACE inhibitors, aminosalicylic acid, anabolic steroids and male sex hormones, azapropazone, chloramphenicol, ciofibrate, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluconazole, fluoxetine, guanethidine, ifosfamide, MAO-inhibitors, miconazole, oxpentifylline (high dose parenteral), oxyphenbutazone, para-aminosalicylic acid, phenylbutazone, probenecid, quinolones, salicylates, sulphinpyrazone, sulfonamide antibiotics, tetracyclines, tritoqualine, trofosfamide.
Drugs which may attenuate the hypoglycaemic action of Glimepiride include:
In addition to insulin and other oral antidiabetic agents, drugs which may potentiate the hypoglycaemic action of Glimepiride include: ACE inhibitors, aminosalicylic acid, anabolic steroids and male sex hormones, azapropazone, chloramphenicol, ciofibrate, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluconazole, fluoxetine, guanethidine, ifosfamide, MAO-inhibitors, miconazole, oxpentifylline (high dose parenteral), oxyphenbutazone, para-aminosalicylic acid, phenylbutazone, probenecid, quinolones, salicylates, sulphinpyrazone, sulfonamide antibiotics, tetracyclines, tritoqualine, trofosfamide.
Drugs which may attenuate the hypoglycaemic action of Glimepiride include:
- Acetazoiamide, barbiturates, calcium channel blockers, corticosteroids, diazoxide, diuretics, glucagon, isoniazid, laxatives, nicotinic acid (high doses), oestrogens, phenothiazines, phenytoin, progestagens, rifampicin, sympathomimetic agents, thyroid hormones.
- H2 receptor antagonists, beta-blockers, clonidine and reserpine may lead to either potentiation or weakening of the blood-glucose-lowering effect.
- Concomitant treatment with a beta-receptor blocker, clonidine, guanethidine or reserpine may mask the warning symptoms of a hypoglycaemic attack.
- Acute and chronic aicohol intake may either potentiate or attenuate the activity of Glimepiride in an unpredictable fashion.
Pregnancy & lactationView
Glimepiride must not be taken during pregnancy; a changeover to insulin is necessary. Patients planning a pregnancy must inform their physician, and should change over to insulin. Ingestion of Glimepiride with breast milk feeding may harm the child. Therefore, Glimepiride must not be taken by breastfeeding women. Either a changeover or complete discontinuation of breastfeeding is necessary.
Overdose effectsView
Overdosage of sulfonylureas, including Glimepiride, can produce hypoglycaemia. Mild hypoglycaemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustments in drug dosage or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycaemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medicai emergencies requiring immediate hospitalization. If hypoglycaemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate that will maintain the blood glucose at a level above 100 mg/dl. Patients should be closely monitored for a minimum of 24 to 48 hours, because hypoglycaemia may recur after apparent clinical recovery.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Amynil
Glimepiride
Amynil
Glimepiride
Indications
Type 2 DM
Indication detailsView
Glimepiride is indicated in following conditions-
- Glimepiride is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with noninsulin dependent (Type II) diabetes mellitus (NIDDM) whose hyperglycaemia cannot be controlled by diet and exercise alone.
- Glimepiride may be used concomitantly with metformin when diet, exercise, and Glimepiride or metformin alone does not result in adequate glycaemic control.
- Glimepiride is also indicated for use in combination with insulin to lower blood glucose in patients whose hyperglycaemia cannot be controlled by diet and exercise in conjunction with an oral hypoglycaemic agent.
- Combined use of Glimepiride and insulin may increase the potential for hypoglycaemia.
Therapeutic classView
Sulfonylureas
PharmacologyView
Glimepiride is a sulfonylurea antidiabetic agent which decreases blood glucose concentration. The primary mechanism of action of Glimepiride appears to be dependent on stimulating the release of insulin from functioning pancreatic beta cells. Glimepiride acts in concert with glucose by improving the sensitivity of beta cells to physiological glucose stimulus, resulting in insulin secretion. In addition, extrapancreatic effects like reduction of basal hepatic glucose production, increased peripheral tissue sensitivity to insulin and glucose uptake may also play role in the activity of Glimepiride. In non-fasting diabetic patients, the hypoglycaemic action of a single dose of Glimepiride persists for 24 hours.
DosageView
In principle, the dosage of Glimepiride is governed by the desired blood sugar level. The dosage of Glimepiride must be the lowest which is sufficient to achieve the desired metabolic control. The initial and the maintenance doses are set based on the results of regular check of glucose in blood and urine. Monitoring of glucose levels in blood and urine also serves to detect either primary or secondary failure of therapy.
Initial dose and dose titration: the usual initial dose is 1 mg once daily, if necessary, the daily dose can be increased. Any increase can be based on regular blood sugar monitoring, and should be gradual, i.e., at intervals of 1 to 2 weeks, and carried out stepwise, as follows: 1 mg -> 2 mg -> 3 mg -> 4 mg -> 6 mg.
Dose in patients with well controlled diabetes: the usual dose range in patients with well controlled diabetes is 1 to 4 mg daily.
Distribution of doses: Timing and distribution of doses are decided by the physician, in consideration of the patient's current life-style. Normally, a single daily dose is sufficient. This should be taken immediately before a substantial breakfast or if none is taken immediately before the first main meal. It is very important not to skip meals after taking the drug.
Secondary dosage adjustment: As control of diabetes improves, sensitivity to insuiin increases; therefore, Glimepiride requirement may fall as treatment proceeds. To avoid hypoglycaemia, timely dose reduction or cessation of Glimepiride therapy must be considered. A dose adjustment must also be considered whenever the patient's weight or life-styie changes, or other factors arise which cause an increased susceptibility to hypo or hyperglycaemia.
Changeover from other oral antidiabetics to Glimepiride: There is no exact dosage relationship between Glimepiride and other oral blood sugar lowering agents. When substituting Glimepiride for other such agents, the initial daily dose is 1 mg; this applies even in changeover from maximum dose of other oral blood sugar lowering agents. Any dose increase should be in accordance with guideline given above in 'initial dose and dose titration'. Consideration must be given to the potency and duration of action of the previous blood sugar lowering agent. It may be necessary to interrupt treatment to avoid additive effects which would increase the risk of hypoglycaemia.
Initial dose and dose titration: the usual initial dose is 1 mg once daily, if necessary, the daily dose can be increased. Any increase can be based on regular blood sugar monitoring, and should be gradual, i.e., at intervals of 1 to 2 weeks, and carried out stepwise, as follows: 1 mg -> 2 mg -> 3 mg -> 4 mg -> 6 mg.
Dose in patients with well controlled diabetes: the usual dose range in patients with well controlled diabetes is 1 to 4 mg daily.
Distribution of doses: Timing and distribution of doses are decided by the physician, in consideration of the patient's current life-style. Normally, a single daily dose is sufficient. This should be taken immediately before a substantial breakfast or if none is taken immediately before the first main meal. It is very important not to skip meals after taking the drug.
Secondary dosage adjustment: As control of diabetes improves, sensitivity to insuiin increases; therefore, Glimepiride requirement may fall as treatment proceeds. To avoid hypoglycaemia, timely dose reduction or cessation of Glimepiride therapy must be considered. A dose adjustment must also be considered whenever the patient's weight or life-styie changes, or other factors arise which cause an increased susceptibility to hypo or hyperglycaemia.
Changeover from other oral antidiabetics to Glimepiride: There is no exact dosage relationship between Glimepiride and other oral blood sugar lowering agents. When substituting Glimepiride for other such agents, the initial daily dose is 1 mg; this applies even in changeover from maximum dose of other oral blood sugar lowering agents. Any dose increase should be in accordance with guideline given above in 'initial dose and dose titration'. Consideration must be given to the potency and duration of action of the previous blood sugar lowering agent. It may be necessary to interrupt treatment to avoid additive effects which would increase the risk of hypoglycaemia.
AdministrationView
Glimepiride tablet must be swallowed with sufficient amount of liquid.
Side effectsView
Hypoglycaemia, temporary visual impairment, nausea, vomiting, diarrhoea, abdominal pain, urticaria, fall in blood pressure.
ContraindicationsView
Glimepiride is not suitable for the treatment of insulin dependent (type I) diabetes mellitus, or for the treatment of diabetic ketoacidosis, nor for the treatment of diabetic coma. Glimepiride must not be used in patients hypersensitive to Glimepiride, other sulfonylureas, other sulfonamides, severe hepatic dysfunction, severe impairment of renal function and dialysis patients.
PrecautionsView
in the initial weeks of treatment, the risk of hypoglycaemia may be increased and necessitates careful monitoring. If such risk present it may be necessary to adjust the dosage of Glimepiride, Hypoglycaemia can almost be promptly controlled by immediate intake of carbohydrates (glucose or sugar).
InteractionsView
Based on experience with Glimepiride and known interactions for other sulfonylureas, the following interactions must be considered.
In addition to insulin and other oral antidiabetic agents, drugs which may potentiate the hypoglycaemic action of Glimepiride include: ACE inhibitors, aminosalicylic acid, anabolic steroids and male sex hormones, azapropazone, chloramphenicol, ciofibrate, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluconazole, fluoxetine, guanethidine, ifosfamide, MAO-inhibitors, miconazole, oxpentifylline (high dose parenteral), oxyphenbutazone, para-aminosalicylic acid, phenylbutazone, probenecid, quinolones, salicylates, sulphinpyrazone, sulfonamide antibiotics, tetracyclines, tritoqualine, trofosfamide.
Drugs which may attenuate the hypoglycaemic action of Glimepiride include:
In addition to insulin and other oral antidiabetic agents, drugs which may potentiate the hypoglycaemic action of Glimepiride include: ACE inhibitors, aminosalicylic acid, anabolic steroids and male sex hormones, azapropazone, chloramphenicol, ciofibrate, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluconazole, fluoxetine, guanethidine, ifosfamide, MAO-inhibitors, miconazole, oxpentifylline (high dose parenteral), oxyphenbutazone, para-aminosalicylic acid, phenylbutazone, probenecid, quinolones, salicylates, sulphinpyrazone, sulfonamide antibiotics, tetracyclines, tritoqualine, trofosfamide.
Drugs which may attenuate the hypoglycaemic action of Glimepiride include:
- Acetazoiamide, barbiturates, calcium channel blockers, corticosteroids, diazoxide, diuretics, glucagon, isoniazid, laxatives, nicotinic acid (high doses), oestrogens, phenothiazines, phenytoin, progestagens, rifampicin, sympathomimetic agents, thyroid hormones.
- H2 receptor antagonists, beta-blockers, clonidine and reserpine may lead to either potentiation or weakening of the blood-glucose-lowering effect.
- Concomitant treatment with a beta-receptor blocker, clonidine, guanethidine or reserpine may mask the warning symptoms of a hypoglycaemic attack.
- Acute and chronic aicohol intake may either potentiate or attenuate the activity of Glimepiride in an unpredictable fashion.
Pregnancy & lactationView
Glimepiride must not be taken during pregnancy; a changeover to insulin is necessary. Patients planning a pregnancy must inform their physician, and should change over to insulin. Ingestion of Glimepiride with breast milk feeding may harm the child. Therefore, Glimepiride must not be taken by breastfeeding women. Either a changeover or complete discontinuation of breastfeeding is necessary.
Overdose effectsView
Overdosage of sulfonylureas, including Glimepiride, can produce hypoglycaemia. Mild hypoglycaemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustments in drug dosage or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycaemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medicai emergencies requiring immediate hospitalization. If hypoglycaemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate that will maintain the blood glucose at a level above 100 mg/dl. Patients should be closely monitored for a minimum of 24 to 48 hours, because hypoglycaemia may recur after apparent clinical recovery.
StorageView
Do not store above 30°C. Keep away from light and out of the reach of children.
Amzith
Azithromycin Dihydrate
Amzith
Azithromycin Dihydrate
Indication detailsView
Azithromycin is indicated for infections (caused by susceptible organisms) in lower respiratory tract infections including bronchitis and pneumonia, in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis, in otitis media, and in skin and soft tissue infections. In sexually transmitted diseases in men and women, Azithromycin is indicated in the treatment of non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis.
PharmacologyView
Azithromycin is acid-stable and can therefore be taken orally with no need of protection from gastric acids. It is readily absorbed; its absorption is greater on an empty stomach. Time to peak concentration in adults is 2.1 to 3.2 hours for oral dosage forms. Due to the high concentration in phagocytes, azithromycin is actively transported to the site of infection. During active phagocytosis, large concentrations of azithromycin are released. The concentration of azithromycin in the tissues can be over 50 times higher than in plasma. This is due to ion trapping and the high lipid solubility.
Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.
Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:
Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.
Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:
- Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes
- Aerobic and facultative gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae
- Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis , Mycoplasma pneumoniae , Betalactamase production should have no effect on azithromycin activity.
- Aerobic and facultative gram-positive microorganisms: Streptococci (Groups C,F,G), Viridans group streptococci
- Aerobic and facultative gram-negative microorganisms: Bordetella pertussis, Legionella pneumophila
- Anaerobic microorganisms: Peptostreptococcus species, Prevotella bivia
DosageView
Oral-
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.
Children:
Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.
Children:
- 10 mg/kg body weight once daily for 3 days for child over 6 months
- 200 mg (1 teaspoonful) for 3 days if body weight is 15-25 kg
- 300 mg (1½ teaspoonfuls) for 3 days if body weight is 26-35 kg; 400 mg (2 teaspoonfuls) for 3 days if body weight is 36-45 kg.
- In typhoid fever, 500 mg (2½ teaspoonfuls) once daily for 7-10 days is given.
Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:
- 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7 to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
- The recommended dose of Azithromycin for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin.
- Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.
AdministrationView
Reconstitution procedure of suspension-
- Step 01: Shake the bottle well to loosen the powder.
- Step 02: Add boiled and cooled water up to the water mark of the bottle label.
- Step 03: Shake until powder is completely mixed with water.
Side effectsView
Azithromycin is well tolerated with a low incidence of side effects. The side effects include nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhoea, headache, dizziness, and skin rashes and are reversible upon discontinuation of therapy.
ContraindicationsView
Azithromycin is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated. Azithromycin is contraindicated in patients with hepatic diseases.
PrecautionsView
As with any antibiotic, observation for signs of superinfection with non-susceptible organisms, including fungi, is recommended. No dose adjustment is needed in patients with renal impairment.
InteractionsView
Azithromycin absorption is reduced in presence of food and antacid. In patients receiving ergot alkaloids Azithromycin should be avoided because of the possibility of ergotism resulting from interaction of Azithromycin with the cytochrome P-450 system. As macrolides increase the plasma concentration of digoxin and cyclosporin, caution should be exercised while co-administration. There have been no drug interactions between Azithromycin and Warfarin, Theophylline, Carbamazepine, Methylprednisolone or Cimetidine.
Pregnancy & lactationView
Pregnancy Category of Azithromycin is B. Animal reproduction studies have demonstrated that Azithromycin has no evidence of harm to the fetus. There are no adequate and well controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if adequate alternatives are not available. It is not known whether Azithromycin is secreted in breast milk. So, caution should be exercised when Azithromycin is administered to nursing women.
Overdose effectsView
There is no data on overdosage with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Amzith
Azithromycin Dihydrate
Amzith
Azithromycin Dihydrate
Indication detailsView
Azithromycin is indicated for infections (caused by susceptible organisms) in lower respiratory tract infections including bronchitis and pneumonia, in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis, in otitis media, and in skin and soft tissue infections. In sexually transmitted diseases in men and women, Azithromycin is indicated in the treatment of non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis.
PharmacologyView
Azithromycin is acid-stable and can therefore be taken orally with no need of protection from gastric acids. It is readily absorbed; its absorption is greater on an empty stomach. Time to peak concentration in adults is 2.1 to 3.2 hours for oral dosage forms. Due to the high concentration in phagocytes, azithromycin is actively transported to the site of infection. During active phagocytosis, large concentrations of azithromycin are released. The concentration of azithromycin in the tissues can be over 50 times higher than in plasma. This is due to ion trapping and the high lipid solubility.
Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.
Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:
Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.
Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:
- Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes
- Aerobic and facultative gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae
- Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis , Mycoplasma pneumoniae , Betalactamase production should have no effect on azithromycin activity.
- Aerobic and facultative gram-positive microorganisms: Streptococci (Groups C,F,G), Viridans group streptococci
- Aerobic and facultative gram-negative microorganisms: Bordetella pertussis, Legionella pneumophila
- Anaerobic microorganisms: Peptostreptococcus species, Prevotella bivia
DosageView
Oral-
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.
Children:
Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.
Children:
- 10 mg/kg body weight once daily for 3 days for child over 6 months
- 200 mg (1 teaspoonful) for 3 days if body weight is 15-25 kg
- 300 mg (1½ teaspoonfuls) for 3 days if body weight is 26-35 kg; 400 mg (2 teaspoonfuls) for 3 days if body weight is 36-45 kg.
- In typhoid fever, 500 mg (2½ teaspoonfuls) once daily for 7-10 days is given.
Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:
- 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7 to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
- The recommended dose of Azithromycin for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin.
- Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.
AdministrationView
Reconstitution procedure of suspension-
- Step 01: Shake the bottle well to loosen the powder.
- Step 02: Add boiled and cooled water up to the water mark of the bottle label.
- Step 03: Shake until powder is completely mixed with water.
Side effectsView
Azithromycin is well tolerated with a low incidence of side effects. The side effects include nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhoea, headache, dizziness, and skin rashes and are reversible upon discontinuation of therapy.
ContraindicationsView
Azithromycin is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated. Azithromycin is contraindicated in patients with hepatic diseases.
PrecautionsView
As with any antibiotic, observation for signs of superinfection with non-susceptible organisms, including fungi, is recommended. No dose adjustment is needed in patients with renal impairment.
InteractionsView
Azithromycin absorption is reduced in presence of food and antacid. In patients receiving ergot alkaloids Azithromycin should be avoided because of the possibility of ergotism resulting from interaction of Azithromycin with the cytochrome P-450 system. As macrolides increase the plasma concentration of digoxin and cyclosporin, caution should be exercised while co-administration. There have been no drug interactions between Azithromycin and Warfarin, Theophylline, Carbamazepine, Methylprednisolone or Cimetidine.
Pregnancy & lactationView
Pregnancy Category of Azithromycin is B. Animal reproduction studies have demonstrated that Azithromycin has no evidence of harm to the fetus. There are no adequate and well controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if adequate alternatives are not available. It is not known whether Azithromycin is secreted in breast milk. So, caution should be exercised when Azithromycin is administered to nursing women.
Overdose effectsView
There is no data on overdosage with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Amzith
Azithromycin Dihydrate
Amzith
Azithromycin Dihydrate
Indication detailsView
Azithromycin is indicated for infections (caused by susceptible organisms) in lower respiratory tract infections including bronchitis and pneumonia, in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis, in otitis media, and in skin and soft tissue infections. In sexually transmitted diseases in men and women, Azithromycin is indicated in the treatment of non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis.
PharmacologyView
Azithromycin is acid-stable and can therefore be taken orally with no need of protection from gastric acids. It is readily absorbed; its absorption is greater on an empty stomach. Time to peak concentration in adults is 2.1 to 3.2 hours for oral dosage forms. Due to the high concentration in phagocytes, azithromycin is actively transported to the site of infection. During active phagocytosis, large concentrations of azithromycin are released. The concentration of azithromycin in the tissues can be over 50 times higher than in plasma. This is due to ion trapping and the high lipid solubility.
Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.
Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:
Azithromycin's half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.
Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:
- Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes
- Aerobic and facultative gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae
- Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis , Mycoplasma pneumoniae , Betalactamase production should have no effect on azithromycin activity.
- Aerobic and facultative gram-positive microorganisms: Streptococci (Groups C,F,G), Viridans group streptococci
- Aerobic and facultative gram-negative microorganisms: Bordetella pertussis, Legionella pneumophila
- Anaerobic microorganisms: Peptostreptococcus species, Prevotella bivia
DosageView
Oral-
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.
Children:
Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.
Children:
- 10 mg/kg body weight once daily for 3 days for child over 6 months
- 200 mg (1 teaspoonful) for 3 days if body weight is 15-25 kg
- 300 mg (1½ teaspoonfuls) for 3 days if body weight is 26-35 kg; 400 mg (2 teaspoonfuls) for 3 days if body weight is 36-45 kg.
- In typhoid fever, 500 mg (2½ teaspoonfuls) once daily for 7-10 days is given.
Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:
- 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7 to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
- The recommended dose of Azithromycin for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin.
- Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.
AdministrationView
Reconstitution procedure of suspension-
- Step 01: Shake the bottle well to loosen the powder.
- Step 02: Add boiled and cooled water up to the water mark of the bottle label.
- Step 03: Shake until powder is completely mixed with water.
Side effectsView
Azithromycin is well tolerated with a low incidence of side effects. The side effects include nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhoea, headache, dizziness, and skin rashes and are reversible upon discontinuation of therapy.
ContraindicationsView
Azithromycin is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated. Azithromycin is contraindicated in patients with hepatic diseases.
PrecautionsView
As with any antibiotic, observation for signs of superinfection with non-susceptible organisms, including fungi, is recommended. No dose adjustment is needed in patients with renal impairment.
InteractionsView
Azithromycin absorption is reduced in presence of food and antacid. In patients receiving ergot alkaloids Azithromycin should be avoided because of the possibility of ergotism resulting from interaction of Azithromycin with the cytochrome P-450 system. As macrolides increase the plasma concentration of digoxin and cyclosporin, caution should be exercised while co-administration. There have been no drug interactions between Azithromycin and Warfarin, Theophylline, Carbamazepine, Methylprednisolone or Cimetidine.
Pregnancy & lactationView
Pregnancy Category of Azithromycin is B. Animal reproduction studies have demonstrated that Azithromycin has no evidence of harm to the fetus. There are no adequate and well controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if adequate alternatives are not available. It is not known whether Azithromycin is secreted in breast milk. So, caution should be exercised when Azithromycin is administered to nursing women.
Overdose effectsView
There is no data on overdosage with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Anabolin
Nandrolone Phenylpropionate
Anabolin
Nandrolone Phenylpropionate
Indications
Osteoporosis
Indication detailsView
Nandrolone Phenylpropionate is indicated-
- As an adjunct to specific therapies and dietary measures in pathologic conditions characterized by a negative nitrogen balance
- For the palliative treatment of selected cases of disseminated mammary carcinoma in women
- Osteoporosis.
Therapeutic classView
Anabolic steroid (Androgens), Hormone in bone formation by stimulation
PharmacologyView
Nandrolone Phenylpropionate is an injectable anabolic preparation. The pharmacologically active substance is nandrolone. The phenylpropionate ester gives the preparation a duration of action of about one week after injection. Nandrolone is chemically related to the male hormone. Compared to testosterone, it has an enhanced anabolic and a reduced androgenic activity. This has been demonstrated in animal bioassays and explained by receptor binding studies. The low androgenicity of nandrolone is confirmed in clinical use.
In the human, Nandrolone Phenylpropionate has a nitrogen saving action. This effect on protein metabolism has been established by metabolic studies and is utilized therapeutically in conditions where a protein deficiency exists such as during chronic debilitating diseases and after major surgery and severe trauma. In these conditions, Nandrolone Phenylpropionate serves as a supportive adjunct to specific therapies and dietary measures. In women with disseminated mammary carcinoma, in selected cases Nandrolone Phenylpropionate has been reported to produce objective regressions for many months. Furthermore, Nandrolone Phenylpropionate has been shown to produce relief of bone pain in patients with osteoporosis. The similarly acting nandrolone ester, nandrolone decanoate, has been shown to increase bone mineral content in these patients. Androgenic effects (e.g. virilisation) are relatively uncommon at the recommended dosages. Nandrolone lacks the C17alpha-alkyl group which is associated with the occurrence of liver dysfunction and cholestasis.
In the human, Nandrolone Phenylpropionate has a nitrogen saving action. This effect on protein metabolism has been established by metabolic studies and is utilized therapeutically in conditions where a protein deficiency exists such as during chronic debilitating diseases and after major surgery and severe trauma. In these conditions, Nandrolone Phenylpropionate serves as a supportive adjunct to specific therapies and dietary measures. In women with disseminated mammary carcinoma, in selected cases Nandrolone Phenylpropionate has been reported to produce objective regressions for many months. Furthermore, Nandrolone Phenylpropionate has been shown to produce relief of bone pain in patients with osteoporosis. The similarly acting nandrolone ester, nandrolone decanoate, has been shown to increase bone mineral content in these patients. Androgenic effects (e.g. virilisation) are relatively uncommon at the recommended dosages. Nandrolone lacks the C17alpha-alkyl group which is associated with the occurrence of liver dysfunction and cholestasis.
DosageView
As an adjunct to specific therapies and dietary measures in pathologic conditions characterized by a negative nitrogen balance: Recommended dose is 25-50 mg every week.
For the palliative treatment of selected cases of disseminated mammary carcinoma in women: Recommended dose is 50 mg every week.
Osteoporosis: Recommended dose is 50 mg every week.
For an optimal therapeutic effect it is necessary to administer adequate amounts of vitamins, minerals and protein in a calorie-rich diet. Nandrolone Phenylpropionate should be administered by deep intramuscular injection.
For the palliative treatment of selected cases of disseminated mammary carcinoma in women: Recommended dose is 50 mg every week.
Osteoporosis: Recommended dose is 50 mg every week.
For an optimal therapeutic effect it is necessary to administer adequate amounts of vitamins, minerals and protein in a calorie-rich diet. Nandrolone Phenylpropionate should be administered by deep intramuscular injection.
Side effectsView
High dosages, prolonged treatment and/or too frequent administration may cause:
- Virilisation which appears in sensitive women as hoarseness, acne hirsutism and increase of libido; in prepubertal boys as an increased frequency of erections and phallic enlargement, and in girls as an increase of pubic hair and clitoral hypertrophy. Hoarseness may be the first symptom of vocal change which may end in a long-lasting, sometimes irreversible deepening of the voice.
- Amenorrhoea.
- Inhibition of spermatogenesis.
- Premature epiphyseal closure.
- Fluid retention.
ContraindicationsView
Contraindicated in Pregnancy, Known or suspected carcinoma of the prostate or breast in the male.
PrecautionsView
If signs of virilisation develop, discontinuation of the treatment should be considered, Preferably in consultation with the patient.
It is recommended to monitor patients with any of the following conditions:
It is recommended to monitor patients with any of the following conditions:
- latent or overt cardiac failure, renal dysfunction, hypertension or migraine (or a history of these conditions), since anabolic steroids may occasioally induce fluid retention:
- incomplete statural growth, since anabolic steroids in high dosages may accelerate epiphyseal closure;
- skeletal metastases of breast carcinoma. In these patients
- hypercalcaemia may develop both spontaneously and as a result of anabolic steroid therapy. The later can be indicative of a positive tumour response to the hormonal treatment. Nevertheless, the hypercalcaemia should first be treated appropriately and after restoration of normal calcium levels hormone therapy can be resumed;
- liver dysfunction.
InteractionsView
Anabolic steroids may improve glucose tolerance and decrease the need for insulin or other antidiabetic medicines in diabetics.
Pregnancy & lactationView
This medicine is contraindicated during pregnancy because of possible masculinization of the foetus. There are insufficient data on the use of this medicine during breast-feeding to assess potential harm to the infant or a possible influence on milk production.
Overdose effectsView
The acute toxicity of Nandrolone Phenylpropionate in animals is very low. There are no reports of acute overdosage with Nandrolone Phenylpropionate in the human
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Anacaine HC
Hydrocortisone + Lidocaine
Anacaine HC
Hydrocortisone + Lidocaine
Indications
Soreness and discomfort due to hemorrhoids
Indication detailsView
Hydrocortisone plus Lidocaine cream is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.
Therapeutic classView
Drugs used in Ano-rectal region
PharmacologyView
Hydrocortisone is a corticosteroid used for its anti-inflammatory and immunosuppressive effects. Its anti-inflammatory action is due to the suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability. It may also be used as replacement therapy in adrenocortical insufficiency.
Lidocaine is an amide type local anesthesia. It stabilises the neuronal membrane and inhibits Na ion movements, which are necessary for conduction of impulses. In the heart, lidocaine reduces depolarisation of the ventricles during diastole and automaticity in the His-Purkinje system. Duration of action potential and effective refractory period are also reduced.
Lidocaine is an amide type local anesthesia. It stabilises the neuronal membrane and inhibits Na ion movements, which are necessary for conduction of impulses. In the heart, lidocaine reduces depolarisation of the ventricles during diastole and automaticity in the His-Purkinje system. Duration of action potential and effective refractory period are also reduced.
DosageView
Apply twice daily around the anal opening in a thin layer using an applicator.
Side effectsView
Side effects like Rectal bleeding, Swelling of the skin, Adrenal suppression, Anaphylaxis, Angioedema, Cushing syndrome, Hirsutism, Acne, Cutaneous and subcutaneous atrophy, Dry scaly skin, Urticaria.
ContraindicationsView
Patients with a history of hypersensitivity to any of its ingredients.
PrecautionsView
If extensive areas are treated, the possibility of systemic absorption exists. Systemic absorption of topical steroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glycosuria in some patients. If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy.
InteractionsView
This cream should be used with caution together with dental injection anaesthesia, other local anaesthetics or agents structurally related to local anaesthetics of amide type eg, antiarrhythmic drugs (eg, mexiletine), as the toxic effects of these drugs are additive.
Patients treated with class III antiarrhythmic drugs (eg, amiodarone) should be closely observed and ECG monitoring should be considered, as the cardiac effects of lidocaine and class III antiarrhythmic drugs can be additive.
Drugs that inhibit the metabolism of lidocaine (eg, cimetidine or ?-blockers) may cause potentially toxic plasma concentrations when lidocaine is given in repeated high doses over a long time period. Such interactions are of no clinical importance following short-term treatment with lidocaine at recommended doses.
Patients treated with class III antiarrhythmic drugs (eg, amiodarone) should be closely observed and ECG monitoring should be considered, as the cardiac effects of lidocaine and class III antiarrhythmic drugs can be additive.
Drugs that inhibit the metabolism of lidocaine (eg, cimetidine or ?-blockers) may cause potentially toxic plasma concentrations when lidocaine is given in repeated high doses over a long time period. Such interactions are of no clinical importance following short-term treatment with lidocaine at recommended doses.
Pregnancy & lactationView
Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
Lactation: Unknown if distributed in breast milk; exercise caution
Lactation: Unknown if distributed in breast milk; exercise caution
Anacare
Anastrozole
Anacare
Anastrozole
Indications
Ovulation induction
Indication detailsView
Anastrozole is indicated in-
- Treatment of early breast cancer in hormone receptor positive post-menopausal women.
- Adjuvant treatment of early breast cancer in hormone receptor positive
- postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen.
- Reduction in the incidence of contralateral breast cancers in post menopausal women receiving Anastrozole as adjuvant treatment for early breast cancer.
- Treatment of advanced breast cancer in post-menopausal women.
Therapeutic classView
Hormonal Chemotherapy
PharmacologyView
Anastrazole exerts its anti-estrogenic effects via selective and competitive inhibition of the aromatase enzyme found predominantly in the adrenal glands, liver, and fatty tissues. Many breast cancers are hormone receptor-positive, meaning their growth is stimulated and/or maintained by the presence of hormones such as estrogen or progesterone. In postmenopausal women, estrogen is primarily derived from the conversion of adrenally-produced androgens into estrogens by the aromatase enzyme- by competitively inhibiting the biosynthesis of estrogen at these enzymes, anastrozole effectively suppresses circulating estrogen levels and, subsequently, the growth of hormone receptor-positive tumours.
DosageView
Adults Including the Elderly: One tablet (1 mg) to be taken orally once a day.
Children: The use of Anastrozole is not recommended in children, as efficacy has not been established
Renal Impairment: No dose change is recommended.
Hepatic Impairment: No dose change is recommended.
Children: The use of Anastrozole is not recommended in children, as efficacy has not been established
Renal Impairment: No dose change is recommended.
Hepatic Impairment: No dose change is recommended.
Side effectsView
Very common side effects: Hot flushes, asthenia, joint stiffness, arthritis, headache, nausea, rash etc. Common side effects: Hair thinning, allergic reactions, diarrhea, vomiting, somnolence etc.
PrecautionsView
Anastrozole is not recommended for use in children or in pre-menopausal women as safety and efficacy have not been established in these groups of patients.
- Anastrozole has not been investigated in patients with severe hepatic or severe renal impairment. The potential risk/benefit to such patients should be carefully considered before administration of Anastrozole.
- As Anastrozole lowers circulating estrogen levels, it may cause a reduction in bone mineral density with a possible consequent increased risk of fracture.
InteractionsView
Tamoxifen and/or other therapies containing estrogen should not be co-administered with Anastrozole.
Pregnancy & lactationView
Anastrozole must not be administered during pregnancy or lactation.
Overdose effectsView
There is limited clinical experience of overdose of Anastrozole. There are no reports where a patient has taken a dose in excess of 60 mg. No toxicity was observed and no clinically relevant adverse effects have been seen.
StorageView
Store in a cool & dry place, protected from light and moisture. Keep out of reach of children.
Anacort
Hydrocortisone
Anacort
Hydrocortisone
Indications
Supplement in adrenal insufficiency during minor surgery under general anaesthesia
Indication detailsView
Hydrocortisone is indicated for use in the following conditions:
- Primary or secondary adrenocortical insufficiency
- Acute adrenocortical insufficiency
- Shock unresponsive to conventional therapy
- Congenital adrenal hyperplasia
- Hypercalcemia associated with cancer
- Nonsuppurative thyroiditis
- Rheumatic Disorders
- Dermatologic Diseases (Allergic States, Severe seborrheic dermatitis, Severe psoriasis, Pemphigus, Severe erythema multiforme)
- Control of severe or incapacitating allergic conditions (Bronchial asthma, Contact dermatitis, Atopic dermatitis, Serum sickness, Seasonal or perennial allergic rhinitis, Drug hypersensitivity reactions, Urticarial transfusion reactions, Acute noninfectious laryngeal edema)
- Ophthalmic Diseases (Herpes zoster ophthalmicus, Iritis, iridocyclitis, Chorioretinitis, Diffuse posterior uveitis and choroiditis, Optic neuritis)
- Gastrointestinal Diseases
- Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy
- Loeffler's syndrome
- Aspiration pneumonitis
- Hematologic Disorders (Acquired, autoimmune hemolytic anemia, Idiopathic thrombocytopenic purpura in adults, Secondary thrombocytopenia, Erythroblastopenia)
- Neoplastic Diseases (Leukemias and lymphomas in adults, Acute leukemia of childhood)
- Edematous States
- Acute exacerbations of multiple sclerosis
Therapeutic classView
Glucocorticoids
PharmacologyView
Hydrocortisone inhibits prostaglandin synthesis by inhibiting the enzyme phospholipase A2. Hydrocortisone reduces various vasoactive agents released during inflammation. It also controls the rate of protein synthesis.
DosageView
Tablet: The initial dosage of Hydrocortisone Tablets may vary from 20 mg to 240 mg of hydrocortisone per day depending on the specific disease entity being treated. In situations of less severity, lower doses will generally suffice, while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, Hydrocortisone Tablets should be discontinued and the patient transferred to other appropriate therapy.
It should be emphasized that dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patients. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response. It should be kept in mind that constant monitoring is needed in regard to drug dosage. If, after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually, rather than abruptly.
Injection:
It should be emphasized that dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patients. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response. It should be kept in mind that constant monitoring is needed in regard to drug dosage. If, after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually, rather than abruptly.
Injection:
- Adult: By IM injection or slow IV injection or infusion. The initial dose of Hydrocortisone sterile powder is 100 mg to 500 mg, depending on the severity of the condition. This dose may be repeated at intervals of 2, 4 or 6 hours as indicated by the patient's response and clinical condition.
- Children: By slow IV injection, up to 1 year 25 mg, 1-5 years 50 mg, 6-12 years 100 mg.
Side effectsView
Hydrocortisone is generally well tolerated except in prolonged high doses. It may cause cardiac arrhythmia, esophageal candidiasis, menstrual irregularity, decreased carbohydrate & glucose tolerance, fluid retention, increased appetite, weight gain, euphoria, mood swings, depression, insomnia, acne etc.
ContraindicationsView
Hydrocortisone is contraindicated in severe systemic fungal infections and patients with known hypersensitivity to any component of this product.
PrecautionsView
Hydrocortisone should be used with caution in patients with a history of peptic ulceration as it increases the incidence of peptic ulceration. This drug should be used with caution in patients with congestive heart failure, hypertension, glaucoma, diabetic mellitus and epilepsy.
InteractionsView
Drugs that induce hepatic enzymes such as Phenobarbital, Phenytoin and Rifampin may increase the clearance of corticosteroids and may require increases in corticosteroid dose to achieve the desired response. Drugs such as Troleandomycin and Ketoconazole may inhibit the metabolism of corticosteroids and thus decrease their clearance. Therefore, the dose of corticosteroid should be titrated to avoid steroid toxicity.
Pregnancy & lactationView
This should be prescribed in pregnancy and lactation only if absolutely required.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Anadol
Tramadol Hydrochloride
Anadol
Tramadol Hydrochloride
Indications
Renal colic
Indication detailsView
Tramadol is used for the treatment of moderate to severe painful conditions. These include:
- Postoperative pain
- Colic and spastic pain
- Cancer pain
- Joint pain
- Neck and back pain
- Pain associated with osteoporosis.
Therapeutic classView
Opioid analgesics
PharmacologyView
Tramadol is a centrally acting synthetic analgesic compound. It inhibits the re uptake of neurotransmitters- serotonin and noradrenaline. Thus it modifies the transmission of pain impulses by activating both descending serotonergic pathways and noradrenergic pathways involved in analgesia. The analgesic effects of Tramadol are mediated via stimulation of mu-opioid receptors and indirect modulation of central monoaminergic inhibitory pathways.
DosageView
Capsule or Tablet: Usual doses are 50 to 100 mg every four to six hours. For acute pain an initial dose of 100 mg is required. For chronic painful conditions an initial dose of 50 mg is recommended. Subsequent doses should be 50 to 100 mg administered 4-6 hourly. The dose level and frequency of dosing will depend on the severity of the pain.The total daily dosage by mouth should not exceed 400 mg.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
Side effectsView
Commonly occurring side-effects are dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, pruritus, CNS stimulation, asthenia, sweating, dyspepsia, dry mouth, diarrhoea. Less commonly occurring side-effects include malaise, allergic reaction, weight loss, vasodilatation, palpitations, abdominal pain, anorexia, flatulence, GI bleeding, hepatitis, stomatitis etc.
ContraindicationsView
Tramadol is contraindicated in persons having hypersensitivity to this drug. It is also contraindicated in acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.
PrecautionsView
Respiratory depression: When large doses of tramadol are administered with anaesthetic with anaesthetic medications or alcohol, respiratory depression may result. Therefore, tramadol should be administered cautiously in patients at risk for respiratory depression.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
InteractionsView
In general, physician need not be concerned about drugs interacting with Tramadol. The monoamine oxidase (MAO) inhibitors represent the only drug class not recommended for combination with Tramadol. Concomitant administration of carbamazepine with Tramadol causes a significant increase in Tramadol metabolism and it requires to increase the dose of Tramadol.
Pregnancy & lactationView
Safe use of Tramadol in pregnancy has not been established. Tramadol has been shown to cross the placenta. There are no adequate and well-controlled studies in pregnant women. Therefore, Tramadol should be used during pregnancy only if the potential benefit justifies the risk to the foetus. Tramadol Hydrochloride should not be administered during breast feeding as Tramadol and its metabolites have been detected in breast milk.
Pediatric usageView
In children from the age of 1 year Tramadol Hydrochloride can be given in a dose of 1-2 mg/kg body weight. However,suppository (100 mg Tramadol Hydrochloride) should not be administered in children and adolescents below the age of 14 years. Tramadol Hydrochloride 100 mg SR Capsules have not been studied in children. Therefore, safety and efficacy have not been established and the product should not be used in children.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Anadol
Tramadol Hydrochloride
Anadol
Tramadol Hydrochloride
Indications
Renal colic
Indication detailsView
Tramadol is used for the treatment of moderate to severe painful conditions. These include:
- Postoperative pain
- Colic and spastic pain
- Cancer pain
- Joint pain
- Neck and back pain
- Pain associated with osteoporosis.
Therapeutic classView
Opioid analgesics
PharmacologyView
Tramadol is a centrally acting synthetic analgesic compound. It inhibits the re uptake of neurotransmitters- serotonin and noradrenaline. Thus it modifies the transmission of pain impulses by activating both descending serotonergic pathways and noradrenergic pathways involved in analgesia. The analgesic effects of Tramadol are mediated via stimulation of mu-opioid receptors and indirect modulation of central monoaminergic inhibitory pathways.
DosageView
Capsule or Tablet: Usual doses are 50 to 100 mg every four to six hours. For acute pain an initial dose of 100 mg is required. For chronic painful conditions an initial dose of 50 mg is recommended. Subsequent doses should be 50 to 100 mg administered 4-6 hourly. The dose level and frequency of dosing will depend on the severity of the pain.The total daily dosage by mouth should not exceed 400 mg.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
Side effectsView
Commonly occurring side-effects are dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, pruritus, CNS stimulation, asthenia, sweating, dyspepsia, dry mouth, diarrhoea. Less commonly occurring side-effects include malaise, allergic reaction, weight loss, vasodilatation, palpitations, abdominal pain, anorexia, flatulence, GI bleeding, hepatitis, stomatitis etc.
ContraindicationsView
Tramadol is contraindicated in persons having hypersensitivity to this drug. It is also contraindicated in acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.
PrecautionsView
Respiratory depression: When large doses of tramadol are administered with anaesthetic with anaesthetic medications or alcohol, respiratory depression may result. Therefore, tramadol should be administered cautiously in patients at risk for respiratory depression.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
InteractionsView
In general, physician need not be concerned about drugs interacting with Tramadol. The monoamine oxidase (MAO) inhibitors represent the only drug class not recommended for combination with Tramadol. Concomitant administration of carbamazepine with Tramadol causes a significant increase in Tramadol metabolism and it requires to increase the dose of Tramadol.
Pregnancy & lactationView
Safe use of Tramadol in pregnancy has not been established. Tramadol has been shown to cross the placenta. There are no adequate and well-controlled studies in pregnant women. Therefore, Tramadol should be used during pregnancy only if the potential benefit justifies the risk to the foetus. Tramadol Hydrochloride should not be administered during breast feeding as Tramadol and its metabolites have been detected in breast milk.
Pediatric usageView
In children from the age of 1 year Tramadol Hydrochloride can be given in a dose of 1-2 mg/kg body weight. However,suppository (100 mg Tramadol Hydrochloride) should not be administered in children and adolescents below the age of 14 years. Tramadol Hydrochloride 100 mg SR Capsules have not been studied in children. Therefore, safety and efficacy have not been established and the product should not be used in children.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Anadol
Tramadol Hydrochloride
Anadol
Tramadol Hydrochloride
Indications
Renal colic
Indication detailsView
Tramadol is used for the treatment of moderate to severe painful conditions. These include:
- Postoperative pain
- Colic and spastic pain
- Cancer pain
- Joint pain
- Neck and back pain
- Pain associated with osteoporosis.
Therapeutic classView
Opioid analgesics
PharmacologyView
Tramadol is a centrally acting synthetic analgesic compound. It inhibits the re uptake of neurotransmitters- serotonin and noradrenaline. Thus it modifies the transmission of pain impulses by activating both descending serotonergic pathways and noradrenergic pathways involved in analgesia. The analgesic effects of Tramadol are mediated via stimulation of mu-opioid receptors and indirect modulation of central monoaminergic inhibitory pathways.
DosageView
Capsule or Tablet: Usual doses are 50 to 100 mg every four to six hours. For acute pain an initial dose of 100 mg is required. For chronic painful conditions an initial dose of 50 mg is recommended. Subsequent doses should be 50 to 100 mg administered 4-6 hourly. The dose level and frequency of dosing will depend on the severity of the pain.The total daily dosage by mouth should not exceed 400 mg.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
Side effectsView
Commonly occurring side-effects are dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, pruritus, CNS stimulation, asthenia, sweating, dyspepsia, dry mouth, diarrhoea. Less commonly occurring side-effects include malaise, allergic reaction, weight loss, vasodilatation, palpitations, abdominal pain, anorexia, flatulence, GI bleeding, hepatitis, stomatitis etc.
ContraindicationsView
Tramadol is contraindicated in persons having hypersensitivity to this drug. It is also contraindicated in acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.
PrecautionsView
Respiratory depression: When large doses of tramadol are administered with anaesthetic with anaesthetic medications or alcohol, respiratory depression may result. Therefore, tramadol should be administered cautiously in patients at risk for respiratory depression.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
InteractionsView
In general, physician need not be concerned about drugs interacting with Tramadol. The monoamine oxidase (MAO) inhibitors represent the only drug class not recommended for combination with Tramadol. Concomitant administration of carbamazepine with Tramadol causes a significant increase in Tramadol metabolism and it requires to increase the dose of Tramadol.
Pregnancy & lactationView
Safe use of Tramadol in pregnancy has not been established. Tramadol has been shown to cross the placenta. There are no adequate and well-controlled studies in pregnant women. Therefore, Tramadol should be used during pregnancy only if the potential benefit justifies the risk to the foetus. Tramadol Hydrochloride should not be administered during breast feeding as Tramadol and its metabolites have been detected in breast milk.
Pediatric usageView
In children from the age of 1 year Tramadol Hydrochloride can be given in a dose of 1-2 mg/kg body weight. However,suppository (100 mg Tramadol Hydrochloride) should not be administered in children and adolescents below the age of 14 years. Tramadol Hydrochloride 100 mg SR Capsules have not been studied in children. Therefore, safety and efficacy have not been established and the product should not be used in children.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Anadol SR
Tramadol Hydrochloride
Anadol SR
Tramadol Hydrochloride
Indications
Renal colic
Indication detailsView
Tramadol is used for the treatment of moderate to severe painful conditions. These include:
- Postoperative pain
- Colic and spastic pain
- Cancer pain
- Joint pain
- Neck and back pain
- Pain associated with osteoporosis.
Therapeutic classView
Opioid analgesics
PharmacologyView
Tramadol is a centrally acting synthetic analgesic compound. It inhibits the re uptake of neurotransmitters- serotonin and noradrenaline. Thus it modifies the transmission of pain impulses by activating both descending serotonergic pathways and noradrenergic pathways involved in analgesia. The analgesic effects of Tramadol are mediated via stimulation of mu-opioid receptors and indirect modulation of central monoaminergic inhibitory pathways.
DosageView
Capsule or Tablet: Usual doses are 50 to 100 mg every four to six hours. For acute pain an initial dose of 100 mg is required. For chronic painful conditions an initial dose of 50 mg is recommended. Subsequent doses should be 50 to 100 mg administered 4-6 hourly. The dose level and frequency of dosing will depend on the severity of the pain.The total daily dosage by mouth should not exceed 400 mg.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
Sustained Release Capsule or Tablet: One SR capsule or tablet every 12 hours, for example first one in the morning and then at the same time in the evening. The number of capsules taken at a time will depend upon severity of pain, but it should not be taken more frequently than every 12 hours.The total daily dosage by mouth should not exceed 400 mg.
Injection: A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of postoperative pain,the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg.
Suppository: Tramadol suppository should be administered rectally. For adults usual dose is 100 mg Tramadol Hydrochloride 6 hourly. In general, 400 mg Tramadol Hydrochloride (4 Tramadol suppository) per day sufficient. However, for the treatment of Cancer pain and severe pain after operations much higher daily doses can be used.
Side effectsView
Commonly occurring side-effects are dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, pruritus, CNS stimulation, asthenia, sweating, dyspepsia, dry mouth, diarrhoea. Less commonly occurring side-effects include malaise, allergic reaction, weight loss, vasodilatation, palpitations, abdominal pain, anorexia, flatulence, GI bleeding, hepatitis, stomatitis etc.
ContraindicationsView
Tramadol is contraindicated in persons having hypersensitivity to this drug. It is also contraindicated in acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.
PrecautionsView
Respiratory depression: When large doses of tramadol are administered with anaesthetic with anaesthetic medications or alcohol, respiratory depression may result. Therefore, tramadol should be administered cautiously in patients at risk for respiratory depression.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids.
Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.
Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since tramadol inhibits the uptake of norepinephrine and serotonin.
Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.
InteractionsView
In general, physician need not be concerned about drugs interacting with Tramadol. The monoamine oxidase (MAO) inhibitors represent the only drug class not recommended for combination with Tramadol. Concomitant administration of carbamazepine with Tramadol causes a significant increase in Tramadol metabolism and it requires to increase the dose of Tramadol.
Pregnancy & lactationView
Safe use of Tramadol in pregnancy has not been established. Tramadol has been shown to cross the placenta. There are no adequate and well-controlled studies in pregnant women. Therefore, Tramadol should be used during pregnancy only if the potential benefit justifies the risk to the foetus. Tramadol Hydrochloride should not be administered during breast feeding as Tramadol and its metabolites have been detected in breast milk.
Pediatric usageView
In children from the age of 1 year Tramadol Hydrochloride can be given in a dose of 1-2 mg/kg body weight. However,suppository (100 mg Tramadol Hydrochloride) should not be administered in children and adolescents below the age of 14 years. Tramadol Hydrochloride 100 mg SR Capsules have not been studied in children. Therefore, safety and efficacy have not been established and the product should not be used in children.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Anaflex
Naproxen Sodium
Anaflex
Naproxen Sodium
Indications
Systemic lupus erythematosus (SLE)
Indication detailsView
Naproxen is indicated for the relief of sign and symptoms of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, juvenile arthritis, tendonitis, bursitis & acute gout. It is also indicated for the management of primary dysmenorrhea & pain.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
Naproxen is a non steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic & antipyretic properties. It is rapidly absorbed from the gastrointestinal tract and achieves 95% bioavailability.
DosageView
Naproxen Tablet-
- Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis: The usual dose is 500-1000 mg daily in two divided doses after meals.
- Management of pain, primary dysmenorrhea, acute tendonitis & bursitis: Recommended starting dose is 500 mg followed by 500 mg every 12 hours or 250 mg every 6-8 hours. The initial total daily dose should not exceed 1250 mg and thereafter, the total daily dose should not exceed 1000 mg.
- Acute gout: Recommended starting dose is 750 mg followed by 250 mg every 8 hours until the attack has subsided.
- For Juvenile rheumatoid arthritis: The usual dose for children over 2 years is 10 mg/kg/day given as two divided doses at 12-hours intervals. Therapy in children under 2 years of age is not recommended.
- Is to be applied 2-6 times a day as required and is not recommended for use in children.
Side effectsView
Most frequently reported side effects include following:
- Gastrointestinal: Heartburn, abdominal pain, nausea, diarrhea, dyspepsia.
- Central Nervous System: Headache, vertigo, drowsiness.
- Dermatological: Pruritus (itching), purpura.
- Cardiovascular: Edema, palpitation.
- Others: Visual disturbances, hearing disturbances.
ContraindicationsView
Naproxen is contraindicated in patients with known hypersensitivity to Naproxen. It should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. It is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
InteractionsView
ACE inhibitors: diminish the antihypertensive effect of ACE inhibitors.
Antacids & Sucralfate: delay the absorption of Naproxen.
Aspirin: increase adverse effects.
Diuretics: reduce the natriuretic effect of Furosemide and Thiazides.
Methotrexate: enhance the toxicity of Methotrexate.
Warfarin: increase the risk of GI bleeding.
Selective Serotonin Reuptake Inhibitors (SSRI): increase the risk of GI bleeding.
Antacids & Sucralfate: delay the absorption of Naproxen.
Aspirin: increase adverse effects.
Diuretics: reduce the natriuretic effect of Furosemide and Thiazides.
Methotrexate: enhance the toxicity of Methotrexate.
Warfarin: increase the risk of GI bleeding.
Selective Serotonin Reuptake Inhibitors (SSRI): increase the risk of GI bleeding.
Pregnancy & lactationView
US FDA pregnancy category of Naproxen is C. So, Naproxen should be avoided in pregnancy & lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
StorageView
Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.
Anaflex
Naproxen Sodium
Anaflex
Naproxen Sodium
Indications
Systemic lupus erythematosus (SLE)
Indication detailsView
Naproxen is indicated for the relief of sign and symptoms of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, juvenile arthritis, tendonitis, bursitis & acute gout. It is also indicated for the management of primary dysmenorrhea & pain.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
Naproxen is a non steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic & antipyretic properties. It is rapidly absorbed from the gastrointestinal tract and achieves 95% bioavailability.
DosageView
Naproxen Tablet-
- Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis: The usual dose is 500-1000 mg daily in two divided doses after meals.
- Management of pain, primary dysmenorrhea, acute tendonitis & bursitis: Recommended starting dose is 500 mg followed by 500 mg every 12 hours or 250 mg every 6-8 hours. The initial total daily dose should not exceed 1250 mg and thereafter, the total daily dose should not exceed 1000 mg.
- Acute gout: Recommended starting dose is 750 mg followed by 250 mg every 8 hours until the attack has subsided.
- For Juvenile rheumatoid arthritis: The usual dose for children over 2 years is 10 mg/kg/day given as two divided doses at 12-hours intervals. Therapy in children under 2 years of age is not recommended.
- Is to be applied 2-6 times a day as required and is not recommended for use in children.
Side effectsView
Most frequently reported side effects include following:
- Gastrointestinal: Heartburn, abdominal pain, nausea, diarrhea, dyspepsia.
- Central Nervous System: Headache, vertigo, drowsiness.
- Dermatological: Pruritus (itching), purpura.
- Cardiovascular: Edema, palpitation.
- Others: Visual disturbances, hearing disturbances.
ContraindicationsView
Naproxen is contraindicated in patients with known hypersensitivity to Naproxen. It should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. It is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
InteractionsView
ACE inhibitors: diminish the antihypertensive effect of ACE inhibitors.
Antacids & Sucralfate: delay the absorption of Naproxen.
Aspirin: increase adverse effects.
Diuretics: reduce the natriuretic effect of Furosemide and Thiazides.
Methotrexate: enhance the toxicity of Methotrexate.
Warfarin: increase the risk of GI bleeding.
Selective Serotonin Reuptake Inhibitors (SSRI): increase the risk of GI bleeding.
Antacids & Sucralfate: delay the absorption of Naproxen.
Aspirin: increase adverse effects.
Diuretics: reduce the natriuretic effect of Furosemide and Thiazides.
Methotrexate: enhance the toxicity of Methotrexate.
Warfarin: increase the risk of GI bleeding.
Selective Serotonin Reuptake Inhibitors (SSRI): increase the risk of GI bleeding.
Pregnancy & lactationView
US FDA pregnancy category of Naproxen is C. So, Naproxen should be avoided in pregnancy & lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
StorageView
Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.
Anaflex
Naproxen Sodium
Anaflex
Naproxen Sodium
Indications
Systemic lupus erythematosus (SLE)
Indication detailsView
Naproxen is indicated for the relief of sign and symptoms of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, juvenile arthritis, tendonitis, bursitis & acute gout. It is also indicated for the management of primary dysmenorrhea & pain.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
Naproxen is a non steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic & antipyretic properties. It is rapidly absorbed from the gastrointestinal tract and achieves 95% bioavailability.
DosageView
Naproxen Tablet-
- Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis: The usual dose is 500-1000 mg daily in two divided doses after meals.
- Management of pain, primary dysmenorrhea, acute tendonitis & bursitis: Recommended starting dose is 500 mg followed by 500 mg every 12 hours or 250 mg every 6-8 hours. The initial total daily dose should not exceed 1250 mg and thereafter, the total daily dose should not exceed 1000 mg.
- Acute gout: Recommended starting dose is 750 mg followed by 250 mg every 8 hours until the attack has subsided.
- For Juvenile rheumatoid arthritis: The usual dose for children over 2 years is 10 mg/kg/day given as two divided doses at 12-hours intervals. Therapy in children under 2 years of age is not recommended.
- Is to be applied 2-6 times a day as required and is not recommended for use in children.
Side effectsView
Most frequently reported side effects include following:
- Gastrointestinal: Heartburn, abdominal pain, nausea, diarrhea, dyspepsia.
- Central Nervous System: Headache, vertigo, drowsiness.
- Dermatological: Pruritus (itching), purpura.
- Cardiovascular: Edema, palpitation.
- Others: Visual disturbances, hearing disturbances.
ContraindicationsView
Naproxen is contraindicated in patients with known hypersensitivity to Naproxen. It should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. It is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
InteractionsView
ACE inhibitors: diminish the antihypertensive effect of ACE inhibitors.
Antacids & Sucralfate: delay the absorption of Naproxen.
Aspirin: increase adverse effects.
Diuretics: reduce the natriuretic effect of Furosemide and Thiazides.
Methotrexate: enhance the toxicity of Methotrexate.
Warfarin: increase the risk of GI bleeding.
Selective Serotonin Reuptake Inhibitors (SSRI): increase the risk of GI bleeding.
Antacids & Sucralfate: delay the absorption of Naproxen.
Aspirin: increase adverse effects.
Diuretics: reduce the natriuretic effect of Furosemide and Thiazides.
Methotrexate: enhance the toxicity of Methotrexate.
Warfarin: increase the risk of GI bleeding.
Selective Serotonin Reuptake Inhibitors (SSRI): increase the risk of GI bleeding.
Pregnancy & lactationView
US FDA pregnancy category of Naproxen is C. So, Naproxen should be avoided in pregnancy & lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
StorageView
Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.
Anaflex Max
Naproxen Sodium + Esomeprazole Magnesium
Anaflex Max
Naproxen Sodium + Esomeprazole Magnesium
Indications
Systemic lupus erythematosus (SLE)
Indication detailsView
Naproxen & Esomeprazole is indicated for the relief of signs & symptoms of-
- Osteoarthritis
- Rheumatoid arthritis
- Ankylosing spondylitis &
- To decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
This consists of an immediate release Esomeprazole Magnesium layer & an enteric-coated Naproxen core. As a result, Esomeprazole is released first into the stomach, prior to the dissolution of Naproxen in the small intestine.
Naproxen is a NSAID with analgesic & antipyretic properties. The mechanism of action of Naproxen is to inhibit the prostaglandin synthesis. Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/k+ -ATPase in the gastric parietal cell by acting specifically on the proton pump, Esomeprazole blocks the final step in acid production, thus reducing gastric acidity.
Naproxen is a NSAID with analgesic & antipyretic properties. The mechanism of action of Naproxen is to inhibit the prostaglandin synthesis. Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/k+ -ATPase in the gastric parietal cell by acting specifically on the proton pump, Esomeprazole blocks the final step in acid production, thus reducing gastric acidity.
DosageView
Carefully consider the potential benefits & risks of this tablet & other treatment options before deciding to use this tablet. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. If a dose of Esomeprazole lower than a total daily dose of 40 mg is more appropriate, a different treatment should be considered.
Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis-
Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis-
- Adults: One tablet twice daily of either: 375 mg naproxen/20 mg of esomeprazole; or 500 mg naproxen/20 mg of esomeprazole
- Weight greater than 50 kg: 375 mg naproxen/20 mg of esomeprazole; or 500 mg naproxen/20 mg of esomeprazole
- Weight 38 kg to less than 50 kg: One tablet twice daily of 375 mg naproxen/20 mg of esomeprazole.
AdministrationView
Do not split, chew, crush or dissolve the tablet. This tablet is to be taken at least 30 minutes before meals.
Side effectsView
In general, this preparation is well tolerated. The most common adverse reactions in clinical trials (>5%): erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain, nausea etc.
ContraindicationsView
- Known hypersensitivity to any component of this tablet or substituted benzimidazoles.
- History of asthmay urticaria or other allergic-type reactions after taking aspirin or other NSAIDs.
- Use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery.
PrecautionsView
Patients with known CV disease/risk factors may be at greater risk. This tablet should be used with caution in patients with fluid retention or heart failure.
InteractionsView
With medicine:
- Concomitant use of NSAIDs may reduce the antihypertensive effect of ACE inhibitors, diuretics & beta-blockers
- Concomitant use of this tablet and warfarin may result in an increased risk of a bleeding complication.
- Esomeprazole inhibits gastric acid secretion & may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg. Ketoconazole, iron salts and digoxin).
Pregnancy & lactationView
Pregnancy category C. In late pregnancy, it should be avoided because it may cause premature closure of the ductus arteriosus. This tablet should not be used in nursing mothers due to the Naproxen component.
Pediatric usageView
Elderly patients: Studies indicate that although the total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Use caution when high doses are required & some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly use the lowest effective dose.
Patients with Moderate to Severe Renal impairment: Naproxen-containing products are not recommended for use in patients with moderate to severe or severe renal impairment (creatinine clearance <30 ml/min).
Hepatic insufficiency: Monitor patients with mild to moderate hepatic impairment closely & consider a possible dose reduction based on the Naproxen component of this tablet. This is not recommended in patients with severe hepatic impairment because Esomeprazole dosage should not exceed 20 mg daily in these patients.
Patients with Moderate to Severe Renal impairment: Naproxen-containing products are not recommended for use in patients with moderate to severe or severe renal impairment (creatinine clearance <30 ml/min).
Hepatic insufficiency: Monitor patients with mild to moderate hepatic impairment closely & consider a possible dose reduction based on the Naproxen component of this tablet. This is not recommended in patients with severe hepatic impairment because Esomeprazole dosage should not exceed 20 mg daily in these patients.
Overdose effectsView
There is no clinical data on overdosage with this tablet.
Overdose of Naproxen: Significant naproxen overdosage may be characterized by lethargy, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, transient alteration in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, vomiting etc.
Overdose of Esomeprazole: The major signs of acute toxicity were reduced motor activity, changes in respiratory frequency, tremor and intermittent clonic convulsions etc.
Overdose of Naproxen: Significant naproxen overdosage may be characterized by lethargy, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, transient alteration in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, vomiting etc.
Overdose of Esomeprazole: The major signs of acute toxicity were reduced motor activity, changes in respiratory frequency, tremor and intermittent clonic convulsions etc.
StorageView
Store at temperature of below 30°C, protect from light & moisture. Keep out of reach of children.
Anaflex Max
Naproxen Sodium + Esomeprazole Magnesium
Anaflex Max
Naproxen Sodium + Esomeprazole Magnesium
Indications
Systemic lupus erythematosus (SLE)
Indication detailsView
Naproxen & Esomeprazole is indicated for the relief of signs & symptoms of-
- Osteoarthritis
- Rheumatoid arthritis
- Ankylosing spondylitis &
- To decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
This consists of an immediate release Esomeprazole Magnesium layer & an enteric-coated Naproxen core. As a result, Esomeprazole is released first into the stomach, prior to the dissolution of Naproxen in the small intestine.
Naproxen is a NSAID with analgesic & antipyretic properties. The mechanism of action of Naproxen is to inhibit the prostaglandin synthesis. Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/k+ -ATPase in the gastric parietal cell by acting specifically on the proton pump, Esomeprazole blocks the final step in acid production, thus reducing gastric acidity.
Naproxen is a NSAID with analgesic & antipyretic properties. The mechanism of action of Naproxen is to inhibit the prostaglandin synthesis. Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/k+ -ATPase in the gastric parietal cell by acting specifically on the proton pump, Esomeprazole blocks the final step in acid production, thus reducing gastric acidity.
DosageView
Carefully consider the potential benefits & risks of this tablet & other treatment options before deciding to use this tablet. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. If a dose of Esomeprazole lower than a total daily dose of 40 mg is more appropriate, a different treatment should be considered.
Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis-
Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis-
- Adults: One tablet twice daily of either: 375 mg naproxen/20 mg of esomeprazole; or 500 mg naproxen/20 mg of esomeprazole
- Weight greater than 50 kg: 375 mg naproxen/20 mg of esomeprazole; or 500 mg naproxen/20 mg of esomeprazole
- Weight 38 kg to less than 50 kg: One tablet twice daily of 375 mg naproxen/20 mg of esomeprazole.
AdministrationView
Do not split, chew, crush or dissolve the tablet. This tablet is to be taken at least 30 minutes before meals.
Side effectsView
In general, this preparation is well tolerated. The most common adverse reactions in clinical trials (>5%): erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain, nausea etc.
ContraindicationsView
- Known hypersensitivity to any component of this tablet or substituted benzimidazoles.
- History of asthmay urticaria or other allergic-type reactions after taking aspirin or other NSAIDs.
- Use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery.
PrecautionsView
Patients with known CV disease/risk factors may be at greater risk. This tablet should be used with caution in patients with fluid retention or heart failure.
InteractionsView
With medicine:
- Concomitant use of NSAIDs may reduce the antihypertensive effect of ACE inhibitors, diuretics & beta-blockers
- Concomitant use of this tablet and warfarin may result in an increased risk of a bleeding complication.
- Esomeprazole inhibits gastric acid secretion & may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg. Ketoconazole, iron salts and digoxin).
Pregnancy & lactationView
Pregnancy category C. In late pregnancy, it should be avoided because it may cause premature closure of the ductus arteriosus. This tablet should not be used in nursing mothers due to the Naproxen component.
Pediatric usageView
Elderly patients: Studies indicate that although the total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Use caution when high doses are required & some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly use the lowest effective dose.
Patients with Moderate to Severe Renal impairment: Naproxen-containing products are not recommended for use in patients with moderate to severe or severe renal impairment (creatinine clearance <30 ml/min).
Hepatic insufficiency: Monitor patients with mild to moderate hepatic impairment closely & consider a possible dose reduction based on the Naproxen component of this tablet. This is not recommended in patients with severe hepatic impairment because Esomeprazole dosage should not exceed 20 mg daily in these patients.
Patients with Moderate to Severe Renal impairment: Naproxen-containing products are not recommended for use in patients with moderate to severe or severe renal impairment (creatinine clearance <30 ml/min).
Hepatic insufficiency: Monitor patients with mild to moderate hepatic impairment closely & consider a possible dose reduction based on the Naproxen component of this tablet. This is not recommended in patients with severe hepatic impairment because Esomeprazole dosage should not exceed 20 mg daily in these patients.
Overdose effectsView
There is no clinical data on overdosage with this tablet.
Overdose of Naproxen: Significant naproxen overdosage may be characterized by lethargy, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, transient alteration in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, vomiting etc.
Overdose of Esomeprazole: The major signs of acute toxicity were reduced motor activity, changes in respiratory frequency, tremor and intermittent clonic convulsions etc.
Overdose of Naproxen: Significant naproxen overdosage may be characterized by lethargy, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, transient alteration in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, vomiting etc.
Overdose of Esomeprazole: The major signs of acute toxicity were reduced motor activity, changes in respiratory frequency, tremor and intermittent clonic convulsions etc.
StorageView
Store at temperature of below 30°C, protect from light & moisture. Keep out of reach of children.
Anaflex SR
Naproxen Sodium
Anaflex SR
Naproxen Sodium
Indications
Systemic lupus erythematosus (SLE)
Indication detailsView
Naproxen is indicated for the relief of sign and symptoms of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, juvenile arthritis, tendonitis, bursitis & acute gout. It is also indicated for the management of primary dysmenorrhea & pain.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
Naproxen is a non steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic & antipyretic properties. It is rapidly absorbed from the gastrointestinal tract and achieves 95% bioavailability.
DosageView
Naproxen Tablet-
- Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis: The usual dose is 500-1000 mg daily in two divided doses after meals.
- Management of pain, primary dysmenorrhea, acute tendonitis & bursitis: Recommended starting dose is 500 mg followed by 500 mg every 12 hours or 250 mg every 6-8 hours. The initial total daily dose should not exceed 1250 mg and thereafter, the total daily dose should not exceed 1000 mg.
- Acute gout: Recommended starting dose is 750 mg followed by 250 mg every 8 hours until the attack has subsided.
- For Juvenile rheumatoid arthritis: The usual dose for children over 2 years is 10 mg/kg/day given as two divided doses at 12-hours intervals. Therapy in children under 2 years of age is not recommended.
- Is to be applied 2-6 times a day as required and is not recommended for use in children.
Side effectsView
Most frequently reported side effects include following:
- Gastrointestinal: Heartburn, abdominal pain, nausea, diarrhea, dyspepsia.
- Central Nervous System: Headache, vertigo, drowsiness.
- Dermatological: Pruritus (itching), purpura.
- Cardiovascular: Edema, palpitation.
- Others: Visual disturbances, hearing disturbances.
ContraindicationsView
Naproxen is contraindicated in patients with known hypersensitivity to Naproxen. It should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. It is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
InteractionsView
ACE inhibitors: diminish the antihypertensive effect of ACE inhibitors.
Antacids & Sucralfate: delay the absorption of Naproxen.
Aspirin: increase adverse effects.
Diuretics: reduce the natriuretic effect of Furosemide and Thiazides.
Methotrexate: enhance the toxicity of Methotrexate.
Warfarin: increase the risk of GI bleeding.
Selective Serotonin Reuptake Inhibitors (SSRI): increase the risk of GI bleeding.
Antacids & Sucralfate: delay the absorption of Naproxen.
Aspirin: increase adverse effects.
Diuretics: reduce the natriuretic effect of Furosemide and Thiazides.
Methotrexate: enhance the toxicity of Methotrexate.
Warfarin: increase the risk of GI bleeding.
Selective Serotonin Reuptake Inhibitors (SSRI): increase the risk of GI bleeding.
Pregnancy & lactationView
US FDA pregnancy category of Naproxen is C. So, Naproxen should be avoided in pregnancy & lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
StorageView
Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.