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Etrib
Etoricoxib
Etrib
Etoricoxib
Indications
Rheumatoid arthritis
Indication detailsView
Etoricoxib is indicated for the symptomatic relief of-
- Osteoarthritis (OA)
- Rheumatoid arthritis (RA)
- Ankylosing spondylitis, and
- The pain and signs of inflammation associated with acute gouty arthritis.
- For the short-term treatment of moderate pain associated with dental surgery.
Therapeutic classView
Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.
DosageView
Adult and adolescent over 16 years:
- Osteoarthritis: The recommended dose is 30 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 60 mg once daily may increase efficacy.
- Rheumatoid arthritis: The recommended dose is 90 mg once daily.
- Ankylosing spondylitis: The recommended dose is 90 mg once daily.
- Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
- Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.
Side effectsView
Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.
ContraindicationsView
- Hypersensitivity to the active substance or to any of the excipients.
- Active peptic ulceration or active gastro-intestinai (Gl) bleeding.
- Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors.
- Pregnancy and lactation.
- Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score 10).
- Estimated renal creatinine clearance <30 ml/min.
- Children and adolescents under 16 years of age.
- Inflammatory bowel disease.
- Congestive heart failure (NYHA ll-IV).
- Patients with hypertension whose blood pressure is persistently elevated above 140/90 mmHg and has not been adequately controlled.
- Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.
PrecautionsView
- Caution is advised with treatment of patients most at risk of developing a gastrointestinal complication with NSAIDs; the elderly, patients using any other NSAID or acetylsalicylic acid concomitantly or patients with a prior history of gastrointestinal disease, such as ulceration and Gl bleeding.
- Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with Etoricoxib after careful consideration.
- Administration of Etoricoxib may cause a reduction in prostaglandin formation and, secondarily, in renal blood flow, and thereby impair renal function. Monitoring of renal function in such patients should be considered.
- Caution should be exercised in patients with a history of cardiac failure, left ventricular dysfunction, or hypertension and in patients with pre-existing edema from any other reason.
- Any patients with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormalliver function test has occurred, should be monitored. If signs of hepatic insufficiency occur, or if persistently abnormal liver function tests (three times the upper limit of normal) are detected, Etoricoxib should be discontinued.
- Etoricoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
- Etoricoxib may mask fever and other signs of inflammation. Caution should be exercised when co-administering Etoricoxib with warfarin or other oral anticoagulants.
InteractionsView
With medicine:
- Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
- Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
- Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
- Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
- Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.
Pregnancy & lactationView
The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.
Overdose effectsView
Administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the Gl tract, employ clinical monitoring, and institute supportive therapy, if required.
StorageView
Store at a temperature of below 30°C, protect from light & moisture. Keep out of reach of children.
Etrifal Ustukhudus
Lavendar [Lavendula stoechas]
Etrifal Ustukhudus
Lavendar [Lavendula stoechas]
Indications
Headache
Indication detailsView
This is indicated in-
- Chronic catarrh
- Headache
- Epilepsy
- Nervous debility
- Weak vision
- Paralysis
Therapeutic classView
Herbal and Nutraceuticals
PharmacologyView
This is a unique combination of Lavendar (Lavendula stoechas) and other natural ingredients, which is very effective in the treatment of headache and chronic catarrh. It strengthens the brain, relieves emotional tension, depression and insomnia. It stimulates nerves that beneficial in the treatment of paralysis, epilepsy and weak vision.
DosageView
1-2 teaspoonful(s) 1-2 times daily or as prescribed by the physicians.
Side effectsView
No significant side effect has been observed in proper dosage.
ContraindicationsView
There is no known contraindication.
PrecautionsView
Keep out of reach of the children.
StorageView
Protect from light. Keep in cool & dry place.
Etrocin
Erythromycin (Oral)
Etrocin
Erythromycin (Oral)
Indications
Susceptible infections
Indication detailsView
Erythromycin is highly effective in the treatment of a wide variety of clinical infections.
- Upper respiratory tract infections: Tonsilitis, Peritonsillar abscess, Pharyngitis, laryngitis, Sinusitis. Secondary infections in colds and influenza.
- Lower respiratory tract infections: Tracheitis, acute and chronic bronchitis.
- Ear infections: Otitis media, otitis externa, mastoiditis.
- Eye infections: Blepharitis, established trachoma.
- Skin and Soft tissue infections: Boils and carbuncles, impetigo, abscesses, pustular acne, paromychia, cellulitis, erysipelas.
- Gastrointestinal tract infections: Cholecystitis, staphylococcal enterocolitis.
- Prophylaxis: Pre and post-operative, trauma, burns, rheumatic fever.
- Other infections: Osteomyelitis, diptheria, scarlet fever, whooping cough.
Therapeutic classView
Anti-diarrhoeal Antimicrobial drugs, Macrolides
PharmacologyView
Erythromycin inhibits microsomal protein synthesis in susceptible organisms by inhibiting the translocation process. Specific binding to the 50S subunit or 70S ribosome occurs in these organisms but there is no binding to the stable 80S mammalian ribosome. Erythromycin is active against many Grampositive bacteria, some Gram-negative bacteria and against mycoplasmas and chlamydia.
Absorption: Erythromycin base is destroyed by acid and is therefore administered in the form of stable ester. The rates of absorption of the base and esters are diminished by the presence of food. The stearate is hydrolyzed in the intestine and the free erythromycin absorbed.
Blood concentration: After an oral dose of 500 mg. of the base of stearate, peak serum concentrations of 0.9 to 1.4 or 0.4 to 1.8 mg/ml. respectively are attained in 1 to 4 hours. Half-life: The serum half-life is 1.2 to 4 hours. In subjects with oliguria, the half-life is about 5 hours.
Distribution: Erythromycin is widely distributed throughout body tissue and fluids with some retention in the liver and spleen, protein binding of erythromycin base is 73%. Erythromycin enters the cerebrospinal fluid when the meninges are inflamed. It also crosses the placenta and is excreted in the milk.
Excretion: 5 to 15 % of the dose of erythromycin is excreted in the urine and large amounts of the unchanged active substance are excreted in the bile.
Absorption: Erythromycin base is destroyed by acid and is therefore administered in the form of stable ester. The rates of absorption of the base and esters are diminished by the presence of food. The stearate is hydrolyzed in the intestine and the free erythromycin absorbed.
Blood concentration: After an oral dose of 500 mg. of the base of stearate, peak serum concentrations of 0.9 to 1.4 or 0.4 to 1.8 mg/ml. respectively are attained in 1 to 4 hours. Half-life: The serum half-life is 1.2 to 4 hours. In subjects with oliguria, the half-life is about 5 hours.
Distribution: Erythromycin is widely distributed throughout body tissue and fluids with some retention in the liver and spleen, protein binding of erythromycin base is 73%. Erythromycin enters the cerebrospinal fluid when the meninges are inflamed. It also crosses the placenta and is excreted in the milk.
Excretion: 5 to 15 % of the dose of erythromycin is excreted in the urine and large amounts of the unchanged active substance are excreted in the bile.
DosageView
Adult and Children over 8 years: 250-500 mg every six hours for mild to moderate infections. This may be increased upto 4 gm. or more daily in severe cases.
Elderly: No special dosage recommendation. Erythromycin may be administered if desired, three times daily or twice daily by giving one-third or half of the total daily requirement 8 hourly or 12 hourly respectively.
Children aged 2 to 8 years: 250 mg. every six hours or 30-50 mg/kg body weight per day divided into four equal dosage.
Infants and Children upto 2 years: 500 mg. in divided doses or 30-50 mg/kg body weight in divided doses.
Elderly: No special dosage recommendation. Erythromycin may be administered if desired, three times daily or twice daily by giving one-third or half of the total daily requirement 8 hourly or 12 hourly respectively.
Children aged 2 to 8 years: 250 mg. every six hours or 30-50 mg/kg body weight per day divided into four equal dosage.
Infants and Children upto 2 years: 500 mg. in divided doses or 30-50 mg/kg body weight in divided doses.
Side effectsView
Allergic reactions are rare and mild although anaphylaxis has occurred. Occasionally there is abdominal discomfort after oral administration, sometimes with nausea and vomiting. This discomfort usually subsides after a few days without it being necessary to reduce the dosage.
ContraindicationsView
Known hypersensitivity to Erythromycin.
PrecautionsView
Erythromycin should be given with care in patients with impaired hepatic function, as erythromycin is excreted principally in the bile.
InteractionsView
Recent data from studies of erythromycin reveals that its use in patients who are receiving high dosage of theophylline may be associated with an increase of serum theophylline levels and potential theophylline toxicity. In such cases this dose of theophylline should be reduced.
Pregnancy & lactationView
Clinical and Laboratory studies have been shown no evidence in human of teratogenicity or toxicity. However, caution should be exercised when prescribing this drug to pregnant patients and lactating mothers since erythromycin crosses the placental barrier and is excreted in breast milk.
Overdose effectsView
In case of overdosage, Erythromycin should be discontinued. Overdosage should be handled with the prompt elimination of unabsorbed drug and all other appropriate measures should be instituted. Erythromycin is not removed by peritoneal dialysis or haemodialysis.
ReconstitutionView
Direction for reconstitution of suspension: Shake the bottle to loosen powder. Add 60 ml or 100 ml of boiled and cooled water to the dry powder of the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in suspension.
Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator and unused portion should be discarded after 7 days.
Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator and unused portion should be discarded after 7 days.
StorageView
Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.
Etrocin
Erythromycin (Oral)
Etrocin
Erythromycin (Oral)
Indications
Susceptible infections
Indication detailsView
Erythromycin is highly effective in the treatment of a wide variety of clinical infections.
- Upper respiratory tract infections: Tonsilitis, Peritonsillar abscess, Pharyngitis, laryngitis, Sinusitis. Secondary infections in colds and influenza.
- Lower respiratory tract infections: Tracheitis, acute and chronic bronchitis.
- Ear infections: Otitis media, otitis externa, mastoiditis.
- Eye infections: Blepharitis, established trachoma.
- Skin and Soft tissue infections: Boils and carbuncles, impetigo, abscesses, pustular acne, paromychia, cellulitis, erysipelas.
- Gastrointestinal tract infections: Cholecystitis, staphylococcal enterocolitis.
- Prophylaxis: Pre and post-operative, trauma, burns, rheumatic fever.
- Other infections: Osteomyelitis, diptheria, scarlet fever, whooping cough.
Therapeutic classView
Anti-diarrhoeal Antimicrobial drugs, Macrolides
PharmacologyView
Erythromycin inhibits microsomal protein synthesis in susceptible organisms by inhibiting the translocation process. Specific binding to the 50S subunit or 70S ribosome occurs in these organisms but there is no binding to the stable 80S mammalian ribosome. Erythromycin is active against many Grampositive bacteria, some Gram-negative bacteria and against mycoplasmas and chlamydia.
Absorption: Erythromycin base is destroyed by acid and is therefore administered in the form of stable ester. The rates of absorption of the base and esters are diminished by the presence of food. The stearate is hydrolyzed in the intestine and the free erythromycin absorbed.
Blood concentration: After an oral dose of 500 mg. of the base of stearate, peak serum concentrations of 0.9 to 1.4 or 0.4 to 1.8 mg/ml. respectively are attained in 1 to 4 hours. Half-life: The serum half-life is 1.2 to 4 hours. In subjects with oliguria, the half-life is about 5 hours.
Distribution: Erythromycin is widely distributed throughout body tissue and fluids with some retention in the liver and spleen, protein binding of erythromycin base is 73%. Erythromycin enters the cerebrospinal fluid when the meninges are inflamed. It also crosses the placenta and is excreted in the milk.
Excretion: 5 to 15 % of the dose of erythromycin is excreted in the urine and large amounts of the unchanged active substance are excreted in the bile.
Absorption: Erythromycin base is destroyed by acid and is therefore administered in the form of stable ester. The rates of absorption of the base and esters are diminished by the presence of food. The stearate is hydrolyzed in the intestine and the free erythromycin absorbed.
Blood concentration: After an oral dose of 500 mg. of the base of stearate, peak serum concentrations of 0.9 to 1.4 or 0.4 to 1.8 mg/ml. respectively are attained in 1 to 4 hours. Half-life: The serum half-life is 1.2 to 4 hours. In subjects with oliguria, the half-life is about 5 hours.
Distribution: Erythromycin is widely distributed throughout body tissue and fluids with some retention in the liver and spleen, protein binding of erythromycin base is 73%. Erythromycin enters the cerebrospinal fluid when the meninges are inflamed. It also crosses the placenta and is excreted in the milk.
Excretion: 5 to 15 % of the dose of erythromycin is excreted in the urine and large amounts of the unchanged active substance are excreted in the bile.
DosageView
Adult and Children over 8 years: 250-500 mg every six hours for mild to moderate infections. This may be increased upto 4 gm. or more daily in severe cases.
Elderly: No special dosage recommendation. Erythromycin may be administered if desired, three times daily or twice daily by giving one-third or half of the total daily requirement 8 hourly or 12 hourly respectively.
Children aged 2 to 8 years: 250 mg. every six hours or 30-50 mg/kg body weight per day divided into four equal dosage.
Infants and Children upto 2 years: 500 mg. in divided doses or 30-50 mg/kg body weight in divided doses.
Elderly: No special dosage recommendation. Erythromycin may be administered if desired, three times daily or twice daily by giving one-third or half of the total daily requirement 8 hourly or 12 hourly respectively.
Children aged 2 to 8 years: 250 mg. every six hours or 30-50 mg/kg body weight per day divided into four equal dosage.
Infants and Children upto 2 years: 500 mg. in divided doses or 30-50 mg/kg body weight in divided doses.
Side effectsView
Allergic reactions are rare and mild although anaphylaxis has occurred. Occasionally there is abdominal discomfort after oral administration, sometimes with nausea and vomiting. This discomfort usually subsides after a few days without it being necessary to reduce the dosage.
ContraindicationsView
Known hypersensitivity to Erythromycin.
PrecautionsView
Erythromycin should be given with care in patients with impaired hepatic function, as erythromycin is excreted principally in the bile.
InteractionsView
Recent data from studies of erythromycin reveals that its use in patients who are receiving high dosage of theophylline may be associated with an increase of serum theophylline levels and potential theophylline toxicity. In such cases this dose of theophylline should be reduced.
Pregnancy & lactationView
Clinical and Laboratory studies have been shown no evidence in human of teratogenicity or toxicity. However, caution should be exercised when prescribing this drug to pregnant patients and lactating mothers since erythromycin crosses the placental barrier and is excreted in breast milk.
Overdose effectsView
In case of overdosage, Erythromycin should be discontinued. Overdosage should be handled with the prompt elimination of unabsorbed drug and all other appropriate measures should be instituted. Erythromycin is not removed by peritoneal dialysis or haemodialysis.
ReconstitutionView
Direction for reconstitution of suspension: Shake the bottle to loosen powder. Add 60 ml or 100 ml of boiled and cooled water to the dry powder of the bottle. For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in suspension.
Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator and unused portion should be discarded after 7 days.
Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator and unused portion should be discarded after 7 days.
StorageView
Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.
Eucera
Urea (10%)
Eucera
Urea (10%)
Indications
Psoriasis
Indication detailsView
Urea 10% cream is indicated for-
- Ichthyosis and dry skin conditions
- Management of eczemas
- Management of psoriasis
Therapeutic classView
Topical urea preparations
PharmacologyView
Topical urea is bacteriostatic, bactericidal, fungistatic, proteolytic, hygroscopic and has mild local anesthetic properties. These actions are dose dependent. Most of its therapeutic applications depend on its hygroscopic properties. The hygroscopic property is due to its ability to cause configurational change in proteins in the stratum corneum. A 10% urea cream has been shown to increase the water holding capacity of ichthyotic scale by 100% after 3 weeks of treatment. There is no information available about percutaneous absorption of urea. Therapeutic effects depend on local concentrations, not on systemic absorption of the drug. If absorbed, urea would be excreted unchanged in the urine.
DosageView
Urea 10% cream is applied topically. Wash affected areas well, rinse off all traces of soap, dry and apply sparingly twice daily. Occlusive dressings may be used, but are usually unnecessary because of the self-occlusive nature of the cream.
Use in children: Urea 10% cream can be used in all age groups.
Use in children: Urea 10% cream can be used in all age groups.
Side effectsView
No serious toxicity has been reported with topical urea. Historically it is considered a safe drug. But on some occasions, topical urea has been shown to cause burning and irritation, if applied to inflamed, broken or exudative skin eruptions.
ContraindicationsView
This is contraindicated in any other ingredient of this preaparation.
PrecautionsView
In some instances, urea 10% cream may cause local irritation and edema, when applied to sensitive skin. If the condition is aggravated or there is no improvement the doctor should be consulted. Avoid application to moist or broken skin.
InteractionsView
No hazardous drug interaction has been reported.
Pregnancy & lactationView
Urea cream can be used during pregnancy and lactation.
StorageView
Keep out of the reach of children. Do not freeze. Keep at cool and dry place.
Eucilone
Triamcinolone Acetonide (Injection)
Eucilone
Triamcinolone Acetonide (Injection)
Indications
Severe erythema multiforme (Stevens-Johnson syndrome)
Indication detailsView
Post-traumatic osteoarthritis, synovitis of osteoarthritis, rheumatoid arthritis, acute and sub-acute bursitis, epicondylitis, acute non-specific tenosynovitis, acute gouty arthritis, psoriatic arthritis, ankylosing spondylitis, juvenile rheumatoid arthritis, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, bullous dermatitis herpetiformis, severe seborrheic dermatitis, severe psoriasis, bronchial asthma, contact dermatitis, atopic dermatitis, seasonal or perennial allergic rhinitis.
Therapeutic classView
Corticosteroid, Glucocorticoids, Triamcinolone & Combined preparations
PharmacologyView
The antiinflammatory actions of corticosteroids are thought to involve lipocortins, phospholipase A2 inhibitory proteins which, through inhibition of arachidonic acid, control the biosynthesis of prostaglandins and leukotrienes. Firstly, however, these glucocorticoids bind to the glucocorticoid receptors which translocate into the nucleus and bind DNA (GRE) and change genetic expression both positively and negatively. The immune system is suppressed by corticosteroids due to a decrease in the function of the lymphatic system, a reduction in immunoglobulin and complement concentrations, the precipitation of lymphocytopenia, and interference with antigen-antibody binding.
DosageView
Adults and children over 12 years of age: Initial dose is 60 mg. Dosage is usually adjusted within the range of 40 to 80 mg. For local areas, dose for adults is up to 10 mg for smaller areas and up to 40 mg for larger areas.
Children 6 to 12 years: Initial dose is 40 mg
Children 6 to 12 years: Initial dose is 40 mg
Side effectsView
Cushingoid syndrome, weakness, bruising or purpura, aggravation of infections, peptic ulcer, activation of latent or aggravation of existing diabetes, altered menstrual cycle, hirsutism.
ContraindicationsView
Triamcinolone Acetonide injection is contraindicated in patients with a sensitivity to the active or inactive ingredients.
PrecautionsView
Triamcinolone Acetonide injection should be used cautiously in patients with ocular herpes simplex, nonspecific ulcerative colitis, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis, Cushing's syndrome, diabetes mellitus, congestive heart failure, chronic nephritis.
InteractionsView
Aminoglutethimide: Aminoglutethimide may lead to a loss of corticosteroid-induced adrenal suppression.
Amphotericin B injection and potassium-depleting agents: When corticosteroids are administered concomitantly with potassium-depleting agents (ie, amphotericin B, diuretics), patients should be observed closely for development of hypokalemia. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.
Antibiotics: Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance.
Anticholinesterases: Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy.
Anticoagulants, oral: Coadministration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.
Antidiabetics: Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.
Antitubercular drugs: Serum concentrations of isoniazid may be decreased.
Cholestyramine: Cholestyramine may increase the clearance of corticosteroids.
Cyclosporine: Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.
Digitalis glycosides: Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.
Estrogens, including oral contraceptives: Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.
Hepatic enzyme inducers (eg, barbiturates, phenytoin, carbamazepine, rifampin): Drugs which induce hepatic microsomal drug metabolizing enzyme activity may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased.
Ketoconazole: Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to an increased risk of corticosteroid side effects.
Nonsteroidal anti-inflammatory drugs (NSAIDs): Concomitant use of aspirin (or other nonsteroidal anti-inflammatory drugs) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids.
Skin tests: Corticosteroids may suppress reactions to skin tests.
Vaccines: Patients on prolonged corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible.
Amphotericin B injection and potassium-depleting agents: When corticosteroids are administered concomitantly with potassium-depleting agents (ie, amphotericin B, diuretics), patients should be observed closely for development of hypokalemia. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.
Antibiotics: Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance.
Anticholinesterases: Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy.
Anticoagulants, oral: Coadministration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.
Antidiabetics: Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.
Antitubercular drugs: Serum concentrations of isoniazid may be decreased.
Cholestyramine: Cholestyramine may increase the clearance of corticosteroids.
Cyclosporine: Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.
Digitalis glycosides: Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.
Estrogens, including oral contraceptives: Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.
Hepatic enzyme inducers (eg, barbiturates, phenytoin, carbamazepine, rifampin): Drugs which induce hepatic microsomal drug metabolizing enzyme activity may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased.
Ketoconazole: Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to an increased risk of corticosteroid side effects.
Nonsteroidal anti-inflammatory drugs (NSAIDs): Concomitant use of aspirin (or other nonsteroidal anti-inflammatory drugs) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids.
Skin tests: Corticosteroids may suppress reactions to skin tests.
Vaccines: Patients on prolonged corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible.
Pregnancy & lactationView
Triamcinolone Acetonide injection should be used during pregnancy, nursing mothers if the possible benefits of the medication justify the potential hazards to the fetus or nursing infant.
Pediatric usageView
Use in the elderly: The common adverse effects of systemic corticosteroids such as osteoporosis or hypertension may be associated with more serious consequences in old age. Close clinical supervision is recommended.
Use in children: As corticosteroids can suppress growth, the development of infants and children on prolonged corticosteroid therapy should be carefully observed. Caution should be taken in the event of exposure to chicken pox, measles or other communicable diseases. Children should not be vaccinated or immunized while on corticosteroid therapy. Corticosteroids may also affect endogenous steroid production.
Use in children: As corticosteroids can suppress growth, the development of infants and children on prolonged corticosteroid therapy should be carefully observed. Caution should be taken in the event of exposure to chicken pox, measles or other communicable diseases. Children should not be vaccinated or immunized while on corticosteroid therapy. Corticosteroids may also affect endogenous steroid production.
Overdose effectsView
Treatment of acute overdosage is by supportive and symptomatic therapy. For chronic overdosage in the face of severe disease requiring continuous steroid therapy, the dosage of the corticosteroid may be reduced only temporarily, or alternate day treatment may be introduced.
StorageView
Store at controlled room temperature, 20-25°C, avoid freezing and protect from light.
Eucon
Ranitidine Hydrochloride
Eucon
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.
Eucon
Ranitidine Hydrochloride
Eucon
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.
Eucot
Hydrocortisone
Eucot
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.
Eucron
Gliclazide
Eucron
Gliclazide
Indications
Type 2 DM
Indication detailsView
Gliclazide is a medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to the sulphonylurea group). Gliclazide is used in a certain form of diabetes (type 2 diabetes Mellitus) in adults, when diet, exercise and weight loss alone do not have an adequate effect on keeping blood sugar at the correct level.
Therapeutic classView
Sulfonylureas
PharmacologyView
Gliclazide is a second generation sulfonylurea drug that has hypoglycaemic and potentially useful hematological properties. It stimulates the release of insulin from pancreatic β-cells by facilitating Ca+2 transport across the β-cell membranes and decreases hepatic glucose output.
DosageView
Film-coated tablet: The usual initial dose is 40 to 80 mg daily. The dose can be increased up to 320 mg daily in divided doses when needed. The drug should be taken before meal. For children, Gliclazide is not used because it is contraindicated in juvenile-onset diabetes.
Modified release preparation: Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The dose is determined by the doctor, depending on your blood and possibly urine sugar levels. Change in external factors (weight reduction, lifestyle, stress) or improvements in the blood sugar control may require changed gliclazide doses.
The recommended daily dose is one to four tablets (maximum 120 mg) in a single intake at breakfast time. This depends on the response to treatment. Gliclazide MR tablet is for oral use. Take your tablet(s) with a glass of water at breakfast time (and preferably at the same time each day). Swallow your whole tablet(s) in one piece. Do not chew or crush. You must always eat a meal after taking your tablet(s).
If a combination therapy of gliclazide with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor a GLP-1 receptor agonist or insulin is initiated your doctor will determine the proper dose of each medicine individually for you. If you notice that your blood sugar levels are high although you are taking the medicine as prescribed, you should contact your doctor or pharmacist.
If you take more Gliclazide tablets than you should: If you take too many tablets, contact your doctor or the nearest hospital Accident & Emergency department immediately. The signs of overdose are those of low blood sugar (hypoglycaemia). The symptoms can be helped by taking sugar (4 to 6 lumps) or sugary drinks straight away, followed by a substantial snack or meal. If the patient is unconscious immediately inform a doctor and call the emergency services. The same should be done if somebody, (for instance a child), has taken the product unintentionally. Unconscious patients must not be given food or drink. It should be ensured that there is always a pre-informed person that can call a doctor in case of emergency.
If you forget to take Gliclazide tablet: It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Gliclazide MR tablet, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Gliclazide MR tablet: As the treatment for diabetes is usually lifelong, you should discuss with your doctor before stopping this medicinal product. Stopping could cause high blood sugar (hyperglycaemia) which increases the risk of developing complications of diabetes. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Modified release preparation: Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The dose is determined by the doctor, depending on your blood and possibly urine sugar levels. Change in external factors (weight reduction, lifestyle, stress) or improvements in the blood sugar control may require changed gliclazide doses.
The recommended daily dose is one to four tablets (maximum 120 mg) in a single intake at breakfast time. This depends on the response to treatment. Gliclazide MR tablet is for oral use. Take your tablet(s) with a glass of water at breakfast time (and preferably at the same time each day). Swallow your whole tablet(s) in one piece. Do not chew or crush. You must always eat a meal after taking your tablet(s).
If a combination therapy of gliclazide with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor a GLP-1 receptor agonist or insulin is initiated your doctor will determine the proper dose of each medicine individually for you. If you notice that your blood sugar levels are high although you are taking the medicine as prescribed, you should contact your doctor or pharmacist.
If you take more Gliclazide tablets than you should: If you take too many tablets, contact your doctor or the nearest hospital Accident & Emergency department immediately. The signs of overdose are those of low blood sugar (hypoglycaemia). The symptoms can be helped by taking sugar (4 to 6 lumps) or sugary drinks straight away, followed by a substantial snack or meal. If the patient is unconscious immediately inform a doctor and call the emergency services. The same should be done if somebody, (for instance a child), has taken the product unintentionally. Unconscious patients must not be given food or drink. It should be ensured that there is always a pre-informed person that can call a doctor in case of emergency.
If you forget to take Gliclazide tablet: It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Gliclazide MR tablet, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Gliclazide MR tablet: As the treatment for diabetes is usually lifelong, you should discuss with your doctor before stopping this medicinal product. Stopping could cause high blood sugar (hyperglycaemia) which increases the risk of developing complications of diabetes. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Side effectsView
Like all medicines, Gliclazide can cause side effects, although not everybody gets them. The most commonly observed side effect is low blood sugar (hypoglycaemia). If left untreated these symptoms could progress to drowsiness, loss of consciousness or possibly coma. If an episode of low blood sugar is severe or prolonged, even if it is temporarily controlled by eating sugar, you should seek immediate medical attention.
Liver disorders: There have been isolated reports of abnormal iiver function, which can cause yellow skin and eyes. If you get this, see your doctor immediately. The symptoms generally disappear if the medicine is stopped. Your doctor will decide whether to stop your treatment.
Skin disorders: Skin reactions such as rash, redness, itching, hives, blisters, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty) have been reported. Rash may progress to widespread blistering or peeling of the skin. If you develop this, stop taking, seek urgent advice from a doctor and tell him that you are taking this medicine. Exceptionally, signs of severe hypersensitivity reactions have been reported: initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature.
Blood disorders: Decrease in the number of cells in the blood (e.g. platelets, red and white blood cells) which may cause paleness, prolonged bleeding, bruising, sore throat and fever have been reported. These symptoms usually vanish when the treatment is discontinued.
Digestive disorders: Abdominal pain, nausea, vomiting, indigestion, diarrhoea, and constipation. These effects are reduced when Gliclazide is taken with a meal as recommended.
Eye disorders: Your vision may be affected for a short time especially at the start of treatment. This effect is due to changes in blood sugar levels.
As for another sulfonylurea, the following adverse events have been observed: cases of severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels, reduction in blood sodium (hyponatraemia), symptoms of liver impairment (for instance jaundice) which in most cases disappeared after withdrawal of the sulfonylurea, but may lead to life-threatening liver failure in isolated cases.
Reporting of side effects: If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.
Liver disorders: There have been isolated reports of abnormal iiver function, which can cause yellow skin and eyes. If you get this, see your doctor immediately. The symptoms generally disappear if the medicine is stopped. Your doctor will decide whether to stop your treatment.
Skin disorders: Skin reactions such as rash, redness, itching, hives, blisters, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty) have been reported. Rash may progress to widespread blistering or peeling of the skin. If you develop this, stop taking, seek urgent advice from a doctor and tell him that you are taking this medicine. Exceptionally, signs of severe hypersensitivity reactions have been reported: initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature.
Blood disorders: Decrease in the number of cells in the blood (e.g. platelets, red and white blood cells) which may cause paleness, prolonged bleeding, bruising, sore throat and fever have been reported. These symptoms usually vanish when the treatment is discontinued.
Digestive disorders: Abdominal pain, nausea, vomiting, indigestion, diarrhoea, and constipation. These effects are reduced when Gliclazide is taken with a meal as recommended.
Eye disorders: Your vision may be affected for a short time especially at the start of treatment. This effect is due to changes in blood sugar levels.
As for another sulfonylurea, the following adverse events have been observed: cases of severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels, reduction in blood sodium (hyponatraemia), symptoms of liver impairment (for instance jaundice) which in most cases disappeared after withdrawal of the sulfonylurea, but may lead to life-threatening liver failure in isolated cases.
Reporting of side effects: If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.
ContraindicationsView
Do not take Gliclazide:
- if you are allergic to gliclazide or to other medicines of the same group (sulfonylurea), or to other related medicines (hypoglycaemic sulfonamides)
- if you have insulin-dependent diabetes (type 1)
- if you have ketone bodies and sugar in your urine (this may mean you have diabetic ketoacidosis), a diabetic pre-coma or coma
- if you have severe kidney or liver disease
- if you are taking medicines to treat fungal infections
- if you are breastfeeding
PrecautionsView
Talk to your doctor before taking Gliclazide. You should observe the treatment plan prescribed by your doctor to achieve proper blood sugar levels. This means, apart from regular tablet intake, to observe the dietary regimen, have physical exercise and, where necessary, reduce weight During gliclazide treatment regular monitoring of your blood (and possibly urine) sugar level and also your glycated haemoglobin (HbA1c) is necessary. In the first few weeks of treatment, the risk of having reduced blood sugar levels (hypoglycaemia) may be increased. So particularly close medical monitoring is necessary.
Low blood sugar (Hypoglycaemia) may occur:
The following signs and symptoms may also occur: sweating, clammy skin, anxiety, fast or irregular heartbeat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris).
If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop convulsions, lose self-control, your breathing may be shallow and your heartbeat slowed down, you may become unconscious.
In most cases the symptoms of low blood sugar vanish very quickly when you consume .some form of sugar, (for instance, glucose tablets, sugar cubes, sweet juice, sweetened tea).
You should therefore always carry some form of sugar with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. Please contact your doctor or the nearest hospital if taking sugar does not help or if the symptoms recur.
Symptoms of low blood sugar may be absent, less obvious or develop very slowly or you are not aware in time that your blood sugar level has dropped. This may happen if you are an elderly patient taking certain medicines (for instance those acting on the central nervous system and beta-blockers).
If you are in stressful situations (e.g. accidents, surgical operations, fever etc.) your doctor may temporarily switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide has not yet sufficiently reduced the blood sugar when you have not complied with the treatment plan prescribed by your doctor if you take St. John’s Wort (Hypericum perforatum) preparations or in special stress situations. These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and reduced performance.
Blood glucose disturbances (low blood sugar and high bold sugar) can occur when Gliclazide is prescribed at the same time as medicines to a class of antibiotics called fluoroquinolone, especially in elderly patients. In this case, your doctor will remind you of the importance of monitoring your blood glucose.
If you have a family history of or know you have the hereditary condition glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormality of red blood cells), lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur. Contact your doctor before taking this medicinal product.
Gliclazide is not recommended for use in children due to lack of data.
Low blood sugar (Hypoglycaemia) may occur:
- if you take meals irregularly or skip meals altogether,
- if you are fasting
- if you are malnourished
- if you change your diet
- if you increase your physical activity and carbohydrate intake does not match this increase,
- if you drink alcohol, especially in combination with skipped meals,
- if you take other medicines or natural remedies at the same time,
- if you take too high doses of gliclazide,
- if you suffer from particular hormone-induced disorders (functional disorders of the thyroid gland, pituitary gland or adrenal cortex),
- if your kidney function or liver function is severely decreased.
The following signs and symptoms may also occur: sweating, clammy skin, anxiety, fast or irregular heartbeat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris).
If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop convulsions, lose self-control, your breathing may be shallow and your heartbeat slowed down, you may become unconscious.
In most cases the symptoms of low blood sugar vanish very quickly when you consume .some form of sugar, (for instance, glucose tablets, sugar cubes, sweet juice, sweetened tea).
You should therefore always carry some form of sugar with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. Please contact your doctor or the nearest hospital if taking sugar does not help or if the symptoms recur.
Symptoms of low blood sugar may be absent, less obvious or develop very slowly or you are not aware in time that your blood sugar level has dropped. This may happen if you are an elderly patient taking certain medicines (for instance those acting on the central nervous system and beta-blockers).
If you are in stressful situations (e.g. accidents, surgical operations, fever etc.) your doctor may temporarily switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide has not yet sufficiently reduced the blood sugar when you have not complied with the treatment plan prescribed by your doctor if you take St. John’s Wort (Hypericum perforatum) preparations or in special stress situations. These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and reduced performance.
Blood glucose disturbances (low blood sugar and high bold sugar) can occur when Gliclazide is prescribed at the same time as medicines to a class of antibiotics called fluoroquinolone, especially in elderly patients. In this case, your doctor will remind you of the importance of monitoring your blood glucose.
If you have a family history of or know you have the hereditary condition glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormality of red blood cells), lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur. Contact your doctor before taking this medicinal product.
Gliclazide is not recommended for use in children due to lack of data.
InteractionsView
Other medicines and Gliclazide: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
The blood sugar lowering effect of gliclazide may be strengthened and signs of low blood sugar levels may occur when one of the follow ng medicines is taken:
Gliclazide may increase the effects of medicines that reduce blood clotting (warfarin).
Consult your doctor before you start taking another medicinal product. If you go into hospital tell the medical staff you are taking gliclazide.
Gliclazide with food and drink: Gliclazide can be taken with food and non-alcoholic drinks. Drinking alcohol is not recommended as it can alter the control of your diabetes in an unpredictable manner.
Driving and using machines: Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycaemia), or too high (hyperglycaemia) or if you develop visual problems as a result of such conditions. Bear in mind that you could endanger yourself or others (for instance when driving a car or using machines). Please ask your doctor whether you can drive a car if you:
The blood sugar lowering effect of gliclazide may be strengthened and signs of low blood sugar levels may occur when one of the follow ng medicines is taken:
- other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists or insulin),
- antibiotics (sulphonamides, clarithromycin)
- medicines to treat high blood pressure or heart failure (beta-blockers. ACE-inhibitors such as captopril, or enalapril)
- medicines to treat fungal infections (miconazole, fluconazole)
- medicines to treat ulcers in the stomach or duodenum (H2 receptor antagonists),
- medicines to treat depression (monoamine oxidase inhibitors)
- painkiller or antirheumatics (phenylbutazone, ibuprofen)
- medicines containing alcohol
- medicines to treat disorders of the central nervous system (chlorpromazine)
- medicines reducing inflammation (corticosteroids)
- medicines to treat asthma or used during labour (intravenous salbutamol, ritodrine and terbutaline)
- medicines to treat breast disorders, heavy menstrual bleeding and endometriosis (danazol)
- St John's Wort- Hypericum perforatum- preparations
Gliclazide may increase the effects of medicines that reduce blood clotting (warfarin).
Consult your doctor before you start taking another medicinal product. If you go into hospital tell the medical staff you are taking gliclazide.
Gliclazide with food and drink: Gliclazide can be taken with food and non-alcoholic drinks. Drinking alcohol is not recommended as it can alter the control of your diabetes in an unpredictable manner.
Driving and using machines: Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycaemia), or too high (hyperglycaemia) or if you develop visual problems as a result of such conditions. Bear in mind that you could endanger yourself or others (for instance when driving a car or using machines). Please ask your doctor whether you can drive a car if you:
- have frequent episodes of low blood sugar (hypoglycaemia)
- have few or no warning signals of low blood sugar (hypoglycaemia)
Pregnancy & lactationView
Gliclazide is not recommended for use during pregnancy. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You must not take Gliclazide while you are breastfeeding.
StorageView
Keep out of the reach and sight of children. Do not use this medicine after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of that month. Store below 30°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Eudaxen
Diazoxide
Eudaxen
Diazoxide
Indications
Hypoglycemia
Indication detailsView
Diazoxide tablets are used orally in the treatment of intractable hypoglycemia.
Hypoglycaemia: Diazoxide administered orally is indicated for the treatment of intractable hypoglycaemia with severe symptoms from a variety of causes including idiopathic hypoglycaemia in infancy, leucine-sensitive or unclassified; functional islet cell tumours both malignant and benign if inoperable, extra-pancreatic neoplasms producing hypoglycaemia; glycogen storage disease; hypoglycaemia of unknown origin. Diazoxide also causes salt and water retention.
Hypoglycaemia: Diazoxide administered orally is indicated for the treatment of intractable hypoglycaemia with severe symptoms from a variety of causes including idiopathic hypoglycaemia in infancy, leucine-sensitive or unclassified; functional islet cell tumours both malignant and benign if inoperable, extra-pancreatic neoplasms producing hypoglycaemia; glycogen storage disease; hypoglycaemia of unknown origin. Diazoxide also causes salt and water retention.
Therapeutic classView
Combination Oral hypoglycemic preparations
PharmacologyView
As a diuretic, Diazoxide inhibits active chloride reabsorption at the early distal tubule via the Na-CI cotransporter, resulting in an increase in the excretion of sodium, chloride, and water. Thiazides like Diazoxide also inhibit sodium ion transport across the renal tubular epithelium through binding to the thiazide sensitive sodium-chloride transporter. This results in an increase in potassium excretion via the sodium-potassium exchange mechanism. The antihypertensive mechanism of Diazoxide is less well understood although it may be mediated through its action on carbonic anhydrases in the smooth muscle or through its action on the large-conductance calcium-activated potassium (KCa) channel, also found in the smooth muscle. As a antihypoglycemic, Diazoxide inhibits insulin release from the pancreas, probably by opening potassium channels in the beta cell membrane.
Pharmacodynamics: Diazoxide is a potassium channel activator. Its mechanism of action revolves around enhancing cell membrane permeability to potassium ions. This action consequently elicits the relaxation of local smooth muscles. This switches off voltage-gated calcium ion channels which inhibits the generation of an action potential.
Pharmacodynamics: Diazoxide is a potassium channel activator. Its mechanism of action revolves around enhancing cell membrane permeability to potassium ions. This action consequently elicits the relaxation of local smooth muscles. This switches off voltage-gated calcium ion channels which inhibits the generation of an action potential.
DosageView
For both adults and children: a starting oral dose of 5mg/kg body weight divided into 2 or 3 equal doses per 24 hours will establish the patient's response and thereafter the dose can be increased until the symptoms and blood glucose level respond satisfactorily. Regular determinations of the blood glucose in the initial days of treatment are essential. The usual maintenance dose is 3-8mg/kg/day given in two or three divided doses.
Patients with renal impairment: Reduced doses may be required in patients with impaired renal function.
In children with leucine-sensitive hypoglycaemia: A dosage range of 15- 20mg/kg/day is suggested.
In adults with benign or malignant islet-cell tumours producing large quantities of insulin: High dosages of up to 1,000mg per day have been used.
Patients with renal impairment: Reduced doses may be required in patients with impaired renal function.
In children with leucine-sensitive hypoglycaemia: A dosage range of 15- 20mg/kg/day is suggested.
In adults with benign or malignant islet-cell tumours producing large quantities of insulin: High dosages of up to 1,000mg per day have been used.
Side effectsView
The adverse reactions are thrombocytopenia, pancreatitis, hypotension, diarrhea, heart failure etc.
ContraindicationsView
In the treatment of hypoglycaemia, Diazoxide is contraindicated in all cases which are amenable to surgery or other specific therapy. Hypersensitivity to any component of the preparation or other thiazides
PrecautionsView
In the treatment of hypoglycaemia it is necessary that the blood pressure be monitored regularly. Retention of sodium and water is likely to necessitate therapy with an oral diuretic such as frusemide or ethacrynic acid The dosage of either of the diuretics mentioned may be up to 1g daily. It must be appreciated that if diuretics are employed then both the hypotensive and hyperglycaemic activities of Diazoxide will be potentiated and it is likely that the dosage of Diazoxide will require adjustment downwards. In patients with severe renal failure it is desirable to maintain, with diuretic therapy, urinary volumes in excess of 1 litre daily. Hypokalaemia should be avoided by adequate potassium replacement.
Diazoxide should be used with caution in patients with cardiac failure or impaired cardiac reserve in whom sodium and water retention may worsen or precipitate congestive heart failure. A direct effect on myocardium and cardiac function cannot be excluded.
Diazoxide should be used with care in patients with impaired cardiac or cerebral circulation and in patients with aortic coarctation, aortic stenosis, arteriovenous shunt, heart failure or other cardiovascular disorders in which an increase in cardiac output could be detrimental.
Diazoxide should be administered with caution to patients with hyperuricaemia or a history of gout, and it is advisable to monitor serum uric acid concentration.
Whenever Diazoxide is given over a prolonged period regular haematological examinations are indicated to exclude changes in white blood cell and platelet counts.
Also in children there should be regular assessment of growth, bone and psychological maturation.
The very rapid, almost complete protein binding of Diazoxide requires cautious dosage to be used in patients whose plasma proteins may be lower than normal
Diazoxide should be used with caution in patients with cardiac failure or impaired cardiac reserve in whom sodium and water retention may worsen or precipitate congestive heart failure. A direct effect on myocardium and cardiac function cannot be excluded.
Diazoxide should be used with care in patients with impaired cardiac or cerebral circulation and in patients with aortic coarctation, aortic stenosis, arteriovenous shunt, heart failure or other cardiovascular disorders in which an increase in cardiac output could be detrimental.
Diazoxide should be administered with caution to patients with hyperuricaemia or a history of gout, and it is advisable to monitor serum uric acid concentration.
Whenever Diazoxide is given over a prolonged period regular haematological examinations are indicated to exclude changes in white blood cell and platelet counts.
Also in children there should be regular assessment of growth, bone and psychological maturation.
The very rapid, almost complete protein binding of Diazoxide requires cautious dosage to be used in patients whose plasma proteins may be lower than normal
InteractionsView
Drugs potentiated by Diazoxide therapy include: oral diuretics, antihypertensive agents and anticoagulants. Phenytoin levels should be monitored as increased dosage may be needed if administered concurrently with diazoxide. The risk of hyperglycaemia may be increased by concurrent administration of corticosteroids or oestrogen-progestogen combinations.
Pregnancy & lactationView
Pregnancy: Reproduction studies using the oral preparation in rats have revealed increased fetal resorptions and delayed parturition, as well as fetal skeletal anomalies; evidence of skeletal and cardiac teratogenic effects in rabbits has been noted with intravenous administration. The drug has also been demonstrated to cross the placental barrier in animals and to cause degeneration of the fetal pancreatic beta cells. Since there are no adequate data on fetal effects of this drug when given to pregnant women, safety in pregnancy has not been established. When the use of Diazoxide is considered, the indications should be limited to those specified above for adults, and the potential benefits to the mother must be weighed against possible harmful effects to the fetus. Diazoxide Tablets are only to be used in pregnant women when the indicated condition is deemed to put the mother's life at risk. Prolonged oral therapy of Diazoxide during pregnancy has been reported to cause alopecia in the newborn.
Nursing mothers: Information is not available concerning the passage of Diazoxide in breast milk. Because many drugs are excreted in human milk and because of the potential for adverse reactions from Diazoxide in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Nursing mothers: Information is not available concerning the passage of Diazoxide in breast milk. Because many drugs are excreted in human milk and because of the potential for adverse reactions from Diazoxide in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Overdose effectsView
Excessive dosage of Diazoxide can result in hyperglycaemia. Severe hyperglycaemia may be corrected by giving insulin and less severe hyperglycaemia may respond to oral hypoglycaemics. Hypotension may be managed with intravenous fluids and in severe cases may require sympathomimetics.
StorageView
Store below 30°C. Store in the original container in order to protect from moisture. Keep Diazoxide out of reach and sight of the children.
Eudrate
Urea (10%)
Eudrate
Urea (10%)
Indications
Psoriasis
Indication detailsView
Urea 10% cream is indicated for-
- Ichthyosis and dry skin conditions
- Management of eczemas
- Management of psoriasis
Therapeutic classView
Topical urea preparations
PharmacologyView
Topical urea is bacteriostatic, bactericidal, fungistatic, proteolytic, hygroscopic and has mild local anesthetic properties. These actions are dose dependent. Most of its therapeutic applications depend on its hygroscopic properties. The hygroscopic property is due to its ability to cause configurational change in proteins in the stratum corneum. A 10% urea cream has been shown to increase the water holding capacity of ichthyotic scale by 100% after 3 weeks of treatment. There is no information available about percutaneous absorption of urea. Therapeutic effects depend on local concentrations, not on systemic absorption of the drug. If absorbed, urea would be excreted unchanged in the urine.
DosageView
Urea 10% cream is applied topically. Wash affected areas well, rinse off all traces of soap, dry and apply sparingly twice daily. Occlusive dressings may be used, but are usually unnecessary because of the self-occlusive nature of the cream.
Use in children: Urea 10% cream can be used in all age groups.
Use in children: Urea 10% cream can be used in all age groups.
Side effectsView
No serious toxicity has been reported with topical urea. Historically it is considered a safe drug. But on some occasions, topical urea has been shown to cause burning and irritation, if applied to inflamed, broken or exudative skin eruptions.
ContraindicationsView
This is contraindicated in any other ingredient of this preaparation.
PrecautionsView
In some instances, urea 10% cream may cause local irritation and edema, when applied to sensitive skin. If the condition is aggravated or there is no improvement the doctor should be consulted. Avoid application to moist or broken skin.
InteractionsView
No hazardous drug interaction has been reported.
Pregnancy & lactationView
Urea cream can be used during pregnancy and lactation.
StorageView
Keep out of the reach of children. Do not freeze. Keep at cool and dry place.
Eukrim
Urea (10%)
Eukrim
Urea (10%)
Indications
Psoriasis
Indication detailsView
Urea 10% cream is indicated for-
- Ichthyosis and dry skin conditions
- Management of eczemas
- Management of psoriasis
Therapeutic classView
Topical urea preparations
PharmacologyView
Topical urea is bacteriostatic, bactericidal, fungistatic, proteolytic, hygroscopic and has mild local anesthetic properties. These actions are dose dependent. Most of its therapeutic applications depend on its hygroscopic properties. The hygroscopic property is due to its ability to cause configurational change in proteins in the stratum corneum. A 10% urea cream has been shown to increase the water holding capacity of ichthyotic scale by 100% after 3 weeks of treatment. There is no information available about percutaneous absorption of urea. Therapeutic effects depend on local concentrations, not on systemic absorption of the drug. If absorbed, urea would be excreted unchanged in the urine.
DosageView
Urea 10% cream is applied topically. Wash affected areas well, rinse off all traces of soap, dry and apply sparingly twice daily. Occlusive dressings may be used, but are usually unnecessary because of the self-occlusive nature of the cream.
Use in children: Urea 10% cream can be used in all age groups.
Use in children: Urea 10% cream can be used in all age groups.
Side effectsView
No serious toxicity has been reported with topical urea. Historically it is considered a safe drug. But on some occasions, topical urea has been shown to cause burning and irritation, if applied to inflamed, broken or exudative skin eruptions.
ContraindicationsView
This is contraindicated in any other ingredient of this preaparation.
PrecautionsView
In some instances, urea 10% cream may cause local irritation and edema, when applied to sensitive skin. If the condition is aggravated or there is no improvement the doctor should be consulted. Avoid application to moist or broken skin.
InteractionsView
No hazardous drug interaction has been reported.
Pregnancy & lactationView
Urea cream can be used during pregnancy and lactation.
StorageView
Keep out of the reach of children. Do not freeze. Keep at cool and dry place.
Eumovate
Clobetasone Butyrate
Eumovate
Clobetasone Butyrate
Indications
Seborrhoeic dermatitis
Indication detailsView
Clobetasone preparations are indicated for the treatment of eczema and dermatitis of all types including atopic eczema, photodermatitis, otitis externa, primary irritant allergic dermatitis (including napkin rash), intertrigo, prurigo nodularis, seborrhoeic dermatitis and insect bite reactions. Clobetasone may be used as a maintenance therapy between courses of one of the more active topical steroids.
Therapeutic classView
Clobetasol / Clobetasone & Combined Preparations
PharmacologyView
Clobetasone Butyrate is a topically active corticosteroid, which provides an exceptional combination of activity and safety. It is more effective in the treatment of eczemas than 1% Hydrocortisone, or the less active synthetic steroid preparations that are in common use. It has little effect on hypothalamic-pituitary-adrenal function. All topical corticosteroids can cause cutaneous atrophy if grossly misused. However, study in animal and human models indicates that Clobetasone Butyrate causes less thinning of the epidermis than the other topical steroid tested.
DosageView
Apply to the affected area up to four times a day until improvement occurs, when the frequency of application may be reduced.
Side effectsView
Local atrophic changes; pigmentation changes & hypertrichosis. Increased liability to infection. Infections may be masked. Acute adrenal insufficiency. Growth retardation in child. Cushingoid symptoms. Amenorrhoea, hyperhidrosis, skin thinning
ContraindicationsView
Pregnancy (in high doses), Presence of acute infections, Treatment of rosacea, Leg ulcers, Acne vulgaris, Widespread plaque psoriasis. Child <1 yr.
PrecautionsView
May be absorbed in sufficient amounts to cause systemic effects when applied topically to large areas, broken skin or under occlusive dressings. Peptic ulcer, osteoporosis, psychoses or severe psychoneuroses. Not to be used indiscriminately for pruritus. CHF or hypertension. Diabetes mellitus, epilepsy, glaucoma, infectious diseases, ocular herpes simplex, chronic renal failure and uraemia. Active or doubtfully quiescent tuberculosis. Local treatment of eye disorders. Elderly. Prolonged use on the face.
InteractionsView
Potentially hazardous interactions- none has been reported. Potentially useful interactions- none has been reported.
Pregnancy & lactationView
There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate and intrauterine growth retardation. There may therefore be a very small risk of such effects in the human fetus.
Overdose effectsView
Acute overdosage is very unlikely to occur, in the case of chronic overdosage or misuse the features of hypercorticism may appear and in this situation topical steroids should be discontinued.
StorageView
Store below 30˚ C. Do not freeze. Protect from light.
Eumovate
Clobetasone Butyrate
Eumovate
Clobetasone Butyrate
Indications
Seborrhoeic dermatitis
Indication detailsView
Clobetasone preparations are indicated for the treatment of eczema and dermatitis of all types including atopic eczema, photodermatitis, otitis externa, primary irritant allergic dermatitis (including napkin rash), intertrigo, prurigo nodularis, seborrhoeic dermatitis and insect bite reactions. Clobetasone may be used as a maintenance therapy between courses of one of the more active topical steroids.
Therapeutic classView
Clobetasol / Clobetasone & Combined Preparations
PharmacologyView
Clobetasone Butyrate is a topically active corticosteroid, which provides an exceptional combination of activity and safety. It is more effective in the treatment of eczemas than 1% Hydrocortisone, or the less active synthetic steroid preparations that are in common use. It has little effect on hypothalamic-pituitary-adrenal function. All topical corticosteroids can cause cutaneous atrophy if grossly misused. However, study in animal and human models indicates that Clobetasone Butyrate causes less thinning of the epidermis than the other topical steroid tested.
DosageView
Apply to the affected area up to four times a day until improvement occurs, when the frequency of application may be reduced.
Side effectsView
Local atrophic changes; pigmentation changes & hypertrichosis. Increased liability to infection. Infections may be masked. Acute adrenal insufficiency. Growth retardation in child. Cushingoid symptoms. Amenorrhoea, hyperhidrosis, skin thinning
ContraindicationsView
Pregnancy (in high doses), Presence of acute infections, Treatment of rosacea, Leg ulcers, Acne vulgaris, Widespread plaque psoriasis. Child <1 yr.
PrecautionsView
May be absorbed in sufficient amounts to cause systemic effects when applied topically to large areas, broken skin or under occlusive dressings. Peptic ulcer, osteoporosis, psychoses or severe psychoneuroses. Not to be used indiscriminately for pruritus. CHF or hypertension. Diabetes mellitus, epilepsy, glaucoma, infectious diseases, ocular herpes simplex, chronic renal failure and uraemia. Active or doubtfully quiescent tuberculosis. Local treatment of eye disorders. Elderly. Prolonged use on the face.
InteractionsView
Potentially hazardous interactions- none has been reported. Potentially useful interactions- none has been reported.
Pregnancy & lactationView
There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate and intrauterine growth retardation. There may therefore be a very small risk of such effects in the human fetus.
Overdose effectsView
Acute overdosage is very unlikely to occur, in the case of chronic overdosage or misuse the features of hypercorticism may appear and in this situation topical steroids should be discontinued.
StorageView
Store below 30˚ C. Do not freeze. Protect from light.
Euphor
Fluphenazine + Nortriptyline
Euphor
Fluphenazine + Nortriptyline
Indications
Gastric problems
Indication detailsView
This is indicated in
- Mild to moderate mixed anxiety/depression
- Emotional disturbance
- Sleep disorder
- Gastric problems
Therapeutic classView
Combined anxiolytics & anti-depressant drugs
PharmacologyView
Nortriptyline hydrochloride is a tricyclic antidepressant. Nortriptyline inhibits the uptake of norepinephrine and serotonin at nerve terminals. In contrast to its parent compound amitriptyline which is equally potent in inhibiting the uptake of norepinephrine and serotonin, Nortriptyline has a greater effect on norepinephrine reuptake than on serotonin reuptake.
Fluphenazine is a tranquilizer of the phenothiazine type with piperazine side chain. Fluphenazine primarily acts as a neuroleptic drug whose main therapeutic effect is believed to reside in potent dopamine (specially D2) receptor antagonism.
Fluphenazine is a tranquilizer of the phenothiazine type with piperazine side chain. Fluphenazine primarily acts as a neuroleptic drug whose main therapeutic effect is believed to reside in potent dopamine (specially D2) receptor antagonism.
DosageView
Adults: One tablet 2 to 3 times daily.
Side effectsView
Tardive dyskinesias have been reported in phenothiazine therapy; usually after prolonged courses given at doses adequately to control psychotic illness. Blood dyscrasia, Malignant Neuroleptic syndrome and sudden death have been reported rarely. Agranulocytosis is a rare but potentially fatal adverse effect of Nortriptyline Hydrochloride.
ContraindicationsView
It is contraindicated in :
- History of gradual epilepsy or organic brain damage
- Blood dyscrasia
- Severe cardiac insufficiency
- Renal or liver damage
- Patients taking monoamine oxidase inhibitor (MAOI)
- Younger children
- Hypersensitivity to any component of the preparation
PrecautionsView
Precautions should be taken in patients with glaucoma, prostate enlargement, cardiac failure and myocardial infarction, and in concurrent administration with CNS depressants. The drug may impair alertness and abilities to drive a car or operate machinery.
InteractionsView
Interactions with barbiturates, alcohol, and narcotic drugs may occur, so central depressants should be administered with caution.
Pregnancy & lactationView
The safety in human pregnancy has not been yet established. The use of this drug in lactation is not recommended, as it is excreted in breast milk.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Eupi
Omeprazole
Eupi
Omeprazole
Indications
Zollinger-Ellison syndrome
Indication detailsView
Omeprazole is indicated for the treatment of-
- Gastric and duodenal ulcer
- NSAID-associated duodenal and gastric ulcer
- As prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
- Gastro-esophageal reflux disease
- Long-term management of acid reflux disease
- Acid-related dyspepsia
- Severe ulcerating reflux esophagitis
- Prophylaxis of acid aspiration during general anesthesia
- Zollinger-Ellison syndrome
- Helicobacter pylori-induced peptic ulcer.
Therapeutic classView
Proton Pump Inhibitor
PharmacologyView
Omeprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. It inhibits gastric acid secretion by blocking hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system in the gastric parietal cell. After oral administration, the onset of the antisecretory effect occurs within one hour, with the maximum effect occurring within two hours and inhibition of secretion lasts up to 72 hours. When the drug is discontinued, secretory activity returns gradually, over 3 to 5 days.
DosageView
Oral-
IV Injection-
- Benign gastric and duodenal ulcer: 20 mg once daily for 4 weeks in duodenal ulceration, 8 weeks in gastric ulceration; in severe or recurrent cases, dose to be increased to 40 mg daily; maintenance dose for recurrent duodenal ulcer, 20 mg once daily; in prevention of relapse in duodenal ulcer, 10-20 mg daily.
- NSAID-associated duodenal or gastric ulcer: 20 mg once daily for 4 weeks, continued for further 4 weeks, if not fully healed. 20 mg once daily is used as prophylaxis in patients with a history of NSAID-associated duodenal or gastric ulcers.
- Gastro-esophageal reflux disease: 20 mg once daily for 4 weeks, continued for further 4-8 weeks, if not fully healed; 40 mg once daily has been given for 8 weeks in gastro-esophageal reflux disease, refractory to other treatment; maintenance dose is 20 mg once daily.
- Long-term management of acid reflux disease: 10-20 mg daily.
- Acid-related dyspepsia: 10-20 mg once daily for 2-4 weeks.
- Prophylaxis of acid aspiration: 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery.
- Zollinger-Ellison syndrome: Initially 60 mg once daily; usual range 20-120 mg daily (If daily dose is more than 80 mg, 2 divided dose should be used).
- Helicobacter pylori eradication regimen in peptic ulcer disease: Omeprazole is recommended at a dose of 20 mg twice daily in association with antimicrobial agents as detailed below: Amoxicillin 500 mg and Metronidazole 400 mg both three times a day for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice a day for one week, or Amoxicillin 1 g and Clarithromycin 500 mg both twice a day for one week.
- Paeditaric use in severe ulcerating reflux esophagitis (Child>1 year): If body-weight 10-20 kg, 10-20 -mg once daily for 4-12 weeks; if body-weight over 20 kg, 20-40 mg once daily for 4-12 weeks.
IV Injection-
- Prophylaxis of acid aspiration: Omeprazole 40 mg to be given slowly (over a period of 5 minutes) as an intravenous injection, one hour before surgery.
- Duodenal ulcer, gastric ulcer or reflux oesophagitis: In patients with duodenal ulcer, gastric ulcer or reflux oesophagitis where oral medication is inappropriate, Omeprazole IV 40 mg once daily is recommended.
- Zollinger- Ellison syndrome (ZES): In patients with Zollinger-Ellison Syndrome the recommended initial dose of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided & given twice daily.
AdministrationView
Direction for use of IV Injection: Omeprazole lyophilized powder and water for injection is for intravenous administration only and must not be given by any other route. Omeprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml water for injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes at a maximum rate of 4 ml/minute. Use only freshly prepared solution. The solution should be used within 4 hours of reconstitution.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Side effectsView
Omeprazole is generally well tolerated. Nausea, abdominal colic, paresthesia, dizziness and headache have been stated to be generally mild and transient and not requiring a reduction in dosage.
ContraindicationsView
Omeprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.
PrecautionsView
When gastric ulcer is suspected, the possibility of gastric malignancy should be excluded before treatment with Omeprazole is instituted, as treatment may alleviate the symptoms and delay diagnosis.
InteractionsView
Omeprazole can prolong the elimination of diazepam, warfarin and phenytoin. So, reduction of warfarin or phenytoin dose may be necessary when Omeprazole is added to the treatment. There is no evidence of an interaction of Omeprazole with theophylline, propranolol or antacids.
Pregnancy & lactationView
US FDA pregnancy category of Omeprazole is C. However, results from three prospective epidemiological studies indicate no adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child. There is no information available on the passage of Omeprazole into breast milk or its effects on the neonate. Breast-feeding should, therefore, be discontinued, if the use of Omeprazole is considered essential.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Eupi
Omeprazole
Eupi
Omeprazole
Indications
Zollinger-Ellison syndrome
Indication detailsView
Omeprazole is indicated for the treatment of-
- Gastric and duodenal ulcer
- NSAID-associated duodenal and gastric ulcer
- As prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
- Gastro-esophageal reflux disease
- Long-term management of acid reflux disease
- Acid-related dyspepsia
- Severe ulcerating reflux esophagitis
- Prophylaxis of acid aspiration during general anesthesia
- Zollinger-Ellison syndrome
- Helicobacter pylori-induced peptic ulcer.
Therapeutic classView
Proton Pump Inhibitor
PharmacologyView
Omeprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. It inhibits gastric acid secretion by blocking hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system in the gastric parietal cell. After oral administration, the onset of the antisecretory effect occurs within one hour, with the maximum effect occurring within two hours and inhibition of secretion lasts up to 72 hours. When the drug is discontinued, secretory activity returns gradually, over 3 to 5 days.
DosageView
Oral-
IV Injection-
- Benign gastric and duodenal ulcer: 20 mg once daily for 4 weeks in duodenal ulceration, 8 weeks in gastric ulceration; in severe or recurrent cases, dose to be increased to 40 mg daily; maintenance dose for recurrent duodenal ulcer, 20 mg once daily; in prevention of relapse in duodenal ulcer, 10-20 mg daily.
- NSAID-associated duodenal or gastric ulcer: 20 mg once daily for 4 weeks, continued for further 4 weeks, if not fully healed. 20 mg once daily is used as prophylaxis in patients with a history of NSAID-associated duodenal or gastric ulcers.
- Gastro-esophageal reflux disease: 20 mg once daily for 4 weeks, continued for further 4-8 weeks, if not fully healed; 40 mg once daily has been given for 8 weeks in gastro-esophageal reflux disease, refractory to other treatment; maintenance dose is 20 mg once daily.
- Long-term management of acid reflux disease: 10-20 mg daily.
- Acid-related dyspepsia: 10-20 mg once daily for 2-4 weeks.
- Prophylaxis of acid aspiration: 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery.
- Zollinger-Ellison syndrome: Initially 60 mg once daily; usual range 20-120 mg daily (If daily dose is more than 80 mg, 2 divided dose should be used).
- Helicobacter pylori eradication regimen in peptic ulcer disease: Omeprazole is recommended at a dose of 20 mg twice daily in association with antimicrobial agents as detailed below: Amoxicillin 500 mg and Metronidazole 400 mg both three times a day for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice a day for one week, or Amoxicillin 1 g and Clarithromycin 500 mg both twice a day for one week.
- Paeditaric use in severe ulcerating reflux esophagitis (Child>1 year): If body-weight 10-20 kg, 10-20 -mg once daily for 4-12 weeks; if body-weight over 20 kg, 20-40 mg once daily for 4-12 weeks.
IV Injection-
- Prophylaxis of acid aspiration: Omeprazole 40 mg to be given slowly (over a period of 5 minutes) as an intravenous injection, one hour before surgery.
- Duodenal ulcer, gastric ulcer or reflux oesophagitis: In patients with duodenal ulcer, gastric ulcer or reflux oesophagitis where oral medication is inappropriate, Omeprazole IV 40 mg once daily is recommended.
- Zollinger- Ellison syndrome (ZES): In patients with Zollinger-Ellison Syndrome the recommended initial dose of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided & given twice daily.
AdministrationView
Direction for use of IV Injection: Omeprazole lyophilized powder and water for injection is for intravenous administration only and must not be given by any other route. Omeprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml water for injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes at a maximum rate of 4 ml/minute. Use only freshly prepared solution. The solution should be used within 4 hours of reconstitution.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Side effectsView
Omeprazole is generally well tolerated. Nausea, abdominal colic, paresthesia, dizziness and headache have been stated to be generally mild and transient and not requiring a reduction in dosage.
ContraindicationsView
Omeprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.
PrecautionsView
When gastric ulcer is suspected, the possibility of gastric malignancy should be excluded before treatment with Omeprazole is instituted, as treatment may alleviate the symptoms and delay diagnosis.
InteractionsView
Omeprazole can prolong the elimination of diazepam, warfarin and phenytoin. So, reduction of warfarin or phenytoin dose may be necessary when Omeprazole is added to the treatment. There is no evidence of an interaction of Omeprazole with theophylline, propranolol or antacids.
Pregnancy & lactationView
US FDA pregnancy category of Omeprazole is C. However, results from three prospective epidemiological studies indicate no adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child. There is no information available on the passage of Omeprazole into breast milk or its effects on the neonate. Breast-feeding should, therefore, be discontinued, if the use of Omeprazole is considered essential.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Eupi
Omeprazole
Eupi
Omeprazole
Indications
Zollinger-Ellison syndrome
Indication detailsView
Omeprazole is indicated for the treatment of-
- Gastric and duodenal ulcer
- NSAID-associated duodenal and gastric ulcer
- As prophylaxis in patients with a history of NSAID-associated duodenal and gastric ulcer
- Gastro-esophageal reflux disease
- Long-term management of acid reflux disease
- Acid-related dyspepsia
- Severe ulcerating reflux esophagitis
- Prophylaxis of acid aspiration during general anesthesia
- Zollinger-Ellison syndrome
- Helicobacter pylori-induced peptic ulcer.
Therapeutic classView
Proton Pump Inhibitor
PharmacologyView
Omeprazole, a substituted benzimidazole, is an inhibitor of gastric acid secretion. It inhibits gastric acid secretion by blocking hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system in the gastric parietal cell. After oral administration, the onset of the antisecretory effect occurs within one hour, with the maximum effect occurring within two hours and inhibition of secretion lasts up to 72 hours. When the drug is discontinued, secretory activity returns gradually, over 3 to 5 days.
DosageView
Oral-
IV Injection-
- Benign gastric and duodenal ulcer: 20 mg once daily for 4 weeks in duodenal ulceration, 8 weeks in gastric ulceration; in severe or recurrent cases, dose to be increased to 40 mg daily; maintenance dose for recurrent duodenal ulcer, 20 mg once daily; in prevention of relapse in duodenal ulcer, 10-20 mg daily.
- NSAID-associated duodenal or gastric ulcer: 20 mg once daily for 4 weeks, continued for further 4 weeks, if not fully healed. 20 mg once daily is used as prophylaxis in patients with a history of NSAID-associated duodenal or gastric ulcers.
- Gastro-esophageal reflux disease: 20 mg once daily for 4 weeks, continued for further 4-8 weeks, if not fully healed; 40 mg once daily has been given for 8 weeks in gastro-esophageal reflux disease, refractory to other treatment; maintenance dose is 20 mg once daily.
- Long-term management of acid reflux disease: 10-20 mg daily.
- Acid-related dyspepsia: 10-20 mg once daily for 2-4 weeks.
- Prophylaxis of acid aspiration: 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery.
- Zollinger-Ellison syndrome: Initially 60 mg once daily; usual range 20-120 mg daily (If daily dose is more than 80 mg, 2 divided dose should be used).
- Helicobacter pylori eradication regimen in peptic ulcer disease: Omeprazole is recommended at a dose of 20 mg twice daily in association with antimicrobial agents as detailed below: Amoxicillin 500 mg and Metronidazole 400 mg both three times a day for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice a day for one week, or Amoxicillin 1 g and Clarithromycin 500 mg both twice a day for one week.
- Paeditaric use in severe ulcerating reflux esophagitis (Child>1 year): If body-weight 10-20 kg, 10-20 -mg once daily for 4-12 weeks; if body-weight over 20 kg, 20-40 mg once daily for 4-12 weeks.
IV Injection-
- Prophylaxis of acid aspiration: Omeprazole 40 mg to be given slowly (over a period of 5 minutes) as an intravenous injection, one hour before surgery.
- Duodenal ulcer, gastric ulcer or reflux oesophagitis: In patients with duodenal ulcer, gastric ulcer or reflux oesophagitis where oral medication is inappropriate, Omeprazole IV 40 mg once daily is recommended.
- Zollinger- Ellison syndrome (ZES): In patients with Zollinger-Ellison Syndrome the recommended initial dose of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided & given twice daily.
AdministrationView
Direction for use of IV Injection: Omeprazole lyophilized powder and water for injection is for intravenous administration only and must not be given by any other route. Omeprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml water for injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 to 5 minutes at a maximum rate of 4 ml/minute. Use only freshly prepared solution. The solution should be used within 4 hours of reconstitution.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set with any other drug.
Side effectsView
Omeprazole is generally well tolerated. Nausea, abdominal colic, paresthesia, dizziness and headache have been stated to be generally mild and transient and not requiring a reduction in dosage.
ContraindicationsView
Omeprazole is contraindicated in patients with known hypersensitivity to any of the components of the formulation.
PrecautionsView
When gastric ulcer is suspected, the possibility of gastric malignancy should be excluded before treatment with Omeprazole is instituted, as treatment may alleviate the symptoms and delay diagnosis.
InteractionsView
Omeprazole can prolong the elimination of diazepam, warfarin and phenytoin. So, reduction of warfarin or phenytoin dose may be necessary when Omeprazole is added to the treatment. There is no evidence of an interaction of Omeprazole with theophylline, propranolol or antacids.
Pregnancy & lactationView
US FDA pregnancy category of Omeprazole is C. However, results from three prospective epidemiological studies indicate no adverse effects of Omeprazole on pregnancy or on the health of the fetus/newborn child. There is no information available on the passage of Omeprazole into breast milk or its effects on the neonate. Breast-feeding should, therefore, be discontinued, if the use of Omeprazole is considered essential.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Eurix
Cefuroxime Axetil
Eurix
Cefuroxime Axetil
Indications
Urinary tract infection
Indication detailsView
It is indicated for the treatment of infections caused by sensitive bacteria.
- Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
- Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes.
- Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains)
- Lower respiratory tract infections including pneumoniae, caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, E. coli
- Acute bacterial exacerbation of chronic bronchitis and Secondary bacterial infections of Acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains).
- Skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
- Urinary tract infections caused by E.coli or Klebsiella pneumoniae.
- Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
- Gonorrhoea caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae.
- Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.
Therapeutic classView
Second generation Cephalosporins
PharmacologyView
Cefuroxime is a well-characterized and effective antibacterial agent, which has broad-spectrum bactericidal activity against a wide range of common pathogens, including β-lactamase producing strains. Cefuroxime has good stability to bacterial β-lactamase and consequently, is active against many ampicillin-resistant and amoxycillin-resistant strains.
DosageView
Tablet or Suspension-
Adolescents and adults (13 years and older)-- Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
- Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
- Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
- Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
- Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
- Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
- Uncomplicated Gonorrhoea: 1000 mg Single dose
- Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
- MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
- Early Lyme disease: 500 mg b.i.d. for 20 days
- Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
- Acute otitis media: 30 mg/kg/day b.i.d for 10 days
- Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
- Impetigo: 30 mg/kg/day b.i.d for 10 days
Parenteral-
- Adult: 750 mg three times daily by IM or IV injection. In severe infections, dose can be increased upto 1.5 gm three times daily by IV injection. The frequency may be increased to four times daily, if necessary, giving total daily doses of 3 to 6 gms.
- Children (above 3 months of age): 30 - 100 mg/kg/day given in 3 or 4 equally divided doses. A dose of 60 mg/kg/day is appropriate for most infections.
- Neonate: 30 - 100 mg/kg/day given in 2 or 3 equally divided doses.
- Surgical prophylaxis: 1.5 gm by IV injection at induction of anaesthesia; up to 3 further doses of 750 mg may be given by IV/IM injection every 8 hours for high risk procedures.
- Pneumonia: 1.5 gm IV injection twice daily for 2-3 days, followed by 500 mg twice daily (oral) for 7-10 days.
Acute exacerbations of chronic bronchitis: 750 mg twice daily (IM or IV injection) for 2-3 days, followed by 500 mg twice daily (oral) for 5-10 days. (Duration of both parenteral and oral therapy is determined by the severity of the infection and the clinical status of the patient.)- In Gonorrhoea: Adult: 1.5 gm as a single dose (as 2 x 750mg injections intramuscularly with different sites, e.g. each buttock).
- Adult: 3 gm IV injection three times daily.
- Children (above 3 months of age): 200-240 mg/kg/day by IV injection in 3 or 4 divided doses reduced to 100 mg/kg/day after 3 days or on clinical improvement.
- Neonate: 100 mg/kg/day by IV injection at initial dose, reduced to 50 mg/kg/day, When clinically indicated.
- Adult: 1.5 gm IV injection four times daily.
- Children (above 3 months of age): 150 mg/kg/day (not to exceed the maximum adult dose) in equally divided doses every 8 hours.
AdministrationView
The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 24 hours at room temperature or 48 hours at 5o C
Side effectsView
Adverse effects to Cefuroxime have occurred infrequently and have been generally mild and transient in nature. Effects reported include rashes and gastrointestinal disturbances. As with other antibiotics, prolonged use may result in the overgrowth of non susceptible organisms e.g. Candida.
ContraindicationsView
Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.
PrecautionsView
Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis. Cephalosporin antibiotics may in general be given safely to patients who are hypersensitive to penicillin although cross reactions have reported. Cefuroxime has shown, that is not likely to be a problem at the recommended to dose levels.
InteractionsView
No potentially hazardous interactions have been reported.
Pregnancy & lactationView
US FDA pregnancy category of Cefuroxime is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefuroxime have been shown to be excreted in human milk. So, caution should be exercised when Cefuroxime is administered to a nursing woman.
ReconstitutionView
For 750 mg intramuscular injection: Add 3 ml water for injection to vial and then shake gently for dispersion.
For 750 mg intravenous injection: Add 8 ml water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.
For 1.5 g intravenous injection: Add 16 ml Water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.
For 750 mg intravenous injection: Add 8 ml water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.
For 1.5 g intravenous injection: Add 16 ml Water for injection to vial and then shake gently for dispersion. The solution should be slowly injected directly into a vein over a 3 to 5 minutes period.
StorageView
Store in a cool, dry place (below 30o C), away from light & moisture. Keep out of the reach of children.