CIDPRO
OMEPRAZOLE · by INDUS PHARMA
Composition
Cap 10 mg/20 mg/40 mg: Omeprazole 10 mg/20 mg/40 mg. Tab 10 mg/20 mg/40 mg: Omeprazole 10 mg/20 mg/40 mg. Inf IV 40 mg: Omeprazole (as sodium salt) 40 mg; powder in vial.
Indications & Dosage
Helicobacter pylori eradication: Adult: 20 mg twice daily, in combination with amoxicillin and clarithromycin; or in combination with amoxicillin and metronidazole; or in combination with clarithromycin and metronidazole. Eradication failure of Helicobacter pylori infection: Adult: 20 mg twice daily, in combination with tripotassium dicitrato bismuthate, tetracycline and metronidazole. Benign gastric ulceration, duodenal ulceration: Adult: 20 mg once daily for 8 weeks, increased if necessary to 40 mg once daily, in severe or recurrent cases. Prevention of relapse in gastric ulcer and duodenal ulcer: Adult: 20 mg once daily, increased if necessary to 40 mg once daily. NSAID-associated duodenal ulcer NSAID-associated gastric ulcer NSAID-associated gastro duodenal erosions: Adult: 20 mg once daily for 4 weeks, continued for a further 4 weeks if not fully healed. Prophylaxis in patients with NSAID-associated; duodenal ulcer, gastric ulcer, gastro duodenal lesions, dyspeptic symptoms: Adult: 20 mg once daily Zollinger-Ellison syndrome: Adult: ORAL: Initially 60 mg once daily; usual dose 20-120 mg daily, total daily doses greater than 80mg should be given in 2 divided doses BY IV INJ, OR BY IV INF: Adult: Initially 60 mg once daily, adjusted according to response, total daily doses greater than 60 mg should be given in 2 divided doses, injection to be given over 5 min, INF to be given over 20-30 min Gastro-oesophageal reflux disease: Adult: 20 mg once daily for 4 weeks, continued for a further 4-8 weeks if not fully healed; maintenance 20 mg once daily Gastro-oesophageal reflux disease refractory to other treatment: Adult: 40 mg once daily for 8 weeks; maintenance 20 mg once daily Acid reflux disease (long-term management): Adult: 10 mg once daily, increased to 20 mg once daily, dose only increased if symptoms return Acid-related dyspepsia: Adult: 10-20 mg once daily for 2-4 weeks according to response. Treatment and prevention of, benign gastric ulcers, duodenal ulcers, NSAID-associated ulcers, and gastro-oesophageal reflux disease: BY IV INJ, OR BY IV INF: Adult: 40 mg once daily until oral administration possible, injection to be given over 5 minutes, INF to be given over 20-30 minutes Major peptic ulcer bleeding (following endoscopic treatment): BY IV INF: Adult: Initially 80 mg, to be given over 40-60 minutes, then (by continuous intravenous INF) 8 mg/hour for 72 hours, subsequent dose then changed to oral therapy.
Administration
Intermittent or continuous IV infusion in Glucose 5% or NaCI 0.9%.Reconstitute each 40 mg vial with infusion fluid and dilute to 100 ml; for intermittent infusion, give 40 mg over 20-30 min.
Stability
Reconstituted solution is stable for 3 hours in Glucose 5% or 12 hours in NaCI 0.9%.
Precautions
Exclude malignancy before treatment, hepatic impairment (not more than 20 mg dose daily). Monitor serum B12 in severely ill children on long term treatment.
Interactions
Itraconazole. Diazepam, phenytoin, warfarin, digoxin, keto-conazole.
Pregnancy
Risk cannot be ruled out.
Lactation
Contraindicated or not recommended.
Side Effects
Agitation, impotence, increased risk of GI infections, increase in liver enzymes, thrombocytopenia, skin rashes, headache, GI upset, paraesthesia, dizziness, somnolence, insomnia, arthralgia, myalgia,.Agitation, impotence, increased risk of GI infections, increase in liver enzymes, thrombocytopenia, skin rashes, headache, GI upset, paraesthesia, dizziness, somnolence, insomnia, arthralgia, myalgia,.