Omeprazole

Indication

Eradication of Helicobacter pylori, duodenal ulcers, gastric ulcers, gastro-esophageal reflux disease (GERD), Zollinger-Ellison (ZE) syndrome, benign gastric ulcer, NSAID associated peptic ulcer, NSAID associated gastroduodenal erosions. Prevention of stress ulcer, acid aspiration syndrome during an...read more

Dosage and Administration

Omeprazole should be taken before meal.

H. pylori eradication: 20 mg twice daily in combination with tripotassium dicitratobismuthate, tetracycline and metronidazole.

Duodenal Ulcer: 20 mg once daily for 4 weeks. In severe cases, 40 mg once daily for 4 weeks.

Gastric Ulcer: 20 mg once daily for 8 weeks. In severe cases, 40 mg once daily for 8 weeks.

Resistant Ulcer: 40 mg daily for 4 weeks. For long-term therapy, the maintenance dose is 40 mg daily.

NSAID-induced peptic ulcer and gastroduodenal erosion: 20 mg once daily for 4 weeks, followed by a further 4 weeks if not fully healed.

Gastro-esophageal reflux disease: 40 mg once daily for 8 weeks, may be continued at 20 mg once daily.

Zollinger-Ellison Syndrome: Adult: Initially 60 mg, usual dose 20-120 mg daily, total daily dose greater than 80 mg should be given in 2 individual doses.

Composition

Each hard gelatin capsule contains:

Omeprazole B.P ... 20 mg.

Description

Omeprazole is a substituted benzimidazole 5- Methoxy-2-[ (RS)-[(4-methoxy-3, 5-dimethylpyridin - 2-yl) methyl] sulfinyl]-1 H-benzimidazole, a compound that inhibit gastric acid secretion. The empirical formula is C 17H19Np3s with a molecular weight of 345.4.

Clinical Pharmacology

Omeprazole is a potent proton pump inhibitor. It suppresses gastric acid secretion by irreversible inhibition of H+fK+_ ATPase at the secretory surface of gastric parietal cells. Thus, it blocks the final step of acid secretion. Even after rapid disappearance from the plasma, it can still be detecte...read more

Pharmacokinetics

Omeprazole is rapidly absorbed, and absorption is not affected by food. Omeprazole has been developed to various formulations to improve bioavailability from gastrointestinal tract. Consequently, its pharmacokinetics may vary with different formulations of the drug. The absorption of omeprazole, as ...read more

Contraindication

Patients who are hypersensitive to omeprazole and any components of the medication.

Precaution

Before giving omeprazole to patients with gastric ulcers, the possibility of malignancy should be excluded since it may mask symptoms and delay diagnosis. Use with caution in liver disease.

To avoid the risk of developing the undesirable effects, Omeprazole should not be given in pregnancy and in lactation if not need essentially. Animal studies have not shown evidence of any hazard from the administration of omeprazole during pregnancy and lactation and there is no evidence of fetal t...read more

Adverse Effects

Nausea, headache, diarrhea, constipation, flatulence and abdominal pain, but rare. Skin rash has occurred in a few patients. Serious side effects may include Clostridium difficile colitis, an increased risk of pneumonia, an increased risk of bone fractures and the potential of masking stomach cancer...read more

Drug Interaction

Decreased gastric acidity may alter absorption of drugs for which intra-gastric acidity affects drug bioavailability, eg, ketoconazole, itraconazole, digoxin and atazanavir. Omeprazole may inhibit the metabolism of warfarin, diazepam and phenytoin. Enzyme inhibition of omeprazole decreases the effec...read more

Storage

Store below 30°C in cool and dry place. Protect from light and moisture.

Keep out of reach and sight of children.

Presentation

10 x 10's Blisters.