Generic

Indications

Omeprazole is used to treat ulcers in the stomach and duodenum. Duodenal and gastric ulcers caused by NSAIDs. In patients with a history of NSAID-related duodenal and gastric ulcers, as a preventative measure Gastro-esophageal reflux disease (GERD) is a type of gastro-esophageal reflux Acid reflux disease management over time Dyspepsia caused by stomach acid Reflux esophagitis with ulcers is a serious condition.

Pharmacology

Omeprazole, a substituted benzimidazole, works as a gastric acid secretion inhibitor. It blocks the hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system in the gastric parietal cell, inhibiting gastric acid secretion. Within one hour after oral administration, the antisecretory effect kicks in.

Administration & Dosage

Oral-

• 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.

Interaction

Diazepam, warfarin, and phenytoin can all be delayed by omeprazole. When Omeprazole is added to the treatment, it may be necessary to reduce the dose of warfarin or phenytoin. Omeprazole does not appear to interact with theophylline, propranolol, or antacids.

Contraindications

Omeprazole is not recommended for patients who have a known hypersensitivity to any of the formulation’s ingredients.

Side Effect

Omeprazole is a medication that is generally well tolerated. Nausea, abdominal colic, paresthesia, dizziness, and headache have all been reported to be mild and transient, requiring no dosage adjustments.

Pregnancy & Lactation

Omeprazole is classified as a pregnancy category C by the US Food and Drug Administration. However, three prospective epidemiological studies show that Omeprazole has no negative effects on pregnancy or the health of the fetus/newborn child.

Precautions & Warnings

When a gastric ulcer is suspected, the possibility of a gastric cancer should be ruled out first, as treatment with Omeprazole may mask the symptoms and delay diagnosis.

Therapeutic Class

Inhibitor of the proton pump

Storage Conditions

Keep the temperature below 30°C and away from light and moisture. Keep out of children’s reach.

Pharmaceutical Name

Beximco Pharmaceuticals Ltd.