Generic

Omeprazole

Indications

Omeprazole is used to treat ulcers in the stomach and duodenum.

• Duodenal and stomach ulcers caused by NSAIDs
• In individuals with a history of NSAID-related duodenal and stomach ulcers, as a preventative measure
• Gastro-esophageal reflux disease (GERD) is a kind of gastro-esophageal reflux
• Acid reflux disease management over time
• Dyspepsia caused by stomach acid
• Reflux esophagitis with ulcers is a serious condition.
• Acid aspiration prevention during general anesthesia
• Syndrome of Zollinger-Ellison
• Peptic ulcer caused by Helicobacter pylori.

Pharmacology

Omeprazole, a substituted benzimidazole, works as a stomach acid secretion inhibitor. It blocks the hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system in the gastric parietal cell, inhibiting gastric acid production. After oral treatment, the antisecretory action begins within one hour, peaks within two hours, and secretion suppression lasts up to 72 hours. Secretory activity gradually resumes once the medication is stopped, usually within 3 to 5 days.

Dosage & Administration

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.

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.

Interaction

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

Contraindications

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

Side Effect

Omeprazole is a medication that is typically well tolerated. Nausea, stomach colic, paresthesia, dizziness, and headache have all been reported to be minor and transitory, needing 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 impact on pregnancy or the health of the fetus/newborn kid. There is no information on Omeprazole’s transit via breast milk or its effects on the newborn. If the usage of Omeprazole is judged necessary, breast-feeding should be terminated.

Precautions & Warnings

When a stomach ulcer is suspected, the potential of a gastric cancer should be ruled out first, as therapy with Omeprazole may mask the symptoms and delay detection.

Therapeutic Class

Proton Pump Inhibitor

Storage Conditions

Keep away from light and heat in a dry area. Keep out of children’s reach.

Pharmaceutical Name

General Pharmaceuticals Ltd.