Generic Name: Omeprazole 40mg
Manufacturer/Distributor: General Pharmaceuticals Ltd.
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Indications
Omeprazole is used to treat ulcers in the stomach and duodenum.
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 the 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 a 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.
Pediatric 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 is 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, breastfeeding should be terminated.
Precautions & Warnings
When a stomach ulcer is suspected, the potential of gastric cancer should be ruled out first, as therapy with Omeprazole may mask the symptoms and delay detection.
Storage Conditions
Keep away from light and heat in a dry area. Keep out of children's reach.
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