Description
Indications
Omeprazole is used to treat the following conditions:
- Ulcers of 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
- A 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
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 the daily dose is more than 80 mg, 2 divided doses 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 bodyweight 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.
Administration
Direction for use of IV Injection: Omeprazole lyophilized powder and water for injection is for intravenous administration only and must not be given by any other route. Omeprazole IV injection should be given as a slow intravenous injection. The solution for IV injection is obtained by adding 10 ml water for injection to the vial containing powder. After reconstitution, the injection should be given slowly over a period of at least 2 to 5 minutes at a maximum rate of 4 ml/minute. Use only freshly prepared solutions. The solution should be used within 4 hours of reconstitution.
Direction for use of IV Infusion: Omeprazole IV infusion should be given as an intravenous infusion over a period of 20-30 minutes or more. The contents of one vial must be dissolved in 100 ml saline for infusion or 100 ml 5% Dextrose for infusion. The solution should be used within 12 hours when Omeprazole is dissolved in saline and within 6 hours when dissolved in 5% Dextrose. The reconstituted solution should not be mixed or co-administered in the same infusion set as any other drug.
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 Effects
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.
Therapeutic Class
Storage Conditions
Keep away from light and heat in a dry area. Keep out of children’s reach.
