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Opal 40
Generic
- Omeprazole
Indications
Omeprazole is indicated for the treatment of:
- Gastric and duodenal ulcers
- NSAID-associated gastric and duodenal ulcers
- Prophylaxis for patients with a history of NSAID-associated ulcers
- Gastroesophageal reflux disease (GERD)
- Long-term management of acid reflux
- Acid-related dyspepsia
- Erosive esophagitis
- Prophylaxis of acid aspiration during general anesthesia
- Zollinger-Ellison syndrome
- Helicobacter pylori-associated peptic ulcers (as part of combination therapy)
Pharmacology
Omeprazole is rapidly absorbed, and its absorption is not affected by food. Being acid-labile, its absorption is also dose-dependent. The bioavailability of omeprazole may be increased in elderly patients and those with impaired liver function. After absorption, it is metabolized primarily in the liver by the cytochrome P450 enzyme system and eliminated through the urine. The elimination half-life ranges from 0.5 to 3 hours, but its effect on inhibiting acid secretion lasts longer, allowing it to be administered once daily. Approximately 95% of omeprazole is bound to plasma proteins.
Dosage
Capsules:
- GERD: 20-40 mg daily for 4-12 weeks; maintenance dose: 20 mg daily.
- Peptic Ulcers: 20 mg daily, or 40 mg in severe cases, for 4 weeks (duodenal) or 8 weeks (gastric); maintenance dose: 20 mg daily.
- Helicobacter pylori eradication: 40 mg daily in divided doses with antibiotics (triple therapy).
- NSAID-associated ulcers: 20 mg daily, also used for prophylaxis.
- Zollinger-Ellison Syndrome: Initial dose of 60 mg daily, adjusted individually; doses above 80 mg should be divided and administered twice daily.
- Acid-related dyspepsia: 20 mg daily for 2-4 weeks.
Injection:
- Duodenal ulcers, gastric ulcers, or reflux esophagitis: 40 mg IV once daily, typically for 2-3 days before transitioning to oral treatment.
- Zollinger-Ellison Syndrome: Individual dosing adjustments are necessary. IV treatment should be administered over 20-30 minutes. For elderly or patients with impaired liver function, the dose may need adjustment (maximum: 20 mg daily). No dose adjustment is needed for renal impairment.
Administration
For IV injection, reconstitute omeprazole 40 mg with 10 ml of the provided solvent. Administer slowly over at least 2.5 minutes (maximum rate: 4 ml/min). Use the solution within 4 hours of reconstitution. IV infusion should be administered over 20-30 minutes, and the reconstituted solution should be used immediately.
Interaction
Omeprazole can delay the elimination of diazepam, phenytoin, and warfarin, necessitating dose adjustments and monitoring when used concurrently. There is no interaction with theophylline, propranolol, metoprolol, lidocaine, quinidine, amoxicillin, or antacids. Co-administration with digoxin may increase digoxin bioavailability by 10%. Absorption is not affected by alcohol or food.
Contraindications
Omeprazole is contraindicated in patients with known hypersensitivity to the drug. For patients with suspected gastric ulcers, the possibility of malignancy should be ruled out before starting omeprazole, as it may mask symptoms and delay diagnosis.
Side Effects
Omeprazole is generally well-tolerated, and adverse effects are typically mild and reversible. These include:
- Common: Skin rash, headache, nausea, diarrhea, abdominal pain, constipation, and flatulence.
- Rare: Dizziness, somnolence, insomnia, arthralgia, myalgia, blurred vision, taste disturbances, peripheral edema, increased sweating, gynecomastia, liver enzyme increases, and thrombocytopenia.
Severe reactions like hepatic failure, interstitial nephritis, or mental confusion are very rare and often occur in seriously ill patients.
Pregnancy & Lactation
There is no conclusive evidence regarding the safety of omeprazole during pregnancy in humans, although animal studies show no teratogenic effects. It is not known if omeprazole passes into breast milk, so breastfeeding should be discontinued if omeprazole use is necessary.
Precautions & Warnings
Before starting omeprazole treatment, especially for gastric ulcers, it is essential to exclude gastric cancer, as omeprazole can mask symptoms and delay diagnosis.
Therapeutic Class
Proton Pump Inhibitor (PPI)
Storage Conditions
Store below 30°C in a dry place, protected from light.
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