Omeprazole Sodium Capsules
Composition:
Each capsule contains:
- Omeprazole Sodium, equivalent to Omeprazole (20mg, or 40mg depending on the strength)
Description:
Omeprazole is a proton pump inhibitor (PPI) that suppresses gastric acid secretion by inhibiting the H+/K+-ATPase enzyme system in the gastric parietal cells. It is used to treat acid-related gastrointestinal disorders.
Indications:
Omeprazole Sodium Capsules are indicated for:
- Gastroesophageal Reflux Disease (GERD)
- Erosive Esophagitis
- Peptic Ulcer Disease (gastric and duodenal ulcers)
- Helicobacter pylori eradication (in combination with antibiotics)
- Zollinger-Ellison Syndrome and other hypersecretory conditions
- Non-steroidal anti-inflammatory drug (NSAID)-induced ulcers prevention
Dosage & Administration:
Recommended Dosage for Adults:
- GERD & Erosive Esophagitis: 20-40 mg once daily for 4-8 weeks
- Peptic Ulcer Disease:
- Duodenal Ulcer: 20 mg once daily for 4 weeks
- Gastric Ulcer: 40 mg once daily for 4-8 weeks
- H. pylori Eradication (Triple Therapy):
- Omeprazole 20 mg twice daily + Clarithromycin 500 mg twice daily + Amoxicillin 1 g twice daily for 10-14 days
- Zollinger-Ellison Syndrome: 60 mg once daily, adjusted as needed
- NSAID-induced Ulcer Prevention: 20 mg once daily
Pediatric Dosage:
- GERD (Children ≥1 year & ≥10 kg): 10-20 mg once daily
- Erosive Esophagitis (Children ≥1 year & ≥20 kg): 20-40 mg once daily
Administration:
- Take before meals, preferably in the morning
- Swallow the capsule whole with water
- If difficulty swallowing, open the capsule and mix the granules with a small amount of applesauce (do not crush or chew the granules)
Dose Adjustments:
- Hepatic Impairment: Maximum 20 mg/day in severe liver disease
- Renal Impairment & Elderly: No dosage adjustment required
Contraindications:
- Hypersensitivity to Omeprazole or other PPIs
- Coadministration with atazanavir or rilpivirine
Precautions:
- Long-term use may increase the risk of:
- Clostridium difficile-associated diarrhea
- Osteoporosis-related fractures
- Vitamin B12 deficiency
- Hypomagnesemia
- Evaluate patients with persistent symptoms for gastric malignancy
Adverse Reactions:
- Common: Headache, nausea, diarrhea, abdominal pain, constipation
- Serious: Hypomagnesemia, interstitial nephritis, Clostridium difficile infection
Drug Interactions:
- Warfarin: Increased bleeding risk-monitor INR
- Methotrexate: May increase methotrexate toxicity
- Clopidogrel: May reduce antiplatelet effect-use alternative PPI if necessary
Overdose & Management:
- Symptoms: Dizziness, confusion, tachycardia
- Treatment: Supportive care (no specific antidote)
Storage Conditions:
- Store below 25°C, protect from moisture and light




