COMPOSITION
Each gastro-resistant tablet contains:
- Rabeprazole Sodium I.P. equivalent to Rabeprazole 20 mg
CLINICAL PHARMACOLOGY
Rabeprazole is a proton pump inhibitor (PPI) that suppresses gastric acid secretion by inhibiting the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell.
It leads to profound and prolonged inhibition of gastric acid secretion, aiding in the healing of acid-related damage.
Onset of action occurs within 1 hour, with significant acid suppression lasting up to 24 hours.
INDICATIONS AND USAGE
Treatment of gastroesophageal reflux disease (GERD) and erosive esophagitis.
Management of duodenal and gastric ulcers.
Eradication of Helicobacter pylori infection in combination therapy.
Treatment of Zollinger-Ellison Syndrome and other pathological hypersecretory conditions.
CONTRAINDICATIONS
- Hypersensitivity to Rabeprazole, substituted benzimidazoles, or any component of the formulation.
- Co-administration with rilpivirine-containing products.
- Children below 12 years unless specifically prescribed.
PRECAUTIONS
- Long-term use may lead to vitamin B12 deficiency, hypomagnesemia, and increased risk of bone fractures.
- Monitor for Clostridium difficile-associated diarrhea in patients with persistent diarrhea.
- Should be used with caution in hepatic impairment.
DRUG INTERACTIONS
- May interfere with drugs requiring gastric pH for absorption (e.g., ketoconazole, iron salts, atazanavir).
- May reduce efficacy of clopidogrel by inhibiting CYP2C19.
- Increased risk of digoxin toxicity when co-administered.
PREGNANCY & LACTATION
- Use during pregnancy only if clearly needed (Category B).
- Not known whether it is excreted in human milk; caution advised during lactation.
- Consult a healthcare professional before use in pregnancy or breastfeeding.
DOSAGE AND ADMINISTRATION
- Recommended dose: 20 mg once daily, preferably before meals.
- In GERD and peptic ulcers: generally used for 4-8 weeks.
- Swallow whole, do not crush or chew.
ADVERSE REACTIONS
- Common: Headache, diarrhea, nausea, abdominal pain.
- Uncommon: Rash, dizziness, dry mouth, flatulence.
- Rare but serious: Hypomagnesemia, interstitial nephritis, or severe allergic reactions