
Acin75 mg/5 ml
Biopharma Laboratories Ltd.
Ranitidine is a histamine H2-receptor antagonist historically indicated for the following conditions, where it remains available in a given country/market: Established/approved uses: short-term…
Ranitidine is a histamine H2-receptor antagonist historically indicated for the following conditions, where it remains available in a given country/market:
Important regulatory note: Ranitidine-containing products were withdrawn from the market in several countries (including a market withdrawal requested by the US FDA in April 2020) after testing found that levels of a probable human carcinogen, N-nitrosodimethylamine (NDMA), could increase in the product over time and with storage, including under normal conditions. Continued availability of Ranitidine therefore depends on the current regulatory status in the local market; patients should confirm with a physician or pharmacist whether Ranitidine is currently authorized and, where alternatives (such as other H2-blockers or proton pump inhibitors) are recommended instead.
| Indication | Adult dose | Pediatric dose |
|---|---|---|
| Active duodenal or gastric ulcer | 150 mg twice daily, or 300 mg once daily at bedtime, for 4-8 weeks | Age 1 month-16 years: 2-4 mg/kg/day in two divided doses (max 300 mg/day) |
| Maintenance of healed ulcer | 150 mg once daily at bedtime | Not routinely established; individualize under specialist guidance |
| GERD | 150 mg twice daily | Age 1 month-16 years: 5-10 mg/kg/day in divided doses |
| Erosive esophagitis | 150 mg four times daily | As above for GERD, under specialist supervision |
| Pathological hypersecretory conditions (e.g. Zollinger-Ellison syndrome) | 150 mg twice daily, titrated up to 6 g/day in divided doses if needed | Not established; specialist management required |
| Heartburn/acid indigestion (low-dose OTC-type use, where marketed) | 75-150 mg as needed, not exceeding labeled maximum | Not recommended without physician advice |
Renal impairment: in patients with creatinine clearance below 50 mL/min, the recommended dose of Ranitidine is 150 mg once every 24 hours, with dosage interval adjustment as clinically indicated. Ranitidine should be taken exactly as directed by the prescribing physician, and only where it remains authorized for sale in the local market (see Description for regulatory background).
Ranitidine is generally well tolerated where it remains available. Reported side effects include:
Patients should seek prompt medical attention for signs of hypersensitivity, unusual bruising/bleeding, jaundice, or persistent confusion.
Ranitidine is contraindicated in patients with known hypersensitivity to ranitidine or to any component of the formulation, and in patients with known hypersensitivity to other H2-receptor antagonists (due to potential cross-sensitivity).
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