Product Overview

– Enzol Injection Ranitidine is a H2 receptor antagonist used primarily for reducing gastric acid secretion.

– Each 2ml ampoule contains 50mg of ranitidine hydrochloride and is intended for use by registered medical practitioners.

Clinical Pharmacology

– Mechanism of Action: Ranitidine inhibits both basal and stimulated gastric acid secretion, effectively reducing volume, acidity, and pepsin content.

Pharmacokinetics:

  – Absorption: Peak plasma concentration occurs within 15 minutes post-injection.

  – Distribution: Low plasma protein binding (15%) with a large volume of distribution (96-142 L).

  – Elimination: Terminal half-life of 2-3 hours, primarily eliminated via the kidneys.

Indications and Usage

– Indicated for treating benign gastric and duodenal ulcers, reflux oesophagitis, and stress ulcer prophylaxis in seriously ill patients.

– Also used in Zollinger-Ellison Syndrome and for gastro-oesophageal reflux in children aged 6 months to 18 years.

Contraindications

– Hypersensitivity to Ranitidine or any excipients  .

Drug Interactions

– Ranitidine may alter the absorption and metabolism of other drugs, necessitating dosage adjustments.

– Notably affects drugs metabolized by the cytochrome P450 system and can alter gastric pH, impacting drug bioavailability.

Warnings and Precautions

– May mask symptoms of gastric carcinoma; malignancy should be ruled out before treatment.

– Increased risk of community-acquired pneumonia in certain populations.

– Caution in patients with renal impairment; dosage adjustments are necessary.

Side Effects

– Very Rare: Blood count changes, hypersensitivity reactions, mental confusion, and bradycardia.

– Common: Abdominal pain, constipation, and nausea.

Dosage and Administration

– Adults: 50mg via slow IV injection or IM every 6-8 hours.

– Children: Doses adjusted based on weight, with a maximum of 50mg.

– Renal Impairment: Reduced doses recommended for patients with severe impairment  .

Pregnancy and Lactation

– Ranitidine crosses the placenta; use only if essential  .

– Excreted in breast milk; caution advised during nursing  .

Storage

– Store below 30ºC and protect from light.