ZANTAC

What it is

ZANTAC is a histamine H2-receptor antagonist. It contains ranitidine 150 mg or 300 mg per tablet. ZANTAC tablets are intended for oral administration.

Approved indications

— Short-term treatment of proven duodenal ulcer and maintenance treatment to reduce the risk of relapse in duodenal ulcer. — Short-term treatment of proven gastric ulcer and maintenance treatment for periods up to one year to reduce the risk of relapse in patients with documented healing of benign gastric ulcer. — Short-term symptomatic treatment of reflux oesophagitis unresponsive to conservative antireflux measures and simple drug therapies such as antacids, and maintenance treatment to reduce the risk of relapse of reflux oesophagitis. — Treatment of scleroderma oesophagitis. — Treatment of gastrinoma (Zollinger-Ellison syndrome).

Dosing overview

It is not necessary to time the ranitidine dose in relation to meals. In patients with renal impairment or renal failure, dosage should be reduced as accumulation of ranitidine can occur.

Key safety warnings

Treatment with a histamine H2-antagonist may mask symptoms associated with carcinoma of the stomach and therefore may delay diagnosis of the condition. Accordingly, where gastric ulcer is suspected, the possibility of malignancy should be excluded before therapy with ranitidine is instituted. Agents that elevate gastric pH may increase the already present risk of nosocomial pneumonia in intubated ICU patients receiving mechanical ventilation. In patients such as the elderly, persons with chronic lung disease, diabetes or the immunocompromised, there may be an increased risk of developing community-acquired pneumonia. A large epidemiological study showed an increased risk of developing community-acquired pneumonia in current users of H2-histamine receptor antagonists versus those who had stopped treatment, with an observed adjusted relative risk of 1.63 (95% CI, 1.07–2.48). In patients with a history of acute porphyria, rare clinical reports suggest that ranitidine may precipitate acute porphyric attacks. Ranitidine should therefore be avoided in patients with a history of acute porphyria.

Contraindications

ZANTAC is contraindicated in patients with a known hypersensitivity to ranitidine hydrochloride or any components in this preparation.

PBS listing

ZANTAC tablets at 150 mg and 300 mg are listed on the PBS as unrestricted items with an ex-manufacturer price of A$3.50 each.

Regulatory history

ZANTAC 300 mg tablets (ARTG 53323) were first listed on 20 November 1995. ZANTAC DOUBLE STRENGTH 300 mg tablets (ARTG 95076) were first listed on 11 July 2003. ZANTAC 150 mg tablets were registered with ARTG entries 445896 (first listed 18 April 2024) and 427731 (first listed 23 April 2024).