TACIDINE

What it is

TACIDINE is a capsule containing 150 mg or 300 mg of nizatidine as the active ingredient. Nizatidine is a histamine H2-receptor antagonist.

Approved indications

— Treatment of active duodenal ulcer for up to 8 weeks. — Maintenance therapy for duodenal ulcer patients at a reduced dosage of 150 mg at bedtime after healing of the active duodenal ulcer. — Treatment of benign gastric ulcer for up to 8 weeks. — Treatment of oesophagitis, including erosive and ulcerative oesophagitis and associated heartburn due to reflux for up to 12 weeks.

Dosing overview

For patients with moderate to severe renal insufficiency, the dose should be reduced; for creatinine clearance 20 to 50 mL/min, 150 mg daily, and for less than 20 mL/min, 150 mg every 2 days.

Key safety warnings

Symptomatic response to nizatidine therapy does not preclude the presence of gastric malignancy, and prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration. There is a possibility of nosocomial pulmonary infections associated with bacterial colonisation of the stomach in patients in Intensive Care Units receiving drugs which suppress acid secretion. 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, with an observed adjusted relative risk of 1.63 (95% CI, 1.07–2.48). The prolonged use of H2-receptor antagonists may impair the absorption of protein-bound vitamin B12 and may contribute to the development of cyanocobalamin deficiency.

Contraindications

Nizatidine is contraindicated in patients with known hypersensitivity to the drug or excipients, and because cross sensitivity in this class of compounds has been observed, nizatidine should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists.

Regulatory history

TACIDINE 150 mg and 300 mg capsule blister packs were first listed on the ARTG on 29 April 2003.