TAZAC PULVULES

What it is

TAZAC PULVULES contains nizatidine 150 mg or 300 mg as the active ingredient in hard gelatin capsules. Nizatidine is a competitive, reversible inhibitor of histamine at the histamine H2-receptors, particularly those in the gastric parietal cells.

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 (creatinine clearance 20 to 50 mL/min), the dose should be reduced to 150 mg daily; for creatinine clearance 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 in current users of histamine H2-receptor antagonists versus those that had stopped treatment. 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.

PBS listing

Both the 150 mg and 300 mg capsule strengths are listed on the PBS with 2 items each, with both restricted and unrestricted restrictions available, at an ex-manufacturer price of A$16.77.

Regulatory history

The 300 mg capsule strength was first listed on the ARTG on 29 June 1994. The 150 mg capsule strength was first listed on the ARTG on 11 May 2017.