AUSFAM

What it is

Ausfam is a tablet containing famotidine, available in two strengths of 20 mg or 40 mg.

Approved indications

— Duodenal ulcer — Benign gastric ulcer — Zollinger-Ellison syndrome — Prevention of relapses of duodenal ulceration — Short-term (no more than 12 weeks) symptomatic relief of gastroesophageal reflux not responsive to conservative measures — Healing of oesophageal erosion or ulceration associated with gastroesophageal reflux disease — Prevention of relapses of symptoms and erosions or ulcerations associated with gastroesophageal reflux disease

Dosing overview

Key safety warnings

In elderly patients, those with chronic lung disease, diabetes, or immunocompromised status, there may be an increased risk of developing community-acquired pneumonia. A large epidemiological study showed an increased risk with current H2 receptor antagonist use versus cessation, with an observed adjusted relative risk of 1.63 (95% CI, 1.07–2.48). Gastric malignancy should be excluded prior to initiation of therapy for gastric ulcer with Ausfam. Symptomatic response of gastric ulcer to therapy does not preclude the presence of gastric malignancy. Central nervous system adverse effects have been reported in patients with moderate (creatinine clearance < 50 mL/minute) and severe (creatinine clearance < 10 mL/minute) renal insufficiency. Consequently, famotidine dosage should be reduced in these patients. Some patients have experienced adverse reactions such as dizziness, headache, confusion or hallucinations while taking famotidine. Patients should avoid driving vehicles or operating machinery if they experience these symptoms.

Contraindications

Ausfam is contraindicated in patients with hypersensitivity to famotidine or any other component of the product. Cross-sensitivity in this class of compounds has been observed, so famotidine should not be administered to patients with a history of hypersensitivity to other histamine H2-receptor antagonists. Ausfam is also contraindicated for administration to breastfeeding women.

PBS listing

Ausfam 40 mg tablets are listed on the PBS with 2 items and ex-manufacturer price of A$3.58. Ausfam 20 mg tablets are listed on the PBS with 2 items and ex-manufacturer price of A$3.58.

Regulatory history

Ausfam 40 mg and 20 mg tablets were first registered on the ARTG on 8 April 2003. An additional ARTG entry for Ausfam 20 mg tablets was registered on 24 January 2024.