MEMANTINE GENERICHEALTH

What it is

MEMANTINE GENERICHEALTH is a film-coated tablet containing either 10 mg or 20 mg of memantine hydrochloride.

Approved indications

— Treatment of the symptoms of moderately severe to severe Alzheimer's disease.

Dosing overview

The recommended maintenance dose for adults is 20 mg per day, achieved by upward titration of 5 mg per week. During the titration period, patients take 5 mg daily in week 1, 10 mg daily in week 2, and 15 mg daily in week 3. Patients with moderate renal impairment should receive 10 mg daily, which may be increased to 20 mg daily according to the standard titration scheme if tolerated well after at least 7 days of treatment. Patients with severe renal impairment should receive 10 mg daily. No dosage adjustment is required for patients with mild or moderate hepatic impairment.

Key safety warnings

Memantine is contraindicated in patients with epilepsy, and caution is recommended in patients with a former history of convulsions or patients with predisposing factors for epilepsy. Animal studies have reported adverse effects of memantine on the visual system, including abnormal lysosomal storage, lens opacity, corneal opacity, and other ocular changes at systemic exposures above clinical levels. However, specific ophthalmological examinations in a 6-month clinical study did not disclose any ocular changes in the double-blind placebo-controlled treatment period. Patients with recent myocardial infarction, uncompensated congestive heart failure, and uncontrolled hypertension were excluded from most clinical trials, and these patients should be closely supervised. Concomitant use of N-methyl-D-aspartate (NMDA) antagonists such as amantadine, ketamine or dextromethorphan should be avoided, as these compounds act at the same receptor system and may result in more frequent or pronounced adverse drug reactions.

Contraindications

MEMANTINE GENERICHEALTH is contraindicated in patients with hypersensitivity to either the active ingredient or any of the excipients, and in patients with a current seizure disorder or with any history of seizures.

PBS listing

The 10 mg tablet is listed on the PBS with streamlined and authority required restrictions at an ex-manufacturer price of A$28.09.

Regulatory history

The original Ebixa product was first approved on 17 April 2003. MEMANTINE GENERICHEALTH tablets containing 5 mg, 10 mg, 15 mg and 20 mg memantine hydrochloride were first listed on the ARTG on 17 November 2011.