APO-GALANTAMINE MR

What it is

APO-GALANTAMINE MR is galantamine (as hydrobromide) modified release capsules available in strengths of 8 mg, 16 mg and 24 mg.

Approved indications

— Mild to moderately severe dementia of the Alzheimer type.

Dosing overview

APO-GALANTAMINE MR modified release capsules should be administered once daily in the morning, preferably with food. The recommended starting dose is 8 mg a day for four weeks. The initial maintenance dose is 16 mg a day and patients should be maintained on this dose for at least 4 weeks. An increase to the maximum recommended maintenance dose of 24 mg a day should be considered after appropriate assessment including evaluation of clinical benefit and tolerability.

Key safety warnings

Because of their pharmacological action, cholinomimetics may have vagotonic effects on heart rate, including bradycardia and all types of atrioventricular node block, with particular importance to patients with sick sinus syndrome or other supraventricular cardiac conduction disturbances or who concomitantly use medicines that significantly reduce heart rate such as digoxin and beta blockers. In clinical trials, use of galantamine has been associated with syncope and rarely with severe bradycardia, and there have been reports of QT prolongation in patients using therapeutic doses and of torsades de pointes in association with overdose. Patients at increased risk of developing peptic ulcers, including those receiving concurrent nonsteroidal anti-inflammatory drugs, should be monitored for symptoms, although clinical studies with galantamine showed no increase in the incidence of either peptic ulcer disease or gastrointestinal bleeding relative to placebo. Serious skin reactions including Stevens-Johnson syndrome and acute generalised exanthematous pustulosis have been reported in patients receiving galantamine, and it is recommended that patients be informed about the signs of serious skin reactions and that use be discontinued at the first appearance of skin rash. Patients with Alzheimer's disease lose weight, treatment with cholinesterase inhibitors including galantamine has been associated with weight loss in these patients, and patient weight should be monitored during therapy.

Contraindications

APO-GALANTAMINE MR is contraindicated in patients with known hypersensitivity to galantamine hydrobromide or any excipients used in the formulation. Since no data are available on the use of galantamine in patients with severe hepatic impairment (Child-Pugh score greater than 9) or severe renal impairment (creatinine clearance less than 9 mL/min), galantamine is contraindicated in these populations.

Regulatory history

APO-GALANTAMINE MR galantamine (as hydrobromide) 8 mg, 16 mg and 24 mg modified release capsules were first registered on the ARTG on 20 January 2012.