GALANTYL

What it is

GALANTYL contains galantamine (as hydrobromide) as the active ingredient, available as modified release capsules in strengths of 8 mg, 16 mg or 24 mg.

Approved indications

— Mild to moderately severe dementia of the Alzheimer type.

Dosing overview

GALANTYL 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. Galantamine should be given with caution 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. Cholinomimetics should be given with caution to patients in the immediate post-myocardial infarction period, who have new-onset atrial fibrillation, who have second-degree heart block or greater, who have unstable angina pectoris, uncorrected electrolyte disturbance or congestive cardiac failure, especially NYHA group III-IV. In clinical trials, use of galantamine has been associated with syncope and rarely with severe bradycardia. There have been reports of QT prolongation in patients using therapeutic doses of galantamine and of torsades de pointes in association with overdose. Galantamine should therefore be used with caution in patients with prolongation of the QT interval, in patients treated with drugs affecting the QT interval, or in patients with relevant pre-existing cardiac disease or electrolyte disturbances. Patients at increased risk of developing peptic ulcers, such as those with a history of ulcer disease or those predisposed to these conditions, including those receiving concurrent nonsteroidal anti-inflammatory drugs, should be monitored for symptoms. Cholinomimetics are believed to have some potential to cause seizures. Convulsions have been reported with galantamine. Cholinomimetics should be prescribed with care for patients with a history of severe asthma or obstructive pulmonary disease. Similarly, caution should be exercised in treating patients with active pneumonia. Serious skin reactions (Stevens-Johnson syndrome and acute generalised exanthematous pustulosis) have been reported in patients receiving galantamine. It is recommended that patients be informed about the signs of serious skin reactions, and that use of galantamine 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. During therapy, patient's weight should be monitored.

Contraindications

Galantamine is contraindicated in patients with known hypersensitivity to galantamine hydrobromide or any excipients used in the formulation. Galantamine is contraindicated in patients with severe hepatic impairment (Child-Pugh score greater than 9) or severe renal impairment (creatinine clearance less than 9 mL/min).

Regulatory history

GALANTYL galantamine modified release capsules in strengths of 8 mg, 16 mg and 24 mg were first listed on the ARTG on 23 April 2010.