DONEPEZIL-WGR

What it is

DONEPEZIL-WGR contains donepezil hydrochloride and is supplied as film-coated tablets for oral administration in strengths of 5 mg or 10 mg.

Approved indications

— Mild Alzheimer's disease — Moderate Alzheimer's disease — Severe Alzheimer's disease

Dosing overview

Treatment is initiated at 5 mg/day given once daily. DONEPEZIL-WGR tablets should be taken orally in the evening, just prior to retiring. DONEPEZIL-WGR can be taken with or without food. The 5 mg/day dose should be maintained for at least one month to allow the earliest clinical responses to treatment to be assessed and to allow steady-state concentrations of donepezil hydrochloride to be achieved. Following a one-month clinical assessment of treatment at 5 mg/day, the dose of DONEPEZIL-WGR can be increased to 10 mg/day given once daily. The maximum recommended daily dose is 10 mg.

Key safety warnings

Donepezil, as a cholinesterase inhibitor, is likely to exaggerate succinylcholine-type muscle relaxation during anaesthesia. Because of their pharmacological action, cholinesterase inhibitors may have vagotonic effects on heart rate such as bradycardia. The potential for this action may be particularly important to patients with sick sinus syndrome or other supraventricular cardiac conduction conditions, such as sinoatrial or atrioventricular block. There have been post-marketing reports of cardiac conduction conditions including atrioventricular block, QTc interval prolongation and Torsade de Pointes. Through their primary action, cholinesterase inhibitors may be expected to increase gastric acid secretion due to increased cholinergic activity. Therefore, patients at increased risk of developing ulcers, such as those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs, should be monitored closely for symptoms of active or occult gastrointestinal bleeding. Neuroleptic malignant syndrome has been reported to occur very rarely in patients treated with donepezil, with or without concomitant antipsychotic medication. NMS is a potentially life-threatening condition characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated serum creatine phosphokinase levels.

Contraindications

DONEPEZIL-WGR is contraindicated in patients with a known hypersensitivity to donepezil hydrochloride, piperidine derivatives, or to any excipients used in the formulation.

Regulatory history

DONEPEZIL-WGR was first registered on the ARTG on 22 October 2012, with two variants: 5 mg and 10 mg tablets in blister pack format, sponsored by GM Pharma.