REMINYL

What it is

REMINYL contains galantamine (as hydrobromide) as the active ingredient, supplied as modified release capsules in strengths of 8 mg, 16 mg and 24 mg.

Approved indications

— Treatment of mild to moderately severe dementia of the Alzheimer type.

Dosing overview

REMINYL 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 for at least 4 weeks, with consideration of an increase to the maximum recommended maintenance dose of 24 mg a day after appropriate assessment including evaluation of clinical benefit and tolerability. If treatment is interrupted for longer than several days, treatment should be re-initiated with the lowest daily dose and gradually increased to the maximum tolerated dose.

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, which may be particularly important in patients with sick sinus syndrome or other supraventricular cardiac conduction disturbances or who concomitantly use medicines that significantly reduce heart rate. 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 with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs, should be monitored for symptoms. The use of REMINYL is not recommended in patients with gastrointestinal obstruction or recovering from gastrointestinal surgery. Cholinomimetics are believed to have some potential to cause seizures, and convulsions have been reported with galantamine. Cholinomimetics should be prescribed with care for patients with a history of severe asthma or obstructive pulmonary disease, and caution should be exercised in treating patients with active pneumonia. 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, with use 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 during therapy patient's weight should be monitored.

Contraindications

REMINYL 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. The use of REMINYL is not recommended in patients with gastrointestinal obstruction or recovering from gastrointestinal surgery. The use of REMINYL is not recommended in patients with urinary outflow obstruction or recovering from bladder surgery.

PBS listing

REMINYL capsules (prolonged release) are listed on the PBS in three strengths: 8 mg, 16 mg and 24 mg (as hydrobromide), with ex-manufacturer prices of A$20.35, A$24.89 and A$29.66 respectively. Each strength has 2 PBS items with authority required and streamlined restrictions.

Regulatory history

REMINYL was first registered on the ARTG on 19 May 2004, with three product registrations for 8 mg, 16 mg and 24 mg modified release capsules.