Composition: Galantamine (as hydrobromide) 4mg, 8mg, 12mg.
Presentation: Film-coated tablets, 4mg off-white, 8mg pink, 12mg orange-brown.
Action:
Antidementia drug. Selective, competitive and reversible inhibitor of acetylcholinesterase.
Indications: Symptomatic treatment of mild to moderately severe dementia of
the Alzheimer type.
Contraindications: Hypersensitivity to active substance or excipients; severe
hepatic impairment (Child-Pugh score greater than 9); severe renal impairment
(creatinine clearance less than 9ml/min); both significant renal and hepatic
dysfunction.
Dosage and administration: Adults and elderly, galantamine should be administered
twice a day, preferably with morning and evening meals. Recommended starting
dose 8mg/day (4mg twice a day) for four weeks. Initial maintenance dose 16mg/day
for at least four weeks. An increase to 24mg/day should be considered on an
individual basis after appropriate assessment. In patients not showing an increased
response or not tolerating 24mg/day, a dose reduction to 16mg/day should be
considered. Maintenance treatment can be continued for as long as therapeutic
benefit exists.
Moderate hepatic impairment, galantamine plasma levels may be increased. Dosing
should begin with 4mg once daily, preferably in the morning, for at least one
week and then 4mg twice daily for at least four weeks. Daily doses should not
exceed 8mg twice daily. For mild hepatic impairment, no dosage adjustment required.
Renal impairment, for patients with a creatinine clearance greater than 9ml/min
no dosage adjustment required.
Children, not recommended.
Pregnancy, use with caution.
Lactation, excreted in human breast milk. Women should not breastfeed during
use.
Overdosage: Signs and symptoms as for other cholinomimetics. See SPC for treatment.
Precautions: As for other cholinomimetics. Galantamine is not recommended in
patients with gastrointestinal obstruction or recovering from gastrointestinal
surgery, or in patients with urinary outflow obstruction or recovering from
bladder surgery. Treatment has been associated with weight loss and weight should
be monitored. Galantamine may cause dizziness and somnolence which could affect
the ability to drive or use machines.
Drug interactions: Galantamin should not be used concomitantly with other cholino-
mimetics and antagonises the effects of anticholinergic medication. A pharmacodynamic
interaction is possible with drugs that significantly reduce the heart rate
(eg, digoxin, beta-blockers). Formal interaction studies showed an increase
in galantamine bioavailability during co-administration with paroxetine (CYP2D6
inhibitor), ketoconazole and erythromycin (CYP3A4 inhibitors). During initiation
of treatment with potent inhibitors of CYP2D6 and CYP3A4, increased incidence
of cholinergic side effects may be experienced and a reduction of galantamine
maintenance dose can be considered.
Side effects: Most common adverse events (incidence Ž5 per cent and twice
the frequency of placebo) included nausea, vomiting, diarrhoea, abdominal pain,
dyspepsia, anorexia, fatigue, dizziness, headache, somnolence and weight decrease.
Other common adverse events (incidence Ž 5 per cent and Ž placebo)
included confusion, falls, injury, insomnia, rhinitis and urinary tract infection.
Infrequently, tremor. Syncope and severe bradycardia have also been reported.
Net price: 4mg 14 £13.65; 8mg 14 £17.08, 56 £68.32; 12mg 56
£84, 168 £252.
Supplier: Shire Pharmaceuticals, East Anton, Andover, Hampshire SP10 5RG. Tel
01264 333455, fax 01264 333460. Reminyl is being co-marketed with Janssen-Cilag.
Legal class: POM.