Indications and Usage
Galantamine hydrobromide is indicated for the treatment of mild to moderate
dementia of the Alzheimer's type.
The dosage of galantamine hydrobromide shown to be effective in controlled
clinical trials is 16 to 32 mg/day given as twice daily dosing. As the dose of
32 mg/day is less well tolerated than lower doses and does not provide increased
effectiveness, the recommended dose range is 16 to 24 mg/day given in a BID
regimen. The dose of 24 mg/day did not provide a statistically significant
greater clinical benefit than 16 mg/day. It is possible, however, that a daily
dose of 24 mg of galantamine might provide additional benefit for some patients.
The recommended starting dose of galantamine is 4 mg twice a day (8 mg/day). The
dose should be increased to the initial maintenance dose of 8 mg twice a day (16
mg/day) after a minimum of 4 weeks. A further increase to 12 mg twice a day (24
mg/day) should be attempted after a minimum of 4 weeks at 8 mg twice a day (16
mg/day). Dose increases should be based upon assessment of clinical benefit and
tolerability of the previous dose
Galantamine should be administered twice a day, preferably with morning and
Patients and caregivers should be advised to ensure adequate fluid intake during
treatment. If therapy has been interrupted for several days or longer, the
patient should be restarted at the lowest dose and the dose escalated to the
The abrupt withdrawal of galantamine in those patients who had been receiving
doses in the effective range was not associated with an increased frequency of
adverse events in comparison with those continuing to receive the same doses of
that drug. The beneficial effects of galantamine are lost, however, when the
drug is discontinued.
For patients with moderate renal impairment the dose should
generally not exceed 16 mg/day.
In patients with severe renal impairment (creatinine clearance <9 mL/min),
the use of galantamine is not recommended
National Institutes of Health, U.S. National Library of Medicine,
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The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical
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