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Uses

Alzheimer’s Disease

Palliative treatment of mild to moderate dementia of the Alzheimer’s type (Alzheimer’s disease); does not alter the underlying disease process of dementia.

Mild Cognitive Impairment

Has been investigated in patients with mild cognitive impairment† who did not meet diagnostic criteria for Alzheimer’s disease but was associated with a higher incidence of death than placebo in these studies. (See Mortality under Cautions.) Not approved by FDA for this use, and manufacturer is not seeking approval.

Dosage and Administration

Administration

Oral Administration

Administer conventional tablets or oral solution orally twice daily, preferably with morning and evening meals.

Administer extended-release capsules orally once daily in the morning, preferably with food.

Administering the drug with food and using a slow escalation of dosage (i.e., increasing dosage at intervals ≥4 weeks) may reduce the incidence of adverse GI effects (e.g., nausea, vomiting).

Administer oral solution using the graduated pipette provided by the manufacturer; refer to accompanying patient information for instructions. Dilute appropriate dose of oral solution in 100 mL of a nonalcoholic beverage just prior to administration and stir well; entire mixture should be consumed.

Dosage

Available as galantamine hydrobromide; dosage is expressed in terms of galantamine.

If galantamine therapy has been interrupted for more than a few days for any reason and reinitiation of the drug is not contraindicated, resume therapy using the lowest dosage and titrate upward to prior dosages.

Adults

Alzheimer’s Disease

Oral

Initially, 4 mg twice daily (as conventional tablets or oral solution) or 8 mg once daily (as extended-release capsules). Dosage may be increased after a minimum of 4 weeks to 8 mg twice daily (as conventional tablets or oral solution) or 16 mg once daily (as extended-release capsules).

Subsequent increases to 12 mg twice daily (as conventional tablets or oral solution) or 24 mg once daily (as extended-release capsules) should be attempted after a minimum of 4 weeks of treatment at the previous dosage.

Maintenance dosage recommended by the manufacturer is 8–12 mg twice daily (as conventional tablets and oral solution) or 16–24 mg once daily (as extended-release capsules). Galantamine 16–24 mg once daily (as extended-release capsules) was as effective as galantamine 8–12 mg twice daily (as conventional tablets). Higher dosages (e.g., 16 mg twice daily) do not result in greater efficacy and are less well tolerated than lower dosages.

Special Populations

Dosage in Hepatic Impairment

Alzheimer’s Disease

Oral

Dosage generally should not exceed 16 mg daily in patients with moderate hepatic impairment (Child-Pugh score of 7–9). Use not recommended in patients with severe hepatic impairment (Child-Pugh score of 10–15).

Dosage in Renal Impairment

Alzheimer’s Disease

Oral

Dosage generally should not exceed 16 mg daily in patients with moderate renal impairment. Use not recommended in patients with severe renal impairment (Cl_cr <9 mL/minute).