Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.
Mode of Action
Galantamine is a centrally-acting cholinesterase inhibitor, elevating acetylcholine in the cerebral cortex. Glutamine and serotonin levels may also be increase. It has nicotinic receptor agonist properties.
Interaction
ncreased serum concentrations when used with drugs that inhibit CYP2D6 (e.g. quinidine, fluoxetine, fluvoxamine, and paroxetine) and CYP3A4 (e.g. ketoconazole and ritonavir). Cimetidine may increase the bioavailability of galantamine. Increased risk of gastric ulcer when used with NSAIDs.
Potentially Fatal: Amiodarone, ?-blockers, diltiazem or verapamil; NSAIDs; digoxin.
Pregnancy Category Note
Pregnancy Category: B
Lactation: unknown
Adult Dose
Alzheimer Disease
Initial
4 mg PO q12hr
Maintenance
Titrate to 8-12 mg PO q12hr; increase by 4 mg q12hr at no less than 4 week intervals
Hepatic Impairment
Moderate: (Child-Pugh score 7-9): Not to exceed 16 mg/day
Severe: Not recommended
Child Dose
Not recommended
Renal Dose
Renal Impairment
Moderate: Not to exceed 16 mg/day
Severe (CrCl <9 mL/min): Not recommended
Administration
Should be taken with food.
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