Galantamine

What it is and how it works

Mechanism of Action Although the etiology of cognitive impairment in Alzheimer's disease (AD) is not fully understood, it has been reported that acetylcholine-producing neurons degenerate in the brains of patients with Alzheimer's disease. The degree of this cholinergic loss has been correlated with degree of cognitive impairment and density of amyloid plaques (a neuropathological hallmark of Alzheimer's disease). Galantamine, a tertiary alkaloid, is a competitive and reversible inhibitor of acetylcholinesterase. While the precise mechanism of galantamine's action is unknown, it is postulated to exert its therapeutic effect by enhancing cholinergic function.

Indications

Galantamine hydrobromide extended-release capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer's type. Galantamine hydrobromide is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type

Dosage and administration (summary)

Recommended starting dosage is 8 mg/day in morning; increase to initial maintenance dose of 16 mg/day after a minimum of 4 weeks. Based on clinical benefit and tolerability, dosage may be increased to 24 mg/day after a minimum of 4 weeks at 16 mg/day. Take with food; ensure adequate fluid intake during treatment Hepatic impairment: should not exceed 16 mg/day for moderate hepatic impairment; do not use in patients with severe hepatic impairment Renal impairment: should not exceed 16 mg/day for creatinine clearance 9 to 59 mL/min; do not use in patients with creatinine clearance less than 9 mL/min.

Contraindications

Galantamine hydrobromide extended-release capsules are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. Known hypersensitivity to galantamine hydrobromide or any excipients

Warnings and precautions

Serious skin reactions: discontinue at first appearance of skin rash All patients should be considered at risk for adverse effects on cardiac conduction, including bradycardia and AV block, due to vagotonic effects on sinoatrial and atrioventricular nodes Active or occult gastrointestinal bleeding: monitor, especially those with an increased risk for developing ulcers Cholinomimetics may cause bladder outflow obstruction Monitor for respiratory adverse events in patients with a history of severe asthma or obstructive pulmonary disease Serious Skin Reactions Serious skin reactions (Stevens-John…

Pregnancy

Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of galantamine hydrobromide extended-release capsules in pregnant women. In studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decrea…

Storage and supply

How Supplied Galantamine hydrobromide extended-release capsules are supplied as follows: 24 mg (Size 2 caramel opaque/caramel opaque capsules imprinted ‘837’ with black ink on cap and body filled with caramel color capsule shaped uncoated tablet plain on both sides).

Source: Galantamine Hydrobromide (Galantamine Hydrobromide) — US FDA prescribing information, 2025-09-12, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.