Galantamine is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. It is available as tablets, extended-release capsules and oral solution. MedsAcross supplies Galantamine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Galantamine tablets are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. Galantamine Tables are a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type
Source: US FDA prescribing information
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. This is accomplished by increasing the concentration of acetylcholine through reversible inhibition of its hydrolysis by cholinesterase.
Source: US FDA prescribing information
Galantamine tablets: Recommended starting dosage is 4 mg twice daily, increase to initial maintenance dosage of 8 mg twice daily after a minimum of 4 weeks. Based on clinical benefit and tolerability, dosage may be increased to 12 mg twice daily after a minimum of 4 weeks at 8 mg twice daily. Take with meals, 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
Source: US FDA prescribing information
Galantamine tablets 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
Source: US FDA prescribing information
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
Source: US FDA prescribing information
Serious adverse reactions are discussed in more detail in the following sections of the labeling: Serious skin reactions Cardiovascular Conditions Gastrointestinal Conditions Genitourinary Conditions Neurological Conditions Pulmonary Conditions Deaths in subjects with mild cognitive impairment (MCI) The most common adverse reactions (≥ 5%) were nausea, vomiting, diarrhea, dizziness, headache, decreased appetite, and weight decreased
Source: US FDA prescribing information
Potential to interfere with the activity of anticholinergic medications. Synergistic effect expected when given concurrently with succinylcholine, other cholinesterase inhibitors, similar neuromuscular blocking agents, or cholinergic agonists
Source: US FDA prescribing information
Galantamine Tablets USP should be stored at 25°C (77°F), excursions permitted between 15°C to 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
7 presentations of Galantamine, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Galantamine 4 mg tabletOralGeneric name | — | US FDA | Available on request |
| Galantamine 16 mg extended-release capsuleOralGeneric name | — | US FDA | Available on request |
| Galantamine 24 mg extended-release capsuleOralGeneric name | — | US FDA | Available on request |
| Galantamine 8 mg extended-release capsuleOralGeneric name | — | US FDA | Available on request |
| Galantamine 8 mg tabletOralGeneric name | — | US FDA | Available on request |
| Galantamine 12 mg tabletOralGeneric name | — | US FDA | Available on request |
| Galantamine 4 mg/mL oral solutionOralGeneric name | — | US FDA | Available on request |
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 28 February 2001 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Galantamine in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 7 presentations of Galantamine and sources them for licensed hospitals, importers and physicians against valid import documents.
Yes. The US FDA first approved Galantamine on 28 February 2001, according to Drugs@FDA.
No listed presentation of Galantamine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Galantamine is classified under ATC code N06DA04 (Galantamine).
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