Country: United States
Language: English
Source: NLM (National Library of Medicine)
GALANTAMINE HYDROBROMIDE (UNII: MJ4PTD2VVW) (GALANTAMINE - UNII:0D3Q044KCA)
Aphena Pharma Solutions - Tennessee, LLC
GALANTAMINE HYDROBROMIDE
GALANTAMINE 16 mg
ORAL
PRESCRIPTION DRUG
Galantamine hydrobromide extended-release capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. Galantamine hydrobromide extended-release capsules are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation.
Galantamine hydrobromide extended-release capsules contain white to off-white matrix tablets. 8 mg white opaque cap and body, size 1 hard gelatin capsules with inscription “WPI 3496” 16 mg pink opaque cap and white opaque body, size 1 hard gelatin capsules with the inscription “WPI 3497” 24 mg pink opaque cap and body, size 1 hard gelatin capsules with the inscription “WPI 3498” The capsules are supplied as follows: 8 mg capsules – bottles of 30 NDC 0591-3496-30 8 mg capsules – bottles of 500 NDC 0591-3496-05 16 mg capsules – bottles of 30 NDC 0591-3497-30 16 mg capsules – bottles of 500 NDC 0591-3497-05 24 mg capsules – bottles of 30 NDC 0591-3498-30 24 mg capsules – bottles of 500 NDC 0591-3498-05 Storage and Handling Galantamine hydrobromide extended-release capsules should be stored at 20° to 25°C (68°-77°F). [See USP controlled room temperature.] Keep out of reach of children. Galantamine hydrobromide extended-release capsules are manufactured by: Watson Laboratories, Inc. Corona, CA 92880 USA Distributed by: Watson Pharma, Inc. Corona, CA 92880 USA Issued: June 2008 173479 0608B
Abbreviated New Drug Application
GALANTAMINE HYDROBROMIDE - GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- GALANTAMINE HYDROBROMIDE EXTENDED-RELEASE CAPSULES Issued: June 2008 RX ONLY DESCRIPTION Galantamine hydrobromide is a reversible, competitive acetylcholinesterase inhibitor. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl- 6H-benzofuro[3a,3,2-ef][2]benzazepin-6-ol hydrobromide. It has a molecular formula of C H NO •HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is: Galantamine hydrobromide extended-release capsules are available in opaque hard gelatin extended- release capsules of 8 mg (white), 16 mg (pink and white), and 24 mg (pink) containing galantamine hydrobromide, equivalent to respectively 8, 16 and 24 mg galantamine base. Inactive ingredients include gelatin, hydroxypropyl cellulose, magnesium stearate, colloidal silicon dioxide and titanium dioxide. The 16 mg capsule and 24 mg capsule also contain red ferric oxide. CLINICAL PHARMACOLOGY 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. This is accomplished by increasing the concentration of acetylcholine through reversible inhibition of its hydrolysis by cholinesterase. If this mechanism is correct, galantamine’s ef Read the complete document