GALANTAMINE HYDROBROMIDE capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GALANTAMINE HYDROBROMIDE (UNII: MJ4PTD2VVW) (GALANTAMINE - UNII:0D3Q044KCA)

Available from:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

GALANTAMINE HYDROBROMIDE

Composition:

GALANTAMINE 16 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

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