GALANTAMINE- galantamine tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (Kansainvälinen yleisnimi):

GALANTAMINE HYDROBROMIDE

Koostumus:

GALANTAMINE 4 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Galantamine tablets are indicated for the treatment of mild to moderate dementia of the Alzheimer's type. Galantamine tablets are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation.

Tuoteyhteenveto:

Galantamine Tablets, USP are available as 4 mg, 8 mg, or 12 mg tablets. The 4 mg tablet is a blue film-coated, round tablet debossed with M on one side of the tablet and G21 on the other side. They are available as follows: NDC 0615-7541-39 blisterpacks of 30 tablets The 8 mg tablet is a blue film-coated, round tablet debossed with M on one side of the tablet and G22 on the other side. They are available as follows: NDC 0615-7542-39 blisterpacks of 30 tablets The 12 mg tablet is a blue film-coated, round tablet debossed with M on one side of the tablet and G23 on the other side. They are available as follows: NDC 0615-7543-39 blisterpacks of 30 tablets Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Dispense in a tight light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 MAY 2008 GLNT:R1

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

GALANTAMINE- GALANTAMINE TABLET, FILM COATED
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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GALANTAMINE
DESCRIPTION
Galantamine hydrobromide, USP is a reversible, competitive
acetylcholinesterase inhibitor. It is known
chemically as
(4a_S_,6_R_,8a_S_)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6_H_-
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 off-white powder and is
sparingly soluble in water. The structural formula for galantamine
hydrobromide is:
Galantamine tablets for oral use are available in blue film-coated,
round tablets of 4 mg, 8 mg or 12 mg.
Each 4 mg, 8 mg and 12 mg (base equivalent) tablet contains 5.126 mg,
10.253 mg and 15.379 mg of
galantamine hydrobromide, respectively. Inactive ingredients include
colloidal silicon dioxide, FD&C
Blue No. 2 Aluminum Lake, hypromellose, magnesium stearate,
microcrystalline cellulose,
polydextrose, polyethylene glycol, sodium lauryl sulfate, sodium
starch glycolate, titanium dioxide and
triacetin.
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 effect may lessen as the disease process
advances and fewer cholinergic neurons