RAZADYNE- galantamine hydrobromide tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

galantamine hydrobromide (UNII: MJ4PTD2VVW) (galantamine - UNII:0D3Q044KCA)

Tilgængelig fra:

Rebel Distributors Corp

INN (International Name):

galantamine hydrobromide

Sammensætning:

galantamine hydrobromide 8 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

RAZADYNE® ER/RAZADYNE® (galantamine hydrobromide) is indicated for the treatment of mild to moderate dementia of the Alzheimer's type. RAZADYNE® ER/RAZADYNE® (galantamine hydrobromide) is contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation.

Produkt oversigt:

RAZADYNE® Tablets are imprinted “JANSSEN” on one side, and “G” and the strength “4”, “8”, or “12” on the other. 4 mg off-white tablet: bottles of 30 NDC 21695-184-30 12 mg orange-brown tablet: bottles of 30 NDC 21695-591-30 RAZADYNE® Tablets should be stored at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep out of reach of children. RAZADYNE® Tablets are manufactured by: JOLLC, Gurabo, Puerto Rico 00778 RAZADYNE® Tablets are manufactured for: Ortho-McNeil Neurologics, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. Titusville, NJ 08560 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320 US Patent No. 4,663,318 © Ortho-McNeil-Janssen Pharmaceuticals, Inc.

Autorisation status:

New Drug Application

Produktets egenskaber

RAZADYNE- GALANTAMINE HYDROBROMIDE TABLET, FILM COATED
REBEL DISTRIBUTORS CORP
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RAZADYNE
GALANTAMINE HBR
TABLETS
DESCRIPTION
RAZADYNE ER/RAZADYNE (galantamine hydrobromide) is galantamine
hydrobromide, a
reversible, competitive acetylcholinesterase inhibitor. Galantamine
hydrobromide 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 an
empirical 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:
RAZADYNE ER is available in opaque hard gelatin extended-release
capsules of 8 mg (white), 16 mg
(pink), and 24 mg (caramel) containing galantamine hydrobromide,
equivalent to respectively 8, 16 and
24 mg galantamine base. Inactive ingredients include gelatin, diethyl
phthalate, ethylcellulose,
hypromellose, polyethylene glycol, titanium dioxide and sugar spheres
(sucrose and starch). The 16 mg
capsule also contains red ferric oxide. The 24 mg capsule also
contains red ferric oxide and yellow
ferric oxide.
RAZADYNE for oral use is available in circular biconvex film-coated
immediate-release tablets of
4 mg (off-white), 8 mg (pink), and 12 mg (orange-brown). Each 4, 8,
and 12 mg (base equivalent) tablet
contains 5.126, 10.253, and 15.379 mg of galantamine hydrobromide,
respectively. Inactive ingredients
include colloidal silicon dioxide, crospovidone, hypromellose, lactose
monohydrate, magnesium
stearate, microcrystalline cellulose, propylene glycol, talc, and
titanium dioxide. The 4 mg tablets
contain yellow ferric oxide. The 8 mg tablets contain red ferric
oxide. The 12 mg tablets contain red
ferric oxide and FD&C yellow #6 aluminum lake.
RAZADYNE is also available as a 4 mg/mL oral solution. The inactive
ingredients for this solution
are methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium
saccharin, sodium hydroxide and
purified water.
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