Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
galantamine hydrobromide (UNII: MJ4PTD2VVW) (galantamine - UNII:0D3Q044KCA)
Rebel Distributors Corp
galantamine hydrobromide
galantamine hydrobromide 8 mg
ORAL
PRESCRIPTION DRUG
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.
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.
New Drug Application
RAZADYNE- GALANTAMINE HYDROBROMIDE TABLET, FILM COATED REBEL DISTRIBUTORS CORP ---------- 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. Baca dokumen lengkap