Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
BISOPROLOL FUMARATE (UNII: UR59KN573L) (BISOPROLOL - UNII:Y41JS2NL6U)
Bryant Ranch Prepack
ORAL
PRESCRIPTION DRUG
Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents. Bisoprolol fumarate is contraindicated in patients with cardiogenic shock, overt cardiac failure, second or third degree AV block, and marked sinus bradycardia.
NDC: 71335-9755-3: 180 FILM COATED TABLETs in a BOTTLE NDC: 71335-9755-1: 30 FILM COATED TABLETs in a BOTTLE NDC: 71335-9755-2: 120 FILM COATED TABLETs in a BOTTLE NDC: 71335-9755-4: 90 FILM COATED TABLETs in a BOTTLE
Abbreviated New Drug Application
BISOPROLOL FUMARATE - BISOPROLOL FUMARATE TABLET, FILM COATED BRYANT RANCH PREPACK ---------- BISOPROLOL FUMARATE TABLETS, USP DESCRIPTION Bisoprolol fumarate is a synthetic, beta -selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is (±)-1-[4-[[2-(1- Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol( _E_)-2- butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta- blocking activity. Its empirical formula is (C H NO ) •C H O and its structure is: Bisoprolol fumarate has a molecular weight of 766.97. It is a white crystalline powder which is approximately equally hydrophilic and lipophilic, and is readily soluble in water, methanol, ethanol, and chloroform. Bisoprolol fumarate tablets, USP are available as 5 and 10 mg tablets for oral administration. Inactive ingredients include Colloidal Silicon Dioxide, Corn Starch, Dibasic Calcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, and Titanium Dioxide. The 5 mg tablets also contain FD&C Red # 40/Allura Red AC aluminum lake, FD&C Yellow # 6/Sunset Yellow FCF aluminum lake. CLINICAL PHARMACOLOGY Bisoprolol fumarate is a beta -selective (cardioselective) adrenoceptor blocking agent without significant membrane stabilizing activity or intrinsic sympathomimetic activity in 1 18 31 4 2 4 4 4 1 its therapeutic dosage range. Cardioselectivity is not absolute, however, and at higher doses (≥ 20 mg) bisoprolol fumarate also inhibits beta -adrenoceptors, chiefly located in the bronchial and vascular musculature; to retain selectivity it is therefore important to use the lowest effective dose. PHARMACOKINETICS AND METABOLISM The absolute bioavailability after a 10 mg oral dose of bisoprolol fumarate is about 80%. Absorption is not affected by the presence of food. The first pass metabolism of bisoprolol fumarate is about 2 Baca dokumen lengkapnya