Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
BISOPROLOL FUMARATE (UNII: UR59KN573L) (BISOPROLOL - UNII:Y41JS2NL6U)
Unichem Pharmaceuticals (USA), Inc.
BISOPROLOL FUMARATE
BISOPROLOL FUMARATE 5 mg
ORAL
PRESCRIPTION DRUG
BISOPROLOL FUMARATE is 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.
BISOPROLOL FUMARATE is supplied as 5 mg and 10 mg tablets. The 5 mg tablet is pink colored, biconvex, round, film coated tablet debossed with UL on one side and scored on the other side with 5 debossed on either side of the score. Bottles of 30: NDC 29300-126-13 Bottles of 100: NDC 29300-126-01 Bottles of 500: NDC 29300-126-05 The 10 mg tablet is white colored, biconvex, round, film coated tablet debossed with UL on one side and 10 on the other side. Bottles of 30: NDC 29300-127-13 Bottles of 100: NDC 29300-127-01 Bottles of 500: NDC 29300-127-05 Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight, light-resistant containers. Please address medical inquiries to Unichem's toll free # 1-866-562-4616.
Abbreviated New Drug Application
BISOPROLOL FUMARATE - BISOPROLOL FUMARATE TABLET UNICHEM PHARMACEUTICALS (USA), INC. ---------- BISOPROLOL FUMARATE TABLETS USP Rx Only DESCRIPTION BISOPROLOL FUMARATE USP 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 molecular 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 (Pregelatinized), Crospovidone, Dibasic Calcium Phosphate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80 and Titanium Dioxide. The 5 mg tablets also contain Red and Yellow Iron Oxide. CLINICAL PHARMACOLOGY BISOPROLOL FUMARATE is a beta -selective (cardioselective) adrenoceptor blocking agent without significant membrane stabilizing activity or intrinsic sympathomimetic activity in 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 1 18 31 4 2 4 4 4 1 2 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 20%. Binding to serum pr Lees het volledige document