Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
BISOPROLOL FUMARATE (UNII: UR59KN573L) (BISOPROLOL - UNII:Y41JS2NL6U)
Eon Labs, Inc.
BISOPROLOL FUMARATE
BISOPROLOL FUMARATE 5 mg
ORAL
PRESCRIPTION DRUG
Bisoprolol fumarate tablets, USP 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.
Bisoprolol Fumarate Tablets, USP, for oral administration, are available as 5 mg Pink, round, biconvex, film-coated, debossed “E ” over “771” and bisected on the other side and supplied as: NDC 0185-0771-30 bottles of 30 NDC 0185-0771-01 bottles of 100 10 mg White, round, biconvex, film-coated, debossed “E ” over “774” and plain on the other side and supplied as: NDC 0185-0774-30 bottles of 30 NDC 0185-0774-01 bottles of 100 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. KEEP TIGHTLY CLOSED. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by Sandoz Inc. Princeton, NJ 08540 46192536 Rev. September 2016 MF0771REV09/16
Abbreviated New Drug Application
BISOPROLOL FUMARATE- BISOPROLOL FUMARATE TABLET, COATED EON LABS, INC. ---------- BISOPROLOL FUMARATE TABLETS, USP RX ONLY DESCRIPTION Bisoprolol fumarate tablets, USP (bisoprolol fumarate) is a synthetic, beta -selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate, USP 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 766.96. 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 mg and 10 mg tablets for oral administration. The tablets contain the following inactive ingredients: colloidal silicon dioxide, corn starch, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate and titanium dioxide. In addition, the 5 mg tablets contain FD&C yellow No. 6 aluminum lake and FD&C red No. 40 aluminum lake. 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 (greater than or equal to 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 Đọc toàn bộ tài liệu