Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
BISOPROLOL FUMARATE (UNII: UR59KN573L) (BISOPROLOL - UNII:Y41JS2NL6U)
American Health Packaging
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: Unit dose packages of 30 (3 x 10) NDC 68084-487-21 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. FOR YOUR PROTECTION: Do not use if blister is torn or broken. 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.
Abbreviated New Drug Application
BISOPROLOL FUMARATE- BISOPROLOL FUMARATE TABLET, COATED AMERICAN HEALTH PACKAGING ---------- BISOPROLOL FUMARATE TABLETS USP 8248721/0817 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: (C H NO ) C H O M.W. 766.96 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 i Lestu allt skjalið