Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
BISOPROLOL FUMARATE (UNII: UR59KN573L) (BISOPROLOL - UNII:Y41JS2NL6U)
Mylan Pharmaceuticals Inc.
BISOPROLOL FUMARATE
BISOPROLOL FUMARATE 5 mg
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 tablets are contraindicated in patients with cardiogenic shock, overt cardiac failure, second or third degree AV block and marked sinus bradycardia.
Bisoprolol Fumarate Tablets, USP are supplied as 5 mg or 10 mg tablets. The 5 mg tablet is a purple, film-coated, round, tablet debossed with 523 above the score on one side of the tablet and M on the other side. It is available as follows: NDC 0378-0523-93 bottles of 30 tablets NDC 0378-0523-77 bottles of 90 tablets NDC 0378-0523-01 bottles of 100 tablets The 10 mg tablet is a white, film-coated, round, unscored tablet debossed with 524 on one side of the tablet and M on the other side. It is available as follows: NDC 0378-0524-93 bottles of 30 tablets NDC 0378-0524-77 bottles of 90 tablets NDC 0378-0524-25 bottles of 250 tablets 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 using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 1/2018 BISO:R8
Abbreviated New Drug Application
BISOPROLOL FUMARATE- BISOPROLOL FUMARATE TABLET, FILM COATED MYLAN PHARMACEUTICALS INC. ---------- DESCRIPTION Bisoprolol fumarate, USP is a synthetic, beta -selective (cardio-selective) 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. Each tablet for oral administration contains either 5 mg or 10 mg of bisoprolol fumarate. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate and titanium dioxide. Each 5 mg tablet also contains FD&C Blue No. 2 Aluminum Lake and FD&C Red No. 40 Aluminum Lake. _Meets USP Dissolution Test 2._ 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 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 f Læs hele dokumentet