BISOPROLOL FUMARATE tablet, film coated

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

BISOPROLOL FUMARATE (UNII: UR59KN573L) (BISOPROLOL - UNII:Y41JS2NL6U)

Inapatikana kutoka:

Viona Pharmaceuticals Inc

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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.

Bidhaa muhtasari:

Bisoprolol fumarate tablets, USP is supplied as 5 mg and 10 mg tablets. Bisoprolol fumarate tablets, USP 5 mg are light pink to pink colored, round shaped, film-coated tablets, debossed with "111" on one side and scored on the other side, supplied as follows: NDC 72578-111-06 in bottles of 30 tablets with child-resistant closure. NDC 72578-111-01 in bottles of 100 tablets with child-resistant closure. Bisoprolol fumarate tablets, USP 10 mg are white to off white colored with occasional greyish to black speckles, round shaped, film-coated tablets, debossed with "112" on one side and plain on the other side, supplied as follows: NDC 72578-112-06 in bottles of 30 tablets with child-resistant closure. NDC 72578-112-01 in bottles of 100 tablets with child-resistant closure.   Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container. Call your doctor for medical advice about side effects. You may report side effects to Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088.

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

BISOPROLOL FUMARATE- BISOPROLOL FUMARATE TABLET, FILM COATED
VIONA PHARMACEUTICALS INC
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BISOPROLOL FUMARATE TABLETS, USP
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 766.96. It is a white
crystalline powder
which is approximately equally hydrophilic and lipophilic and is very
soluble in water and
methanol; freely soluble in chloroform, glacial acetic acid and
ethanol; slightly soluble in
ethyl acetate and acetone.
Bisoprolol fumarate tablets, USP is available as 5 mg and 10 mg
tablets for oral
administration.
Each tablet contains following inactive ingredients: butylated
hydroxyanisole, colloidal
silicon dioxide, crospovidone, dibasic calcium phosphate anhydrous,
hypromellose,
magnesium stearate, microcrystalline cellulose, polyethylene glycol
and titanium dioxide.
Additionally, each 5 mg tablet contains D&C yellow #10 Aluminum Lake
and FD&C red
#40 Aluminum Lake.
FDA approved dissolution test specifications differ from USP.
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
1
18
31
4 2
4
4
4
1
2
the bronchial and vascular musculature; to retain selectivity it is
therefore important to
use the lowest effective dose.
PHARMACOKINETICS AND METABOLISM
The absolute bioavail