BISOPROLOL FUMARATE tablet, film coated

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Alembic Labs LLC

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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.

পণ্য সারাংশ:

 BISOPROLOL FUMARATE Tablets, USP is supplied as 5 mg and 10 mg tablets. The 5 mg tablet is white, round, biconvex, film-coated, scored and debossed with “S5” on one side NDC 15955-373-30 bottles of 30 NDC 15955-373-50 bottles of 500 The 10 mg tablet is white, round, biconvex, film-coated and debossed with “S10” on one side NDC 15955-374-30 bottles of 30 NDC 15955-374-50 bottles of 500 Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].   Protect from light and moisture. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.   Manufactured for: Alembic Labs LLC West Caldwell, NJ 07006 Manufactured by: Aenova France SAS Saint-Quentin-Fallavier, France Rev. 11/2020

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

BISOPROLOL FUMARATE - BISOPROLOL FUMARATE TABLET, FILM COATED
ALEMBIC LABS LLC
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BISOPROLOL FUMARATE TABLETS, USP
RX ONLY
DESCRIPTION
BISOPROLOL FUMARATE 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 is available as 5 and 10 mg tablets
for oral
administration.
Inactive ingredients include Colloidal Silicon Dioxide, partially
Pregelatinized Starch, Crospovidone,
Anhydrous Dibasic Calcium Phosphate, Hypromellose, Magnesium Stearate,
Microcrystalline
Cellulose, Polyethylene Glycol, Titanium Dioxide and Talc.
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.
1
18
31
4 2
4
4
4
1
2
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 proteins is approximately 30%. Peak plasma
concentrations occur wit