BISOPROLOL FUMARATE tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Rebel Distributors Corp

INN (nemzetközi neve):

BISOPROLOL FUMARATE

Összetétel:

BISOPROLOL FUMARATE 5 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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.

Termék összefoglaló:

BISOPROLOL FUMARATE is supplied as 5 mg and 10 mg tablets. The 5 mg tablet is pink colored, biconvex, round, film coated tablets debossed with UL on one side and scored on the other side with 5 debossed on either side of the score. Bottles of 30: NDC 21695-667-30 Bottles of 90: NDC 21695-667-90 The 10 mg tablet is white colored, biconvex, round, film coated tablets debossed with UL on one side and 10 on the other side. Bottles of 30: NDC 21695-670-30 Bottles of 90: NDC 21695-670-90 Store at 200 to 250 C (680 to 770 F). [See USP Controlled Room Temperature]. Protect from moisture. Dispense in tight, light-resistant containers.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

BISOPROLOL FUMARATE- BISOPROLOL FUMARATE TABLET
REBEL DISTRIBUTORS CORP
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BISOPROLOL FUMARATE TABLETS USP
Rx Only
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 766.97. 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 are available as 5 and 10 mg tablets
for oral
administration.
Inactive ingredients include Colloidal Silicon Dioxide, Corn Starch
(Pregelatinized), Crospovidone,
Dibasic Calcium Phosphate, Hypromellose, Magnesium Stearate,
Microcrystalline Cellulose,
Polyethylene Glycol, Polysorbate 80 and Titanium Dioxide. The 5 mg
tablets also contain Red and
Yellow Iron Oxide.
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 fumarate is about 20%.
1
18
31
4 2
4
4
4
1
2
Binding to serum proteins is app