BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE tablet film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Bryant Ranch Prepack

INN (International Name):

BISOPROLOL FUMARATE

Sammensætning:

BISOPROLOL FUMARATE 10 mg

Recept type:

PRESCRIPTION DRUG

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE- BISOPROLOL FUMARATE AND
HYDROCHLOROTHIAZIDE TABLET, FILM COATED
BRYANT RANCH PREPACK
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DESCRIPTION
Bisoprolol fumarate and hydrochlorothiazide tablets, USP are indicated
for the treatment of
hypertension. It combines two antihypertensive agents in a once-daily
dosage: a synthetic beta -
selective (cardioselective) adrenoceptor blocking agent (bisoprolol
fumarate) and a benzothiadiazine
diuretic (hydrochlorothiazide).
Bisoprolol fumarate is chemically described as
(±)-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 it has a molecular
weight of 766.97. Its structural formula is:
Bisoprolol fumarate, USP is a white crystalline powder, approximately
equally hydrophilic and
lipophilic, and readily soluble in water, methanol, ethanol, and
chloroform.
Hydrochlorothiazide (HCTZ) is
6-Chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7-sulfonamide 1,1-
dioxide. Hydrochlorothiazide, USP is a white, or practically white,
practically odorless crystalline
powder. It is slightly soluble in water, sparingly soluble in dilute
sodium hydroxide solution, freely
soluble in n-butylamine and dimethylformamide, sparingly soluble in
methanol, and insoluble in ether,
chloroform, and dilute mineral acids. Its molecular formula is C H ClN
O S and it has a molecular
weight of 297.73. Its structural formula is:
Each bisoprolol fumarate and hydrochlorothiazide tablet, for oral
administration, contains one of the
following combinations of bisoprolol fumarate/hydrochlorothiazide: 2.5
mg/6.25 mg, 5 mg/6.25 mg or
10 mg/6.25 mg. Each tablet also contains the following inactive
ingredients: anhydrous lactose,
colloidal silicon dioxide, croscarmellose sodium, hypromellose,
magnesium stearate, microcrystalline
cel