bisoprolol fumarate hydrochlorothiazide- Bisoprolol Fumarate and hydrochlorothiazide tablet, film coated

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

Bisoprolol Fumarate (UNII: UR59KN573L) (Bisoprolol - UNII:Y41JS2NL6U), Hydrochlorothiazide (UNII: 0J48LPH2TH) (Hydrochlorothiazide - UNII:0J48LPH2TH)

Доступно од:

Watson Laboratories, Inc.

INN (Међународно име):

Bisoprolol Fumarate and hydrochlorothiazide

Фармацеутски облик:

TABLET, FILM COATED

Састав:

2.5 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Bisoprolol and hydrochlorothiazide is indicated in the management of hypertension. Bisoprolol and hydrochlorothiazide is contraindicated in patients in cardiogenic shock, overt cardiac failure (see WARNINGS), second or third degree AV block, marked sinus bradycardia, anuria, and hypersensitivity to either component of this product or to other sulfonamide-derived drugs.

Резиме производа:

Bisoprolol Fumarate and Hydrochlorothiazide Tablets (film-coated) are supplied as follows: 2.5 mg Bisoprolol fumarate/6.25 mg hydrochlorothiazide tablets: Yellow, round, biconvex, film-coated tablets debossed WATSON and 841 , in bottles of 100 and 500. 5 mg Bisoprolol fumarate/6.25 mg hydrochlorothiazide tablets: Pink, round, biconvex, film-coated tablets debossed WATSON and 842 , in bottles of 100 and 500. 10 mg Bisoprolol fumarate/6.25 mg hydrochlorothiazide tablets: White, round, biconvex, film-coated tablets debossed WATSON and 843 , in bottles of 30 and 100. Store at controlled room temperature 15°-30°C (59°-86°F). Dispense in a well-closed container as defined in USP/NF. Manufactured for : Watson Laboratories, Inc. Corona, CA 92880 USA Manufactured by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45215 USA Revised: July 2003

Карактеристике производа

BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE- BISOPROLOL FUMARATE AND
HYDROCHLOROTHIAZIDE TABLET, FILM COATED
WATSON LABORATORIES, INC.
----------
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS
REVISED: JULY 2003
RX ONLY
DESCRIPTION
Bisoprolol fumarate and hydrochlorothiazide is 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 is a white crystalline powder, approximately
equally hydrophilic and lipophilic,
and readily soluble in water, methanol, ethanol, and chloroform.
Hydrochlorothiazide USP (HCTZ) is
6-Chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7-sulfonamide
1,1-dioxide. It is a white, or practically white, practically odorless
crystalline powder. It is slightly
soluble in water, sparingly soluble in dilute sodiumum 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 CIN O S and it
has a molecular weight of
297.73. Its structural formula is:
1
18
31
4 2
4
4
4
7
8
3
4
2
Each tablet, for oral administration contains 2.5 mg bisoprolol
fumarate and 6.25 mg
hydrochlorothiazide, 5 mg bisoprolol fumarate and 6.25 mg
hydrochlorothiazide, or 10 mg bisoprolol
fumarate and 6.25 mg hydrochlorothiazide. In addition, each tablet
contains the following inactive
ingredients: colloidal silicone dioxide, dibasi