BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE tablet, coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

BISOPROLOL FUMARATE (UNII: UR59KN573L) (BISOPROLOL - UNII:Y41JS2NL6U), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Saatavilla:

Physicians Total Care, Inc.

INN (Kansainvälinen yleisnimi):

BISOPROLOL FUMARATE

Koostumus:

BISOPROLOL FUMARATE 2.5 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension. Bisoprolol fumarate 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.

Tuoteyhteenveto:

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, for oral administration, are available as: 2.5 mg/6.25 mg : Round, convex, orange, film-coated tablets, plain on one side and debossed "E " over "701" on the other side and supplied as: 5 mg/6.25 mg: Round, convex, red, film-coated tablets, plain on one side and debossed "E " over "704" on the other side and supplied as: 10 mg/6.25 mg: Round, convex, white, film-coated tablets, plain on one side and debossed "E " over "707" on the other side and supplied as: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Sandoz Inc. Princeton, NJ 08540 OS7596 Rev. 05/11 MF0701REV05/11 MG #16359 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma      74146

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE - BISOPROLOL FUMARATE AND
HYDROCHLOROTHIAZIDE TABLET, COATED
PHYSICIANS TOTAL CARE, INC.
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BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS
DESCRIPTION
Bisoprolol fumarate and hydrochlorothiazide tablets are indicated for
the treatment of hypertension. It
combines two antihypertensive agents in a once-daily dosage: a
synthetic beta1-selective
(cardioselective) adrenoceptor blocking agent (bisoprolol fumarate)
and a benzothiadiazine diuretic
(hydrochlorothiazide).
Bisoprolol fumarate USP 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
empirical 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 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 sodium hydroxide
solution, freely soluble in n-butylamine
and dimethylformamide, sparingly soluble in methanol, and insoluble in
ether, chloroform, and dilute
mineral acids. Its empirical formula is C H CIN O S and it has a
molecular weight of 297.73. Its
structural formula is:
Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, 2.5 mg/6.25
mg for oral administration
contains:
Bisoprolol fumarate
USP....................................................................................................2.5
mg
18
31
4 2
4
4
4
7
8
3
4
2
Hydrochlorothiazide USP
....................................................................................