BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE tablet, film coated

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Viona Pharmaceuticals Inc

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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

Prehľad produktov:

Bisoprolol fumarate and hydrochlorothiazide tablets, USP 2.5 mg/6.25 mg are light yellow to yellow colored with occasional greyish to black speckles, round shaped, film-coated tablets, debossed with '113' on one side and plain on other side and are supplied as follows: NDC 72578-113-06 in bottles of 30 tablets with child-resistant closure. NDC 72578-113-01 in bottles of 100 tablets with child-resistant closure. NDC 72578-113-05 in bottles of 500 tablets. Bisoprolol fumarate and hydrochlorothiazide tablets, USP 5 mg/6.25 mg are light pink to pink colored, round shaped, film-coated tablets, debossed with '114' on one side and plain on other side and are supplied as follows: NDC 72578-114-06 in bottles of 30 tablets with child-resistant closure. NDC 72578-114-01 in bottles of 100 tablets with child-resistant closure. NDC 72578-114-05 in bottles of 500 tablets. Bisoprolol fumarate and hydrochlorothiazide tablets, USP 10 mg/6.25 mg are white to off-white colored with occasional greyish to black speckles, round shaped, film-coated tablets, debossed with '115' on one side and plain on other side and are supplied as follows: NDC 72578-115-06 in bottles of 30 tablets with child-resistant closure. NDC 72578-115-01 in bottles of 100 tablets with child-resistant closure. NDC 72578-115-05 in bottles of 500 tablets. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE- BISOPROLOL FUMARATE
AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED
VIONA PHARMACEUTICALS INC
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BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS, USP
RX ONLY
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, 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 molecular formula is (C
H
NO ) •C H O and it has a molecular
weight of 766.96. Its structural formula is:
Bisoprolol fumarate is a white crystalline powder, approximately
equally hydrophilic and
lipophilic and very soluble in water and methanol; freely soluble in
chloroform, glacial
acetic acid and ethanol; slightly soluble in ethyl acetate and
acetone.
Hydrochlorothiazide (HCTZ), USP is
6-Chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7-
sulfonamide, 1,1-dioxide. It is a white or practically white
crystalline powder. It is very
slightly soluble in methanol, sparingly soluble in acetonitrile,
soluble in 1% NaOH solution,
practically insoluble or insoluble in water, ethanol. Its molecular
formula is C H ClN O S
and it has a molecular weight of 297.74. Its structural formula is:
1
18
31
4 2
4
4
4
7
8
3
4 2
Each bisoprolol fumarate and hydrochlorothiazide tablets, USP 2.5
mg/6.25 mg for oral
administration contains:
Bisoprolol fumarate,
USP………………………….……………..2.5 mg
Hydrochlorothiazide,
USP………………………………………..6.25 mg
Each bisoprolol fumarate and hydrochlorothiazide tablets, USP 5
m