BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

RedPharm Drug, Inc.

INN (International Name):

BISOPROLOL FUMARATE

Composition:

BISOPROLOL FUMARATE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP are supplied as 2.5 mg/6.25 mg Light yellow coloured, biconvex, round, film coated tablets debossed with UL on one side and | on other side. Bottles of 30: NDC 29300-187-13 Bottles of 100: NDC 29300-187-01 Bottles of 500: NDC 29300-187-05 Bottles of 1000: NDC 29300-187-10 5 mg/6.25 mg Salmon pink coloured, biconvex, round, film coated tablets debossed with UL on one side and | | on other side. Bottles of 30: NDC 29300-188-13 Bottles of 100: NDC 29300-188-01 Bottles of 500: NDC 29300-188-05 Bottles of 1000: NDC 29300-188-10 10 mg/6.25 mg White coloured, biconvex, round, film coated tablets debossed with UL on one side and | | | on other side. Bottles of 30: NDC 29300-189-13 Bottles of 100: NDC 29300-189-01 Bottles of 500: NDC 29300-189-05 Bottles of 1000: NDC 29300-189-10 Store at 200 to 250C (680 to 770F) [See USP Controlled Room Temperature]. Dispense in a tight container. Please address medical inquiries to Unichem's toll free # 1-866-562-4616.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE- BISOPROLOL FUMARATE
AND HYDROCHLOROTHIAZIDE TABLET
REDPHARM DRUG, INC.
----------
SPL UNCLASSIFIED SECTION
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 beta1-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 (C18H31NO4)2•C4H4O4 and
it has a molecular
weight of 766.97. Its structural formula is:
[Bisoprolol Fumarate]
Bisoprolol fumarate 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-2H-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 molecular
formula is C7H8ClN3O4S2 and it has a molecular weight of 297.73. Its
structural
formula is:
[Hydrochlorothiazide]
Each Bisoprolol Fumarate and Hydrochlorothiazide tablet 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 tablet USP 5 mg/6.25
mg for oral
administration contains:
Bisoprolol fumarate USP….. 5 mg
Hydrochlorothiazide USP…. 6.25 mg
Each Bi