BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE- bisoprolol fumarate and hydrochlorothiazide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals Inc.

INN (International Name):

HYDROCHLOROTHIAZIDE

Composition:

HYDROCHLOROTHIAZIDE 6.25 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 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 20:   NDC 68788-6880-2 Bottles of 30:   NDC 68788-6880-3 Bottles of 60:   NDC 68788-6880-6 Bottles of 90:   NDC 68788-6880-9 Bottles of 100:   NDC 68788-6880-1 Store at 200 to 250 C (680 to 770 F) [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
PREFERRED PHARMACEUTICALS INC.
----------
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 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 (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 C H ClN O S and it has a molecular
weight of 297.73. Its structural
1
18
31
4 2
4
4
4
7
8
3
4
2
formula is:
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