BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE tablet, coated

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:

Eon Labs, Inc.

INN (International Name):

BISOPROLOL FUMARATE

Composition:

BISOPROLOL FUMARATE 2.5 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 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.

Product summary:

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: NDC 0185-0701-30 bottles of 30 NDC 0185-0701-01 bottles of 100 NDC 0185-0701-05 bottles of 500 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: NDC 0185-0704-30 bottles of 30 NDC 0185-0704-01 bottles of 100 NDC 0185-0704-05 bottles of 500 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: NDC 0185-0707-30 bottles of 30 NDC 0185-0707-01 bottles of 100 NDC 0185-0707-05 bottles of 500 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. KEEP TIGHTLY CLOSED Protect from light and moisture. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. 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. Distributed by Sandoz Inc. Princeton, NJ 08540 Rev. September 2020 MF0701REV09/20

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE- BISOPROLOL FUMARATE AND
HYDROCHLOROTHIAZIDE TABLET, COATED
EON LABS, INC.
----------
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS
RX ONLY
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
18
31
4 2
4
4
4
7
8
3
4
2
contains:
Bisoprolol fumarate, USP
..................................................................................................2.5
mg
Hydrochlorothiazide, USP
......................................................................................