BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE tablet, film 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:

Mylan Pharmaceuticals 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 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 available containing 2.5 mg/6.25 mg, 5 mg/6.25 mg or 10 mg/6.25 mg of bisoprolol fumarate, USP and hydrochlorothiazide, USP. The 2.5 mg/6.25 mg tablets are orange, film-coated, round, unscored tablets debossed with 501 on one side of the tablet and M on the other side. They are available as follows: NDC 0378-0501-01 bottles of 100 tablets NDC 0378-0501-05 bottles of 500 tablets The 5 mg/6.25 mg tablets are blue, film-coated, round, unscored tablets debossed with 503 on one side of the tablet and M on the other side. They are available as follows: NDC 0378-0503-01 bottles of 100 tablets NDC 0378-0503-05 bottles of 500 tablets The 10 mg/6.25 mg tablets are white, film-coated, round, unscored tablets debossed with 505 on one side of the tablet and M on the other side. They are available as follows: NDC 0378-0505-01 bottles of 100 tablets NDC 0378-0505-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Hyderabad — 500 096, India 75079355 Revised: 3/2021 MX:BFHCTZ:R3

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE- BISOPROLOL FUMARATE
AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
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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-[[α-(2-Isopropoxyethoxy)-4-toly]oxy]-
3-(isopropylamino)-2-propanol fumarate (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, USP 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-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 molecular
formula is C H ClN O S and it has a molecular weight of 297.73. Its
structural formula
is:
Each bisoprolol fumarate and hydrochlorothiazide tablet, for oral
administration,
1
18
31
4 2
4
4
4
7
8
3
4 2
Each bisoprolol fumarate and hydrochlorothiazide tablet, for oral
administration,
contains one of the following combinations of bisoprolol
fumarate/hydrochlorothiazide:
2.5 mg/6.25 mg, 5 mg/6.25 mg or 10 mg/6.25 mg. Each tablet also
contains the
following inactive ingredients: anhydrous lactose, colloidal silicon
dioxide, croscarmellose
s