BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE tablet, film coated

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Fáanlegur frá:

Mylan Pharmaceuticals Inc.

INN (Alþjóðlegt nafn):

BENAZEPRIL HYDROCHLORIDE

Samsetning:

BENAZEPRIL HYDROCHLORIDE 5 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Benazepril hydrochloride and hydrochlorothiazide tablets are indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION). Benazepril hydrochloride and hydrochlorothiazide tablets are contraindicated in patients who are anuric. Benazepril hydrochloride and hydrochlorothiazide tablets are also contraindicated in patients who are hypersensitive to benazepril, to any other ACE inhibitor, to hydrochlorothiazide, or to other sulfonamide-derived drugs. Hypersensitivity reactions are more likely to occur in patients with a history of allergy or bronchial asthma. Benazepril hydrochloride and hydrochlorothiazide tablets are also contraindicated in patients with a history of angioedema with or without previous ACE inhibitor treatment. Benazepril hydrochloride and hydrochlorothiazide tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer benazepril hydrochloride and h

Vörulýsing:

Benazepril Hydrochloride and Hydrochlorothiazide Tablets are available containing benazepril hydrochloride USP, 5 mg and hydrochlorothiazide USP, 6.25 mg; benazepril hydrochloride USP, 10 mg and hydrochlorothiazide USP, 12.5 mg; benazepril hydrochloride USP, 20 mg and hydrochlorothiazide USP, 12.5 mg; or benazepril hydrochloride USP, 20 mg and hydrochlorothiazide USP, 25 mg. The 5 mg/6.25 mg tablets are beige, film-coated, oval, scored tablets debossed with M 725 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-4725-01 bottles of 100 tablets The 10 mg/12.5 mg tablets are beige, film-coated, round, scored tablets debossed with M above the score and 735 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4735-01 bottles of 100 tablets The 20 mg/12.5 mg tablets are beige, film-coated, capsule-shaped, scored tablets debossed with M to the left of the score and 745 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4745-01 bottles of 100 tablets The 20 mg/25 mg tablets are beige, film-coated, oval, scored tablets debossed with M to the left of the score and 775 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4775-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture and light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 8/2020 BZHCTZ:R8

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE- BENAZEPRIL
HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
----------
WARNING: FETAL TOXICITY: WHEN PREGNANCY IS DETECTED, DISCONTINUE
BENAZEPRIL
HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS AS SOON AS POSSIBLE.
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO THE
DEVELOPING FETUS (SEE WARNINGS: FETAL TOXICITY).
DESCRIPTION
Benazepril hydrochloride, USP is a white to off-white crystalline
powder, soluble (> 100 mg/mL) in
water, in ethanol, and in methanol. Benazepril hydrochloride's
chemical name is (3S)-3-[[(1S)-1-
Carboxy-3-phenylpropyl]amino]-2,3,4,5-tetrahydro-2-oxo-1_H_-1-benzazepine-1-acetic
acid, 3-ethyl
ester, monohydrochloride; its structural formula is:
Its molecular formula is C
H N O ·HCl, and its molecular weight is 460.96.
Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl
angiotensin-converting enzyme
inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage
of the ester group.
Hydrochlorothiazide, USP is a white, or practically white, practically
odorless, crystalline powder. It
is slightly soluble in water; freely soluble in sodium hydroxide
solution, in _n_-butylamine, and in
dimethylformamide; sparingly soluble in methanol; and insoluble in
ether, in chloroform, and in dilute
mineral acids. Hydrochlorothiazide's chemical name is
6-Chloro-3,4-dihydro-2_H_-1,2,4-
benzothiadiazine-7-sulfonamide 1,1-dioxide; its structural formula is:
Its molecular formula is C H ClN O S , and its molecular weight is
297.73.
Hydrochlorothiazide is a thiazide diuretic.
Benazepril hydrochloride and hydrochlorothiazide tablets are a
combination of benazepril
hydrochloride and hydrochlorothiazide. The tablets are formulated for
oral administration with a
combination of 5 mg, 10 mg, or 20 mg of benazepril hydrochloride, USP
and 6.25 mg, 12.5 mg or 25 mg
of hydrochlorothiazide, USP. The inactive ingredients of the tablets
are anhydrous lactose, black iron
oxide, col