BENAZEPRIL HYDROCHLORIDE- benazepril hydrochloride tablet, film coated BENAZEPRIL HYDROCHLORIDE- benazepril hydrochloride tabl

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Benazepril hydrochloride (UNII: N1SN99T69T) (Benazeprilat - UNII:JRM708L703)

Available from:

Trigen Laboratories, Inc.

INN (International Name):

Benazepril hydrochloride

Composition:

Benazepril hydrochloride 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Benazepril hydrochloride tablets, USP are indicated for the treatment of hypertension. Benazepril Hydrochloride tablets may be used alone or in combination with thiazide diuretics. Benazepril hydrochloride tablets are contraindicated in patients who are hypersensitive to benazepril or to any other ACE inhibitor. Benazepril hydrochloride tablets are also contraindicated in patients with a history of angioedema with or without previous ACE inhibitor treatment.

Product summary:

Benazepril hydrochloride tablets, USP, 5 mg, are round, white, film-coated tablets, debossed "627" on one side and plain on the other side, packaged as follows: NDC 13811-627-10 bottle of 100 tablets (with desiccant) Benazepril hydrochloride tablets, USP, 10 mg, are round, red, film-coated tablets, debossed "628" on one side and plain on the other side, packaged as follows: NDC 13811-628-10 bottle of 100 tablets (with desiccant) NDC 13811-628-50 bottle of 500 tablets (with desiccant) Benazepril hydrochloride tablets, USP, 20 mg, are round, grey, film-coated tablets, debossed "629" on one side and plain on the other side, packaged as follows: NDC 13811-629-10 bottle of 100 tablets (with desiccant) NDC 13811-629-50 bottle of 500 tablets (with desiccant) Benazepril hydrochloride tablets, USP, 40 mg, are round, blue, film-coated tablets, debossed "630" on one side and plain on the other side, packaged as follows: NDC 13811-630-10 bottle of 100 tablets (with desiccant) NDC 13811-630-50 bottle of 500 tablets (with desiccant) Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container (USP).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED
BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED
TRIGEN LABORATORIES, INC.
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BENAZEPRIL HYDROCHLORIDE TABLETS, USP
Trigen Laboratories, Inc.
RX ONLY
PRESCRIBING INFORMATION
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE BENAZEPRIL HYDROCHLORIDE
TABLETS AS SOON AS
POS S IBLE.
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 is a white to off-white crystalline powder,
soluble (>100 mg/mL) in water, in
ethanol, and in methanol. Its chemical name is benazepril
3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-
propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1_H_-1-(3S)-benzazepine-1-acetic
acid monohydrochloride; its
structural formula is
Its empirical formula is C
H N O •HCl, and its molecular weight is 460.96.
Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl
angiotensin-converting enzyme
inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage
of the ester group.
Benazepril hydrochloride, USP is supplied as round, film-coated
tablets containing 5 mg, 10 mg, 20 mg,
and 40 mg of benazepril hydrochloride for oral administration.
The inactive ingredients are carnauba wax, colloidal silicon dioxide,
crospovidone, hypromellose,
lactose monohydrate, magnesium stearate, microcrystalline cellulose,
polydextrose, polyethylene
glycol, pregelatinized starch, titanium dioxide, and triacetin.
The 10 mg tablet also contains FD&C Red No. 40 aluminum lake.
The 20 mg tablet also contains black iron oxide and yellow iron oxide.
The 40 mg tablet also contains FD&C Blue No. 2 aluminum lake.
24
28
2
5
Benazepril hydrochloride tablets USP, 5 mg, 10 mg, 20 mg and 40 mg
meet USP Dissolution Test 2.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Benazepril and benazeprilat inhibit angiotensin-converting enzyme
(ACE) in human subjects and animals.
ACE is a peptidyl dipeptidase that catalyze