BENAZEPRIL HYDROCHLORIDE tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703)

Available from:

Proficient Rx LP

INN (International Name):

BENAZEPRIL HYDROCHLORIDE

Composition:

BENAZEPRIL HYDROCHLORIDE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Benazepril hydrochloride tablets, USP are indicated for the treatment of hypertension. It 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. Do not co-administer aliskiren with angiotensin receptor blockers, ACE inhibitors, including benazepril hydrochloride in patients with diabetes.

Product summary:

Benazepril hydrochloride tablets, USP, 20 mg, are round, grey, film-coated tablets, debossed “S” on one side and “343” on the other side, packaged as follows: NDC 63187-393-30 bottle of 30 tablets (with desiccant) NDC 63187-393-60 bottle of 60 tablets (with desiccant) NDC 63187-393-90 bottle of 90 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). You may report side effects to Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd Linhai, Zhejiang 317024, China Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Version: 01/2014 07713-01

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET, COATED
PROFICIENT RX LP
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BENAZEPRIL HYDROCHLORIDE TABLETS, USP, FILM COATED FOR ORAL USE
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
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 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. 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.
24
28
2
5
ACE is a peptidyl dipeptidase that catalyzes the conversion of
angiotensin I to the vasoconstrictor
substance, angiotensin II. Angiotensin II also s