BENAZEPRIL HYDROCHLORIDE- benazepril hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals, 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. In using benazepril consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that benazepril hydrochloride tablets do not have a similar risk (see WARNINGS). Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in nonblacks. Benazepril hydrochloride tablets are contraindicated in patients who are hypersensitive to this product or to any other ACE inhibitor. Benazepril hydrochloride tablets are also contraindicated in patients with

Product summary:

Benazepril hydrochloride tablets, USP, 5 mg, are round, white, film-coated tablets, debossed “341” on one side and plain on the other side, packaged as follows: Bottle of 30 - 68788-9050-3 Bottle of 60 - 68788-9050-6 Bottle of 90 - 68788-9050-9 Bottle of 100 - 68788-9050-1 Bottle of 120 - 68788-9050-8 Benazepril hydrochloride tablets, USP, 10 mg, are round, red, film-coated tablets, debossed “342” on one side and plain on the other side, packaged as follows: Bottle of 30 - 68788-9051-3 Bottle of 60 - 68788-9051-6 Bottle of 90 - 68788-9051-9 Bottle of 100 - 68788-9051-1 Bottle of 120 - 68788-9051-8 Benazepril hydrochloride tablets, USP, 20 mg, are round, grey, film-coated tablets, debossed “343” on one side and plain on the other side, packaged as follows: Bottle of 30 - 68788-9052-3 Bottle of 60 - 68788-9052-6 Bottle of 90 - 68788-9052-9 Bottle of 100 - 68788-9052-1 Bottle of 120 - 68788-9052-8 Benazepril hydrochloride tablets, USP, 40 mg, are round, blue, film-coated tablets, debossed “344” on one side and plain on the other side, packaged as follows: Bottle of 30 - 68788-9053-3 Bottle of 60 - 68788-9053-6 Bottle of 90 - 68788-9053-9 Bottle of 100 - 68788-9053-1 Bottle of 120 - 68788-9053-8 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 FDA at 1-800-FDA-1088 Manufactured for: Ranbaxy Pharmaceutical Inc. Jacksonville, FL 32257 USA Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd Linhai, Zhejiang, China Version: 04/2010 Repackaged By: Preferred Pharmaceuticals, Inc Anaheim, CA 92807

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED
PREFERRED PHARMACEUTICALS, INC
----------
RX ONLY
PRESCRIBING INFORMATION
USE IN PREGNANCY
WHEN USED IN PREGNANCY, ACE INHIBITORS CAN CAUSE INJURY AND EVEN DEATH
TO THE DEVELOPING
FETUS. WHEN PREGNANCY IS DETECTED, BENAZEPRIL HYDROCHLORIDE TABLETS
SHOULD BE DISCONTINUED
AS SOON AS POSSIBLE. SEE WARNINGS, FETAL/NEONATAL MORBIDITY AND
MORTALITY.
DESCRIPTION
Benazepril hydrochloride, USP 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.
ACE is a peptidyl dipeptidase that catalyzes the conversion of
angiotensin I to the vasoconstrictor
substance, angiotensin II. Angiotensin II also stimulates aldosterone
secretion