benazepril hydrochloride- Benazepril Hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Benazepril Hydrochloride (UNII: N1SN99T69T) (Benazepril - UNII:UDM7Q7QWP8)

Available from:

ETHEX

INN (International Name):

Benazepril Hydrochloride

Pharmaceutical form:

TABLET, FILM COATED

Composition:

5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Benazepril hydrochloride tablets are indicated for the treatment of hypertension. Benazepril hydrochloride tablets may be used alone or in combination with thiazide diuretics.  In using benazepril hydrochloride tablets, 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.

Product summary:

Benazepril hydrochloride 5 mg tablets are white, film-coated tablets, debossed “ETH” on one side and “341” on the other side, packaged as follows: NDC 58177-341-04   bottle of 100 tablets (with desiccant) Benazepril hydrochloride 10 mg tablets are red, film-coated tablets, debossed “ETH” on one side and “342” on the other side, packaged as follows: NDC 58177-342-04   bottle of 100 tablets (with desiccant) NDC 58177-342-08   bottle of 500 tablets (with desiccant) Benazepril hydrochloride 20 mg tablets are gray, film-coated tablets, debossed “ETH” on one side and “343” on the other side, packaged as follows: NDC 58177-343-04   bottle of 100 tablets (with desiccant) NDC 58177-343-08   bottle of 500 tablets (with desiccant) Benazepril hydrochloride 40 mg tablets are blue, film-coated tablets, debossed “ETH” on one side and “344” on the other side, packaged as follows: NDC 58177-344-04   bottle of 100 tablets (with desiccant) NDC 58177-344-08   bottle of 500 tablets (with desiccant) Store at controlled room temperature 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F). [See USP Controlled Room Temperature.] Protect from moisture. Do not store above 30°C (86°F). Dispense in a tight container (USP). Manufactured by KV Pharmaceutical Co. for ETHEX Corporation St. Louis, MO  63044

Summary of Product characteristics

BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED
ETHEX
----------
USE IN PREGNANCY
WHEN USED IN PREGNANCY DURING THE SECOND AND THIRD TRIMESTERS, 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 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 is supplied as 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, magnesium stearate,
microcrystalline cellulose,
polydextrose, polyethylene glycol, 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.
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 by the adrenal cortex.
Inhibition of ACE results in decreased plasma angiotensin II, which
leads to decreased vasopressor
activity and to decreased aldosterone s