BENAZEPRIL HYDROCHLORIDE- benazepril hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

St. Mary's Medical Park Pharmacy

INN (International Name):

BENAZEPRIL HYDROCHLORIDE

Composition:

BENAZEPRIL HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Benazepril HCl tablets, USP are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. Benazepril HCl, USP is contraindicated in patients who are hypersensitive to benazepril or to any other ACE inhibitor. Benazepril HCl, USP is 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 HCl, USP in patients with diabetes.

Product summary:

Benazepril HCl tablets, USP, 10 mg, are supplied as white, biconvex, round, uncoated tablets, debossed with “52” on one side and “A” on the other side. NDC 60760-0081-90 bottles of 90 Storage: Store at 20º to 25°C (68° to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container as defined in the USP. Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 Rev. 01-2015-00

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET
ST. MARY'S MEDICAL PARK PHARMACY
----------
BENAZEPRIL HYDROCHLORIDE TABLETS, USP
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE BENAZEPRIL HYDROCHLORIDE 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 (HCl), USP 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 HCl tablets, USP are supplied as white, round, biconvex
tablets containing either 5 mg, 10
mg, 20 mg, or 40 mg of benazepril HCl, USP for oral administration.
The inactive ingredients are
crospovidone, lactose anhydrous, magnesium stearate, microcrystalline
cellulose, pregelatinized corn
starch and talc.
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 secretion. The latter decrease
may result in a small increase of
serum potassium. Hypertensive patients treated with benazepril HCl
alone for up to 52 weeks had
elevations of serum potassium of up to 0.2 mEq/L. Similar patients
treated with ben