BENAZEPRIL- 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:

STAT RX USA LLC

INN (International Name):

BENAZEPRIL HYDROCHLORIDE

Composition:

BENAZEPRIL HYDROCHLORIDE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Benazepril hydrochloride is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. In using Benazepril hydrochloride, 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 does 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 is contraindicated in patients who are hypersensitive to this product or to any other ACE inhibitor. Benazepril hydrochloride is also contraindicated in patients with a history of angioedema with or without pre

Product summary:

Benazepril Hydrochloride Tablets, USP are supplied as follows: 5 mg (white biconvex, round, uncoated tablets, debossed with “51” on one side and “A” on the other side) Bottles of 30:     NDC 65162-751-03 Bottles of 100:   NDC 65162-751-10 Bottles of 500: NDC 65162-751-50 10 mg (white biconvex, round, uncoated tablets, debossed with “52” on one side and “A” on the other side) Bottles of 30:     NDC 65162-752-03 Bottles of 100:   NDC 65162-752-10 Bottles of 500: NDC 65162-752-50 20 mg (white biconvex, round, uncoated tablets, debossed with “53” on one side and “A” on the other side) Bottles of 30:     NDC 65162-753-03 Bottles of 100:   NDC 65162-753-10 Bottles of 500: NDC 65162-753-50 40 mg (white biconvex, round, uncoated tablets, debossed with “54” on one side and “A” on the other side) Bottles of 30:     NDC 65162-754-03 Bottles of 100:   NDC 65162-754-10 Bottles of 500: NDC 65162-754-50 Store at 20º to 25°C (68° to 77ºF) (see USP Controlled Room Temperature) Dispense in tight container (USP). Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by Amneal Pharmaceuticals Glasgow, KY 42141 Rev. 12-2009

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BENAZEPRIL - BENAZEPRIL HYDROCHLORIDE TABLET
STAT RX USA LLC
----------
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 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-1H-1-(3S)-benzazepine-1-acetic acid
monohydrochloride; its structural
formula is
BENAZEPRIL 20MG STRUCTURE
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 Tablets, USP are supplied as white and round
biconvex tablets containing 5
mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride 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
hydrochloride alone for up to 52 weeks
had elevations of serum potassium of up to 0.2 mEq/L. Similar patients
treated with