BENAZEPRIL HYDROCHLORIDE tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Major Pharmaceuticals

INN (Algemene Internationale Benaming):

BENAZEPRIL HYDROCHLORIDE

Samenstelling:

BENAZEPRIL HYDROCHLORIDE 5 mg

Prescription-type:

PRESCRIPTION DRUG

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET
MAJOR PHARMACEUTICALS
----------
BENAZEPRIL HYDROCHLORIDE TABLETS, USP
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
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
24
28
2
5
had elevations of serum potassium of up to