BENAZEPRIL HYDROCHLORIDE tablet film coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Unit Dose Services

INN (Internationale Bezeichnung):

BENAZEPRIL HYDROCHLORIDE

Zusammensetzung:

BENAZEPRIL HYDROCHLORIDE 10 mg

Verschreibungstyp:

PRESCRIPTION DRUG

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED
UNIT DOSE SERVICES
----------
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 by the adren