BENAZEPRIL HYDROCHLORIDE tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

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Ladda ner Produktens egenskaper (SPC)
14-01-2018

Aktiva substanser:

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

Tillgänglig från:

St Marys Medical Park Pharmacy

INN (International namn):

BENAZEPRIL HYDROCHLORIDE

Sammansättning:

BENAZEPRIL HYDROCHLORIDE 20 mg

Receptbelagda typ:

PRESCRIPTION DRUG

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

                                BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET
ST MARYS 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-1H-1-(3S)-benzazepine-1-acetic
acid monohydrochloride;
its structural formula is
Its empirical formula is C24H28N2O5•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 benaze
                                
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