QUINAPRIL HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

QUINAPRIL (UNII: RJ84Y44811) (QUINAPRILAT - UNII:34SSX5LDE5)

Available from:

Carilion Materials Management

INN (International Name):

QUINAPRIL

Composition:

QUINAPRIL 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Quinapril hydrochloride tablets are contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an ACE inhibitor. Do not co-administer quinapril hydrochloride tablets with aliskiren in patients with diabetes.

Product summary:

NDC:68151-1022-1 in a PACKAGE of 1 TABLET, FILM COATEDS Store at controlled room temperature 15º–30ºC (59º–86ºF). Protect from light.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

QUINAPRIL HYDROCHLORIDE- QUINAPRIL HYDROCHLORIDE TABLET, FILM COATED
CARILION MATERIALS MANAGEMENT
----------
QUINAPRIL HYDROCHLORIDE TABLETS
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE QUINAPRIL HYDROCHLORIDE
TABLETS AS SOON AS
POS S IBLE.
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO THE
DEVELOPING FETUS. SEE WARNINGS: FETAL TOXICITY
DESCRIPTION
Quinapril hydrochloride is the hydrochloride salt of quinapril, the
ethyl ester of a non-sulfhydryl,
angiotensin-converting enzyme (ACE) inhibitor, quinaprilat.
Quinapril hydrochloride is chemically described as [3S-[2[R*(R*)],
3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-
phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic
acid,
monohydrochloride. Its empirical formula is C H N O •HCl and its
structural formula is:
Quinapril hydrochloride is a white to off-white amorphous powder that
is freely soluble in aqueous
solvents.
Quinapril hydrochloride tablets contain 5 mg, 10 mg, 20 mg, or 40 mg
of quinapril for oral
administration. Each tablet also contains candelilla wax,
crospovidone, gelatin, lactose, magnesium
carbonate, magnesium stearate, synthetic red iron oxide, and titanium
dioxide.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Quinapril is deesterified to the principal metabolite, quinaprilat,
which is an inhibitor of ACE activity in
human subjects and animals. ACE is a peptidyl dipeptidase that
catalyzes the conversion of angiotensin I
to the vasoconstrictor, angiotensin II. The effect of quinapril in
hypertension and in congestive heart
failure (CHF) appears to result primarily from the inhibition of
circulating and tissue ACE activity,
thereby reducing angiotensin II formation. Quinapril inhibits the
elevation in blood pressure caused by
intravenously administered angiotensin I, but has no effect on the
pressor response to angiotensin II,
norepinephrine or epinephrine. Angiotensin II also stimulates the
secretion of aldosterone from the
adrenal cortex, thereby facilitating renal sodium and