QUINAPRIL tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

QUINAPRIL HYDROCHLORIDE (UNII: 33067B3N2M) (QUINAPRILAT - UNII:34SSX5LDE5)

Available from:

Bryant Ranch Prepack

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Quinapril 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

QUINAPRIL- QUINAPRIL TABLET, FILM COATED
BRYANT RANCH PREPACK
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QUINAPRIL TABLETS, USP, 5 MG, 10 MG, 20 MG, AND 40 MG 1050 1051 1045
1053 RX ONLY
USE IN PREGNANCY
When pregnancy is detected, quinapril tablets should be discontinued
as soon as possible. See , .
WHEN USED IN PREGNANCY DURING THE SECOND AND THIRD TRIMESTERS, ACE
INHIBITORS CAN CAUSE
INJURY AND EVEN DEATH TO THE DEVELOPING FETUS.WARNINGSFETAL/NEONATAL
MORBIDITY AND
MORTALITY
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 [3 -[2[ *( *)],3
*]]-2-[2-[[1-(ethoxycarbonyl)-3-
phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic
acid,
monohydrochloride. Its structural formula is: _SRRR_
C H N O •HCl M.W. 474.98
Quinapril hydrochloride is a white to off-white amorphous powder that
is freely soluble in aqueous
solvents.
Quinapril tablets, USP contain 5 mg, 10 mg, 20 mg, or 40 mg of
quinapril for oral administration. In
addition, each tablet also contains the following inactive
ingredients: crospovidone, FD&C Blue No. 2
Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Yellow No. 6
Aluminum Lake, gelatin,
hypromellose, lactose monohydrate, magnesium carbonate, magnesium
stearate, polyethylene glycol,
titanium dioxide, and triacetin.
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 appears to result primarily
from the inhibition of circulating and tissue ACE activity, thereby
reducing angiotensin II formation.
253025
Quinapril inhibits the elevation in blood pressure caused by
intravenously administered angiotensin I,
but has no effect on the pressor response to angioten