QUINAPRIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cipla USA Inc.

INN (International Name):

QUINAPRIL HYDROCHLORIDE

Composition:

QUINAPRIL 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hypertension Quinapril is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with quinapril. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of

Product summary:

Quinapril tablets, USP are supplied as follows: 5-mg tablets : brown, round biconvex tablets de-bossed with I on the left side of bisect and G on the right side of bisect and 267 on other. NDC 69097-839-05 bottles of 90 tablets NDC 69097-839-15 bottles of 1000 tablets 10-mg tablets : brown, round biconvex tablets de-bossed with IG on one side and 268 on other. NDC 69097-841-05 bottles of 90 tablets NDC 69097-841-15 bottles of 1000 tablets 20-mg tablets : brown, round biconvex tablets de-bossed with IG on one side and 269 on other. NDC 69097-842-05 bottles of 90 tablets NDC 69097-842-15 bottles of 1000 tablets 40-mg tablets : brown, oval biconvex tablets de-bossed with IG on one side and 270 on other. NDC 69097-843-05 bottles of 90 tablets NDC 69097-843-15 bottles of 1000 tablets Dispense in well-closed containers as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] Protect from light. Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 Manufactured for: Cipla USA Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059 Rev: 05/2020   SAP code: 21083900

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

QUINAPRIL- QUINAPRIL TABLET
CIPLA USA INC.
----------
QUINAPRIL TABLETS, USP
RX ONLY
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE QUINAPRIL 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
Quinapril hydrochloride, USP is the hydrochloride salt of quinapril,
the ethyl ester of a
non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor,
quinaprilat.
Quinapril hydrochloride, USP 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, USP is a white to off-white amorphous powder
that is freely
soluble in aqueous solvents.
Quinapril tablets, USP contain quinapril hydrochloride equivalent to 5
mg, 10 mg, 20 mg,
or 40 mg of quinapril for oral administration. Each tablet also
contains lactose
monohydrate, magnesium carbonate, magnesium stearate, crospovidone,
povidone and
opadry brown (hypromellose, titanium dioxide, iron oxide and
macrogol).
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
25
30
2
5
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 fl