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:

Ranbaxy Pharmaceuticals Inc.

INN (International Name):

QUINAPRIL HYDROCHLORIDE

Composition:

QUINAPRIL 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Quinapril tablets, USP are 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 tablets, USP. 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

Product summary:

Quinapril tablets, USP are supplied as follows: 5 mg tablets : White to off-white, round, convex faced, film coated tablets, debossed with “18 ’’ on one side and break line on the other side. NDC 63304-548-30 bottles of 30 tablets NDC 63304-548-90 bottles of 90 tablets NDC 63304-548-10 bottles of 1000 tablets 10 mg tablets : White to off-white, round, convex faced, film coated tablets, debossed with “ RX549 ’’ on one side and plain on the other side. NDC 63304-549-30 bottles of 30 tablets NDC 63304-549-90 bottles of 90 tablets NDC 63304-549-10 bottles of 1000 tablets 20 mg tablets : White to off-white, round, convex faced, film coated tablets, debossed with “ RX550 ’’ on one side and plain on the other side. NDC 63304-550-30 bottles of 30 tablets NDC 63304-550-90 bottles of 90 tablets NDC 63304-550-10 bottles of 1000 tablets 40 mg tablets : White to off-white, round, convex faced, film coated tablets, debossed with “ RX551 ’’ on one side and plain on the other side. NDC 63304-551-30 bottles of 30 tablets NDC 63304-551-90 bottles of 90 tablets NDC 63304-551-10 bottles of 1000 tablets Dispense in well-closed containers as defined in the USP. Protect from light. Store at controlled room temperature, 20 to 25º C (68 to 77º F) with excursions permitted between 15 to 30º C (59 to 86º F). (See USP). To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA October 2015 FDA-12

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

QUINAPRIL- QUINAPRIL TABLET, FILM COATED
RANBAXY PHARMACEUTICALS INC.
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QUINAPRIL TABLETS, USP
RX ONLY
WARNING: FETAL TOXICITY
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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 molecular formula is C
H N O •HCl and its structural formula is:
Quinapril hydrochloride, USP is a white to off-white powder with a
pink cast at times that is freely
soluble in aqueous solvents (water).
Quinapril tablets, USP contain 5 mg, 10 mg, 20 mg, or 40 mg of
quinapril hydrochloride, USP for oral
administration. Each tablet also contains crospovidone, lecithin,
magnesium carbonate, magnesium
stearate, microcrystalline cellulose, polyvinyl alcohol, povidone,
talc, titanium dioxide and xanthan gum.
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 fluid
reabsorption. Reduced aldosterone secretion by quinapril may result in
a small increase in serum
WHEN PREGNANCY IS DETECTED, DISCONTINUE QUINAPRIL HYDROCHLORIDE AS
SOON AS POSSIBLE.
DR