QUINAPRIL- quinapril hydrochloride 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:

Proficient Rx LP

INN (International Name):

QUINAPRIL HYDROCHLORIDE

Composition:

QUINAPRIL 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hypertension 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, D

Product summary:

Quinapril tablets, USP are supplied as follows: Quinapril Tablets USP, 5 mg are brown colored, oval shaped film-coated tablets, debossed with “5” and “2” on either side of the scoreline on one side and “H” on the other side.             Bottles of 30                                                               NDC 63187-874-30             Bottles of 60                                                               NDC 63187-874-60             Bottles of 90                                                           NDC 63187-874-90 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 for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Unit-VII (SEZ) Mahaboob Nagar (Dt)-509302 India Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Revised: 05/2017

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

QUINAPRIL- QUINAPRIL HYDROCHLORIDE TABLET, FILM COATED
PROFICIENT RX LP
----------
QUINAPRIL TABLETS, USP
RX ONLY
WARNING: 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 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.
Quinapril tablets, USP contain 5 mg, 10 mg, 20 mg, or 40 mg of
quinapril for oral administration. Each
tablet also contains colloidal silicon dioxide, crospovidone,
hydroxypropyl cellulose, hypromellose,
iron oxide red, lactose monohydrate, magnesium carbonate, magnesium
stearate, polyethylene glycol,
povidone, 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,
WHEN PREGNANCY IS DETECTED, DISCONTINUE QUINAPRIL 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).
25
30
2
5
norepinephrine or epinephrine. Angiotensin II also stimulates the
secretion of aldos