QUINAPRIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

American Health Packaging

INN (International Name):

QUINAPRIL HYDROCHLORIDE

Composition:

QUINAPRIL 20 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 T

Product summary:

Quinapril tablets USP are supplied as follows: 20-mg tablets: Yellow colored, round shaped, film-coated tablets, debossed with ‘LU’ on one side and ‘F03’ on the other side. Unit dose packages of 30 (5 x 6) NDC 68084-899-25 Storage: Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. Protect from light. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

QUINAPRIL- QUINAPRIL TABLET
AMERICAN HEALTH PACKAGING
----------
QUINAPRIL TABLETS USP
8289921/0720F
RX ONLY
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE QUINAPRIL TABLETS 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 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 tablets USP contain 5 mg (equivalent to 5.416 mg Quinapril
Hydrochloride), 10
mg (equivalent to 10.832 mg Quinapril Hydrochloride), 20 mg
(equivalent to 21.664 mg
Quinapril Hydrochloride), or 40 mg (equivalent to 43.328 mg Quinapril
Hydrochloride) of
quinapril for oral administration. Each film-coated tablet also
contains crospovidone, iron
oxide yellow, lecithin, magnesium carbonate, magnesium stearate,
microcrystalline
cellulose, polyvinyl alcohol, povidone, talc, titanium dioxide and
xanthan gum.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
25
30
2
5
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