QUINAPRIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

BluePoint Laboratories

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 T

Product summary:

Quinapril tablets USP are supplied as follows: 5-mg tablets: Yellow colored, oval shaped, film-coated tablets, debossed with ‘L’ and ‘U’ on either side of the breakline on one side and ‘F01’ on the other side. NDC 68001-189-05 bottles of 90 tablets 10-mg tablets: Yellow colored, circular shaped, film-coated tablets, debossed with ‘LU’ on one side and ‘F02’ on the other side. NDC 68001-188-05 bottles of 90 tablets 20-mg tablets: Yellow colored, round shaped, film-coated tablets, debossed with ‘LU’ on one side and ‘F03’ on the other side. NDC 68001-187-05 bottles of 90 tablets 40-mg tablets : Yellow colored, round shaped, beveled edge film-coated biconvex tablets, debossed with ‘LU’ on one side and ‘F04’ on the other side. NDC 68001-260-05 bottles of 90 tablets Dispense in well-closed containers as defined in the USP. Storage: Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

QUINAPRIL- QUINAPRIL TABLET
BLUEPOINT LABORATORIES
----------
QUINAPRIL TABLETS USP
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 (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
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 e