QUINAPRIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lupin 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 Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Quinapril tablets USP may be used alone or in combination with thiazide diuretics. Heart Failure Quinapril tablets USP is indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. In using quinapril tablets USP, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that quinapril tablets USP does not have a similar risk (see WARNINGS). Black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to non-blacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. Quinapril is contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an ACE inhibitor. Quinapril is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer quinapril within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see WARNINGS and PRECAUTIONS). Do not co-administer quinapril with aliskiren in patients with diabetes.

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 68180-556-09      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 68180-557-09       bottles of 90 tablets NDC 68180-557-03       bottles of 1000 tablets 20-mg tablets: Yellow colored, round shaped, film-coated tablets, debossed with 'LU' on one side and 'F03' on the other side. NDC 68180-558-09       bottles of 90 tablets NDC 68180-558-03       bottles of 1000 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 68180-554-09       bottles of 90 tablets NDC 68180-554-03       bottles of 1000 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
LUPIN PHARMACEUTICALS, INC.
----------
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 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 has n