QUINAPRIL tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

A-S Medication Solutions

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Hypertension Quinapril tablets 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. 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 may be used alone or in combination with thiazide diuretics. Heart Failure Quinapril tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. In using quinapril tablets, 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 do not have a similar risk (see WARNINGS). Angioedema in black patients : 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 tablets are 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 tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer Quinapril tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see WARNINGS and PRECAUTIONS). Do not co-administer quinapril tablets with aliskiren in patients with diabetes.

제품 요약:

Product: 50090-5400 NDC: 50090-5400-0 30 TABLET in a BOTTLE

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

QUINAPRIL- QUINAPRIL TABLET
A-S MEDICATION SOLUTIONS
----------
QUINAPRIL TABLETS, USP
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 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, 10 mg, 20 mg, or 40 mg of
quinapril for oral
administration. Each tablet also contains crospovidone, povidone,
lactose monohydrate,
magnesium carbonate, magnesium stearate, iron oxide red, iron oxide
black, titanium
dioxide, Talc, polyvinyl alcohol and Polyethylene glycol.
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
WHEN PREGNANCY IS DETECTED, DISCONTINUE QUINAPRIL 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
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