QUINAPRIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Solco Healthcare US, LLC

INN (International Name):

QUINAPRIL HYDROCHLORIDE

Composition:

QUINAPRIL 5

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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,

Product summary:

Quinapril Tablets, USP are supplied as follows: 5-mg tablets : Pink, round film-coated tablets, debossed “HH” and a scoreline on one side, and “305” on the other side. NDC 43547-410-09  Bottles of 90 tablets 10-mg tablets : Pink, round film-coated tablets, debossed “HH” on one side and “310” on the other side. NDC 43547-411-09  Bottles of 90 tablets 20-mg tablets : Pink, round film-coated tablets, debossed “HH” on one side and “320” on the other side. NDC 43547-412-09  Bottles of 90 tablets 40-mg tablets : Pink, round film-coated tablets, debossed “HH” on one side and “340” on the other side. NDC 43547-413-09  Bottles of 90 tablets Dispense in well-closed containers as defined in the USP. Storage: Store at 20°C to 25°C (68°F to 77°F); excursion permitted between 15°C and 30°C (59ºF and 86ºF) [see USP Controlled Room Temperature]. Protect from light. You may report side effects to Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 Distributed by: Solco Healthcare US, LLC  Somerset, NJ 08873, USA Manufactured by : Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zhejiang 317024, China Revised: 08/2020 200478-01

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

QUINAPRIL- QUINAPRIL TABLET
SOLCO HEALTHCARE US, LLC
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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