QUINAPRIL tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Camber Pharmaceuticals, Inc.

SNN (starptautisko nepatentēto nosaukumu):

QUINAPRIL HYDROCHLORIDE

Kompozīcija:

QUINAPRIL 5 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Hypertension Quinapril is 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. 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

Produktu pārskats:

Quinapril tablets, USP are supplied as follows: 5-mg tablets : brown, round biconvex tablets de-bossed with I on the left side of bisect and G on the right side of bisect and 267 on other. NDC 31722-267-90 bottles of 90 tablets NDC 31722-267-10 bottles of 1000 tablets 10-mg tablets : brown, round biconvex tablets de-bossed with IG on one side and 268 on other. NDC 31722-268-90 bottles of 90 tablets NDC 31722-268-10 bottles of 1000 tablets 20-mg tablets : brown, round biconvex tablets de-bossed with IG on one side and 269 on other. NDC 31722-269-90 bottles of 90 tablets NDC 31722-269-10 bottles of 1000 tablets 40-mg tablets : brown, oval biconvex tablets de-bossed with IG on one side and 270 on other. NDC 31722-270-90 bottles of 90 tablets NDC 31722-270-10 bottles of 1000 tablets Dispense in well-closed containers as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] Protect from light. Manufactured by: InvaGen Pharmaceuticals, Inc Hauppauge, NY 11788 Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 Rev: 10/15                                                      Barcode: 270-10-2015                                                                   

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

QUINAPRIL- QUINAPRIL TABLET
CAMBER PHARMACEUTICALS, INC.
----------
QUINAPRIL TABLETS, USP
RX ONLY
WARNING: FETAL TOXICITY
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
DESCRIPTION
Quinapril hydrochloride USP is the hydrochloride salt of quinapril,
the ethyl ester of a non-sulfhydryl,
angiotensin-converting enzyme (ACE) inhibitor, quinaprilat.
Quinapril hydrochloride USP 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 SH N S -HCl and
its structural formula is:
Quinapril hydrochloride USP is a white to off-white amorphous powder
that is freely soluble in
aqueous solvents.
Quinapril Tablets USP contain quinapril hydrochloride equivalent to 5
mg, 10 mg, 20 mg, or 40 mg of
quinapril for oral administration.
Each tablet also contains lactose monohydrate, magnesium carbonate,
magnesium stearate,
crospovidone, povidone and opadry brown (hypromellose, titanium
dioxide, iron oxide and macrogol).
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 apeptidyl dipeptidase that
catalyzes the conversion of angiotensin I
to the vasoconstrictor, angiotensin II. The effect of quinapril in
hypertension 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. Reduced aldosterone se