QUINAPRIL tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

QUINAPRIL HYDROCHLORIDE (UNII: 33067B3N2M) (QUINAPRIL - UNII:RJ84Y44811)

Tilgjengelig fra:

Sun Pharmaceutical Industries Limited

INN (International Name):

QUINAPRIL HYDROCHLORIDE

Sammensetning:

QUINAPRIL HYDROCHLORIDE 5 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Hypertension Quinapril hydrochloride tablets are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. In using quinapril hydrochloride tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that quinapril hydrochloride 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 hydrochloride tablets are contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous tr

Produkt oppsummering:

Quinapril Tablets, USP are supplied as follows: 5 mg tablets: brown, oval, biconvex, film-coated tablets debossed with ‘310’ on one side and break line on other side. Bottles of 30’s with Child Resistant Cap……….……NDC 62756-310-83 Bottles of 90’s with Child Resistant Cap……....……NDC 62756-310-81 Bottles of 100’s with Child Resistant Cap……..……NDC 62756-310-88 Bottles of 100’s with Non Child Resistant Cap…..…NDC 62756-310-08 Bottles of 1000’s with Non Child Resistant Cap…...NDC 62756-310-18 10 mg tablets: brown, triangular, biconvex, film-coated tablets debossed with ‘311’ on one side and plain on other side. Bottles of 30’s with Child Resistant Cap……….……NDC 62756-311-83 Bottles of 90’s with Child Resistant Cap………....…NDC 62756-311-81 Bottles of 100’s with Child Resistant Cap………..…NDC 62756-311-88 Bottles of 100’s with Non Child Resistant Cap…..…NDC 62756-311-08 Bottles of 1000’s with Non Child Resistant Cap...…NDC 62756-311-18 20 mg tablets: brown, round, biconvex, film-coated tablets debossed with ‘312’ on one side and plain on other side. Bottles of 30’s with Child Resistant Cap……….……NDC 62756-312-83 Bottles of 90’s with Child Resistant Cap……....……NDC 62756-312-81 Bottles of 100’s with Child Resistant Cap………..…NDC 62756-312-88 Bottles of 100’s with Non Child Resistant Cap….....NDC 62756-312-08 Bottles of 1000’s with Non Child Resistant Cap...…NDC 62756-312-18 40 mg tablets: brown, oval, biconvex, film-coated tablets debossed with ‘313’ on one side and plain on other side. Bottles of 30’s with Child Resistant Cap……….……NDC 62756-313-83 Bottles of 90’s with Child Resistant Cap………....…NDC 62756-313-81 Bottles of 100’s with Child Resistant Cap………..…NDC 62756-313-88 Bottles of 100’s with Non Child Resistant Cap…..…NDC 62756-313-08 Bottles of 1000’s with Non Child Resistant Cap...…NDC 62756-313-18 Dispense in well-closed, light-resistant container as defined in the USP. Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from light. Distributed by: Caraco Pharmaceutical Laboratories, Ltd. 1150 Elijah McCoy Drive, Detroit, MI 48202 Manufactured by:   Sun Pharmaceutical Industries Ltd. Acme Plaza, Andheri-Kurla Road Andheri (East), Mumbai - 400 059, India PGPI0122A ISS. 09/2010

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

QUINAPRIL - QUINAPRIL TABLET, FILM COATED
SUN PHARMACEUTICAL INDUSTRIES LIMITED
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QUINAPRIL TABLETS, USP
USE IN PREGNANCY
WHEN USED IN PREGNANCY DURING THE SECOND AND THIRD TRIMESTERS, ACE
INHIBITORS CAN CAUSE
INJURY AND EVEN DEATH TO THE DEVELOPING FETUS. When pregnancy is
detected, quinapril should be
discontinued as soon as possible. See WARNINGS, Fetal/Neonatal
Morbidity and Mortality.
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 molecular formula is C
H N O •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 5 mg, 10 mg, 20 mg, or 40 mg of
quinapril for oral administration. Each
tablet also contains magnesium carbonate, lactose monohydrate,
crospovidone, gelatin, magnesium
stearate, hydroxypropyl cellulose, hypromellose, iron oxide red,
polyethylene glycol, and titanium
dioxide.
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 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 so