QUINAPRIL- quinapril tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Cardinal Health

INN (International Name):

QUINAPRIL HYDROCHLORIDE

Sammensetning:

QUINAPRIL 40 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Hypertension Quinapril hydrochloride is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. In using quinapril hydrochloride, 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 does 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 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.

Produkt oppsummering:

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 controlled room temperature, 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). [See USP]. Protect from light. Manufactured by: InvaGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 Rev: 12/11

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

QUINAPRIL- QUINAPRIL TABLET
CARDINAL HEALTH
----------
QUINAPRIL TABLETS, USP
RX ONLY
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 tablets
should be discontinued as soon as possible. See WARNINGS,
Fetal/Neonatal Morbidity and
Mortality.
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,
2
30
20
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