QUINAPRIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

quinapril hydrochloride (UNII: 33067B3N2M) (quinapril - UNII:RJ84Y44811)

Available from:

Dr.Reddy's Laboratories Limited

INN (International Name):

quinapril hydrochloride

Composition:

quinapril 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Quinapril hydrochloride is indicated for the treatment of hypertension. It may be used alone or incombination with thiazide diuretics. In using quinapril hydrochloride, consideration should be given to the fact that another angiotensinconvertingenzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renalimpairment or collagen vascular disease. Available data are insufficient to show that quinaprilhydrochloride does not have a similar risk (see WARNINGS). Black patients receiving ACE inhibitor monotherapy have beenreported to have a higher incidence of angioedema compared to non-blacks. It should also be notedthat in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in blackpatients than in non-blacks. Quinapril hydrochloride is contraindicated in patients who are hypersensitive to this product and inpatients with a history of angioedema related to previous treatment with an ACE inhibitor.

Product summary:

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 theright side of bisect and 267 on other. NDC 55111-621-90 bottles of 90 tablets NDC 55111-621 -1 a bottles of 1000 tablets 10-mg tablets: brown, round biconvex tablets de-bossed with IG on one side and 268 on other. NDC 55111-622-90 bottles of 90 tablets NDC 55111-622-1 a bottles of 1000 tablets 20-mg tablets: brown, round biconvex tablets de-bossed with IG on one side and 269 on other. NDC 55111-623-90 bottles of 90 tablets NDC 55111-623-1 a bottles of 1000 tablets 40-mg tablets: brown, oval biconvex tablets de-bossed with IG on one side and 270 on other. NDC 55111-624-90 bottles of 90 tablets NDC 55111-624-10 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 7JOF) with excursions permitted betweenPlacebo 15° to 30°C (59° to 86°F). [See USP]. Protect from light. Manufactured by: InvaGen Pharmaceuticals, Inc Hauppauge, NY 11788 Distributed by: Dr. Reddy's Laboratories Inc., Bridgewater, NJ 08807 USA Rev: 05/09

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

QUINAPRIL- QUINAPRIL TABLET
DR.REDDY'S LABORATORIES LIMITED
----------
QUINAPRIL TABLETS
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-
isoquinolinecarboxylicacid, monohydrochloride. Its empirical formula
is C SH N s -HCI and its
structural formula is:
Quinapril hydrochloride USP is a white to off-white amorphous powder
that is freely soluble
inaqueous solvents.
Quinapril Tablets USP contain quinapril hydrochloride equivalent to 5
mg, 10 mg, 20 mg, or 40 mgof
quinapril for oral administration.
Each tablet also contains lactose monohydrate, magnesium carbonate,
magnesium stearate,crospovidone,
povidone and opadry brown (hypromellose, titanium dioxide, ironoxide
and macrogol).
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Quinapril is deesterified to the principal metabolite, quinaprilat,
which is aninhibitor of ACE activity in
human subjects and animals. ACE is a peptidyl dipeptidase that
catalyzesthe conversion of angiotensin I
to the vasoconstrictor, angiotensin II. The effect of quinapril
inhypertension 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 causedby
intravenously administered angiotensin I, but
has no effect on the pressor response toangiotensin II, norepinephrine
or epinephrine. Angiotensin II
also stimulates the secretion ofaldosterone from the adrenal cortex,
thereby facilitating renal sodium
and