QUINAPRIL tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

QUINAPRIL HYDROCHLORIDE

Composition:

QUINAPRIL HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Quinapril tablets are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. In using quinapril, 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 does not have a similar risk (see WARNINGS ) 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 tablels are 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.

Product summary:

Quinapril tablets, USP are supplied as follows: 5 mg tablets : White to off-white, round, convex faced, film coated tablets, debossed with “ 18 ’’ on one side and break line on the other side. 10 mg tablets : White to off-white, round, convex faced, film coated tablets, debossed with “ RX549 ’’ on one side and plain on the other side. 20 mg tablets : White to off-white, round, convex faced, film coated tablets, debossed with “ RX550 ’’ on one side and plain on the other side. 40 mg tablets : White to off-white, round, convex faced, film coated tablets, debossed with “ RX551 ’’ on one side and plain on the other. Dispense in well-closed containers as defined in the USP. Protect from light. Store at controlled room temperature 20 to 25º C (68º to 77º F) with excursions permitted between 15 to 30º C (59 to 86º F). (See USP). Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA by: Ohm Laboratories, Inc. North Brunswick, NJ 08902 USA June 2007 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK      74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

QUINAPRIL - QUINAPRIL TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
----------
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 tablet 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 is a white to off-white amorphous powder that
is freely soluble in aqueous
solvents.
Quinapril tablets contain 5 mg, 10 mg, 20 mg, or 40 mg of quinapril
for oral administration. Each tablet
also contains crospovidone, lecithin, magnesium carbonate, magnesium
stearate, microcrystalline
cellulose, polyvinyl alcohol, povidone, talc, titanium dioxide and
xanthan gum.
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 sodium
and fluid reabsorption. Reduced aldosterone secreti