QUINAPRIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rebel Distributors Corp

INN (International Name):

QUINAPRIL HYDROCHLORIDE

Composition:

QUINAPRIL 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 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 tablets 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 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.

Product summary:

Quinapril tablets are supplied as follows: 5-mg tablets: Yellow colored, oval shaped, film-coated tablets, debossed with ‘L’ & ‘U’ on either side of the breakline on one side and ‘F01’ on the other side. NDC 21695-393-30      bottles of 30 tablets 10-mg tablets: Yellow colored, circular shaped, film-coated tablets, debossed with ‘LU’ on one side and ‘F02’ on the other side. NDC 21695-394-30      bottles of 30 tablets Dispense in well-closed containers as defined in the USP. Storage: Store at 20°to 25°C (68°to 77°F) [See USP Controlled Room Temperature]. Protect from light. Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States Manufactured by: Lupin Limited Goa 403 722 INDIA Revised: September 2010                                                              ID#:222888 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

QUINAPRIL- QUINAPRIL TABLET
REBEL DISTRIBUTORS CORP
----------
QUINAPRIL TABLETS USP
5 MG, 10 MG, 20 MG AND 40 MG
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 tablets (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 empirical 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 film-
coated tablet also contains crospovidone, iron oxide yellow, 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 adrena