QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

QUINAPRIL HYDROCHLORIDE (UNII: 33067B3N2M) (QUINAPRILAT - UNII:34SSX5LDE5), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Available from:

Aurobindo Pharma Limited

INN (International Name):

QUINAPRIL HYDROCHLORIDE

Composition:

QUINAPRIL 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hypertension Quinapril and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with quinapril and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joi

Product summary:

Quinapril and Hydrochlorothiazide Tablets, USP 10 mg/12.5 mg are Pink colored, scored, oval shaped, biconvex, film-coated tablets debossed with ‘D’ on scored side and ‘18’ on other side.                     Bottles of 90               NDC 65862-161-90 Quinapril and Hydrochlorothiazide Tablets, USP 20 mg/12.5 mg are Pink colored, scored, round shaped, biconvex, film-coated tablets debossed with ‘D’ on scored side and ‘19’ on other side.                     Bottles of 30               NDC 65862-162-30                     Bottles of 90               NDC 65862-162-90 Quinapril and Hydrochlorothiazide Tablets, USP 20 mg/25 mg are Pink colored, round shaped, biconvex, film-coated tablets debossed with ‘D’ on one side and ‘20’ on other side.                     Bottles of 90               NDC 65862-163-90 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad–500 032, India Revised: 05/2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE - QUINAPRIL
HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED
AUROBINDO PHARMA LIMITED
----------
QUINAPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP
RX ONLY
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE QUINAPRIL AND
HYDROCHLOROTHIAZIDE AS SOON AS POSSIBLE.
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO THE DEVELOPING FETUS. SEE WARNINGS: FETAL
TOXICITY
DESCRIPTION
Quinapril and hydrochlorothiazide tablets, USP are fixed-combination
tablet that
combines an angiotensin-converting enzyme (ACE) inhibitor, quinapril
hydrochloride, and
a thiazide diuretic, hydrochlorothiazide.
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.
Hydrochlorothiazide is chemically described as:
6-Chloro-3,4-dihydro-2H-1,2,4-
benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C
H ClN O S and
its structural formula is:
25
30
2
5
7
8
3
4 2
Hydrochlorothiazide USP is a white to off-white, crystalline powder
which is slightly
soluble in water but freely soluble in sodium hydroxide solution.
Quinapril and hydrochlorothiazide tablets, USP are available for oral
use as fixed
combination tablets in three strengths of quinapril with
hydrochlorothiazide: 10 mg
(equivalent to 10.832 mg quinapril hydrochloride USP) with 12.5 mg
(quinapril and
hydrochlorothiazide 10/12.5), 20 mg (equivalent to 21.664 mg quinapril
hydrochloride
USP) with 12.5 mg (quinapril and hydrochlorothiazide 20/12.5), and 20
mg (equivalent to
21.664 mg quinapril hydrochloride USP) with 25 mg (quinapril and
hydrochlorothiazide
20/25). The strength of the quinapril hydrochloride component is in
terms of quinapril.
Inactive ingredients: