QUINAPRIL HYDROCHLORIDE AND 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:

Apotex Corp

INN (International Name):

QUINAPRIL HYDROCHLORIDE

Composition:

QUINAPRIL 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hypertension Quinapril hydrochloride 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 hydrochloride and hydrochlorothiazide. 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 Progr

Product summary:

Quinapril Hydrochloride and Hydrochlorothiazide Tablets 10 mg/12.5 mg are available for oral administration as peach, oval, scored, biconvex, film coated tablets engraved “APO” on one side and “10” bisect “12.5” on the other side.  They are supplied as follows: Bottles of 30 (NDC 60505-3409-3) Bottles of 60 (NDC 60505-3409-6) Bottles of 90 (NDC 60505-3409-9) Bottles of 500 (NDC 60505-3409-5) Bottles of 1,000 (NDC 60505-3409-8)  Quinapril Hydrochloride and Hydrochlorothiazide Tablets 20 mg/12.5 mg are available for oral administration as peach, round, scored, biconvex, film coated tablets engraved “APO” on one side and “20” bisect “12.5” on the other side.  They are supplied as follows: Bottles of 30 (NDC 60505-3410-3) Bottles of 60 (NDC 60505-3410-6) Bottles of 90 (NDC 60505-3410-9) Bottles of 500 (NDC 60505-3410-5) Bottles of 1,000 (NDC 60505-3410-8) Quinapril Hydrochloride and Hydrochlorothiazide Tablets 20 mg/25 mg are available for oral administration as peach, round, biconvex, film coated tablets engraved “APO” on one side and “20” over “25” on the other side.  They are supplied as follows: Bottles of 30 (NDC 60505-3411-3) Bottles of 60 (NDC 60505-3411-6) Bottles of 90 (NDC 60505-3411-9) Bottles of 500 (NDC 60505-3411-5) Bottles of 1,000 (NDC 60505-3411-8)  Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. Protect from moisture. APOTEX INC. QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS 10 mg/12.5 mg, 20 mg/12.5 mg and 20 mg/25 mg   Manufactured by          Manufactured for Apotex Inc.                    Apotex Corp. Toronto, Ontario             Weston, Florida Canada M9L 1T9            USA 33326 Revised: May 2020 Revision: 18

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE- QUINAPRIL
HYDROCHLORIDE
AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED
APOTEX CORP
----------
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS
10 MG/12.5 MG, 20 MG/12.5 MG AND 20 MG/25 MG
RX ONLY
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE QUINAPRIL HYDROCHLORIDE AND
HYDROCHLOROTHIAZIDE TABLETS 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 hydrochloride and hydrochlorothiazide tablets are a
fixed-combination tablets 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 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.
Hydrochlorothiazide is chemically described as:
6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-
sulfonamide 1,1-dioxide. Its empirical formula is C H CIN O S and its
structural formula is:
Hydrochlorothiazide is a white to off-white, crystalline powder which
is slightly soluble in water but
freely soluble in sodium hydroxide solution.
Quinapril hydrochloride and hydrochlorothiazide tablets are available
for oral use as fixed combination
tablets in three strengths of quinapril hydrochloride with
hydrochlorothiazide: 10 mg with 12.5 mg, 20
mg with 12.5 mg, and 20 mg with 25 mg.
Inactive ingredients: copovidone, crospovidone, ferric oxide (yellow
and red), hydroxypropyl
cellulose, hypromellose, magnesium carbonate, polyethylene glycol,
titanium dioxide, zinc stearate.
CLINICAL PHARMACOLOGY
25
30
2
5
7
8
3
4
2
MECHANISM OF ACTION
The principal metabolite of quinapril, quinaprilat, is an inhib