QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE tablet, film coated QUINAPRIL 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:

Greenstone LLC

INN (International Name):

QUINAPRIL HYDROCHLORIDE

Composition:

QUINAPRIL 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 Joint National Committee on

Product summary:

Quinapril and hydrochlorothiazide tablets are available in three different strengths: 10/12.5 tablets: pink, scored elliptical, biconvex, film-coated tablets coded "G 222" on one side. Each tablet contains 10 mg of quinapril and 12.5 mg of hydrochlorothiazide. NDC 59762-0222-1: 90 tablet bottles NDC 59762-1112-9: 90 tablet bottles 20/12.5 tablets: pink, scored triangular, film-coated tablets coded "G 220" on one side. Each tablet contains 20 mg of quinapril and 12.5 mg of hydrochlorothiazide. NDC 59762-0220-1: 90 tablet bottles NDC 59762-3212-9: 90 tablet bottles 20/25 tablets: pink, round, biconvex, film-coated tablets coded "G 223" on one side. Each tablet contains 20 mg of quinapril and 25 mg of hydrochlorothiazide. NDC 59762-0223-1: 90 tablet bottles NDC 59762-5225-9: 90 tablet bottles Dispense in tight containers as defined in the USP. Store at Controlled Room Temperature 20–25°C (68–77°F) [see USP].

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE- QUINAPRIL
HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED
QUINAPRIL AND HYDROCHLOROTHIAZIDE- QUINAPRIL AND
HYDROCHLOROTHIAZIDE TABLET, FILM COATED
GREENSTONE LLC
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QUINAPRIL AND HYDROCHLOROTHIAZIDE TABLETS
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE QUINAPRIL 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 and hydrochlorothiazide tablets are fixed-combination
tablets that combine 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 ClN O S and
its structural formula is:
25
30
2
5
7
8
3
4 2
Hydrochlorothiazide 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 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) with 12.5 mg (quinapril and
hydrochlorothiazide
tablets 10/12.5), 20 mg (equivalent to 21.664 mg quinapril
hydrochloride) with 12.5 mg
(quinapril and hydrochlorothiazide tablets 20/12.5), and 20 mg
(equivalent to 21.664 mg
quinapril hydrochloride) with 25 mg (quinapril and hydrochlorothiazide
tablets 20/25).
Inactive ingredients: cand