QUINAPRIL AND HYDROCHLOROTHIAZIDE 10/12.5 tablet QUINAPRIL AND HYDROCHLOROTHIAZIDE 20/12.5 tablet QUINAPRIL AND HYDROCHLOROTHI

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Cipla USA Inc.

INN (Διεθνής Όνομα):

QUINAPRIL HYDROCHLORIDE

Σύνθεση:

QUINAPRIL 10 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Hypertension: Quinapril and hydrochlorothiazide tablets, USP 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 Na

Περίληψη προϊόντος:

Quinapril and hydrochlorothiazide tablets, USP is available in tablets of three different strengths: 10/12.5 tablets : pink, oval biconvex tablets de-bossed with 'I' on the left side of bisect and 'G' on the right side of bisect on one side and '374' on the other. Each tablet contains 10 mg of quinapril and 12.5 mg of hydrochlorothiazide. NDC 69097-828-05: 90 tablet bottles 20/12.5 tablets : pink, oval biconvex tablets de-bossed with 'I' on the left side of bisect and 'G' on the right side of bisect on one side and '375' on the other. Each tablet contains 20 mg of quinapril and 12.5 mg of hydrochlorothiazide. NDC 69097-829-05: 90 tablet bottles 20/25 tablets : pink, round biconvex tablets de-bossed with 'IG' on one side and '376' on the other. Each tablet contains 20 mg of quinapril and 25 mg of hydrochlorothiazide. NDC 69097-831-05: 90 tablet bottles Dispense in tight containers as defined in the USP. Store at 20°C to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059 Revised: 01/2022 To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd. at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

QUINAPRIL AND HYDROCHLOROTHIAZIDE 10/12.5- QUINAPRIL AND
HYDROCHLOROTHIAZIDE 10/12.5 TABLET
QUINAPRIL AND HYDROCHLOROTHIAZIDE 20/12.5- QUINAPRIL AND
HYDROCHLOROTHIAZIDE 20/12.5 TABLET
QUINAPRIL AND HYDROCHLOROTHIAZIDE 20/25- QUINAPRIL AND
HYDROCHLOROTHIAZIDE 20/25 TABLET
CIPLA USA INC.
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QUINAPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP
RX ONLY
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, USP are fixed-combination
tablet that
combines an angiotensin-converting enzyme (ACE) inhibitor, quinapril
hydrochloride, and
a thiazide diuretic, hydrochlorothiazide.
Quinapril hydrochloride, USP 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, USP is a white to off-white amorphous powder
that is freely
soluble in aqueous solvents.
Hydrochlorothiazide, USP 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:
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 with
12.5 mg (quinapril and hydrochlorothiazide 10/12.5), 20 mg with 12.5
mg (quinapril and
hydrochlorothiazide 20/12.5), and 20 mg with 25 mg (quinapril and
hydrochlorothiazide
20/25). Inactive ingredients: lactose, magnesium carbonate,
crospovidone, povidone,
magnesium steara