QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE tablet

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:

Camber Pharmaceuticals

INN (International Name):

QUINAPRIL HYDROCHLORIDE

Composition:

QUINAPRIL 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hypertension: Quinapril HCl 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 HCl 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

Product summary:

Quinapril HCl 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 31722-374-90: 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 31722-375-90: 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 31722-376-90: 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 for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 Manufactured by: InvaGen Pharmaceuticals, Inc. Hauppauge, NY 11788. Rev: 10/15 Barcode: 376-10-2015

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE- QUINAPRIL
HYDROCHLORIDE
AND HYDROCHLOROTHIAZIDE TABLET
CAMBER PHARMACEUTICALS
----------
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS, USP
RX ONLY
WARNING: FETAL TOXICITY
• WHEN PREGNANCY IS DETECTED, DISCONTINUE QUINAPRIL HCL 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 HCl and hydrochlorothiazide tablets, USP are
fixed-combination tablets that combine 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:
Hydrochlorothiazide, USP is a white to off-white, crystalline powder
which is slightly soluble in water
25
30
2
5
7
8
3
4
2
but freely soluble in sodium hydroxide solution.
Quinapril HCl 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 HCl and
hydrochlorothiazide 10/12.5), 20 mg with 12.5 mg (quinapril HCl and
hydrochlorothiazide 20/12.5), and
20 mg with 25 mg (quinapril HCl and hydrochlorothiazide 20/25).
Inactive ingredients: lactose,
magnesium carbonate, crospovidone, povidone, magnesium stearate and
opadry pink 03B14436
(hypromellose, titanium dioxide, polyethylene glycol and iron oxide
red).
CLINICAL