QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE tablet QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Lupin Pharmaceuticals,Inc.

INN (International Name):

QUINAPRIL HYDROCHLORIDE

Sammensetning:

QUINAPRIL 10 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Hypertension : Quinapril and Hydrochlorothiazide Tablets is 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 Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.   Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. This fixed combination is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION ). In using Quinapril and Hydrochlorothiazide Tablets, consideration should be given to the fact that another angiotensin- converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that quinapril does not have a similar risk (see WARNINGS: Neutropenia/Agranulocytosis ). Angioedema in Black Patients : Black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to non-blacks. It should also be noted that in controlled clinical trials, ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. Quinapril and Hydrochlorothiazide Tablets are contraindicated in patients who are hypersensitive to quinapril or hydrochlorothiazide and in patients with a history of angioedema related to previous treatment with an ACE inhibitor. Quinapril and Hydrochlorothiazide Tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer Quinapril and Hydrochlorothiazide Tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see WARNINGS and PRECAUTIONS ). Because of the hydrochlorothiazide components, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. Do not co-administer Quinapril and Hydrochlorothiazide Tablets with aliskiren:           in patients with diabetes. - in patients with diabetes

Produkt oppsummering:

Quinapril and Hydrochlorothiazide Tablets is available in tablets of three different strengths: 10/12.5 tablets: oval shaped, peach colored, biconvex film coated tablets, debossed with NL/710 on bisected side and plain on the other side. Each tablet contains 10 mg of quinapril and 12.5 mg of hydrochlorothiazide. 43386-710-03: 30 tablet bottles, 43386-710-09: 90 tablet bottles, 43386-710-05: 500 tablet bottles. 20/12.5 tablets: capsule shaped, peach colored biconvex film coated tablets, debossed NL/711 on bisected side and plain on the other side. Each tablet contains 20 mg of quinapril and 12.5 mg of hydrochlorothiazide. 43386-711-03: 30 tablet bottles, 43386-711-09: 90 tablet bottles, 43386-711-05: 500 tablet bottles. 20/25 tablets: round peach colored biconvex film coated tablets debossed with NL/712 on one side and plain on the other side. Each tablet contains 20 mg of quinapril and 25 mg of hydrochlorothiazide. 43386-712-03: 30 tablet bottles, 43386-712-09: 90 tablet bottles, 43386-712-05: 500 tablet bottles. Dispense in tight containers as defined in the USP. Store at Controlled Room Temperature 20–25   C (68–77   F) [see USP]. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc . Baltimore, MD 21202 SAP Code: 269800 Rev. 02/2022

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

QUINAPRIL HCL AND HYDROCHLOROTHIAZIDE - QUINAPRIL HCL AND
HYDROCHLOROTHIAZIDE TABLET
LUPIN PHARMACEUTICALS,INC.
----------
QUINAPRIL AND HYDROCHLOROTHIAZIDE TABLET, 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 is a 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 empirical formula
is C25H30N2O5.
HCl and its structural formula is:
Quinapril hydrochloride is a white to off-white powder crystalline
solid with a pink cast at
times 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
C7H8CIN3O4S2 and
its structural formula is:
M.W. = 297.72
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, USP are available for oral
use as fixed
combination tablets in three strengths of quinapril with
hydrochlorothiazide: 10 mg
(equivalent to 10.83 mg of Quinapril Hydrochloride) with 12.5 mg, 20
mg (equivalent to
21.66 mg of Quinapril Hydrochloride) with 12.5 mg, and 20 mg
(equivalent to 21.66 mg
of Quinapril Hydrochloride) with 25 mg. Inactive ingredients: carnauba
wax NF,
magnesium hydroxide USP, microcrystalline cellulose NF, crospovidone
NF, magnesium
stearate NF, polyvinyl alcohol-part hydrolyzed USP, titanium dioxide
USP, talc USP,
lecithin (soya) NF, FD&C yell