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quinapril hydrochloride and hydrochlorothiazide tablet film coated

INDICATIONS AND USAGE 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 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 hydrochloride 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.

apotex corp


4 years ago OVAL ORANGE APO 10 12 5 quinapril hydrochloride and hydrochlorothiazide tablet film coated

OVAL ORANGE APO 10 12 5

HOW SUPPLIED 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) Dispense in a tight, light-resistant container [see USP]. Protect from moisture. 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]. 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: April 2021 Revision: 20


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