candesartan cilexetil 16 MG Hydrochlorothiazide 12.5 MG Oral Tablet
INDICATIONS AND USAGE Candesartan cilexetil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal 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 candesartan cilexetil 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 dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION ).
Mylan Pharmaceuticals Inc.
ROUND ORANGE M X C1
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candesartan cilexetil 32 MG Hydrochlorothiazide 12.5 MG Oral Tablet
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HOW SUPPLIED
CANDESARtan CILEXETIL AND HYDROCHLOROTHIAZIDE Tablets, USP are available containing 16 mg or 32 mg of candesartan cilexetil, USP and 12.5 mg or 25 mg of hydrochlorothiazide, USP providing for the following available combinations: 16 mg/12.5 mg, 32 mg/12.5 mg or 32 mg/25 mg. The 16 mg/12.5 mg tablets are peach, mottled, round, scored tablets debossed with M on the left side of the score and X on the right side of the score on one side of the tablet and C1 on the other side of the tablet. They are available as follows: NDC 0378-3001-77 bottles of 90 tablets NDC 0378-3001-05 bottles of 500 tablets The 32 mg/12.5 mg tablets are yellow, mottled, round, scored tablets debossed with M on the left side of the score and X on the right side of the score on one side of the tablet and C2 on the other side of the tablet. They are available as follows: NDC 0378-3002-77 bottles of 90 tablets NDC 0378-3002-05 bottles of 500 tablets The 32 mg/25 mg tablets are peach, mottled, round, scored tablets debossed with M on the left of the score and X on the right of the score on one side of the tablet and C3 on the other side of the tablet. They are available as follows: NDC 0378-3003-77 bottles of 90 tablets NDC 0378-3003-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep container tightly closed. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Hyderabad — 500 096, India 75076992 Revised: 8/2020 MX:CNDHTZ:R10
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