candesartan cilexetil 8 mg
1 INDICATIONS AND USAGE Candesartan cilexetil tablets are an angiotensin II receptor blocker (ARB) indicated for: · Treatment of hypertension in adults and children 1 to <17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions (1.1). · Treatment of heart failure (NYHA class II-IV); candesartan cilexetil tablets reduces cardiovascular death and heart failure hospitalization (1.2). 1.1 Hypertension Candesartan cilexetil tablets are indicated for the treatment of hypertension in adults and in children 1 to <17 years of age, 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. 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. Candesartan cilexetil tablets may be used alone or in combination with other antihypertensive agents. 1.2 Heart Failure Candesartan cilexetil tablets are indicated for the treatment of heart failure (NYHA class II-IV) in adults with left ventricular systolic dysfunction (ejection fraction ≤40%) to reduce cardiovascular death and to reduce heart failure hospitalizations [see Clinical Studies (14.2)] . Candesartan cilexetil tablets also have an added effect on these outcomes when used with an ACE inhibitor [see Drug Interactions (7.4)].
Alembic Pharmaceuticals Inc.
ROUND PINK L169
L169 ROUND PINK
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16 HOW SUPPLIED/STORAGE AND HANDLING
CANDESARtan CILEXETIL tablets USP, 4 mg are white to off-white, round, biconvex, uncoated tablets debossed with ‘L168’ on one side and scoring on other side. They are supplied as follows: NDC 62332-341-30 Bottle of 30 tablets NDC 62332-341-90 Bottle of 90 tablets NDC 62332-341-91 Bottle of 1000 tablets
CANDESARtan CILEXETIL tablets USP, 8 mg are light pink, round, biconvex, uncoated mottled tablets debossed with ‘L169’ on one side and scoring on other side. They are supplied as follows: NDC 62332-342-30 Bottle of 30 tablets NDC 62332-342-90 Bottle of 90 tablets NDC 62332-342-91 Bottle of 1000 tablets
CANDESARtan CILEXETIL tablets USP, 16 mg are pink, round, biconvex, uncoated mottled tablets debossed with ‘L170’ on one side and scoring on other side. They are supplied as follows: NDC 62332-343-30 Bottle of 30 tablets NDC 62332-343-90 Bottle of 90 tablets NDC 62332-343-91 Bottle of 1000 tablets Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed.
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