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Atenolol 50 MG Chlorthalidone 25 MG Oral Tablet

INDICATIONS AND USAGE Atenolol and chlorthalidone tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers 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 atenolol and chlorthalidone. 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 1 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 drug is not indicated for initial therapy of hypertension. If the fixed dose combination represents the dose appropriate to the individual patient's needs, it may be more convenient than the separate components.

Zydus Pharmaceuticals (USA) Inc.


4 years ago ROUND WHITE 11 67 Atenolol 50 MG  Chlorthalidone 25 MG Oral Tablet

ROUND WHITE 11 67

HOW SUPPLIED

ATENOLOL AND CHLORTHALIDONE Tablets, USP are uncoated tablets.

ATENOLOL AND CHLORTHALIDONE Tablets USP, 50 mg/25 mg are white to off white, round, biconvex, bevelled tablets, with debossing of '11' above breakline and '67' below breakline on one side and plain on the other side and are supplied as follows: NDC 70710-1167-1 in bottle of 100 tablets with child-resistant closure

ATENOLOL AND CHLORTHALIDONE Tablets USP, 100 mg/25 mg are white to off white, round, biconvex, beveled tablets, with debossing of '11' over '68' on one side and plain on the other side and are supplied as follows: NDC 70710-1168-1 in bottle of 100 tablets with child-resistant closure Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in well-closed, light-resistant containers. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please address medical inquiries to, MedicalAffairs@zydususa.com or Tel.: 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


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