1 INDICATIONS AND USAGE Lisinopril tablet USP is an angiotensin converting enzyme (ACE) inhibitor indicated for: Treatment of hypertension in adults and pediatric patients 6 years of age and older ( 1.1 ) Adjunct therapy for heart failure ( 1.2 ) Treatment of Acute Myocardial Infarction ( 1.3 ) 1.1 hypertension Lisinopril tablet USP is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older 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. 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. Lisinopril tablets USP may be administered alone or with other antihypertensive agents [see CLINICAL STUDIES ( 14.1 )] . 1.2 heart failure Lisinopril tablet USP is indicated to reduce signs and symptoms of systolic heart failure [see CLINICAL STUDIES ( 14.2 )] . 1.3 Reduction of Mortality in Acute Myocardial Infarction Lisinopril tablet USP is indicated for the reduction of mortality in treatment of hemodynamically stable patients within 24 hours of Acute Myocardial Infarction. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers [see CLINICAL STUDIES ( 14.3 )].
lupin pharmaceuticals, inc.
16 HOW SUPPLIED/STORAGE AND HANDLING
LISINOPRIL tablet USP is available as uncoated biconvex tablets in bottles of below mentioned pack size Strength Color Shape scored Side 1 / Side 2 NDC 2.5 mg white to off-white round No LUPIN/2.5 Bottles of 90: 68180-512-09 Bottles of 100: 68180-512-01 Bottles of 500: 68180-512-02 Bottles of 1000: 68180-512-03 5 mg pink round Yes 5/breakline Bottles of 90: 68180-513-09 Bottles of 100: 68180-513-01 Bottles of 500: 68180-513-02 Bottles of 1000: 68180-513-03 Bottles of 5000: 68180-513-05 10 mg pink round No LUPIN/10 Bottles of 90: 68180-980-09 Bottles of 100: 68180-980-01 Bottles of 500: 68180-980-02 Bottles of 1000: 68180-980-03 Bottles of 5000: 68180-980-05 20 mg pink round No LUPIN/20 Bottles of 90: 68180-981-09 Bottles of 100: 68180-981-01 Bottles of 500: 68180-981-02 Bottles of 1000: 68180-981-03 Bottles of 5000: 68180-981-05 30 mg red round No LUPIN/30 Bottles of 90: 68180-982-09 Bottles of 100: 68180-982-01 Bottles of 500: 68180-982-02 Bottles of 1000: 68180-982-03 40 mg yellow round No LUPIN/40 Bottles of 90: 68180-517-09 Bottles of 100: 68180-517-01 Bottles of 500: 68180-517-02 Bottles of 1000: 68180-517-03 Bottles of 2000: 68180-517-04 Store at controlled room temperature, 20Â° to 25Â°C (68Â° to 77Â°F) [see USP]. Protect from moisture, freezing and excessive heat. Dispense in a tight container.
Lupin Pharmaceuticals, Inc.
Lupin Pharmaceuticals, Inc.
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