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lisinopril 40 mg

1.-INDICATIONS AND USAGE- Lisinopril 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 tablets are 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 offatal 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 pharmacologicclasses.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 thoseof 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 morbidityand 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 mostconsistent 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 severehypertension 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 patientswho 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 alower 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., onangina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.Lisinopril may be administered alone or with other antihypertensive agents [see Clinical Studies (14.1)]. 1.2 heart failure Lisinopril tablets are 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 tablets are 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)].

exelan pharmaceuticals, inc


1 year ago
OVAL YELLOW C57 lisinopril 40 mg

OVAL YELLOW C57

1 year ago
OVAL YELLOW C57 lisinopril 40 mg

C57 OVAL YELLOW

16 HOW SUPPLIED/STORAGE AND HANDLING 2.5 mg Tablets: white to off-white, round, unscored tablets, debossed with “C52” on one side and plain on other side are supplied in bottle of 30 tablets (NDC 76282-728-30), bottle of 45 tablets(NDC 76282-728-45), bottle of 90 tablets (NDC 76282-728-90), bottle of 100 tablets (NDC 76282-728-01), bottle of 180 tablets (NDC 76282-728-18), bottle of 500 tablets (NDC 76282-728-05) and 1000 tablets (NDC76282-728-10). 5 mg Tablets: Reddish brown colored, oval shaped tablets, debossed with bisect between “C” and “53” on one side and plain on other side are supplied in bottles of 30 tablets (NDC 76282-729-30), bottle of 45 tablets (NDC 76282-729-45), bottle of 90 tablets (NDC 76282-729-90), bottle of 100 tablets (NDC 76282-729-01), bottle of 180 tablets (NDC 76282-729-18), bottle of 500tablets (NDC 76282-729-05) and 1000 tablets (NDC 76282-729-10). 10 mg Tablets: Reddish brown colored, oval shaped, unscored tablets, debossed with “C54” on one side and plain on other side are supplied in bottles of 30 tablets (NDC 76282-730-30), bottleof 45 tablets (NDC 76282-730-45), bottle of 90 tablets (NDC 76282-730-90), bottle of 100 tablets (NDC 76282-730-01), bottle of 180 tablets (NDC 76282-730-18), bottle of 500 tablets (NDC76282-730-05), bottle of 1000 tablets (NDC 76282-730-10) and bottle of 5000 tablets (NDC 76282-730-50). 20 mg Tablets: Reddish brown colored, oval shaped, unscored tablets, debossed with “C55” on one side and plain on other side are supplied in bottles of 30 tablets (NDC 76282-731-30), bottleof 45 tablets (NDC 76282-731-45), bottle of 90 tablets (NDC 76282-731-90), bottle of 100 tablets (NDC 76282-731-01), bottle of 180 tablets (NDC 76282-731-18), bottle of 500 tablets (NDC76282-731-05), bottle of 1000 tablets (NDC 76282-731-10) and bottle of 5000 tablets (NDC 76282-731-50). 30 mg Tablets: Reddish brown colored, oval shaped, unscored tablets, debossed with “C56” on one side and plain on other side are supplied in bottles of 30 tablets (NDC 76282-732-30), bottleof 45 tablets (NDC 76282-732-45), bottle of 90 tablets (NDC 76282-732-90), bottle of 100 tablets (NDC 76282-732-01), bottle of 180 tablets (NDC 76282-732-18), bottle of 500 tablets (NDC76282-732-05) and 1000 tablets (NDC 76282-732-10). 40 mg Tablets: yellow colored, oval shaped, unscored tablets, debossed with “C57” on one side and plain on other side are supplied in bottles of 30 tablets (NDC 76282-733-30), bottle of 45tablets (NDC 76282-733-45), bottle of 90 tablets (NDC 76282-733-90), bottle of 100 tablets (NDC 76282-733-01), bottle of 180 tablets (NDC 76282-733-18), bottle of 500 tablets (NDC 76282-733-05) and 1000 tablets (NDC 76282-733-10).Store at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP]. Protect from moisture, freezing and excessive heat. Dispense in a tight container.


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