1 INDICATIONS AND USAGE Amlodipine besylate tablets are calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: â€¢Hypertension ( 1.1 ) Ð¾ Amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. â€¢Coronary Artery Disease ( 1.2 ) Ð¾ Chronic Stable Angina Ð¾ Vasospastic Angina (Prinzmetal's or Variant Angina) Ð¾ Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40% 1.1 Hypertension Amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal 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 amlodipine besylate. 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. Amlodipine besylate tablets may be used alone or in combination with other antihypertensive agents. 1.2 Coronary Artery Disease (CAD) Chronic Stable Angina Amlodipine besylate tablets are indicated for the symptomatic treatment of chronic stable angina. Amlodipine besylate tablets may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal's or Variant Angina) Amlodipine besylate tablets are indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine besylate tablets may be used as monotherapy or in combination with other antianginal agents. Angiographically Documented CAD In patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, amlodipine besylate tablets are indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure.
lupin pharmaceuticals, inc.
16 HOW SUPPLIED/STORAGE AND HANDLING 2.5 mg Tablets
AMLODIPINE BESYLATE Tablets USP, 2.5 mg â€“ (
AMLODIPINE BESYLATE equivalent to 2.5 mg of amlodipine per tablet) are supplied as pink color mottled, round, flat-faced, beveled edged tablets debossed with "L" on one side and "28" on the other side and supplied as follows: NDC 68180-719-09 Bottles of 90 NDC 68180-719-03 Bottles of 1000 5 mg Tablets
AMLODIPINE BESYLATE Tablets USP, 5 mg â€“ (
AMLODIPINE BESYLATE equivalent to 5 mg of amlodipine per tablet) are supplied as white to off white capsule shaped tablets debossed with "L" on one side and "29" on the other side and supplied as follows: NDC 68180-720-09 Bottles of 90 NDC 68180-720-03 Bottles of 1000 10 mg Tablets
AMLODIPINE BESYLATE Tablets USP, 10 mg â€“ (
AMLODIPINE BESYLATE equivalent to 10 mg of amlodipine per tablet) are supplied as white to off white round, flat faced, beveled edged tablet debossed with "L" on one side and "32" on the other side and supplied as follows: NDC 68180-721-09 Bottles of 90 NDC 68180-721-03 Bottles of 1000 Storage Store at 20Â° to 25Â°C (68Â° to 77Â°F) [See USP Controlled Room Temperature] and dispense in tight, light-resistant containers (USP). Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States MADE IN INDIA. Revised: February 2022
Lupin Pharmaceuticals, Inc.
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