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amlodipine and atorvastatin tablet film coated

1 INDICATIONS AND USAGE Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine Hypertension Amlodipine is 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. 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 may be used alone or in combination with other antihypertensive agents. Coronary Artery Disease (CAD) Chronic Stable Angina Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal’s or Variant Angina) Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine 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 is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure. Atorvastatin Atorvastatin is indicated: To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).As an adjunct to other LDL-C lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia Amlodipine and atorvastatin tablets are a combination of amlodipine besylate, a calcium channel blocker, and atorvastatin calcium, a HMG CoA-reductase inhibitor, indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine is 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. Amlodipine is indicated for the treatment of Coronary Artery Disease ( 1 ). Atorvastatin is indicated (1): To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C lowering therapies to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia. As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia.

apotex corp.


4 years ago OVAL BLUE APO 10 20 amlodipine and atorvastatin tablet film coated

OVAL BLUE APO 10 20

16 HOW SUPPLIED/STORAGE AND HANDLING

AMLODIPINE AND ATORVASTATIN tablets, USP contain amlodipine besylate and atorvastatin calcium, in the form of propylene glycol solvate, equivalent to

AMLODIPINE AND ATORVASTATIN in the dose strengths described below.

AMLODIPINE AND ATORVASTATIN tablets, USP 5 mg/10 mg are white to off-white, oval, biconvex, film-coated tablets, engraved "5/10" on one side, "APO" on the other side. They are supplied as follows: NDC 60505-3478-3 Bottles of 30 with child-resistant closure

AMLODIPINE AND ATORVASTATIN tablets, USP 5 mg/20 mg are white to off-white, oval, biconvex, film-coated tablets, engraved "5/20" on one side, "APO" on the other side. They are supplied as follows: NDC 60505-3483-3 Bottles of 30 with child-resistant closure

AMLODIPINE AND ATORVASTATIN tablets, USP 5 mg/40 mg are white to off-white, oval, biconvex, film-coated tablets, engraved "5/40" on one side, "APO" on the other side. They are supplied as follows: NDC 60505-3488-3 Bottles of 30 with child-resistant closure

AMLODIPINE AND ATORVASTATIN tablets, USP 5 mg/80 mg are white to off-white, oval, biconvex, film-coated tablets, engraved "5/80" on one side, "APO" on the other side. They are supplied as follows: NDC 60505-3492-3 Bottles of 30 with child-resistant closure

AMLODIPINE AND ATORVASTATIN tablets, USP 10 mg/10 mg are light blue, oval, biconvex, film-coated tablets, engraved "10/10" on one side, "APO" on the other side. They are supplied as follows: NDC 60505-3479-3 Bottles of 30 with child-resistant closure

AMLODIPINE AND ATORVASTATIN tablets, USP 10 mg/20 mg are light blue, oval, biconvex, film-coated tablets, engraved "10/20" on one side, "APO" on the other side. They are supplied as follows: NDC 60505-3484-3 Bottles of 30 with child-resistant closure

AMLODIPINE AND ATORVASTATIN tablets, USP 10 mg/40 mg are light blue, oval, biconvex, film-coated tablets, engraved "10/40" on one side, "APO" on the other side. They are supplied as follows: NDC 60505-3489-3 Bottles of 30 with child-resistant closure

AMLODIPINE AND ATORVASTATIN tablets, USP 10 mg/80 mg are light blue, oval, biconvex, film-coated tablets, engraved "10/80" on one side, "APO" on the other side. They are supplied as follows: NDC 60505-3493-3 Bottles of 30 with child-resistant closure Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.


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