Indication: Warfarin sodium tablets are indicated for: Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE). Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement. Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. Limitations of Use Warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. Once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae. Warfarin sodium tablets are a vitamin K antagonist indicated for: Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism ( 1 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement ( 1 Reduction in the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction ( 1 Limitations of Use Warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage.

Indication: Warfarin sodium tablets are indicated for: Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE). Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement. Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. Limitations of Use Warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. Once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae. Warfarin sodium tablets are a vitamin K antagonist indicated for: Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism ( 1 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement ( 1 Reduction in the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction ( 1 Limitations of Use Warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage.

Indication: INDICATIONS AND USAGE
Atorvastatin calcium tablets are indicated: To reduce the risk of: As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: 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: Atorvastatin calcium tablets are an HMG-CoA reductase inhibitor (statin) indicated (1): To reduce the risk of: As an adjunct to diet to reduce low-density lipoprotein (LDL-C) in: 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:.
SPL PATIENT PACKAGE INSERT
PATIENT INFORMATION Atorvastatin Calcium Tablets, USP What are Atorvastatin Calcium Tablets? to reduce the risk of: heart attack, stroke, certain types of heart surgery and chest pain in adults who do not have heart disease but have other multiple risk factors for heart disease. heart attack and stroke in adults with type 2 diabetes mellitus who do not have heart disease but have other multiple risk factors. heart attack that does not cause death, stroke, certain types of heart surgery, hospitalization for congestive heart failure, and chest pain in adults with heart disease. along with diet to reduce low density lipoprotein cholesterol (LDL-C) or bad cholesterol: in adults with primary hyperlipidemia. in adults and children aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). This is an inherited condition that causes high levels of bad cholesterol. along with other cholesterol lowering treatments or alone if such treatments are unavailable in adults and children aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). This is an inherited condition that causes high levels of bad cholesterol. along with diet for the treatment of adults with: primary dysbetalipoproteinemia (an inherited condition that causes high levels of cholesterol and fat). hypertriglyceridemia. Do not take atorvastatin calcium tablets if you: have liver problems (acute liver failure or decompensated cirrhosis) are allergic to atorvastatin or any of the ingredients in atorvastatin calcium tablets. Stop using atorvastatin calcium tablets and get medical help right away if you have symptoms of a serious allergic reaction including: swelling of your face, lips, tongue or throat problems breathing or swallowing fainting or feeling dizzy very rapid heartbeat severe skin rash or itching flu-like symptoms including fever, sore throat, cough, tiredness, and joint pain Before you take atorvastatin calcium tablets, tell your healthcare provider about all of your medical conditions, including if you: have unexplained muscle aches or weakness drink more than 2 glasses of alcohol daily have diabetes have thyroid problems have kidney problems had a stroke are pregnant or plan to become pregnant. Atorvastatin calcium tablets may harm your unborn baby. If you become pregnant, stop taking atorvastatin calcium tablets and call your healthcare provider right away. are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take atorvastatin calcium tablets or breastfeed. You should not do both. Talk to your healthcare provider about the best way to feed your baby if you take atorvastatin calcium tablets. Tell your healthcare provider about all the medicines you take, your immune system (cyclosporine) cholesterol (gemfibrozil) infections (erythromycin, clarithromycin, itraconazole, ketoconazole, posaconazole, and voriconazole) birth control pills heart failure (digoxin) gout (colchicine) niacin fibrates treating HIV, AIDS, or hepatitis C (anti-virals) tipranavir plus ritonavir glecaprevir plus pibrentasvir ledipasvir plus sofosbuvir simeprevir saquinavir plus ritonavir darunavir plus ritonavir fosamprenavir fosamprenavir plus ritonavir elbasvir plus grazoprevir letermovir nelfinavir Ask your healthcare provider or pharmacist for a list of medicines if you are not sure. Know all the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I take atorvastatin calcium tablets? Take atorvastatin calcium tablets exactly as your healthcare provider tells you to take it. Do not change your dose or stop atorvastatin calcium tablets without talking to your healthcare provider. Your healthcare provider may do blood tests to check your cholesterol levels during your treatment with atorvastatin calcium tablets. Your dose of atorvastatin calcium tablets may be changed based on these blood test results. Take atorvastatin calcium tablets each day at any time of day. Atorvastatin calcium tablets can be taken with or without food. Your healthcare provider may start you on a cholesterol lowering diet before giving you atorvastatin calcium tablets. Stay on this low-fat diet when you take atorvastatin calcium tablets. If you miss a dose of atorvastatin calcium tablets, wait and take the next dose at your regular time. Do not take 2 doses of atorvastatin calcium tablets at the same time. If you take too much atorvastatin calcium tablets or overdose, call your healthcare provider or Poison Control Center at 1-800-222-1222 or go to the nearest emergency room right away. What should I avoid while taking atorvastatin calcium tablets? Avoid drinking more than 1.2 liters of grapefruit juice each day. What are the possible side effects of atorvastatin calcium tablets? Atorvastatin calcium tablets may cause serious side effects including: Muscle pain, tenderness and weakness (myopathy). Tell your healthcare provider right away if you have: unexplained muscle pain, tenderness, or weakness, especially if you also have a fever or feel more tired than usual while you take atorvastatin calcium tablets. muscle problems that do not go away after your healthcare provider has told you to stop taking atorvastatin calcium tablets. Your healthcare provider may do further tests to diagnose the cause of your muscle problems. Your chances of getting muscle problems are higher if you: are taking certain other medicines while you take atorvastatin calcium tablets drink large amounts of grapefruit juice are 65 years of age or older have thyroid problems (hypothyroidism) that are not controlled have kidney problems are taking higher doses of atorvastatin calcium tablets Liver problems. feel tired or weak nausea or vomiting loss of appetite upper belly pain dark amber colored urine yellowing of your skin or the whites of your eyes Increase in blood sugar level. The most common side effects of atorvastatin calcium tablets include: nasal congestion, sore throat, runny nose muscle and joint pain diarrhea pain in extremity urinary tract infection upset stomach nausea musculoskeletal pain muscle spasms trouble sleeping throat pain Talk to your healthcare provider or pharmacist if you have side effects that bother you or that will not go away. These are not all the side effects of atorvastatin calcium tablets. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How do I store Atorvastatin Calcium Tablets Store atorvastatin calcium tablets at room temperature, 68°F to 77°F (20°C to 25°C). Bottles of 30''s and 90''s comes with a child-resistant closure. Do not keep medicine that is out of date or that you no longer need. Keep atorvastatin calcium tablets and all medicines out of the reach of children. General information about the safe and effective use of atorvastatin calcium tablets. What are the ingredients in Atorvastatin Calcium Tablets? Active Ingredient: Inactive Ingredients: Revised:

Indication: Aspirin and extended-release dipyridamole capsules are a combination antiplatelet agent indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis ( 1 Aspirin and extended-release dipyridamole capsules are indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis.

Indication: Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet. Atorvastatin calcium tablets are an HMG-CoA reductase inhibitor indicated as an adjunct therapy to diet to: Reduce the risk of MI, stroke, revascularization procedures, and angina in adult patients without CHD, but with multiple risk factors ( 1. 1 Reduce the risk of MI and stroke in adult patients with type 2 diabetes without CHD, but with multiple risk factors ( 1. 1 Reduce the risk of non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for CHF, and angina in adult patients with CHD ( 1. 1 Reduce elevated total-C, LDL-C, apo B, and TG levels and increase HDL-C in adult patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia ( 1. 2 Reduce elevated TG in adult patients with hypertriglyceridemia and primary dysbetalipoproteinemia ( 1. 2 Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) ( 1. 2 Reduce elevated total-C, LDL-C, and apo B levels in pediatric patients, 10 years to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) after failing an adequate trial of diet therapy ( 1. 2 Limitations of Use: Atorvastatin calcium tablets have not been studied in Fredrickson 1. 3 In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, atorvastatin calcium tablets are indicated to: Reduce the risk of myocardial infarction Reduce the risk of stroke Reduce the risk for revascularization procedures and angina In adult patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, atorvastatin calcium tablets are indicated to: Reduce the risk of myocardial infarction Reduce the risk of stroke In adult patients with clinically evident coronary heart disease, atorvastatin calcium tablets are indicated to: Reduce the risk of non-fatal myocardial infarction Reduce the risk of fatal and non-fatal stroke Reduce the risk for revascularization procedures Reduce the risk of hospitalization for CHF Reduce the risk of angina Atorvastatin calcium tablets are indicated: As an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase HDL-C in adult patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia ( Fredrickson As an adjunct to diet for the treatment of adult patients with elevated serum TG levels ( Fredrickson For the treatment of adult patients with primary dysbetalipoproteinemia ( Fredrickson To reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) as an adjunct to other lipid-lowering treatments (e. , LDL apheresis) or if such treatments are unavailable; As an adjunct to diet to reduce total-C, LDL-C, and apo B levels in pediatric patients,10 years to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) if after an adequate trial of diet therapy the following findings are present: LDL-C remains >= 190 mg/dL or LDL-C remains >= 160 mg/dL and: there is a positive family history of premature cardiovascular disease or two or more other CVD risk factors are present in the pediatric patient Atorvastatin calcium tablets have not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons ( Fredrickson.