Product Description

LIPVAS 40 MG (ATORVASTATIN)

WHAT IS LIPVAS 40 MG (ATORVASTATIN)?

Lipvas (atorvastatin) belongs to a group of drugs called HMG CoA reductase inhibitors, or “statins.” Atorvastatin reduces levels of “bad” cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood while increasing levels of “good” cholesterol (high-density lipoprotein, or HDL). Lipvas is used to treat high cholesterol, and to lower the risk of stroke, heart attack, or other heart complications in people with type 2 diabetes, coronary heart disease, or other risk factors. Lipvas is for use in adults and children who are at least 10 years old.

WHAT IS IMPORTANT INFORMATION FOR LIPVAS 40 MG (ATORVASTATIN)?

You should not take Lipvas if you are pregnant or breastfeeding, or if you have liver disease.

STOP TAKING LIPVAS AND TELL YOUR DOCTOR RIGHT AWAY IF YOU BECOME PREGNANT.

Serious drug interactions can occur when certain medicines are used together with Lipvas. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using. In rare cases, atorvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have a fever, unusual tiredness, and dark-colored urine. Avoid eating foods that are high in fat or cholesterol. Lipvas will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan. Lipvas is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

BEFORE TAKING THIS MEDICINE LIPVAS 40 MG (ATORVASTATIN)

You should not use Lipvas if you are allergic to atorvastatin, or if you have: liver disease; or if you are pregnant or breastfeeding. To make sure Lipvas is safe for you, tell your doctor if you have: muscle pain or weakness; history of liver disease; history of kidney disease; history of stroke (including TIA or “mini-stroke”); a thyroid disorder; or if you drink more than 2 alcoholic beverages daily. Lipvas can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).

This medicine can harm an unborn baby or cause birth defects. Do not use it if you are pregnant. Stop taking Lipvas and tell your doctor right away if you become pregnant Use effective birth control to prevent pregnancy while you are taking this medicine. Atorvastatin may pass into breast milk and could harm a nursing baby. Do not breastfeed while you are taking Lipvas. Atorvastatin is not approved for use by anyone younger than 10 years old.

HOW SHOULD I TAKE LIPVAS 40 MG (ATORVASTATIN)?

Take Lipvas exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended. Lipvas is usually taken once a day, with or without food. Take the medicine at the same time each day. Do not break a Lipvas tablet before taking it. You may need to stop using this medicine for a short time if you have: uncontrolled seizures; an electrolyte imbalance (such as high or low potassium levels in your blood); severely low blood pressure; a severe infection or illness; or surgery or a medical emergency. While using Lipvas, you may need frequent blood tests. Lipvas is only part of a complete treatment program that may also include diet, exercise, and weight control. Follow your doctor’s instructions very closely. Store at room temperature away from moisture, heat, and light.

WHAT IS DOSING INFORMATION FOR LIPVAS 40 MG (ATORVASTATIN)?

Usual Adult Dose for Prevention of Cardiovascular Disease: Initial dose: 10 mg to 80 mg orally once a day. The initial dosage of Lipvas recommended for this patient in the prevention of cardiovascular disease is 10 mg to 80 mg orally once a day. The lipid may be administered at any time of the day without regard for meals.

Dose adjustments should be made at intervals of 2 to 4 weeks. Studies have demonstrated that treatment with atorvastatin is associated with significant reductions in the risk of cardiovascular endpoints and stroke in various patient populations for both primary and secondary prevention.

For primary prevention, atorvastatin treatment was effective in hypertensive patients with normal or mildly elevated cholesterol levels as well as in patients with type II diabetes. Patients had relatively low cholesterol levels at baseline in both trials; however, treatment with atorvastatin still resulted in significant reductions in cardiovascular outcomes and stroke.

For secondary prevention, intensive lipid-lowering therapy with atorvastatin 80 mg/day was associated with a significant incremental clinical benefit beyond therapy with 10 mg/day in patients with stable coronary heart disease. It was also shown to significantly reduce the risk of clinical outcomes in coronary heart disease patients versus usual medical care.

USUAL ADULT DOSE OF LIPVAS 40 MG (ATORVASTATIN)FOR HYPERLIPIDEMIA:

Initial dose: 10, 20, or 40 mg orally once a day. The 40 mg starting dose is recommended for patients who require a reduction in LDL cholesterol of more than 45%. Dose adjustments should be made at intervals of 2 to 4 weeks. Maintenance dose: 10 to 80 mg orally once a day.

USUAL PEDIATRIC DOSE FOR HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA:

10 to 17 years: 10 mg per day (max dose is 20 mg per day). Adjustments should be made at intervals of 4 weeks or more.

WHAT HAPPENS IF I MISS A DOSE FOR LIPVAS 40 MG (ATORVASTATIN)?

Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 12 hours away. Do not take extra medicine to make up for the missed dose.

WHAT HAPPENS IF I OVERDOSE FOR LIPVAS 40 MG (ATORVASTATIN)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

WHAT SHOULD I AVOID WHILE TAKING LIPVAS 40 MG (ATORVASTATIN)?

Avoid eating foods that are high in fat or cholesterol. The lipid will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan. Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage. Grapefruit and grapefruit juice may interact with atorvastatin and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

WHAT IS SIDE EFFECTS FOR LIPVAS 40 MG (ATORVASTATIN)?

Get emergency medical help if you have signs of an allergic reaction to Lipvas: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. In rare cases, Lipvas can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have a fever, unusual tiredness, and dark-colored urine. Also, call your doctor at once if you have: kidney problems – little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; liver problems – nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or signs of a stroke – sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance. Common Lipvas side effects may include muscle or joint pain; diarrhea; or upset stomach. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. See also: Side effects (in more detail)

WHAT OTHER DRUGS WILL AFFECT LIPVAS 40 MG (ATORVASTATIN)?

Certain other drugs can increase your risk of serious muscle problems, and it is very important that your doctor knows if you are using any of them. Tell your doctor about all your current medicines and any you start or stop using, especially: antibiotic or antifungal medicine; birth control pills; cholesterol-lowering medication; heart medication; or medicine to treat HIV or AIDS.