ROSUVASTATIN

INDICATIONS

Rosuvastatin is used for lowering high cholesterol and triglycerides in certain patients. It also increases high-density lipoprotein (HDL, “good”) cholesterol levels. It is also used to slow atherosclerosis (narrowing of the arteries) in patients with high blood cholesterol levels. It is used along with an appropriate diet. Rosuvastatin is an HMG-CoA reductase inhibitor, also known as a “statin.” It works by reducing the production of certain fatty substances in the body, including cholesterol.

INSTRUCTIONS 

Use Rosuvastatin as directed by your doctor.

• Take Rosuvastatin by mouth with or without food.
• If you also take an antacid that has aluminum or magnesium in it, take it at least 2 hours after taking Rosuvastatin. Check with your doctor if you have any questions.
• Continue to take Rosuvastatin even if you feel well. Do not miss any dose.
• If you miss a dose of Rosuvastatin, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Rosuvastatin.

STORAGE

 Store Rosuvastatin at room temperature, between 68 and 77 degrees F (20 to 25 degrees C). Store away from heat, moisture, and light. Keep Rosuvastatin out of the reach of children and away from pets.

Do NOT use Rosuvastatin if:

• you are allergic to any ingredient in Rosuvastatin
• you have liver problems or unexplained abnormal liver function tests
• you are pregnant or breast-feeding
• you are taking itraconazole, mibefradil, or telithromycin.

Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Rosuvastatin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are planning to become pregnant
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have low blood pressure, a serious infection, kidney problems, an underactive thyroid, diabetes, or a history of seizures
• if you are dehydrated or have certain muscle problems (eg, pain, weakness); have increased creatine phosphokinase (CPK) blood levels; or have metabolism, hormonal, or electrolyte problems
• if you are on dialysis
• if you drink alcohol or have a history of liver problems or alcohol abuse
• if you have had an organ transplant or have recently had major surgery or a serious injury.

Some medicines may interact with Rosuvastatin. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Fibrates (eg, gemfibrozil, clofibrate), immunosuppressants (eg, cyclosporine), lopinavir/ritonavir, or niacin because they may increase the risk of muscle or kidney problems
• Anticoagulants (eg, warfarin), cimetidine, ketoconazole, macrolide immunosuppressants (eg, tacrolimus), or spironolactone because the risk of their side effects may be increased by Rosuvastatin.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Rosuvastatin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

• Rosuvastatin may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Rosuvastatin with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
• Drinking alcohol daily or in large amounts may increase the risk of liver problems with Rosuvastatin. Check with your doctor before drinking alcohol while you are taking Rosuvastatin.
• Follow the diet and exercise program given to you by your health care provider.
• Tell your doctor or dentist that you take Rosuvastatin before you receive any medical or dental care, emergency care, or surgery.
• Women who may become pregnant should use effective birth control while taking Rosuvastatin. Check with your doctor if you have questions about using birth control.
• Do NOT take more than the recommended dose without checking with your doctor.
• Report any unexplained muscle pain, tenderness, or weakness to your doctor right away, especially if you also have a fever or general body discomfort.
• Lab tests, including blood cholesterol levels, liver function, kidney function, and creatine phosphokinase (CPK) blood levels, may be performed while you use Rosuvastatin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Rosuvastatin with caution in Asian patients and elderly patients; they may be more sensitive to its effects, especially serious muscle problems (eg, muscle pain, tenderness, or weakness).
• Rosuvastatin should be used with extreme caution in children; safety and effectiveness in children have not been confirmed.
• Pregnancy and breast-feeding: Do not use Rosuvastatin if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Rosuvastatin is found in breast milk. Do not breastfeed while taking Rosuvastatin.

All medicines may cause side effects, but many people have no, or minor, side effects.

Check with your doctor if any of these most common side effectspersist or become bothersome:

Constipation; sore throat.

Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; dark urine; joint pain; muscle pain, tenderness, or weakness (with or without fever or fatigue); pale stools; severe or persistent headache; stomach pain; swelling of the hands, ankles, or feet; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.