What is the most important information I should know about rosuvastatin?
Do not use rosuvastatin if you are pregnant. It could harm the unborn baby or cause birth defects.
You should not take rosuvastatin if you have liver disease, or if you breast-feeding a baby.
What is rosuvastatin?
Rosuvastatin is in a group of drugs called HMG CoA reductase inhibitors, or "statins." Rosuvastatin 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).
Rosuvastatin is used in adults and children who are at least 8 years old, to lower cholesterol and triglycerides (types of fat) in the blood and to slow the build-up of plaque (fatty deposits) in blood vessels.
Rosuvastatin is also used to lower the risk of stroke, heart attack, and other heart complications in certain people with diabetes, coronary heart disease, or other risk factors.
Rosuvastatin is also used to treat hereditary forms of high cholesterol, including the heterozygous type (inherited from one parent) and the homozygous type (inherited from both parents). For the heterozygous type, rosuvastatin can be used in children who are at least 8 years old. For the homozygous type, rosuvastatin can be used in children as young as 7 years old.
Rosuvastatin may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking rosuvastatin?
You should not take rosuvastatin if you are allergic to it, or if you have:
- liver disease; or
- if you are pregnant or breast-feeding.
Do not take rosuvastatin if you are pregnant. It could harm the unborn baby or cause birth defects. Stop taking rosuvastatin and tell your doctor right away if you become pregnant. Use effective birth control to prevent pregnancy while you are taking rosuvastatin.
Rosuvastatin may pass into breast milk and could harm a nursing baby. Do not breast-feed while you are taking rosuvastatin.
To make sure rosuvastatin is safe for you, tell your doctor if you have ever had:
- liver disease;
- kidney disease;
- diabetes;
- a thyroid disorder;
- if you drink more than 2 alcoholic beverages daily;
- if you are of Asian descent; or
- if you are 65 or older.
Rosuvastatin 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).
People of Asian descent may absorb rosuvastatin at a higher rate than other people. Make sure your doctor knows if you are Asian. You may need a lower than normal starting dose.
How should I take rosuvastatin?
Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Rosuvastatin is usually taken once a day, with or without food. Take the medicine at the same time each day.
While using rosuvastatin, you may need frequent blood tests.
Keep using this medicine as directed, even if you feel well. High cholesterol usually has no symptoms. You may need to take rosuvastatin on a long-term basis.
You may need to stop using rosuvastatin 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;
- dehydration; or
- surgery or a medical emergency.
You should not stop using rosuvastatin unless your doctor tells you to.
Rosuvastatin is only part of a 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 happens if I miss a dose?
Take the missed dose as soon as you remember. If you are more than 12 hours late, skip the missed dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking rosuvastatin?
Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.
Avoid using antacids without your doctor's advice. Use only the type of antacid your doctor recommends, and do not take it within 2 hours after taking rosuvastatin. Some antacids can make it harder for your body to absorb rosuvastatin.
Avoid eating foods that are high in fat or cholesterol. Rosuvastatin will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.
What are the possible side effects of rosuvastatin?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
In rare cases, rosuvastatin 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 fever, unusual tiredness, and dark colored urine.
Also call your doctor at once if you have:
- confusion, memory problems;
-
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 kidney problem --little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath.
Common side effects may include:
- liver symptoms (stomach pain, dark urine, jaundice);
- unusual weakness or tired feeling;
- headache, muscle aches; or
- nausea, 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.
What other drugs will affect rosuvastatin?
Using certain other drugs together with rosuvastatin can increase your risk of serious muscle problems. It is very important to tell your doctor about all medicines you use, and those you start or stop using during your treatment with rosuvastatin, especially:
- colchicine;
- cyclosporine;
-
another "statin" medicine --atorvastatin, lovastatin, simvastatin, Lipitor, Pravachol, Zocor, Vytorin, and others;
-
antifungal medicine --fluconazole, itraconazole, ketoconazole;
-
antiviral medicine to treat HIV or hepatitis C --atazanavir, fosamprenavir, lopinavir, ritonavir, simeprevir, tipranavir, and others;
-
a blood thinner --warfarin, Coumadin, Jantoven;
-
other cholesterol medications --fenofibrate, gemfibrozil; or
-
medicines that contain niacin or nicotinic acid --vitamin B3, Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others.
This list is not complete. Other drugs may interact with rosuvastatin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Where can I get more information?
Your pharmacist can provide more information about rosuvastatin.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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