What is the most important information I should know about simvastatin?
You should not take simvastatin if you are pregnant or breast-feeding, or if you have active liver disease.
Some medicines can cause unwanted or dangerous effects when used with simvastatin. Your doctor may need to change your treatment plan if you use certain antibiotics or antifungal medicines, hepatitis C medication, heart medication, or medicines to treat HIV/AIDS.
Stop taking this medication and tell your doctor right away if you become pregnant.
What is simvastatin?
Simvastatin is in a group of drugs called HMG CoA reductase inhibitors, or "statins." Simvastatin 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).
Simvastatin is used to lower cholesterol and triglycerides (types of fat) in the blood.
Simvastatin is also used to lower the risk of stroke, heart attack, and other heart complications in people with diabetes, coronary heart disease, or other risk factors.
Simvastatin is used in adults and children who are at least 10 years old.
Simvastatin may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking simvastatin?
You should not take simvastatin if you are allergic to it, if you are pregnant or breast-feeding, or if you have active liver disease.
The following drugs can increase your risk of serious muscle problems if you take them together with simvastatin. These drugs should not be used while you are taking simvastatin:
- cyclosporine;
- danazol;
- gemfibrozil;
- nefazodone;
- an antibiotic--clarithromycin, erythromycin, telithromycin;
- antifungal medication--itraconazole, ketoconazole, posaconazole, voriconazole;
- hepatitis C medications--boceprevir, telaprevir; or
- HIV/AIDS medication--atazanavir, cobicistat (Stribild, Tybost), darunavir, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir, tipranavir.
Before you start taking simvastatin, tell your doctor if you are already using any of these other medicines:
- lomitapide; or
- heart medication--amiodarone, amlodipine, diltiazem, dronedarone, ranolazine, verapamil.
To make sure simvastatin is safe for you, tell your doctor if you have:
- history of liver disease;
- history of kidney disease;
- diabetes;
- a thyroid disorder; or
- if you drink more than 2 alcoholic beverages daily.
Simvastatin 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).
FDA pregnancy category X. This medicine can harm an unborn baby or cause birth defects. Do not take simvastatin if you are pregnant.
Stop taking this medication and tell your doctor right away if you become pregnant. Use effective birth control to avoid pregnancy while you are taking simvastatin.
Simvastatin may pass into breast milk and could harm a nursing baby. Do not breast-feed while you are taking simvastatin.
How should I take simvastatin?
Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed. Taking too much of this medication may cause serious or life-threatening side effects.
Simvastatin is usually taken at bedtime or with an evening meal. If you take simvastatin more than once daily, take it with meals. Your doctor may occasionally change your dose to make sure you get the best results.
While using simvastatin, you may need frequent blood tests at your doctor's office.
You may need to take simvastatin on a long-term basis for the treatment of high cholesterol. You may need to stop using simvastatin for a short time if you have surgery or a medical emergency. Do not stop taking this medicine unless your doctor tells you to.
Simvastatin 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.
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. Skip the missed dose if it is almost time for your next scheduled 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 simvastatin?
Grapefruit and grapefruit juice may interact with simvastatin and lead to unwanted side effects. Avoid the use of grapefruit products while taking simvastatin.
Avoid eating foods that are high in fat or cholesterol. Simvastatin 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.
What are the possible side effects of simvastatin?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
In rare cases, simvastatin 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:
-
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; or
-
liver problems --nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common side effects may include:
- headache;
- constipation, nausea, stomach pain; or
- cold symptoms such as stuffy nose, sneezing, sore throat.
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 simvastatin?
Many drugs can interact with simvastatin. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with simvastatin, especially:
- delavirdine;
- fenofibrate; or
- fluconazole.
This list is not complete and many other drugs can interact with simvastatin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.
Where can I get more information?
Your pharmacist can provide more information about simvastatin.
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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