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AHLA BHAL TALLI
IVAX PHARMACEUTICALS Sr.o
Generic Name: simvastatin (SIM va sta tin)
Simvastatin is in a group of drugs called HMG CoA reductase inhibitors, or "statins." It 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 other purposes not listed in this medication guide.
Important information about simvastatin
You should not take simvastatin if you are allergic to it, if you are pregnant or breast-feeding, or if you have liver disease. Stop taking this medication and tell your doctor right away if you become pregnant.
Before taking simvastatin, tell your doctor if you have ever had liver or kidney disease, diabetes, or a thyroid disorder, if you are of Chinese descent, or if you drink more than 2 alcoholic beverages daily.
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.
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.
There are many other drugs that can increase your risk of serious medical problems if you take them together with simvastatin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.
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.
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 liver disease.
If you have any of these other conditions, you may need a dose adjustment or special tests:
history of liver disease;
history of kidney disease;
· a thyroid disorder; or
· if you drink more than 2 alcoholic beverages daily.
In rare cases, 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). You may also be more likely to develop this condition if you are of Chinese descent and you take high-dose simvastatin while also taking medication that contains niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others).
Tell your doctor about all other medications you use. 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:
· amiodarone (Cordarone, Pacerone);
· danazol (Danocrine);
· nefazodone (an antidepressant);
· gemfibrozil (Lopid), fenofibric acid (Fibricor, Trilipix), or fenofibrate (Antara, Fenoglide, Lipofen, Lofibra, Tricor, Triglide);
· antibiotics such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);
· antifungal medications such as fluconazole (Diflucan), itraconazole (Sporanox), or ketoconazole (Extina, Ketozole, Nizoral, Xolegal);
· heart or blood pressure medication such as diltiazem (Cartia, Cardizem) or verapamil (Calan, Covera, Isoptin, Verelan);
· HIV medications such as atazanavir (Reyataz), ritonavir (Norvir), lopinavir/ritonavir (Kaletra), saquinavir (Invirase), and others;
· medicines that contain niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others); or
· drugs that weaken your immune system, such as steroids, cancer medicine, or medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), or tacrolimus (Prograf).
FDA pregnancy category X. Simvastatin can harm an unborn baby or cause birth defects. Do not take this medicine if you are pregnant. Stop taking simvastatin and tell your doctor right away if you become pregnant. Use effective birth control to avoid pregnancy while you are taking this medicine. Simvastatin may pass into breast milk and could harm a nursing baby. Do not breast-feed while you are taking simvastatin.
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