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Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Your doctor will need to check your liver before you start using this medicine.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
Do not use niacin/simvastatin if you are also using the following medicines: cyclosporine (Gengraf®, Neoral®, Sandimmune®), danazol (Danocrine®), gemfibrozil (Lopid®), nefazodone (Serzone®), certain antibiotics (such as clarithromycin, erythromycin, itraconazole, ketoconazole, posaconazole, telithromycin, Biaxin®, Ery-Tab®, Ketek®, Nizoral®, Noxafil®, or Sporanox®), certain blood pressure medicines (such as amiodarone, diltiazem, verapamil, Calan®, Cardizem®, Cordarone®, or Verelan®), or certain medicines to treat HIV/AIDS (such as atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, Agenerase®, Crixivan®, Invirase®, Kaletra®, Lexiva®, Norvir®, Reyataz®, or Viracept®). Using these medicines together can cause serious side effects.
Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if it is accompanied by unusual tiredness or fever. These may be symptoms of a muscle condition called rhabdomyolysis, which can lead to serious kidney problems.
If you are taking amlodipine (Norvasc®) or ranolazine (Ranexa®) together with niacin/simvastatin, your niacin/simvastatin dose should not exceed 1000 mg/20 mg per day, unless directed otherwise by your doctor. When used together, these medicines may increase your risk of muscle injury which can lead to kidney failure, particularly at higher doses of simvastatin. Call your doctor right away if you have dark-colored urine, have a fever, have muscle cramps or spasms, have muscle pain or stiffness, feel very tired or weak, or have diarrhea.
Chinese patients who are taking large amounts of niacin (1 gram per day or more) together with simvastatin may have an increased risk for muscle injury. Caution is advised when Chinese patients are taking doses of niacin/simvastatin above 1000 mg/20 mg per day.
Avoid large amounts of grapefruit juice (more than 1 quart each day) while you are taking this medicine. Grapefruit juice may increase the amount of simvastatin in the body which may increase your risk of muscle injury and could result in kidney failure.
Make sure your doctor or dentist knows that you are using this medicine. Stop using this medicine several days before having surgery or medical tests. This medicine may affect the results of certain medical tests.
Check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may affect blood sugar levels. This is important if you are diabetic or prediabetic. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, check with your doctor.
This medicine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert. Change positions slowly when getting up from a sitting or lying position.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
This medicine should not be taken with vitamins containing niacin or nicotinamide.
This medicine may cause a side effect called flushing. Flushing is a feeling of warmth or redness on the face, neck, arms, and occasionally, on the upper chest. To avoid flushing, alcohol, hot beverages, and spicy foods should be avoided around the time you take this medicine. Additionally, your doctor may recommend that you take aspirin 30 minutes before taking this medicine to prevent flushing.
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