Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Incidence not known
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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.
Before prescribing medicine for your high cholesterol, your doctor will probably try to control your cholesterol with a special diet. Such a diet may be low in fats, sugars, or cholesterol. Many people are able to control their cholesterol by carefully following their doctor’s orders for a proper diet and exercise. Medicine is prescribed only when additional help is needed, and is effective only when used together with a special diet and exercise.
This medicine will not cure your high cholesterol problem, but it does help control it. You must continue to take it as directed if you expect to keep your cholesterol levels down.
Swallow the tablet whole. Do not break, crush, or chew it.
It is best to take this medicine at bedtime, with a low-fat meal or snack.
Do not change your dose without checking first with your doctor. The 80 mg dose of simvastatin may increase your risk to have serious muscle problems.
If you are also using cholestyramine (Questran®) or colestipol (Colestid®), take it at least 4 to 6 hours before or after you take this medicine.
The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of simvastatin and niacin combination in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of simvastatin and niacin combination in the elderly. However, elderly patients are more likely to have muscle problems, which may require caution in patients receiving this medicine.
|All Trimesters||X||Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Simvastatin and niacin combination is used together with a proper diet to lower cholesterol and triglyceride (fat-like substances) levels in the blood. Using this medicine may help prevent medical problems caused by such substances clogging the blood vessels. This medicine may also be used to prevent certain types of heart problems in patients with risk factors for heart problems.
Simvastatin and niacin work together to treat cholesterol and lipid (fat) disorders. Niacin is a B-complex vitamin that reduces the amount of cholesterol in the blood. Simvastatin belongs to the group of medicines called HMG-CoA inhibitors, which is sometimes called “statins”. It works by blocking an enzyme that is needed by the body to make cholesterol, thereby reducing the amount of cholesterol in the blood.
This medicine is available only with your doctor’s prescription.