6. Pregnancy and breastfeeding
Simvafar is not recommended in pregnancy and while breastfeeding.
Talk to your doctor if you're planning to become pregnant. It's best to stop taking Simvafar at least 3 months before you start trying for a baby.
If you become pregnant while taking Simvafar, stop taking the medicine and tell your doctor.
What should I avoid while taking Simvafar?
Grapefruit and grapefruit juice may interact with Simvafar and lead to unwanted side effects. Avoid the use of grapefruit products while taking this medicine.
Avoid eating foods that are high in fat or cholesterol. Simvafar 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.
Strong CYP3A4 Inhibitors
These drugs block your body from breaking down Simvafar. This can lead to very high levels of the drug in your body. It can also increase side effects, including rhabdomyolysis.
These drugs should not be used with Simvafar. If treatment with these drugs is required, the use of Simvafar must be on hold during the course of treatment. Examples of these drugs include:
What is Simvafar (Flolipid, Zocor)?
Simvafar is used to lower blood levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides, and increase levels of "good" cholesterol (high-density lipoprotein, or HDL).
Simvafar 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.
Simvafar is used in adults and children who are at least 10 years old.
Simvafar may also be used for purposes not listed in this medication guide.
Q: My doctor has prescribed Zocor. I have taken it for two weeks and it seems to cause my legs to hurt. Why is this?
A: Zocor (Simvafar, generically) has rare side effects of joint pain and muscle cramps. If this is intolerable, your doctor may want to try a different statin, or depending on your cholesterol levels, there may be other alternatives. Statin medications can cause a potentially serious condition known as rhabdomyolysis, a rapid breakdown of skeletal muscle due to injury to muscle tissue. If you are having pain, tenderness, or weakness in the muscles, you could have rhabdomyolysis. You should discuss this with your doctor. For more heart and cholesterol information and medication information, please visit these links: //www.everydayhealth.com/heart-health/ and //www.everydayhealth.com/drugs/Patti Brown, PharmD
What Is Zocor (Simvafar)?
Zocor is the brand name of Simvafar, a prescription drug used to lower blood cholesterol.
Zocor belongs to a class of drugs known as statins, also called HMG-CoA reductase inhibitors.
Statins reduce cholesterol levels in your blood by blocking an enzyme needed to make cholesterol, as well as increasing the number of low-density lipoprotein (LDL or "bad" cholesterol) receptors in the liver, so the liver can process more of the LDL found in your blood.
By lowering cholesterol, statins help to prevent the buildup of plaque in blood vessels, which can lead to atherosclerosis (hardening of the arteries), heart disease, and stroke.
Statins are used to help prevent heart disease in those who don't have it but are at risk, and in those who have already had some form of cardiovascular disease, such as a stroke or heart attack.
Your doctor will prescribe Zocor along with suggesting a healthy diet, weight loss if you need it, and exercise to reduce the risk of heart attack, stroke, and other problems.
Zocor, manufactured by Merck & Co., was approved by the Food and Drug Association (FDA) in 1991. The FDA approved the first generic version of Simvafar in 2006, and now many companies offer the generic version.
Zocor is offered in a tablet form or a disintegrating tablet form.
Q: What effects does Zocor have on the liver? I had hepatitis B 30 years ago. I understand that vitamin C supplements should be limited. Is that also correct? Also, is coQ10 reduced in the liver? This is important for the heart, correct?
A: Zocor (Simvafar) can increase liver enzymes occasionally. Doctors usually watch this by doing blood tests periodically. Studies show that it is usually well-tolerated and taken by many patients. Please keep up with doctor's appointments so that liver function can be continuously monitored. Studies suggest that vitamin C is a excreted through the urine since it is water-soluble. Many medications are metabolized in the liver and therefore, with the history of hepatitis, it is important to monitor liver function frequently. Coenzyme Q10 is sometimes taken to combat the side effects of statins (medications like Zocor) such as muscle pain. Controlling high cholesterol is very important in promoting heart health. Please consult your physician prior to starting any new medications.
Hypersensitivity to Simvafar
Active liver disease or unexplained transaminase elevation
Strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, posaconazole, voriconazole, HIV protease inhibitors, cobicistat, nefazodone, boceprevir, telaprevir), gemfibrozil, cyclosporine, and danazol
Pregnancy and Lactation
Do not use this drug in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
Simvafar is contraindicated while breastfeeding; it is potentially unsafe.
Calcium channel blockers and other drugs that increase risk for myopathy or rhabdomyolysis
Using Simvafar with these drugs can increase the risk of myopathy or rhabdomyolysis. Your doctor may discuss other medication options or lower your dosage of Simvafar. Examples of calcium channel blockers include:
Do not take more than 10 mg of Simvafar with diltiazem or verapamil, or more than 20 mg of Simvafar with amlodipine.
Other drugs that increase risk of myopathy or rhabdomyolysis include:
Contraindicated with Simvafar:
- Posaconazole (New)
- HIV protease inhibitors
S >Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
In the pre-marketing controlled clinical studies and their open extensions (2,423 patients with median duration of follow-up of approximately 18 months), 1.4% of patients were discontinued due to adverse reactions. The most common adverse reactions that led to treatment discontinuation were: gastrointestinal disorders (0.5%), myalgia (0.1%), and arthralgia (0.1%). The most commonly reported adverse reactions (incidence ≥5%) in Simvafar controlled clinical trials were: upper respiratory infections (9.0%), headache (7.4%), abdominal pain (7.3%), constipation (6.6%), and nausea (5.4%).
Mixing Simvafar with herbal remedies and supplements
St John's wort, a herbal medicine taken for depression, reduces the amount of Simvafar in your blood, so it doesn't work as well.
Talk to your doctor if you're thinking about starting St John's wort, as it will change how well Simvafar works.
Q: I have been hearing on TV that Zocor can cause kidney problems. I am having a problem urinating since I started Zocor.
A: The cholesterol-lowering drugs called statins (including Zocor ) are known to cause varying degrees of muscle pain and muscle weakness. A review of package inserts shows that uncomplicated muscle pain has been reported in approximately 1% to 5% of patients taking statins. The more serious side effect of myopathy or rhabdomyolysis is defined by muscle breakdown and increased blood levels of creatine phosphokinase (CPK). The breakdown of the muscle can lead to severe kidney damage and possible kidney failure. If the symptoms of muscle pain or weakness are accompanied by tiredness, fever, nausea and vomiting, brown or dark-colored urine or yellowing skin, patients should contact their health care provider. Information does not suggest that one statin is more likely to cause muscle pain than another. Larger doses of statins raise the risk of muscle pain and weakness as well as the more serious side effect of myopathy. In addition, the use of other drugs in combination with a statin may increase these side effects. These drugs include gemfibrozil, niacin, verapamil, erythromycin, and clarithromycin. Other factors that may increase the risk of muscle pain or weakness include hypothyroidism, surgery or trauma, heavy exercise, excessive alcohol intake, and kidney or liver disease. There are a number of alternatives to the statins for lowering cholesterol, including fibrates, bile acid sequestrants, and niacin. Michelle McDermott, PharmD