"June 9, 2011 -- The FDA today tightened its rules on who should take the highest approved dose of the statin drug simvastatin.
Simvastatin, which lowers LDL "bad" cholesterol, is sold under the brand name Zocor and as a generic drug. "...
SIMCOR is contraindicated in the following conditions:
- Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels [see WARNINGS AND PRECAUTIONS]
- Patients with active peptic ulcer disease
- Patients with arterial bleeding
- Concomitant administration of strong CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, posaconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin and nefazodone) [see WARNINGS AND PRECAUTIONS]
- Concomitant administration of gemfibrozil, cyclosporine, or danazol [see WARNINGS AND PRECAUTIONS]
- Concomitant administration of verapamil or diltiazem [see WARNINGS AND PRECAUTIONS]
- Women who are pregnant or may become pregnant. SIMCOR may cause fetal harm when administered to a pregnant woman. Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol or cholesterol derivatives are essential for fetal development. Atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy should have little impact on long-term outcomes of primary hypercholesterolemia therapy. There are no adequate and well-controlled studies of SIMCOR use during pregnancy; however in rare reports congenital anomalies were observed following intrauterine exposure to HMG-CoA reductase inhibitors. If SIMCOR is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus [see Use In Specific Populations]. In rat and rabbit animal reproduction studies, simvastatin revealed no evidence of teratogenicity. There are no animal reproductive studies conducted with niacin.
- Nursing mothers. SIMCOR contains simvastatin and nicotinic acid. Nicotinic acid is excreted into human milk and it is not known whether simvastatin is excreted into human milk; however a small amount of another drug in this class does pass into breast milk. Because of the potential for serious adverse reactions in nursing infants, women who require SIMCOR treatment should not breastfeed their infants [see Use In Specific Populations].
- Patients with a known hypersensitivity to any component of this product. Hypersensitivity reactions including one of more of the following adverse reactions have been reported for simvastatin and/or niacin extended-release: anaphylaxis, angioedema, urticaria, fever, dyspnea, tongue edema, larynx edema, face edema, peripheral edema, laryngismus, and flushing [see ADVERSE REACTIONS].
Last reviewed on RxList: 3/7/2013
This monograph has been modified to include the generic and brand name in many instances.
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