"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. "...
Patients should be advised about substances they should not take concomitantly with simvastatin [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]. Patients should also be advised to inform other healthcare professionals prescribing a new medication or increasing the dose of an existing medication that they are taking SIMCOR.
All patients starting therapy with SIMCOR should be advised of the risk of myopathy, including rhabdomyolysis, and told to report promptly any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing SIMCOR. The risk of myopathy, including rhabdomyolysis, occurring with the use of SIMCOR is increased when taking certain types of medication or consuming larger quantities of grapefruit juice. Patients should discuss all medication, both prescription and over the counter, with their healthcare professional.
It is recommended that liver enzyme tests be performed before the initiation of SIMCOR, and if signs or symptoms of liver injury occur. All patients treated with SIMCOR should be advised to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.
SIMCOR tablets should be taken at bedtime, after a low-fat snack. Administration on an empty stomach is not recommended.
SIMCOR tablets should not be broken, crushed or chewed, but should be swallowed whole.
If dosing is interrupted for any length of time, their physician should be contacted prior to restarting therapy; re-titration is recommended.
Flushing is a common side effect of niacin therapy that may subside after several weeks of consistent SIMCOR use. Flushing may vary in severity and is more likely to occur with initiation of therapy, or during dose increases. By dosing at bedtime, flushing will most likely occur during sleep. However, if awakened by flushing at night, the patient should get up slowly, especially if feeling dizzy, feeling faint, or taking blood pressure medications.
Use of Aspirin
Taking aspirin approximately 30 minutes before dosing can minimize flushing.
To avoid ingestion of alcohol, hot beverages and spicy foods around the time of taking SIMCOR to minimize flushing.
To notify their physician if they are taking vitamins or other nutritional supplements containing niacin or nicotinamide.
To notify their physician if symptoms of dizziness occur.
If diabetic, to notify their physician of changes in blood glucose.
Women of childbearing age should use an effective method of birth control to prevent pregnancy while using SIMCOR. Discuss future pregnancy plans with your healthcare professional, and discuss when to stop SIMCOR if you are trying to conceive. If you are pregnant, stop SIMCOR and call your healthcare professional.
Women who are breastfeeding should not use SIMCOR. If you have a lipid disorder and are breastfeeding, speak with your healthcare professionals about your lipid disorder and whether or not you should breastfeed your infant.
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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