RiteMED Simvastatin Special Precautions

An attempt should be made to lower cholesterol by other methods such as diet, exercise, and weight loss before instituting therapy with simvastatin. Any other medical problems that can cause high cholesterol should also be treated.
About 1 % of patients who took simvastatin in clinical trials developed elevated levels of some liver enzymes. Patients who had these increases usually had no symptoms. Elevated liver enzymes usually returned to normal levels when therapy with simvastatin was stopped.
Measure liver enzymes before starting treatment with simvastatin and periodically thereafter for the first year of treatment or until one year after the last elevation in dose. If enzyme levels increase, more frequent test should be ordered. If liver enzyme levels remain unusually high discontinue simvastatin.
Use simvastatin with caution in patients who consume substantial amounts of alcohol and/or have a history of liver disease. Since simvastatin is metabolized predominantly in the liver and potentially may accumulate in the plasma of patients with hepatic impairment, such patients should be monitored closely while receiving simvastatin therapy. Simvastatin is classified as FDA pregnancy category X. Its safe use during pregnancy has not been established. Rare reports of congenital abnormality have been received following intrauterine exposure to HMG-CoA reductase inhibitors. Since there is no apparent benefit to therapy with simvastatin during pregnancy, it should be immediately discontinued as soon as pregnancy is recognized. It should be administered to women of child-bearing potential only when such patients are highly unlikely to conceive and have been informed of potential hazards.