Lovastin Special Precautions

In controlled clinical trials, marked persistent increases (to >3 times the upper limit of normal) in serum transaminases occurred in 1.6% of adult patients who received lovastatin for at least 1 year. The increase usually appeared 3-12 months after the start of therapy. It is recommended that liver function tests be performed at baseline and every 4-6 weeks during the first 15 months of therapy with lovastatin and periodically thereafter in all patients. Lovastatin should be used with caution in patients with a history of liver disease.
Rhabdomyolysis has occurred rarely and should be considered in any patient with diffuse myalgias, muscle tenderness and/or marked elevation of creatine phosphokinase (10 times the upper limit of normal).
Most of the patients who have developed myopathy were receiving concomitant therapy with immunosuppressive drugs including cyclosporine, gemfibrozil or lipid-lowering doses of niacin.
Patients should be advised to report promptly unexplained muscle pain, tenderness, weakness, particularly if accompanied by malaise or fever.
Homozygous Familial Hypercholesterolemia: Lovastatin is less effective in patients with rare homozygous familial hypercholesterolemia and appears to be more likely to raise serum transaminase in this group of patients.
Eye: It is recommended that patients placed on lovastatin therapy be examined with a slit lamp before or shortly after initiation of treatment, and annually thereafter as new opacities was noted during clinical trial. However, this finding is inconclusive at the moment.
Use in children: Safety and effectiveness in children have not been established. Treatment of children with lovastatin is not recommended.