Medostatin Special Precautions

Hepatic Effects: Before treatment with lovastatin begins, it is recommended that transaminase tests are performed and the tests be repeated periodically during treatment particularly in patients who have abnormal liver function tests and/or consume substantial quantities of alcohol. If serum transaminase levels increase no more than 3 times the upper limit of normal, the potential risk of continuing lovastatin therapy should be carefully studied against the anticipated benefits. Transaminase measurements should be repeated promptly and if these elevations are persistent or progressive, therapy with lovastatin should be discontinued.
Moderate elevation of serum transaminases have been reported soon after initiation of therapy with lovastatin but these were transient and not accompanied by any symptoms. In such cases, discontinuation of therapy is not required.
Lovastatin should be cautiously used in patients with a previous history of liver disease.
Muscle Effects: Mild elevations of creatine phosphokinase levels are frequently observed in patients treated with lovastatin but these are transient having no clinical significance. Myalgia has also been associated with lovastatin therapy.
More rarely, myopathy has occurred and this should be taken into account for any patient with diffuse myalgias, muscle tenderness or weakness and/or marked elevation of creatine phosphokinase in which case, lovastatin therapy should be discontinued.
Ophthalmic Evaluations: There are no indications that lovastatin has an adverse effect on the human lens.
Homozygous Familial Hypercholesterolemia: In patients with the rare homozygous familial hypercholesterolemia, lovastatin was less effective; possible because these patients have no functional LDL receptors.
Lovastatin appears to be more likely to raise serum transaminases.
Hypertriglyceridemia: Lovastatin is not indicated where hypertriglyceridemia is the abnormality of most concern (ie, hyperlipidemia types I, IV and V).
Use in children: Safety and effectiveness in children have not been established.
Use in the elderly: No apparent increase in the adverse effects in elderly patients has been observed.