Lochol Special Precautions

Muscle effects: Elevation of creatine kinase (CK) levels (from skeletal muscle) have been seen commonly. Therapy with HMG-CoA reductase inhibitors has been associated with myopathy. Myopathy should be considered in any patient with diffuse myalgias, muscle tenderness and/or marked elevations of CK levels (10 times the upper limit of normal). Therapy should be discontinued if markedly elevated CK level occur or if myopathy is diagnosed or suspected. The risk of myopathy with HMG-CoA reductase inhibitors is known to be increased by concomitant immunosuppressive therapy including cyclosporin, and by concomitant therapy with a fibric acid derivative or lipid-lowering doses of niacin (nicotinic acid).
Monitoring carefully patients for any signs and symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and during any periods of upward dosage titration of drug. Simvastatin therapy should be discontinued if these signs are suspected. When patients were promptly discontinued from treatment, muscle symptoms and CK increases resolved.
Hepatic effects: It is recommended that liver function tests should be performed before treatment begins, at 6 and 12 weeks after initiation of therapy and after dose elevation and periodically thereafter (about 6 month intervals) in all patients especially in patients who develop elevated progression (three times the upper limit of normal) and persistence, the drug should be discontinued. Active liver disease or unexplained transaminase elevation are contraindication to the use of simvastatin.
Diet: Before instituting therapy, attempt to control hypercholesterolemia with diet, exercise and weight reduction on obese patients.
Homozygous familial hypercholesterolemia: Simvastatin is less effective in patients with rare homozygous familial hypercholesterolemia, possibly because of a decrease in functional LDL receptors.
Sleep disturbance: Simvastatin may interfere with sleep causing insomnia.
Photosensitivity: Photosensitivity may occur; therefore, caution patients to take protective measures against exposure to ultraviolet or sunlight (ie. sunscreens, protective clothing).
Use in Pregnancy & Lactation: See Use in Pregnancy & Lactation section for further information.
Use in Children: Safety and effectiveness in children have not been established simvastatin is not recommended for use in children.