FDA approves new dosage range and indication for Zocor

Drug Store News, August 24, 1998

Merck received Food and Drug Administration approval to manufacture and market 80 mg tablets of Zocor, based on favorable lipid-lowering results from the Scandinavian Simvastatin Survival Study (4S). According to the study, patients who were treated with Zocor 80 mg at bedtime reduced their LDLs by 47 percent, whereas patients given 40 mg at bedtime decreased their LDL's by 41 percent. The 4S study also prompted a change in the official prescribing information for Zocor to recommend the 20 mg tablet as the usual starting dose. Patients needing only a moderate reduction of LDL cholesterol may still be started at 10 mg.

The incidence of myopathy was 0.7 percent for the 80 mg dosage and 0.2 percent for the 4- mg dosage. Incidence of liver enzyme elevations (sign of potential liver damage) was 2.1 percent for the 80 mg dosage and 0.9 percent for the 40 mg dosage. Patients taking the 80 mg dosage should be advised to receive and additional liver function test at three months.

In addition to pre-existing indications, Zocor has been approved by the FDA to be used as an adjunct to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia. The recommended dosage for patients with FD is 40 mg at bedtime or 80 mg per day in three divided doses of 20 mg, 20 mg and an evening dose of 40 mg.