Publication date: 2018-11-05 11:22
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Persistent increases (to more than 8X the ULN) in serum transaminases have occurred in approximately 6% of patients who received simvastatin in clinical studies. When drug treatment was interrupted or discontinued in these patients, the transaminase levels usually fell slowly to pretreatment levels. The increases were not associated with jaundice or other clinical signs or symptoms. There was no evidence of hypersensitivity.
Moderate (less than 8X ULN) elevations of serum transaminases have been reported following therapy with simvastatin. These changes appeared soon after initiation of therapy with simvastatin, were often transient, were not accompanied by any symptoms and did not require interruption of treatment.
Statins can help prevent and treat heart disease by lowering cholesterol, but they are much more effective when combined with a healthy diet and lifestyle.
Inactive Ingredients: calcium carbonate, USP candelilla wax, FCC croscarmellose sodium, NF hydroxypropyl cellulose, NF lactose monohydrate, NF magnesium stearate, NF microcrystalline cellulose, NF Opadry White YS-6-7595 (hypromellose, polyethylene glycol, talc, titanium dioxide) polysorbate 85, NF simethicone emulsion.