SIMVASEO Tablet

In patients

- with hypersensitivity to any component of this medication.

- with active liver disease or unexplained persistent elevations of serum transaminases.

- during pregnancy and lactation.

Simvastatin is also contraindicated in combination with potent inhibitor of CYP3A4 including itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, clarithromycin, telithromycin and nefazodone.

Minor side effects include constipation, diarrhoea, fatigue, heartburn, and headache. Major side effects include abdominal pain or cramps, blurred vision, dizziness, easy bruising or bleeding, itching, muscle pain or cramps, rash and yellowing of the skin or eyes.

Simvastatin is contraindicated in combination with potent inhibitor of CYP3A4 including itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, clarithromycin, telithromycin and nefazodone.

Contraindicated.

Simvastatin is a specific inhibitor of 3-hydroxy-e-methylflutaryl-coenzyme (HMG-CoA) reductase, the enzyme which catalyzes the conversion of HMG-CoA to mevalonate. However, at therapeutic doses, the enzyme is not completely blocked, thereby allowing biologically necessary amounts of mevalonate to be available. Because the conversion of HMG-CoA of mevalonate is an early step in the biosynthetic pathway of cholesterol, therapy with simvastatin would not be expected to cause an accumulation of potentially toxic sterols. In addition, HMG-CoA is metabolized readily back to acetyl-CoA, that participates in many biosynthetic processes in the body. Although cholesterol is the steroid genesis, Simvastatin caused no increase in biliary lithogenicity and, therefore, would not be expected to increase the incidence of gallstones.