Vytorin Warnings

Vytorin contains simvastatin, the following warnings must be applied.
1. Contraindication in pregnancy and breastfeeding.
2. Contraindication in patients with liver disease.
3. This drug should be discontinued and physicians should be consulted if patients develop symptoms of myalgia at calf, back or whole body.
4. Liver function tests should be performed before treatment begins and 6 and 12 weeks thereafter. Patients who take this drug regularly should have LFTs semiannually or as recommended by physicians. If transaminase levels rise to > 3 times the upper limit of normal, patients should stop taking the drug and consult a physician.
5. Caution should be exercised when statins are taken concomitantly with digoxin or warfarin because serum concentration of digoxin or warfarin will be elevated and may be harmful.
6. The risk of myopathy/rhabdomyolysis may be increased when concomitant use of statin drug with the following drugs: azole antifungals e.g. ketoconazole, itraconazole etc., macrolide antibiotics e.g. erythromycin, clarithromycin etc., HIV protease inhibitors e.g. indinavir, ritonavir, nelfinavir, saquinavir etc., verapamil, diltiazem, gemfibrozil, nicotinic acid, cyclosporine, amiodarone, etc.
7. The risk of myopathy/rhabdomyolysis may be increased in patients who are taking higher doses, elderly, or have hepatic or renal impairment, alcoholism, hypothyroidism etc.
8. Caution should be exercised when statins are taken concomitantly with colchicine especially in elderly or patients with renal impairment because the risk of myopathy/rhabdomyolysis may occur.
9. The risk of higher levels of blood sugar may be increased.