NEOCOM ST
SIMVASTATIN AND EZETIMIBE · by NOVINS
Composition
Tab 10/10 mg: Simvastatin 10 mg, ezetimibe 10 mg. Tab 20/10 mg: Simvastatin 20 mg, ezetimibe 10 mg. Tab 40/10 mg: Simvastatin 40 mg, ezetimibe 10 mg. Tab 80/10 mg: Simvastatin 80 mg, ezetimib
Indications & Dosage
Homozygous familial hypercholesterolaemia, primary hypercholesterolaemia, and mixed hyperlipidaemia, or for patients not adequately controlled by statin alone: Adults: 1 tab of 10/20 mg as single dose in evening. Adjust at minimum 4 wk intervals according to response, max 10 mg ezetimibe and 80 mg simvastatin daily. Children: Not recommended.
Contraindications
Active liver disease, moderate or severe liver impairment.
Precautions
Severe renal impairment. Perform liver function tests before and during treatment, history of liver disease. Advise patients to report unexplained muscle weakness or pain; monitor creatine kinase levels, renal impairment, hypothyroidism, history of muscle toxicity, family or personal history of muscle disorders, alcohol abuse, elderly
Interactions
Digoxin, coumarin anticoagulants, cyclosporin, danazol, amiodarone, verapamil, diltiazem, gemfibrozil and other fibrates, nicotinic acid, erythromycin, clarithromycin, telithromycin, itraconazole, ketoconazole, other CYP3A4 inhibitors, immunosuppressants, nefazodone, protease inhibitors, grapefruit juice, colestipol, cholestyramine.
Pregnancy
Contraindicated in pregnancy.
Lactation
Not recommended.
Side Effects
Headache, flatulence, myalgia, abdominal pain, diarrhoea, fatigue.