Zocor 10 mg - 7 F.C. Tablet

Antilipidemic Agent; HMG-CoA reductase inhibitor used in the treatment of hypercholesterolemia and prevention of atherosclerotic cardiovascular diseases.

-Administered without regard to meals. Administer in the evening for maximal efficacy. -Pediatric dosing: Hyperlipidemia or heterozygous familial hypercholesterolemia: In case of children ≥4 years and <10 years: Very limited data available: Oral: Initial: 5 mg once daily in the evening increasing to 10 mg once daily after 4 weeks and to 20 mg once daily after another 4 weeks as tolerated; maximum daily dose: 20 mg/day, while in case of children ≥10 years and adolescents: Oral: Initial: 10 mg once daily in the evening increasing to 20 mg once daily after 6 weeks and to 40 mg once daily after another 6 weeks as tolerated; maximum daily dose: 40 mg/day.

-Increased serum transaminases and hepatotoxicity, myalgia, myopathy and rhabdomyolysis. -Atrial fibrillation, edema, eczema, abdominal pain, constipation, gastritis, nausea, cystitis, increased serum transaminases, headache, vertigo, increased creatine phosphokinase in blood specimen, bronchitis, upper respiratory infection, skin rash, increased gamma-glutamyl transferase, diarrhea, dyspepsia, flatulence, increased serum alkaline phosphatase and asthenia.

-Should not be given to patients suffering from hypersensitivity to simvastatin. -May cause an increase in HbA1c and fasting blood glucose. -Use with caution in patients who consume large amounts of ethanol and/or have a history of liver disease. -May rarely worsen or precipitate myasthenia gravis. -Use with caution in patients with severe renal impairment. -Use with caution in patients ≥65 years of age; these patients are predisposed to myopathy. -In case of over dose be ready to tell or show what was taken, how much and when it happened, and seek immediate medical attention. For additional information call us on 16676. Always tell your physician your detailed medical history.

Store at room temperature.

-Amiodarone: May increase serum concentrations of the active metabolite(s) of Simvastatin. -Amlodipine: May increase the serum concentration of Simvastatin. -Azithromycin (Systemic): May enhance the myopathic (rhabdomyolysis) effect of Simvastatin. -Ciprofloxacin (Systemic): May enhance the myopathic (rhabdomyolysis) effect of Simvastatin. -Colchicine: May enhance the myopathic (rhabdomyolysis) effect of HMG-CoA Reductase Inhibitors (Statins). -Dabigatran Etexilate: Simvastatin may enhance the anticoagulant effect of Dabigatran Etexilate. -Digoxin: Simvastatin may increase the serum concentration of Digoxin. -Diltiazem: Simvastatin may decrease the serum concentration of Diltiazem. -Erythromycin (Systemic): May increase serum concentrations of the active metabolite(s) of Simvastatin. -Fenofibrate and Derivatives: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). -Fosphenytoin-Phenytoin: May decrease the serum concentration of HMG-CoA Reductase Inhibitors (Statins). -Grapefruit Juice: May increase the serum concentration of Simvastatin. -Niacin: May enhance the myopathic (rhabdomyolysis) effect of Simvastatin. -Niacinamide: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). -Red Yeast Rice: May enhance the adverse/toxic effect of HMG-CoA Reductase Inhibitors (Statins). -Rifampin: May decrease the serum concentration of Simvastatin. -St John's Wort: May decrease serum concentrations of the active metabolite(s) of HMG-CoA Reductase Inhibitors (Statins). -Ticagrelor: May increase the serum concentration of Simvastatin. -Verapamil: May increase serum concentrations of the active metabolite(s) of Simvastatin. -Vitamin K Antagonists (eg, warfarin): HMG-CoA Reductase Inhibitors (Statins) may enhance the anticoagulant effect of Vitamin K Antagonists.

-Adequate contraception is recommended if an HMG-CoA reductase inhibitor (statin) is required in patients who may become pregnant. When a statin is needed in a patient of reproductive potential, a more hydrophilic option (eg, pravastatin, rosuvastatin) may be preferred to limit placental transfer. Because there is potential for fetal harm, statins should be discontinued once pregnancy is recognized. -It is not known if simvastatin is present in breast milk. Due to the potential for adverse events in the breastfed infant, breastfeeding is not recommended during the treatment. -Ask your physician before taking any medication during pregnancy or lactation.

MERCK SHARP & DOHME