SIMVASTATIN
SIMVASYN 40MG FILM-COATED TABLET
40mg Film-coated Tablet
Indication*
Simvastatin tablets are an HMG-CoA reductase inhibitor (statin) indicated as an adjunct therapy to diet to: Reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infraction, stroke, and the need for revascularization procedures procedures in patients at high risk coronary events. Reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia. Reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbetalipoproteinemia. Reduce total-C and LDL-C in adult patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbetalipoproteinemia. Reduce total-C and LDL-C in adult patient with homozygous familial hypercholesterolemia. Reduce elevated total-C, LDL-C and Apo B in boys and postmenarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. Limitations of Use, Simvastatin tablets have not been studied in Fredrickson Types I and V dyslipidemias.
Directions for Use*
Dose range is 5 to 40 mg/day. Recommended usual starting dose is 10 or 20 mg once a day in the evening. Recommended starting dose for patients at high risk of CHD is 40 mg/day. Due to the increased risk of myopathy, including rhabdomyolysis, use of the 80 mg dose of simvastatin tablets should be restricted to patients who have been taking simvastatin 80 mg chronically (e.g,. for 12 months or more) without evidence of muscle toxicity. Patients who are currently tolerating the 80 mg dose of simvastatin tablets who need to be initiated on an interacting drug that is contraindicated or is associated with a dose cap for simvastatin should be switched to an alternative statin with less potential for the drug-drug interaction. Due to the increased risk of myopathy, including rhabdomyolysis, associated with the 80 mg dose of simvastatin tablets, patients unable to achieve their LDL-C goal utilizing the 40 mg dose of simvastatin tablets should not be titrated to the 80 mg dose, but should be placed on alternative LDL-C lowering treatment(s) that provides greater LDL-C lowering. Adolescents (10 to 17 years of age) with HeFH: starting dose is 10 mg/day; maximum recommended dose is 40 mg/day.
Administration*
*written indications, directions, and administration are updated as of January 28, 2024 and may not be accurate with the actual product purchased. Please read the details in the packaging.
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