Simvastatin 10 mg
1. INDICATIONS AND USAGE Simvastatin tablet is indicated: • To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. • As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). • As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). • As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia. Simvastatin tablets are an HMG-CoA reductase inhibitor indicated: ( 1 ) To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.
Accord Healthcare, Inc.
OVAL ORANGE 54
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16. HOW SUPPLIED/STORAGE AND HANDLING
SIMVASTATIN tablets USP 5 mg are brick red coloured, round shaped, biconvex, film coated tablet debossed “SI” on one side and plain on other side. Bottles of 30 Tablets with a child-resistant closure (NDC 16729-156-10) Bottles of 90 Tablets with a child-resistant closure (NDC 16729-156-15) Bottles of 1,000 Tablets (NDC 16729-156-17)
SIMVASTATIN tablets USP 10 mg are brick red coloured, oval shaped, biconvex, film-coated tablets, debossed "S 4" on one side and plain on other side. Bottles of 30 Tablets with a child-resistant closure (NDC 16729-004-10) Bottles of 60 Tablets with a child-resistant closure (NDC 16729-004-12) Bottles of 90 Tablets with a child-resistant closure (NDC 16729-004-15) Bottles of 1,000 Tablets with a child-resistant closure (NDC 16729-004-17)
SIMVASTATIN tablets USP 20 mg are brick red coloured oval shaped, biconvex, film-coated tablets, debossed "S 5" on one side and plain on other side. Bottles of 30 Tablets with a child-resistant closure (NDC 16729-005-10) Bottles of 60 Tablets with a child-resistant closure (NDC 16729-005-12) Bottles of 90 Tablets with a child-resistant closure (NDC 16729-005-15) Bottles of 1,000 Tablets with a child-resistant closure (NDC 16729-005-17)
SIMVASTATIN tablets USP 40 mg are brick red coloured, oval shaped, biconvex, film-coated tablets, debossed "S 6" on one side and plain on other side. Bottles of 30 Tablets with a child-resistant closure (NDC 16729-006-10) Bottles of 60 Tablets with a child-resistant closure (NDC 16729-006-12) Bottles of 90 Tablets with a child-resistant closure (NDC 16729-006-15) Bottles of 1,000 Tablets with a child-resistant closure (NDC 16729-006-17)
SIMVASTATIN tablets USP 80 mg are brick red coloured,capsule-shaped, biconvex, film-coated tablets, debossed with "SMV" on one side and "80" on the other side. Bottles of 30 Tablets with a child-resistant closure (NDC 16729-007-10) Bottles of 60 Tablets with a child-resistant closure (NDC 16729-007-12) Bottles of 90 Tablets with a child-resistant closure (NDC 16729-007-15) Bottles of 1,000 Tablets with a child-resistant closure (NDC 16729-007-17) Storage Store at 68°F to 77°F (20°C to 25°C). [See USP Controlled Room Temperature]. "Dispense in tight containers as defined in the USP"
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