Simvastatin 20 MG Oral Tablet
1 INDICATIONS AND USAGE Simvastatin tablets are 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.
camber pharmaceuticals, inc.
OVAL BROWN H 18
H 18 OVAL BROWN
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16 HOW SUPPLIED/STORAGE AND HANDLING
SIMVASTATIN tablets USP, 5 mg are yellow colored, oval shaped, film coated tablet, debossed with ‘H’ on one side and ‘16’ on other side. They are supplied as follows: Bottles of 30 (NDC 31722-510-30) Bottles of 90 (NDC 31722-510-90) Bottles of 100 (NDC 31722-510-01) Bottles of 1000 (NDC 31722-510-10)
SIMVASTATIN tablets USP, 10 mg are pink colored, oval shaped, film coated tablet, debossed with ‘H’ on one side and ‘17’ on other side. They are supplied as follows: Bottles of 30 (NDC 31722-511-30) Bottles of 90 (NDC 31722-511-90) Bottles of 100 (NDC 31722-511-01) Bottles of 1000 (NDC 31722-511-10)
SIMVASTATIN tablets USP, 20 mg are brown colored, oval shaped, film coated tablet, debossed with ‘H’ on one side and ‘18’ on other side. They are supplied as follows: Bottles of 30 (NDC 31722-512-30) Bottles of 90 (NDC 31722-512-90) Bottles of 100 (NDC 31722-512-01) Bottles of 1000 (NDC 31722-512-10)
SIMVASTATIN tablets USP, 40 mg are brick red colored, oval shaped, film coated tablet, debossed with ‘H’ on one side and ‘19’ on other side. They are supplied as follows: Bottles of 30 (NDC 31722-513-30) Bottles of 90 (NDC 31722-513-90) Bottles of 100 (NDC 31722-513-01) Bottles of 1000 (NDC 31722-513-10)
SIMVASTATIN tablets USP, 80 mg are brick red capsule shaped, film coated tablet, debossed with ‘H’ on one side and ‘20’ on other side. They are supplied as follows: Bottles of 30 (NDC 31722-514-30) Bottles of 90 (NDC 31722-514-90) Bottles of 100 (NDC 31722-514-01) Bottles of 500 (NDC 31722-514-05) Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tightly closed container.
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