Drug Catalog - Product Detail
SIMVASTATIN TB 20MG 90
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68180-0479-02 | LUPIN PHARMACEUTICALS | 90 | 20MG | TABLET |
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Description
11 DESCRIPTION Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus . After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4hydroxy-6-oxo-2 H -pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S -[1α,3α,7β,8β(2 S* ,4 S* ),-8aβ]]. The empirical formula of simvastatin is C 25 H 38 O 5 and its molecular weight is 418.57. Its structural formula is: Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: ascorbic acid, citric acid, hydroxy propyl cellulose, hypromellose, iron oxides, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch, talc and titanium dioxide. Butylated hydroxyanisole is added as a preservative. Structural formula of Simvastatin
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Simvastatin tablets USP 5 mg are tan colored, round, biconvex, film-coated tablets debossed with ‘LL’ on one side and ‘C01’ on the other side. They are supplied as follows: NDC 68180-482-06 Bottles of 30 NDC 68180-482-09 Bottles of 90 NDC 68180-482-03 Bottles of 1000 NDC 68180-482-13 Box containing 6 x 10’s unit dose blisters Simvastatin tablets USP 10 mg are peach colored, oval shaped, biconvex, film-coated tablets debossed with ‘LL’ on one side and ‘C02’ on the other side. They are supplied as follows: NDC 58118-0478-08 Blister pack of 30 NDC 68180-478-01 Bottles of 30 NDC 68180-478-02 Bottles of 90 NDC 68180-478-03 Bottles of 1000 Simvastatin tablets USP 20 mg are tan colored, oval shaped, biconvex, film-coated tablets debossed with ‘LL’ on one side and ‘C03’ on the other side. They are supplied as follows: NDC 68180-479-01 Bottles of 30 NDC 68180-479-02 Bottles of 90 NDC 68180-479-03 Bottles of 1000 Simvastatin tablets USP 40 mg are brick red colored, oval shaped, biconvex, film-coated tablets debossed with ‘LL’ on one side and ‘C04’ on the other side. They are supplied as follows: NDC 68180-480-01 Bottles of 30 NDC 68180-480-02 Bottles of 90 NDC 68180-480-03 Bottles of 1000 Simvastatin tablets USP 80 mg are brick red colored, capsule shaped, biconvex, film-coated tablets debossed with ‘LL’ on one side and ‘C05’ on the other side. They are supplied as follows: NDC 68180-481-01 Bottles of 30 NDC 68180-481-02 Bottles of 90 NDC 68180-481-03 Bottles of 1000 Storage Store between 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Preserve in tight container as defined in USP.
Indications & Usage
1 INDICATIONS AND USAGE Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin can be started simultaneously with diet. Simvastatin is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: Reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events. ( 1.1 ) 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. ( 1.2 ) Reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbetalipoproteinemia. ( 1.2 ) Reduce total-C and LDL-C in adult patients with homozygous familial hypercholesterolemia. ( 1.2 ) 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. ( 1.2 , 1.3 ) Limitations of Use Simvastatin has not been studied in Fredrickson Types I and V dyslipidemias. ( 1.4 ) 1.1 Reductions in Risk of CHD Mortality and Cardiovascular Events In patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, simvastatin tablets are indicated to: Reduce the risk of total mortality by reducing CHD deaths. Reduce the risk of non-fatal myocardial infarction and stroke. Reduce the need for coronary and non-coronary revascularization procedures. 1.2 Hyperlipidemia Simvastatin tablets are indicated to: Reduce elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hyperlipidemia (Fredrickson type IIa, heterozygous familial and nonfamilial) or mixed dyslipidemia (Fredrickson type IIb). Reduce elevated TG in patients with hypertriglyceridemia (Fredrickson type lV hyperlipidemia). Reduce elevated TG and VLDL-C in patients with primary dysbetalipoproteinemia (Fredrickson type lll hyperlipidemia). Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable. 1.3 Adolescent Patients with Heterozygous Familial Hypercholesterolemia (HeFH) Simvastatin tablets are indicated as an adjunct to diet to reduce total-C, LDL-C, and Apo B levels in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with HeFH, if after an adequate trial of diet therapy the following findings are present: LDL cholesterol remains ≥190 mg/dL; or LDL cholesterol remains ≥160 mg/dL and There is a positive family history of premature cardiovascular disease (CVD) or Two or more other CVD risk factors are present in the adolescent patient. The minimum goal of treatment in pediatric and adolescent patients is to achieve a mean LDL-C <130 mg/dL. The optimal age at which to initiate lipid-lowering therapy to decrease the risk of symptomatic adulthood CAD has not been determined. 1.4 Limitations of Use Simvastatin tablets have not been studied in conditions where the major abnormality is elevation of chylomicrons (i.e., hyperlipidemia Fredrickson types I and V).
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Dose range is 5-80 mg/day. ( 2.1 ) Recommended usual starting dose is 20-40 mg once a day in the evening. ( 2.1 ) Recommended starting dose for patients at high risk of CHD is 40 mg/day. ( 2.1 ) Adolescents (10-17 years of age) with HeFH: starting dose is 10 mg/day; maximum recommended dose is 40 mg/day. ( 2.3 ) 2.1 Recommended Dosing The dosage range is 5-80 mg/day. In patients with CHD or at high risk of CHD, simvastatin tablets can be started simultaneously with diet. The recommended usual starting dose is 20 to 40 mg once a day in the evening. For patients at high risk for a CHD event due to existing CHD, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, the recommended starting dose is 40 mg/day. Lipid determinations should be performed after 4 weeks of therapy and periodically thereafter. 2.2 Patients with Homozygous Familial Hypercholesterolemia The recommended dosage is 40 mg/day in the evening or 80 mg/day in 3 divided doses of 20 mg, 20 mg, and an evening dose of 40 mg. Simvastatin tablets should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable. 2.3 Adolescents (10-17 years of age) with Heterozygous Familial Hypercholesterolemia The recommended usual starting dose is 10 mg once a day in the evening. The recommended dosing range is 10-40 mg/day; the maximum recommended dose is 40 mg/day. Doses should be individualized according to the recommended goal of therapy [see NCEP Pediatric Panel Guidelines National Cholesterol Education Program (NCEP): Highlights of the Report of the Expert Panel on Blood Cholesterol Levels in Children and Adolescents. Pediatrics. 89(3):495-501. 1992. and CLINICAL STUDIES (14.2) ]. Adjustments should be made at intervals of 4 weeks or more. 2.4 Patients with Renal Impairment Because simvastatin tablets do not undergo significant renal excretion, modification of dosage should not be necessary in patients with mild to moderate renal impairment. However, caution should be exercised when simvastatin tablets are administered to patients with severe renal impairment; such patients should be started at 5 mg/day and be closely monitored [see WARNINGS AND PRECAUTIONS (5.1) and CLINICAL PHARMACOLOGY (12.3) ]. 2.5 Chinese Patients Taking Lipid-Modifying Doses (≥1 g/day Niacin) of Niacin-Containing Products Because of an increased risk for myopathy, caution should be used when treating Chinese patients with simvastatin coadministered with lipid-modifying doses (≥1 g/day niacin) of niacin-containing products. Because the risk for myopathy is dose-related, Chinese patients should not receive simvastatin 80 mg coadministered with lipid-modifying doses of niacin-containing products. The cause of the increased risk of myopathy is not known. It is also unknown if the risk for myopathy with coadministration of simvastatin with lipid-modifying doses of niacin-containing products observed in Chinese patients applies to other Asian patients. [See WARNINGS AND PRECAUTIONS (5.1) .] 2.6 Coadministration with Other Drugs Concomitant Lipid-Lowering Therapy Simvastatin tablets may be used concomitantly with bile acid sequestrants. Combination therapy with gemfibrozil increases simvastatin exposure. Therefore, if simvastatin tablets are used in combination with gemfibrozil, the dose of simvastatin should not exceed 10 mg/day [see WARNINGS AND PRECAUTIONS (5.1) , DRUG INTERACTIONS (7.2) and CLINICAL PHARMACOLOGY (12.3) ]. Patients taking Cyclosporine or Danazol Simvastatin tablets therapy should begin with 5 mg/day and should not exceed 10 mg/day [see WARNINGS AND PRECAUTIONS (5.1) and DRUG INTERACTIONS (7.3) ]. Patients taking Amiodarone or Verapamil The dose of simvastatin tablets should not exceed 20 mg/day [see WARNINGS AND PRECAUTIONS (5.1) , DRUG INTERACTIONS (7.4) , and CLINICAL PHARMACOLOGY (12.3) ]. Patients taking Diltiazem • The dose of simvastatin tablets should not exceed 40 mg/day [see WARNINGS AND PRECAUTIONS (5.1) , DRUG INTERACTIONS (7.4) , and CLINICAL PHARMACOLOGY (12.3) ].