displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
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-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The empirical formula of simvastatin is C25H38O5 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 Orally Disintegrating Tablets for oral administration contain either 10 mg, 20 mg, 40 mg or 80 mg of simvastatin. The tablets begin disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed. Simvastatin Orally Disintegrating Tablets also contain the following inactive ingredients: crospovidone, glyceryl behenate, hydroxypropyl cellulose, iron oxide yellow (10 mg and 20 mg tablets only), iron oxide red (20 mg and 40 mg tablets only), mint menthol, povidone, silicified microcrystalline cellulose, and sucralose. Butylated hydroxyanisole is added as an preservative.
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
Epidemiological studies have demonstrated that elevated levels of total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), as well as decreased levels of high-density lipoprotein cholesterol (HDL-C) are associated with the development of atherosclerosis and increased cardiovascular risk. Lowering LDL-C decreases this risk. However, the independent effect of raising HDL-C or lowering TG on the risk of coronary and cardiovascular morbidity and mortality has not been determined.
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below).In patients with CHD or at high risk of CHD, Simvastatin Orally Disintegrating Tablets can be started simultaneously with diet.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Hypersensitivity to any component of this medication.Active liver disease or unexplained persistent elevations of serum transaminases (see WARNINGS).
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
In the pre-marketing controlled clinical studies and their open extensions (2,423 patients with mean duration of follow-up of approximately 18 months), 1.4% of patients were discontinued due to adverse experiences attributable to simvastatin. Adverse reactions have usually been mild and transient. Simvastatin has been evaluated for serious adverse reactions in more than 21,000 patients and is generally well tolerated.
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Significant lethality was observed in mice after a single oral dose of 9 g/m2. No evidence of lethality was observed in rats or dogs treated with doses of 30 and 100 g/m2, respectively. No specific diagnostic signs were observed in rodents. At these doses the only signs seen in dogs were emesis and mucoid stools.A few cases of overdosage with simvastatin have been reported; the maximum dose taken was 3.6 g. All patients recovered without sequelae. Until further experience is obtained, no specific treatment of overdosage with simvastatin can be recommended.The dialyzability of simvastatin and its metabolites in man is not known at present.
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
The patient should be placed on a standard cholesterol-lowering diet. In patients with CHD or at high risk of CHD, Simvastatin Orally Disintegrating Tablets can be started simultaneously with diet. The dosage should be individualized according to the goals of therapy and the patient’s response. (For the treatment of adult dyslipidemia, see NCEP Treatment Guidelines. For the reduction in risks of major coronary events, see CLINICAL PHARMACOLOGY, Clinical Studies in Adults.) The dosage range is 5-80 mg/day (see below).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 coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, the recommended starting dose is 40 mg/day. The orally disintegrating tablet should be placed on the tongue where it will dissolve and then be swallowed with the saliva. If necessary, follow with water.Lipid determinations should be performed after 4 weeks of therapy and periodically thereafter. See below for dosage recommendations in special populations (i.e., homozygous familial hypercholesterolemia, adolescents and renal insufficiency) or for patients receiving concomitant therapy (i.e., cyclosporine, danazol, amiodarone, verapamil, or gemfibrozil).
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Simvastatin Orally Disintegrating Tablets 10 mg are yellow, round, biconvex tablets with S10 debossed on one side and ODT on the other side. They are supplied as follows: NDC 63672-0001-1, Bottles of 30
NDC 63672-0001-3, Bottles of 90Simvastatin Orally Disintegrating Tablets 20 mg are peach, round, biconvex tablets with S20 debossed on one side and ODT on the other side. They are supplied as follows: NDC 63672-0002-1, Bottles of 30
NDC 63672-0002-3, Bottles of 90Simvastatin Orally Disintegrating Tablets 40 mg are pink, round, biconvex tablets with S40 debossed on one side and ODT on the other side. They are supplied as follows: NDC 63672-0003-1, Bottles of 30
NDC 63672-0003-3, Bottles of 90Simvastatin Orally Disintegrating Tablets 80 mg are white, round, biconvex tablets with S80 debossed on one side and ODT on the other side. They are supplied as follows: NDC 63672-0004-1, Bottles of 30
NDC 63672-0004-3, Bottles of 90