Simvastatin 20mg Tab, 100ct Bottle

Description

What is Simvastatin and how is it used?

Simvastatin (simvastatin) is a prescription medicine used to lower levels of “bad” cholesterol (low-density lipoprotein or LDL) and to increase levels of “good” cholesterol (high-density lipoprotein or HDL) and to lower triglycerin as well as to reduce the risk of stroke and heart attacks. Simvastatin may be used alone or with other medications.

Simvastatin belongs to a class of drugs called Lipid-Lowering Agents, Statins, HMG-CoA Reductase Inhibitors.

It is not known if Simvastatin is safe and effective in children younger than 10 years of age.

What are possible side effects of Simvastatin?

Simvastatin may cause serious side effects including:

• loss of appetite,
• upper-right side stomach pain,
• tiredness,
• itching,
• dark urine,
• clay-colored stool, and
• yellowing of the skin or eyes

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Simvastatin include:

• headache,
• nausea,
• stomach pain,
• constipation, and
• cold symptoms (stuffy nose, sneezing or sore throat)

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Simvastatin. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

SIMVASTATIN (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-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.

Tablets SIMVASTATIN 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, hydroxypropyl cellulose, hypromellose, iron oxides, lactose, magnesium stearate, microcrystalline cellulose, starch, talc, and titanium dioxide. Butylated hydroxyanisole is added as a preservative.

INDICATIONS

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.

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 is 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.

Hyperlipidemia

SIMVASTATIN is 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 (HoFH) as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.

Adolescent Patients With Heterozygous Familial Hypercholesterolemia (HeFH)

SIMVASTATIN is 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:

1. LDL cholesterol remains ≥190 mg/dL; or
2. 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.

Limitations Of Use

SIMVASTATIN has not been studied in conditions where the major abnormality is elevation of chylomicrons (i.e., hyperlipidemia Fredrickson types I and V).

DOSAGE AND ADMINISTRATION

Recommended Dosing

The usual dosage range is 5 to 40 mg/day. In patients with CHD or at high risk of CHD, SIMVASTATIN can be started simultaneously with diet. The recommended usual starting dose is 10 or 20 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.

Restricted Dosing For 80 mg

Due to the increased risk of myopathy, including rhabdomyolysis, particularly during the first year of treatment, use of the 80-mg dose of SIMVASTATIN 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 [see WARNINGS AND PRECAUTIONS].

Patients who are currently tolerating the 80-mg dose of SIMVASTATIN 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, patients unable to achieve their LDL-C goal utilizing the 40-mg dose of SIMVASTATIN 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.

Coadministration With Other Drugs

Patients Taking Verapamil, Diltiazem, Or Dronedarone

• The dose of SIMVASTATIN should not exceed 10 mg/day [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS, and CLINICAL PHARMACOLOGY].

Patients Taking Amiodarone, Amlodipine Or Ranolazine

• The dose of SIMVASTATIN should not exceed 20 mg/day [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS, and CLINICAL PHARMACOLOGY].

Patients With Homozygous Familial Hypercholesterolemia

The recommended dosage is 40 mg/day in the evening [See DOSAGE AND ADMINISTRATION, Restricted Dosing For 80 mg]. SIMVASTATIN should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.

Simvastatin exposure is approximately doubled with concomitant use of lomitapide; therefore, the dose of SIMVASTATIN should be reduced by 50% if initiating lomitapide. SIMVASTATIN dosage should not exceed 20 mg/day (or 40 mg/day for patients who have previously taken SIMVASTATIN 80 mg/day chronically, e.g., for 12 months or more, without evidence of muscle toxicity) while taking lomitapide.

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 to 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 Guidelines¹ and Clinical Studies]. Adjustments should be made at intervals of 4 weeks or more.

Patients With Renal Impairment

Because SIMVASTATIN does 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 is administered to patients with severe renal impairment; such patients should be started at 5 mg/day and be closely monitored [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

• Tablets SIMVASTATIN 5 mg are buff, oval, film-coated tablets, coded MSD 726 on one side and SIMVASTATIN 5 on the other.
• Tablets SIMVASTATIN 10 mg are peach, oval, film-coated tablets, coded MSD 735 on one side and plain on the other.
• Tablets SIMVASTATIN 20 mg are tan, oval, film-coated tablets, coded MSD 740 on one side and plain on the other.
• Tablets SIMVASTATIN 40 mg are brick red, oval, film-coated tablets, coded MSD 749 on one side and plain on the other.
• Tablets SIMVASTATIN 80 mg are brick red, capsule-shaped, film-coated tablets, coded 543 on one side and 80 on the other.

Storage

Store between 5-30°C (41-86°F).

¹National 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.