SIMVASTATIN

Statin

Brand names: SIMVASTATIN, Zocor

Oral

Mechanism of Action

12.1 Mechanism of Action Simvastatin is a prodrug and is hydrolyzed to its active β-hydroxyacid form, simvastatin acid, after administration. Simvastatin acid and its metabolites are inhibitors of HMG-CoA reductase, the rate-limiting enzyme that converts HMG-CoA to mevalonate, a precursor of cholesterol.

Indications

1 INDICATIONS AND USAGE Simvastatin tablets USP 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

Contraindications

• 4 CONTRAINDICATIONS Simvastatin is contraindicated in the following conditions: Concomitant use of strong CYP3A4 inhibitors (select azole anti-fungals
• macrolide antibiotics
• anti-viral medications
• and nefazodone) [see DRUG INTERACTIONS ( 7.1 )]. Concomitant use of cyclosporine
• including anaphylaxis

FDA Warnings

5 WARNINGS AND PRECAUTIONS Myopathy and Rhabdomyolysis: Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher simvastatin dosage
Chinese patients may be at higher risk for myopathy
Temporarily discontinue simvastatin in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis
Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing simvastatin dosage

Known Side Effects

14 documented side effects by frequency

Fatigue

1-10%

Nausea

1-10%

Shortness of Breath

1-10%

Diarrhea

1-10%

Drug Not Working

1-10%

Dizziness

1-10%

Weakness

1-10%

Falls

1-10%

Headache

1-10%

Muscle Pain

1-10%

Vomiting

1-10%

Joint Pain

1-10%

General Unwellness

1-10%

Limb Pain

0.1-1%

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Compare With

13 available comparisons

Formulations

Dosage Forms

Tablet

Route

Oral