Simvastatin
ZOCOR
What it isHMG-CoA reductase inhibitor for hyperlipidemia and ASCVD prevention; a moderate-intensity statin.
Why this oneIts low cost and long familiarity are offset by more CYP3A4 restrictions than nearly any other statin.
What limits itStrong CYP3A4 inhibitors can precipitate myopathy; common cardiovascular drugs impose dose ceilings. Take it in the evening.
FDA-approved for
- hyperlipidemia (1991)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Hyperlipidemia | Adults | 20 mg | 20–40 mg | 40 mg (80 mg QD only if tolerated chronically ≥12 mo) |
| HeFH | Pediatric ≥10 yr | 10 mg | 10–40 mg | 40 mg |
Renal Severe impairment (CLcr 15–29): start 5 mg QD; no adjustment for mild–moderate
Hepatic Contraindicated in acute liver failure or decompensated cirrhosis
Instructions
- Take orally once daily in the evening
- If a dose is missed, take as soon as possible; do not double the next dose
Contraindications
- Concomitant use of strong CYP3A4 inhibitors (select azole antifungals, macrolide antibiotics, antivirals, nefazodone)
- Concomitant use of cyclosporine, danazol, or gemfibrozil
- Acute liver failure or decompensated cirrhosis
Cautions
- Myopathy and rhabdomyolysis (risk ↑ with age ≥65, hypothyroidism, renal impairment, higher dose)
- Immune-mediated necrotizing myopathy
- Hepatic dysfunction
- Increases in HbA1c and fasting serum glucose
Adverse reactions
- Upper respiratory infection
- Headache
- Abdominal pain
- Constipation
- Nausea
Pregnancy May cause fetal harm; discontinue when pregnancy is recognized
Lactation Breastfeeding not recommended during treatment
NO BOXED WARNINGS
Principal riskMyopathy, dose-related and worsened by CYP3A4 inhibitors
Cost, est. cash$4–$80/month
Generic entry2006
Classes and tags
Clinical profile
Legacy pregnancy categoryX
Defining liabilityMyopathy/rhabdomyolysis and hepatotoxicity; interaction burden varies by agent.
Mechanism of action: Simvastatin ballicule
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