Simvastatin (Simvastatin)
Also sold as: Zocor, Simcard, Simvotin, Endace
Pregnancy
Cat X
Lactation
Avoid
Schedule
H
Forms
Tablet 10mg +2
Indications
- Hypercholesterolemia
- Mixed dyslipidemia
- Cardiovascular risk reduction
- Hypertriglyceridemia
Adult Dosing
Hypercholesterolemia — general
10–40 mg once daily at bedtime
Once daily in the evening — cholesterol synthesis peaks at night
Start 10–20mg; titrate every 4 weeks; maximum recommended dose 40mg due to myopathy risk at 80mg
High cardiovascular risk / secondary prevention
40 mg once daily at bedtime
Once daily
FDA 2011 advisory: 80mg dose restricted to patients already on it for 12+ months without myopathy — new patients should NOT be started on 80mg
Renal Dose Adjustment
| CrCl / eGFR | Dose Adjustment |
|---|---|
| CrCl ≥30 mL/min | No dose adjustment; use standard doses with caution in severe CKD |
| CrCl <30 mL/min | Start at 5–10mg; monitor closely — increased myopathy risk in severe renal impairment |
Hepatic Adjustment
Contraindicated in active liver disease. Simvastatin is a prodrug activated in the liver — impaired hepatic metabolism may increase systemic exposure. Avoid in significant hepatic impairment.
Pregnancy & Lactation
Pregnancy: Category X
Contraindicated — teratogenic. Discontinue before conception.
Lactation: Avoid
Excreted in animal milk; potential harm to infant. Avoid.
Top Drug Interactions
| Interacting Drug | Effect | Severity |
|---|---|---|
| Amiodarone | Inhibits CYP3A4 and P-glycoprotein — increases simvastatin levels. Maximum simvastatin dose of 20mg when co-prescribed with amiodarone. | Major |
| Verapamil / Diltiazem (calcium channel blockers) | Moderate CYP3A4 inhibition — increases simvastatin AUC significantly. Maximum simvastatin dose of 10mg with verapamil or diltiazem. | Major |
| Amlodipine | Mild CYP3A4 inhibition — increases simvastatin exposure. Maximum simvastatin dose of 20mg when co-prescribed. | Major |
| Itraconazole / Ketoconazole (azole antifungals) | Potent CYP3A4 inhibitors — dramatically increase simvastatin levels. Contraindicated combination — risk of life-threatening rhabdomyolysis. | Major |
| Clarithromycin / Erythromycin | Potent CYP3A4 inhibitors — contraindicated with simvastatin. Temporarily withhold simvastatin during antibiotic course. | Major |
| Gemfibrozil | Contraindicated — combination dramatically increases simvastatin levels and myopathy/rhabdomyolysis risk via multiple mechanisms. Use fenofibrate if fibrate + statin combination required. | Major |
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Side Effects
Common
- Myalgia
- Headache
- GI upset — nausea, abdominal pain, constipation
- Transaminase elevation
- Upper respiratory tract infections
Serious / Discontinue If
- Rhabdomyolysis — highest risk among commonly used statins due to extensive CYP3A4 metabolism and numerous interactions
- Myopathy — CK elevation with muscle symptoms
- Immune-mediated necrotising myopathy (IMNM)
- Hepatotoxicity
- New-onset diabetes mellitus
Contraindications
- Concomitant use with strong CYP3A4 inhibitors (itraconazole, ketoconazole, posaconazole, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone)
- Concomitant gemfibrozil, cyclosporine, or danazol
- Active liver disease
- Pregnancy (Category X)
- Breastfeeding
- 80mg dose in new patients (FDA 2011 restriction)
Available Indian Brands
| Brand | Manufacturer | Price (approx) |
|---|---|---|
| Simcard 20mg | Cipla | ₹22/10 tab |
| Simvotin 20mg | Sun Pharma | ₹18/10 tab |
| Zocor 20mg | MSD (Merck) | ₹65/10 tab |
| Endace 20mg | Alkem Laboratories | ₹20/10 tab |
Monitoring Required
- Fasting lipid panel at baseline and 4–12 weeks after any dose change
- LFTs at baseline and if symptoms develop
- CK at baseline in high-risk patients; check if myalgia occurs
- Screen for all interacting drugs before prescribing — most myopathy cases involve drug interactions
- HbA1c / fasting glucose annually
Patient Counseling Points
- Take at bedtime — liver produces most cholesterol at night; evening dosing is more effective for simvastatin
- CRITICAL: Inform every prescriber you take simvastatin — many common drugs interact dangerously
- Do not take clarithromycin, erythromycin, or azole antifungals while on simvastatin without doctor approval
- Report muscle pain, tenderness, or weakness immediately — especially if also feeling feverish
- Avoid large quantities of grapefruit juice
- Do not increase your dose without prescription — 80mg is no longer considered safe for new patients
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Clinically reviewed by: Dr. Suresh Venkataraman, MD (Medicine), Senior Consultant Internal Medicine
Last reviewed: 2026-04-01
References
- FDA Drug Safety Communication: New restrictions on simvastatin 80mg (June 2011)
- ACC/AHA 2018 Cholesterol Guidelines
- Simvastatin Prescribing Information — MSD India
- CDSCO Drug Monograph — Simvastatin
- Drug Interactions with Simvastatin — British Journal of Clinical Pharmacology 2014