Simvastatin
سیمواستاتین
❤️ Cardiovascular SystemStatin (HMG-CoA reductase inhibitor)
Market / country: 🇺🇸 USA
Zocor (US)
🧮 Dose calculator
Hyperlipidemia / heterozygous familial hypercholesterolemia · Regimen source: FDA Simvastatin · 2.2
- • Max recommended 40 mg; 80 mg only for patients on 80 mg ≥12 months without muscle toxicity. With amiodarone, amlodipine or ranolazine max 20 mg. Severe renal impairment: start 5 mg. FDA Simvastatin · 2.1FDA Simvastatin · 2.5FDA Simvastatin · 2.4
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ With strong CYP3A4 inhibitors (azoles, macrolides, antivirals, nefazodone), cyclosporine, danazol or gemfibrozil (and other items in section 4). FDA Simvastatin · 4
- ⛔ Not established under 10 years. FDA Simvastatin · 8.4
Formulations
- 5 mg tablet — tablet 🇺🇸 USA FDA Simvastatin · 3
- 10 mg tablet — tablet 🇺🇸 USA FDA Simvastatin · 3
- 20 mg tablet — tablet 🇺🇸 USA FDA Simvastatin · 3
- 40 mg tablet — tablet 🇺🇸 USA FDA Simvastatin · 3
- 80 mg tablet — tablet 🇺🇸 USA FDA Simvastatin · 3
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Simvastatin · 8.1
“Simvastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, simvastatin may cause fetal harm when administered to pregnant patients based on the mechanism of action [see CLINICAL PHARMACOLOGY ( 12.1 )] .”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Simvastatin · 8.2
“Because of the potential for serious adverse reactions in a breastfed infant, based on the mechanism of action, advise patients that breastfeeding is not recommended during treatment with simvastatin [see USE IN SPECIFIC POPULATIONS (8.1), CLINICAL PHARMACOLOGY ( 12.1 )].”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Simvastatin · 8.4
“The safety and effectiveness of simvastatin as an adjunct to diet to reduce LDL-C have been established in pediatric patients 10 years of age and older with HeFH.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Simvastatin · 8.5
“In a clinical study of patients treated with simvastatin 80 mg daily, patients ≥65 years of age had an increased risk of myopathy, including rhabdomyolysis, compared to patients <65 years of age.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)ANDA078103
- DailyMed (FDA label)FDA Simvastatin
- MedlinePlus (NIH)Simvastatin
- WHO ATC/DDDC10AA01
- Darooyab (Iran)Simvastatin
🇮🇷 Registered in Iran Darooyab · G-1882/Simvastatin
Dosage forms with Iranian generic codes, per Darooyab.
- 02458 · SIMVASTATIN 10MG TAB · قرص سیمواستاتین ۱۰ میلیگرم
- 01673 · SIMVASTATIN 20MG TAB · قرص سیمواستاتین ۲۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Simvastatin · 3FDA Simvastatin · 2.2FDA Simvastatin · 2.1FDA Simvastatin · 2.5FDA Simvastatin · 2.4FDA Simvastatin · 2.3FDA Simvastatin · 8.4FDA Simvastatin · 4FDA Simvastatin · 8.1FDA Simvastatin · 8.2FDA Simvastatin · 8.5FDA Simvastatin · SPL approval / marketing category
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-1882/Simvastatin
- Clinical review⚠ Unverified