SIMVA 10/MG FC TAB 30/FC TAB

Indications

Approved Uses

Adjunct to diet for primary hypercholesterolemia/primary hyperlipidemia (including mixed dyslipidemia), hypertriglyceridemia, and dysbetalipoproteinemia; treatment of heterozygous and homozygous familial hypercholesterolemia; and reduction of risk of major cardiovascular events (e.g., MI, stroke, revascularization) in high-risk patients.

Dosage & Administration

Dosing by Condition

Adults (primary hyperlipidemia/mixed dyslipidemia and cardiovascular risk reduction): 10-20 mg once daily in the evening (up to 40 mg/day usual max; 80 mg only if already stable ≥12 months without myopathy). Homozygous familial hypercholesterolemia: 40 mg once daily in the evening or 80 mg/day in 3 divided doses (only where 80 mg is appropriate per restriction). Pediatrics (HeFH, 10-17 years): start 10 mg once daily in the evening; range 10-40 mg/day.

Initial Dose

10-20mg once daily in the evening

Maintenance Dose

10-40mg once daily.

Maximum Dose

40mg per day. The 80mg dose is restricted to patients who have been taking it for 12 months or more without evidence of muscle injury.

Children's Dosage

Children 10-17 years (girls ≥1 year post-menarche): 10mg once daily in the evening; max 40mg/day for heterozygous familial hypercholesterolemia. Not approved under 10 years of age

Dose Adjustment Notes

Titrate at intervals of ≥4 weeks; avoid initiating 80 mg (reserve only for patients stable on 80 mg ≥12 months without myopathy); apply interaction-based maximum doses (e.g., max 10 mg/day with verapamil or diltiazem; max 20 mg/day with amiodarone or amlodipine or ranolazine); in severe renal impairment consider lower starting dose (e.g., 5 mg/day) and monitor closely.

How to Take

Swallow tablet whole with water. Take once daily in the evening. Can be taken with or without food. Avoid grapefruit juice

Safety & Warnings

Contraindications

Contraindicated in: active liver disease or unexplained persistent transaminase elevations; pregnancy; breastfeeding; hypersensitivity to simvastatin/excipients; and concomitant use with strong CYP3A4 inhibitors, gemfibrozil, cyclosporine, or danazol.

Warnings & Precautions

Major warnings/precautions: myopathy/rhabdomyolysis risk (higher with interacting drugs and higher doses; 80 mg use restricted to patients stable ≥12 months), counsel to report muscle symptoms and check CK when indicated; assess liver enzymes before initiation and if symptoms arise; correct predisposing factors (e.g., hypothyroidism), use caution in renal impairment/older age/alcohol misuse; temporarily withhold during serious acute illness/major surgery; rare immune-mediated necrotizing myopathy may persist after discontinuation.

Age Restriction

Approved for pediatric use in heterozygous familial hypercholesterolemia (HeFH) from age ≥10 years; not indicated for children <10 years.

Drug Interactions

Drug Interactions

Key interactions: contraindicated with strong CYP3A4 inhibitors (e.g., itraconazole/ketoconazole/posaconazole/voriconazole, macrolides like clarithromycin/erythromycin, HIV protease inhibitors/cobicistat, nefazodone), and with gemfibrozil, cyclosporine, danazol; dose limits with amiodarone (max 20 mg/day), amlodipine (max 20 mg/day), ranolazine (max 20 mg/day), verapamil (max 10 mg/day), diltiazem (max 10 mg/day); avoid/temporarily stop with systemic fusidic acid; caution with other fibrates/niacin (↑ myopathy), warfarin (monitor INR), colchicine (↑ myopathy), digoxin (small ↑ levels), and large quantities of grapefruit juice.

Interaction Severity

MAJOR/Contraindicated: strong CYP3A4 inhibitors (e.g., itraconazole/ketoconazole, clarithromycin/erythromycin, HIV protease inhibitors), cyclosporine, danazol, gemfibrozil; avoid/major caution: systemic fusidic acid (risk of rhabdomyolysis). MODERATE (dose limits/monitor): amiodarone (max 20 mg/day), amlodipine (max 20 mg/day), ranolazine (max 20 mg/day), verapamil (max 10 mg/day), diltiazem (max 10 mg/day), other fibrates/niacin (myopathy risk), warfarin (monitor INR), colchicine (myopathy risk), grapefruit juice (avoid large amounts). MINOR: digoxin (monitor levels).

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Contraindicated

Children

Children 10-17 years (girls ≥1 year post-menarche): 10mg once daily in the evening; max 40mg/day for heterozygous familial hypercholesterolemia. Not approved under 10 years of age

Kidney Impairment

CrCl ≥30 mL/min: no adjustment; CrCl <30 mL/min (severe renal impairment): start 5 mg/day and titrate cautiously-use doses >10 mg/day with caution and close monitoring.

Storage & Patient Advice

Missed Dose

If a dose is missed, take the missed dose as soon as possible. Do not double the next dose.

Patient Counseling

Take once daily in the evening, with or without food; avoid grapefruit juice (especially large amounts); report unexplained muscle pain/weakness/tenderness promptly; inform clinicians about all medicines (including antibiotics/antifungals) due to serious interaction risk; avoid use in pregnancy (and generally breastfeeding) and discuss contraception; limit excessive alcohol and seek care for symptoms of liver injury; continue diet/exercise and attend lipid monitoring.

Monitoring Requirements

Fasting lipid panel at baseline and 4-12 weeks after initiation or dose change, then every 3-12 months; liver enzymes (ALT) at baseline and thereafter only if clinically indicated (symptoms/signs of hepatotoxicity); CK only if muscle symptoms or high myopathy risk; if on warfarin, monitor INR after initiation/dose changes.

Pharmacology

Onset of Action

LDL-C reduction is typically seen within ~2 weeks, with maximal effect by ~4-6 weeks.

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: Simvastatin 10mg

OTC Alternatives

No OTC alternative.

Lipid Target

LDL

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