SIMVA 20/MG FC TAB 30/FC TAB

Indications

Approved Uses

Adjunct to diet for treatment of primary hypercholesterolemia and mixed dyslipidemia; treatment of familial hypercholesterolemia (heterozygous and homozygous) as adjunct to other lipid-lowering therapies; and reduction of risk of major cardiovascular events (e.g., myocardial infarction, stroke, coronary revascularization) in patients with established coronary heart disease or at high cardiovascular risk.

Dosage & Administration

Dosing by Condition

Primary hypercholesterolemia/mixed dyslipidemia: 10-20 mg once daily in the evening (or 5 mg in some patients), titrate to 5-40 mg once daily; Familial hypercholesterolemia: 10-40 mg once daily in the evening (HoFH typically as adjunct to other therapies); Cardiovascular risk reduction: 20-40 mg once daily in the evening; avoid initiating 80 mg and reserve only for patients stable on 80 mg ≥12 months without myopathy.

Initial Dose

10-20mg once daily in the evening.

Maintenance Dose

20-40mg once daily in the evening

Maximum Dose

40mg per day for new patients. The 80mg dose is restricted to patients who have been taking it for over 12 months without muscle toxicity.

Children's Dosage

Heterozygous familial hypercholesterolemia in children 10-17 years: 10mg once daily in the evening, max 40mg/day. Not approved for children under 10 years

Dose Adjustment Notes

Titrate at intervals of ≥4 weeks; maximum simvastatin dose 10 mg/day with verapamil or diltiazem; maximum 20 mg/day with amiodarone, amlodipine, or ranolazine; in severe renal impairment use lower starting doses and caution.

How to Take

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

Side Effects

Side Effect Frequency

Common (≥1% to <10%): headache, abdominal pain, constipation, nausea, flatulence/diarrhea, myalgia; increased transaminases. Uncommon (≥0.1% to <1%): myopathy, dizziness/insomnia, rash/pruritus, hepatitis/pancreatitis. Rare (<0.1%): rhabdomyolysis, severe hypersensitivity/angioedema, severe cutaneous reactions (e.g., SJS).

Safety & Warnings

Contraindications

Contraindicated in: hypersensitivity to simvastatin/excipients; active liver disease or unexplained persistent elevations of serum transaminases; pregnancy; breastfeeding; concomitant use of strong CYP3A4 inhibitors (e.g., itraconazole/ketoconazole/posaconazole/voriconazole, HIV protease inhibitors, macrolides such as erythromycin/clarithromycin/telithromycin, nefazodone, cobicistat-containing products); concomitant use of gemfibrozil, cyclosporine, or danazol.

Warnings & Precautions

Key warnings/precautions: myopathy/rhabdomyolysis risk (higher dose, interacting drugs, renal impairment, hypothyroidism, older age, frailty); counsel to report unexplained muscle pain/weakness and check CK when symptomatic; avoid/limit interacting drugs and adhere to dose caps; liver enzyme testing before initiation and as clinically indicated thereafter; restrict 80 mg use to patients stable on 80 mg ≥12 months without myopathy; consider diabetes risk; rare immune-mediated necrotizing myopathy may persist after discontinuation; consider temporary interruption with fusidic acid and in major acute illness/surgery when clinically indicated.

Age Restriction

Not recommended/approved for children <10 years; may be used in ages 10-17 years for heterozygous familial hypercholesterolemia (HeFH) under specialist supervision.

Drug Interactions

Drug Interactions

Major/contraindicated: strong CYP3A4 inhibitors; gemfibrozil; cyclosporine; danazol. Dose-limiting interactions: amiodarone (max simvastatin 20 mg/day), amlodipine (max 20 mg/day), ranolazine (max 20 mg/day), verapamil (max 10 mg/day), diltiazem (max 10 mg/day), lomitapide (limit simvastatin dose; commonly max 20 mg/day). Other clinically important: warfarin (monitor INR), niacin ≥1 g/day and colchicine (↑ myopathy risk), fusidic acid (avoid/temporarily stop statin due to rhabdomyolysis risk).

Interaction Severity

MAJOR/Contraindicated: strong CYP3A4 inhibitors (e.g., itraconazole/ketoconazole, clarithromycin/erythromycin, HIV protease inhibitors), cyclosporine, danazol, gemfibrozil (and generally avoid systemic fusidic acid); MODERATE (dose-limit): amiodarone/amlodipine/ranolazine (max 20 mg/day) and verapamil/diltiazem (max 10 mg/day); warfarin requires INR monitoring; niacin and colchicine increase myopathy risk; grapefruit increases exposure.

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Contraindicated

Children

Heterozygous familial hypercholesterolemia in children 10-17 years: 10mg once daily in the evening, max 40mg/day. Not approved for children under 10 years

Elderly

Standard adult dosing; exercise caution due to increased risk of myopathy in patients ≥65 years - start at lower doses and monitor closely

Kidney Impairment

Severe renal impairment (CrCl 15-29 mL/min): start at 5mg once daily. No adjustment for mild-moderate renal impairment.

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered the same day; if it is near the time of the next dose, skip the missed dose and resume the regular schedule-do not double doses.

Overdose

Overdose data are limited; manage with symptomatic/supportive care (consider activated charcoal if early), monitor CK, liver enzymes, renal function and urine output, and treat rhabdomyolysis with aggressive hydration; no specific antidote and hemodialysis is unlikely to be beneficial.

Patient Counseling

Take once daily in the evening with or without food; avoid grapefruit juice; continue diet/exercise; report unexplained muscle pain/weakness or dark urine promptly; limit alcohol and report symptoms of liver injury; inform clinicians of all medicines (interaction risk); contraindicated in pregnancy-avoid pregnancy and stop if pregnant; do not stop without medical advice.

Monitoring Requirements

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 not routine-check if high risk at baseline and whenever muscle symptoms occur; monitor INR if on warfarin.

Pharmacology

Onset of Action

LDL-C reduction begins within about 1-2 weeks, with near-maximal effect by 4-6 weeks after starting or dose adjustment.

Duration of Effect

LDL-C reduction begins within about 1-2 weeks, with near-maximal effect by 4-6 weeks after starting or dose adjustment; effect is maintained only with continuous daily therapy.

Metabolism

Prodrug hydrolyzed to the active β-hydroxyacid; extensively metabolized hepatically, predominantly via CYP3A4.

Protein Binding

>95%.

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: 20mg simvastatin

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Lipid Target

LDL

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