Drug Index


Mechanism :

Simvastatin is a potent inhibitor of HMG-CoA reductase. Inhibition of HMG-CoA reductase is the basis for an assay in pharmacokinetic studies of the b-hydroxy acid metabolites (active inhibitors) and, following base hydrolysis, active plus latent inhibitors (total inhibitors) in plasma following administration of simvastatin.

Indication :

  • Hypercholesterolemia
  • Familial hypercholesterolemia

Contraindications :

Contraindicated in active liver disease, renal impairment, unexplained increase in transaminases and in hypersensitivity to simvastatin. Liver function tests should be carried out.

Dosing :

<10 years:
Safety and efficacy not established. An initial dose of 5 mg PO once daily titrated up to 10 to 20 mg PO once daily has been used in small studies.
>10 years:
10 mg oral daily evening dose; maximum: 40 mg/day.
Recommended dose:
10-40 mg/day; dose adjustment at 4 weeks or more.

Adverse Effect :

Reversible increases in liver enzymes and creatinine kinase, nausea, diarrhea, constipation, skin rash, peripheral neuropathy, rarely rhabdomyolysis.

Interaction :

Immunosuppressive therapy including Cyclosporin and Prednisolone: May increase plasma statin concentration and the risk of muscle toxicity.
Fibrates/or Nicotinic Acid, Erythromycin, Clarithromycin: May also be associated with an increased risk of serious myopathy.
Itraconazole and Ketoconazole: Increase risk of myopathy with simvastatin.
Warfarin: Anticoagulant effects of warfarin increased by simvastatin.

Renal Dose :

Dose in Renal Impairment GFR (mL/min)
20-50Dose as in normal renal function
10-20Dose as in normal renal function
<1010–20 mg daily. In severe renal impairment doses above 10 mg should be used with caution (doses up to 40 mg have been used)

Dose in Patients undergoing Renal Replacement Therapies
CAPDUnlikely to be dialysed. Dose as in GFR<10 mL/min
HDUnlikely to be dialysed. Dose as in GFR<10 mL/min
HDF/High fluxUnknown dialysability. Dose as in GFR<10 mL/min
CAV/VVHDUnknown dialysability. Dose as in normal renal function

Hepatic Dose :

If there is active hepatic disease or persistent raised liver aminotransaminases, then administration of simvastatin is contraindicated.
02/14/2024 20:39:13 Simvastatin
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