SIMVASTATIN

Indications & Dose:

Primary hypercholesterolaemia, or combined(mixed) hyperlipidaemia in patients who have not responded adequately to diet and other appropriate measures

• BY MOUTH

Adult: 10–20 mg once daily, then increased if necessary up to 80 mg once daily, adjusted at intervals of at least 4 weeks, dose to be taken at night; 80 mg dose only for those with severe hypercholesterolaemia and at high risk of cardiovascular complications

Homozygous familial hypercholesterolaemia in patients who have not responded adequately to diet and other appropriate measures

• BY MOUTH

Adult: Initially 40 mg once daily, then increased if necessary up to 80 mg once daily, adjusted at intervals of at least 4 weeks, dose to be taken at night; 80 mg dose only for those with severe hypercholesterolaemia and at high risk of cardiovascular complications

Prevention of cardiovascular events in patients with atherosclerotic cardiovascular disease or diabetes mellitus

% BY MOUTH

Adult: Initially 20–40 mg once daily, increased if necessary up to 80 mg once daily, adjusted at intervals of at least 4 weeks, dose to be taken at night; 80 mg dose only for those with severe hypercholesterolaemia and at high risk of cardiovascular complications

DOSE ADJUSTMENTS DUE TO INTERACTIONS

Max. 10 mg daily with concomitant bezafibrate or ciprofibrate. Max. 20 mg daily with concomitant amiodarone, verapamil, diltiazem, amlodipine, or ranolazine. Max. 40 mg daily with concomitant lomitapide.

Contraindications:

Active liver disease, Pregnancy & breast feeding

Side Effects:

CNS: Dizziness, headache, insomnia, memory loss, peripheral neuropathy, tremor, vertigo

GI: Abdominal pain, constipation, diarrhea, dyspepsia, flatus, heartburn, liver dysfunction, nausea, pancreatitis, vomiting

GU: Erectile dysfunction, gynecomastia, loss of libido

HEME: Eosinophilia, hemolytic anemia, leukopenia, thrombocytopenia

MS: Muscle cramps, myalgia, myositis, rhabdomyolysis

SKIN: Alopecia, pruritus, rash, Stevens-Jhonson syndrome

Cautions:

Precautions:

Past liver disease, alcoholism, severe acute infections, trauma, hypotension, uncontrolled seizure disorders, severe metabolic disorders, electrolyte imbalances

Interaction:

Drugs 

Azole antifungals (fluconazole, itraconazole, ketoconazole, miconazole): Increased simvastatin levels via inhibition of metabolism with increased risk of rhabdomyolysis

Cbolestyramine, colestipol: Reduced bioBrands Available with Cost of simvastatin

Cyclosporine: Concomitant administration increases risk of severe myopathy or rhabdomyolysis

Danazol: Inhibition of metabolism (CYP3A4) fight to yield increased simvastatin levels with increased risk of rhabdomyolysis

Fluoxetine: Inhibits CYP3A4 hepatic metabolism with risk of rhabdomyolysis

Gemfibrozil: Small increased risk of myopathy with combination, especially at high doses of statin

Isradipine: Isradipine probably decreases simvastatin (like lovastatin) plasma concentrations minimally

Macrolide antibiotics (clarithromycin, erythromycin, troleandomycin): Increased simvastatin levels via inhibition of metabolism with increased risk of rhabdomyolysis

Nefazodone: Inhibit CYP3A4 hepatic metabolism (like lovastatin) with risk of rhabdomyolysis

Niacin: Concomitant administration increases risk of severe myopathy or rhabdomyolysis

Warfarin: Addition of simvastalin may increase hypoprothrombinemic response to warfarin via inhibition of metabolism (CYP2C9)

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: