Indications & Dose:

Adjunct to diet in primary hypercholesterolaemia or combined (mixed) hyperlipidaemia (types IIa and IIb)l

• BY MOUTH USING IMMEDIATE-RELEASE MEDICINES

Adult: Initially 20–40 mg daily, dose to be taken in the evening, increased if necessary up to 80 mg daily in 2 divided doses, dose to be adjusted at intervals of at least 4 weeks

•  BY MOUTH USING MODIFIED-RELEASE MEDICINES

Adult: 80 mg daily, dose form is not appropriate for initial dose titration

Prevention of coronary events after percutaneous coronary intervention l

• BY MOUTH USING IMMEDIATE-RELEASE MEDICINES

Adult: 80 mg daily l

• BY MOUTH USING MODIFIED-RELEASE MEDICINES

Adult: 80 mg daily, dose form is not appropriate for initial dose titration

Contraindications:

Pregnancy, lactation, active liver disease, unexplained transaminase elevations

Cautions:

Precautions:

History of liver disease, heavy ethanol use, patients at risk for rhabdomyolysis (acute infection, hypotension, major surgery, or trauma)

PREGNANCY; contraindicated in breast feeding-present in breast milk (2:1 milk: plasma ratio)

Interaction:

Drugs

Alcohol: 20 g of alcohol within 1 hr of dosing; increased fluvastatin AUC by 30%

Azole antifungals (fluconazole, itraeonazole, ketoeonazole, miconazole: Increased fluvastatin levels via inhibition of metabolism with increased risk of rhabdomyolysis

Cholestyramine, colestipol: Reduced bioBrands Available with Cost of fluvastatin

Cimetidine, ranitidine, omeprazole: Coadministration increases fluvastatin Cmax 43%-70% with 18%23% decrease in plasma clearance

Cyclosporine: Concomitant administration increases risk of severe myopathy or rhabdomyolysis

Danazol: Inhibition of metabolism (CYP3A4) thought to yield increased fluvastatin levels with increased risk of rhabdomyolysis

Fluoxetine: Less likely to inhibit CYP3A4 hepatic metabolism (vs lovastatin) with less risk of rhabdomyolysis

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

Isradipine: Isradipine probably decreases fluvastatin plasma concentrations minimally

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

Niacin: Concomitant administration increases risk of severe hepatotoxicity

Nefazadone: Less likely to inhibit, CYP3A4 hepatic metabolism (vs lovastatin) with less risk of rhabdomyolysis

Rifampin: Coadministration decreases fluvastatin Cmax and AUC

Terbinfine: Minimal effect on the metabolism of fluvastatin

Warfarin: Addition of fluvastatin 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: