FLUVASTATINSODIUM

Indications & Dose:

Adjunct to diet in primary hypercholesterolaemia or combined (mixed) hyperlipidaemia (types IIa and IIb)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 BY MOUTH USING IMMEDIATE-RELEASE MEDICINESAdult: 80 mg daily 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

Side Effects:

CNS: Headache, insomnia GI: Diarrhea, dyspepsia, elevated transaminase levels (1%), hepatotoxicity, nausea EENT: Posterior subcapsular abnormalities MS: Myalgia, myopathy, rhabdomyolysis

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: