Fluvastatin

CLINICAL USE

HMG CoA reductase inhibitor:Primary hypercholesterolaemia Slowing progression of atherosclerosis Secondary prevention of coronary events after percutaneous coronary intervention

DOSE IN NORMAL RENAL FUNCTION

20–80 mg daily in the eveningXL: 80 mg daily

PHARMACOKINETICS

Molecular weight :433.4 (as sodium salt)

%Protein binding :>98

%Excreted unchanged in urine : 6

Volume of distribution (L/kg) :0.35

half-life – normal/ESRD (hrs) :1.4–3.2/–

DOSE IN RENAL IMPAIRMENT

GFR (mL/MIN)

20 to 50 : Dose as in normal renal function

10 to 20 : Dose as in normal renal function

<10 : Dose as in normal renal function

DOSE IN PATIENTS UNDERGOING RENAL REPLACEMENT THERAPIES

CAPD :Removal unlikely. Dose as in normal renal function

HD :Removal unlikely. Dose as in normal renal function

HDF/high flux :Removal unlikely. Dose as in normal renal function

CAV/VVHD :Removal unlikely. Dose as in normal renal function

IMPORTANT DRUG INTERACTIONS

Potentially hazardous interactions with other drugs

Antibacterials: rifampicin increases metabolism; increased risk of myopathy with daptomycin

Anticoagulants: anticoagulant effect enhanced

Ciclosporin: concomitant treatment with ciclosporin may lead to risk of muscle toxicityColchicine: isolated cases of myopathy have been reportedLipid-lowering drugs: increased risk of myopathy with gemfibrozil, fibrates and nicotinic acid – avoid concomitant use with gemfibrozil

ADMINISTRATION

Reconstition

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Route

Oral

Rate of Administration

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Comments

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OTHER INFORMATION

The Committee on Safety of Medicines has advised that rhabdomyolysis associated with lipid-lowering drugs, such as the fibrates and statins, appears to be rare (approx. 1 case in every 100 000 treatment years), but may be increased in those with renal impairment and possibly in those with hypothyroidismManufacturer’s literature indicates fluvastatin is contraindicated in patients with severe renal impairment (creatinine greater than or equal to 160 µmol/L).

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