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Indications

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other non-pharmacologic measures alone has been inadequate.

Pharmacology

Fluvastatin acts by competitively inhibiting HMG-CoA reductase, the enzyme for cholesterol synthesis. It reduces total cholesterol, triglycerides, LDL and VLDL concentrations in plasma. It also increases HDL concentrations.

Dosage & Administration

Oral-
Hyperlipidaemias:
  • Adult: Initially, 20-40 mg once daily in the evening, may increase at intervals of 4 wk to max 80 mg/day.
  • Child: Heterozygous familial hypercholesterolaemia: 9-16 yr 20 mg once daily. If necessary, may increase dose at 6-wkly intervals to 40 mg bid or 80 mg once daily as modified-release.
May be taken with or without food

Interaction

Bleeding and increased prothrombin time with coumarin anticoagulants. May increase the risk of myopathy rhabdomyolysis with HIV protease inhibitors, colchicine, bezafibrate, ciprofibrate or niacin (nicotinic acid), ciclosporin and fluconazole. Reduced bioavailability with concomitant rifampicin.

Contraindications

Acute liver disease or unexplained persistent elevation of serum aminotransferases. Pregnancy and lactation. Avoid admin of two 40 mg conventional cap at one time.

Side Effects

Headache, nausea, abdominal pain, dyspepsia, diarrhoea, bronchitis, sinusitis, insomnia, fatigue, myopathy, myalgia and UTI. Increased blood creatinine phosphokinase and transaminase.

Pregnancy & Lactation

Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

Precautions & Warnings

History of liver disease and hereditary muscular disorders; high alcohol intake; patients who undergone major surgery and under immunosuppressive agents. Manage hypothyroidism prior to treatment. Severe renal impairment.

Use in Special Populations

Mild to moderate renal impairment: No dosage adjustment needed.

Overdose Effects

Management: Symptomatic and supportive treatment.

Therapeutic Class

Other Anti-anginal & Anti-ischaemic drugs, Statins

Storage Conditions

Store between 15-30° C.