Fluvastatin

A to Z Drug Facts

 Actions Increases rate at which body removes cholesterol from blood and reduces production of cholesterol in body by inhibiting enzyme that catalyzes early rate-limiting step in cholesterol synthesis; increases HDL; reduces LDL, VLDL, and triglycerides.

 Indications

Hypercholesterolemia: Reduction of elevated cholesterol and LDL cholesterol levels. Atherosclerosis: To slow the progression of coronary atherosclerosis.

 Contraindications Active liver disease or unexplained persistent elevations of LFTs; pregnancy; lactation.

 Route/Dosage

ADULTS: PO 20 to 80 mg qd.

 Interactions

Azole antifungal agents (eg, fluconazole), cyclosporine, gemfibrozil, macrolide antibiotics (eg, erythromycin), niacin: Severe myopathy or rhabdomyolysis may occur with coadministration. Cholestyramine: Reduced absorption of fluvastatin if taken with or up to 4 hr after cholestyramine. Cimetidine, ranitidine, omeprazole: Fluvastatin serum levels may be increased. Digoxin: Digoxin serum levels may be increased. Rifampicin: Fluvastatin serum levels may be reduced.

 Lab Test Interferences None well documented.

 Adverse Reactions

RESPIRATORY: Upper respiratory tract infection; cough; bronchitis. CNS: Headache; dizziness; insomnia; fatigue. EENT: Rhinitis; sinusitis; pharyngitis. GI: Nausea; vomiting; diarrhea; abdominal pain/cramps; constipation; flatulence; dyspepsia. DERMATOLOGIC: Rash; pruritis. OTHER: Muscle cramps/pain; back pain; arthropathy.

 Precautions

Pregnancy: Category X. Lactation: Excreted in breast milk; do not breastfeed while taking. CHILDREN: Safety and efficacy in children younger than 18 yr not established. Liver dysfunction: Use with caution in patients who consume substantial quantities of alcohol or who have a history of liver disease. LFTs: Perform LFTs before initiating therapy, q 4 to 6 wk during the first 3 mo of therapy, q 6 to 12 wk during the next 12 mo (or after a dose increase), and periodically (eg, q 6 mo) thereafter. Skeletal muscle effects: Rhabdomyolysis with renal dysfunction secondary to myoglobinuria has been reported with other drugs in this class. Temporarily withhold therapy in any patient experiencing an acute or serious condition predisposing to the development of renal failure secondary to rhabdomyolysis (eg, sepsis, hypotension). The risk of myopathy with other drugs in this class was found to be increased if therapy with either cyclosporine, gemfibrozil, erythromycin, or niacin is administered concurrently. Consider myopathy in any patient with diffuse myalgias, muscle tenderness or weakness, or marked elevations of CPK. Endocrine effects: Use caution when administering HMG-CoA reductase inhibitors with drugs that affect steroid levels or activity.

 Administration/Storage

• Swallow each tablet whole. Do not cut, crush, or chew tablets.
• Drink plenty of fluids as the tablets are swallowed.
• May be taken with evening meal or on empty stomach.
• Store at room temperature.

 Assessment/Interventions

• Obtain patient history.
• Ensure that blood cholesterol and triglyceride levels are assessed before beginning therapy and repeated periodically during treatment.
• Place patient on standard cholesterol-lowering diet before beginning therapy, and continue diet during treatment.
• Ensure that LFTs are performed q 4 to 6 wk during first 3 mo of therapy, q 6 to 8 wk during next 18 mo, and q 6 mo thereafter.
• If elevated serum transaminase levels develop during treatment, repeat tests more frequently.
• If transaminase levels rise to 3 times upper limit of normal and are persistent, notify health care provider. Drug may be discontinued.
• If muscle tenderness or weakness develop during therapy, monitor CPK levels. Notify health care provider if CPK levels are markedly increased or if symptoms continue.

 Patient/Family Education

• Caution patient that this medication must not be taken during pregnancy or when pregnancy is possible. Advise patient to use reliable form of birth control while taking this drug.
• Advise patient to take medication with evening meal if possible.
• Explain importance of adhering to low-cholesterol, low-fat diet during treatment. Suggest consultation with nutritionist as needed.
• Instruct patient to report the following symptoms to health care provider: unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or malaise.
• Caution patient to avoid or decrease alcohol intake.
• Advise patient not to take any additional medications or supplementations without approval by health care provider.
• Emphasize importance of returning for follow-up LFT and blood cholesterol test as instructed.
• Explain that this treatment must be continued over years.

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Copyright © 2003 Facts and Comparisons
David S. Tatro
A to Z Drug Facts