Pregnancy Risk Category X
How supplied
Capsules: 20 mg, 40 mg
Action
Inhibits 3-hydroxy-3-methylglutaryl coenzyme A reductase, which is an early (and rate-limiting) step in the synthetic pathway of cholesterol.
Indications & dosage
Reduction of low-density lipoprotein and total cholesterol levels in patients with primary hypercholesterolemia (types IIa and IIb)--
Adults: initially, 20 to 40 mg P.O. h.s., increased p.r.n. to maximum of 80 mg daily (in divided doses).
To slow progression of coronary atherosclerosis in patients with coronary artery disease--
Adults: initially, 20 to 40 mg P.O. h.s., increased p.r.n. to maximum of 80 mg daily (in divided doses).
NEW INDICATION: Elevated triglycerides and apolipoprotein B levels in patients with primary hypercholesterolemia and mixed dyslipidemia whose response to dietary restriction and other nonpharmacologic measures has been inadequate--
Adults: initially, 20 to 40 mg P.O. h.s., increased p.r.n. to maximum of 80 mg daily (in divided doses).
Adverse reactions
CNS: headache, fatigue, dizziness, insomnia.
EENT: sinusitis, rhinitis, pharyngitis.
GI: dyspepsia, diarrhea, nausea, vomiting, abdominal pain, constipation, flatulence.
Hematologic: thrombocytopenia, hemolytic anemia, leukopenia.
Hepatic: increased liver enzymes, elevated CK levels.
Metabolic: abnormal thyroid function tests.
Musculoskeletal: arthralgia, back pain, myalgia.
Respiratory: upper respiratory infection, cough, bronchitis.
Other: hypersensitivity reactions.
Interactions
Drug-drug. Cholestyramine, colestipol: may bind with fluvastatin in the GI tract and decrease absorption. Separate administration times by at least 4 hours.
Cimetidine, omeprazole, ranitidine: decreased fluvastatin metabolism. Monitor for enhanced effects.
Cyclosporine and other immunosuppressants, erythromycin, gemfibrozil, niacin: possible increased risk of polymyositis and rhabdomyolysis. Avoid concomitant use.
Digoxin: may alter digoxin pharmacokinetics. Monitor serum digoxin levels carefully.
Rifampin: enhanced fluvastatin metabolism and decreased plasma levels. Monitor for lack of effect.
Warfarin: increased anticoagulant effect with bleeding. Monitor patient.
Drug-lifestyle. Alcohol use: increased risk of hepatotoxicity. Avoid concomitant use.
Effects on diagnostic tests
None reported.
Contraindications
Contraindicated in patients with hypersensitivity to drug and in those with active liver disease or conditions associated with unexplained persistent elevations of serum transaminase levels; also contraindicated in pregnant and breast-feeding women and in women of childbearing age unless there is no risk of pregnancy.
Nursing considerations
Patient teaching
*Liquid contains alcohol. **May contain tartrazine. †Canada ‡Australia §U.K. OTCOver the counter
Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE-THREATENING