Pregnancy Risk Category C
How supplied
Tablets: 50 mg, 100 mg, 150 mg, 200 mg
Powder for oral suspension: 10 mg/ml, 40 mg/ml
Injection: 200 mg/100 ml, 400 mg/200 ml
Action
Inhibits fungal cytochrome P-450 (responsible for fungal sterol synthesis) and weakens fungal cell walls.
Indications & dosage
Oropharyngeal candidiasis-
Adults: 200 mg P.O. or I.V. on first day, followed by 100 mg once daily. Therapy should last at least 2 weeks.
Children: 6 mg/kg P.O. or I.V. on first day, followed by 3 mg/kg daily for 2 weeks.
Esophageal candidiasis-
Adults: 200 mg P.O. or I.V. on first day, followed by 100 mg once daily. Higher doses (up to 400 mg daily) have been used, depending on patient's condition and tolerance of treatment. Patients should receive drug for at least 3 weeks and for 2 weeks after symptoms resolve.
Children: 6 mg/kg P.O. or I.V. on first day followed by 3 mg/kg daily for at least 3 weeks, and for at least 2 weeks after symptoms resolve. Doses up to 12 mg/kg may be used based on clinical judgment.
Vulvovaginal candidiasis-
Adults: 150 mg P.O. for one dose only or 50 mg P.O. daily for 3 days.
Systemic candidiasis-
Adults: 400 mg P.O. or I.V. on first day, followed by 200 mg once daily. Treatment should continue for at least 4 weeks and for 2 weeks after symptoms resolve.
Children: 6 to 12 mg/kg/day P.O. or I.V.
Cryptococcal meningitis-
Adults: 400 mg P.O. or I.V. on first day, followed by 200 mg once daily. Higher doses (up to 400 mg daily) may be used. Treatment should continue for 10 to 12 weeks after CSF cultures are negative.
Children: 12 mg/kg/day P.O. or I.V. on first day, followed by 6 mg/kg daily for 10 to 12 weeks after CSF culture is negative.
Prevention of candidiasis in bone marrow transplant-
Adults: 400 mg P.O. or I.V. once daily. Start prophylaxis several days before anticipated agranulocytosis. Continue therapy for 7 days after neutrophil count rises above 1,000 cells/mm3.
Suppression of relapse of cryptococcal meningitis in patients with AIDS-
Adults: 200 mg P.O. or I.V. daily.
Children: 3 to 6 mg/kg/day P.O. or I.V.
Adjust-a-dose: For renally impaired patients, if creatinine clearance is 11 to 50 ml/minute, dosage is reduced by 50%. Patients receiving regular hemodialysis treatment should receive the usual dose after each dialysis session.
Adverse reactions
CNS: headache, dizziness.
EENT: taste perversion.
GI: nausea, vomiting, abdominal pain, diarrhea, dyspepsia.
Hematologic: leukopenia, thrombocytopenia.
Hepatic: hepatotoxicity (rare), elevated liver enzymes.
Skin: rash, Stevens-Johnson syndrome (rare).
Other: anaphylaxis.
Interactions
Drug-drug. Cyclosporine, phenytoin, theophylline: may increase plasma concentrations of these drugs. Monitor serum cyclosporine or phenytoin levels.
Isoniazid, oral sulfonylureas, phenytoin, rifampin, valproic acid: increased incidence of elevated hepatic transaminases. Monitor closely.
Oral antidiabetics (glipizide, glyburide, tolbutamide): may increase plasma concentrations of these drugs. Monitor for enhanced hypoglycemic effect.
Rifampin: enhanced metabolism of fluconazole. Monitor for lack of response.
Warfarin: increased risk of bleeding. Monitor PT and INR.
Zidovudine: zidovudine activity may be increased. Monitor closely.
Drug-food. Caffeine: may increase caffeine plasma levels. Ofloxacin or lomefloxacin are alternative drugs.
Effects on diagnostic tests
None reported.
Contraindications
Contraindicated in patients with hypersensitivity to drug.
Nursing considerations
I.V. administration
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