HOW SUPPLIED

Tablets: 50 mg, 100 mg, 150 mg, 200 mg Powder for oral suspension: 10 mg/ml, 40 mg/ml

Injection: 200 mg/lOO 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 LV. 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 mglkg P.O. or LV. 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 LV. 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 LV.

Cryptococcal meningitis _

Adults: 400 mg P.O. or LV. 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.

Dosage adiustment: 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: leukopenilJ, thrombocytocnia.

Hepatic: hepatotoxicity (rare), elevated liver enzymes.

Skin: rash, Stevens-Johnson syndrome (rare).

Other: anaphylaxis.

INTERAOIONS

Drug-drug. Cyclosporine, phenytoin, theophylline: may increase plasma concentrations of these drugs. Serum cyclosporine or phenytoin levels must be monitored.

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. Enhanced hypoglycemic effect may occur.

Rifampin: enhanced metabolism of fluconazole. Lack of response may occur. Warfarin: increased risk of bleeding. PT and INR must be monitored. 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.

SPECIAL CONSIDERATIONS

' Use drug cautiously in patients with hypersensitivity to other antifungal azole Compounds; no data exist regarding crosssensitivity.

' Liver function tests are periodically monitored during prolonged therapy.

' If patient develops mild rash, it must be monitored closely. Drug is discontinued if lesions progress.

' Incidence of adverse reactions appears to be greater in HIV-infected patients.

I. V. administration

' Protective overwrap from LV. bags must not be removed until just before use to ensure product sterility. The plastic container may show some opacity from moisture absorbed during sterilization. This does not affect the drug and diminishes over time. Other drugs should not be added to the I.V. bag.

' Alert: The drug is administered by continuous infusion at a rate not to exceed 200 mg/hour. An infusion pump is used. To prevent air embolism, connecting in a series with other infusions is not recommended. Other drugs are not added to the solution.

Patient teaching

' Take drug as directed, even after he feels better.

' Report adverse reactions promptly.