The daily dose of fluconazole should be based on the nature and severity of the fungal infection. Most cases of vaginal candidiasis respond to single-dose therapy.
Therapy for those types of infections requiring multiple-dose treatment should be continued until clinical parameters or laboratory tests indicate that active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection. Patients with AIDS and cryptococcal meningitis or recurrent oropharyngeal candidiasis usually require maintenance therapy to prevent relapse.
Adults: Cryptococcal Meningitis and Cryptococcal Infections at Other Sites:
Usual Dose: 400 mg on the 1st day followed by 200-400 mg once daily. Duration of treatment for cryptococcal infections will depend on the clinical and mycological response, but is usually at least 6-8 weeks for cryptococcal meningitis.
For the prevention of relapse of cryptococcal meningitis in patients with AIDS, after the patient receives a full course of primary therapy, fluconazole may be administered indefinitely at a daily dose of 200 mg.
Candidemia, Disseminated Candidiasis and Other Invasive Candidal Infections:
Usual Dose: 400 mg on the 1st day followed by 200 mg daily. Depending on the clinical response, the dose may be increased to 400 mg daily. Duration of treatment is based upon the clinical response.
Usual Dose: 50-100 mg once daily for 7-14 days. If necessary, treatment can be continued for longer periods in patients with severely compromised immune function.
For atropic oral candidiasis associated with dentures, the usual dose is 50 mg once daily for 14 days administered concurrently with local antiseptic measures to the denture.
For other candidal infections of mucosa (except genital candidiasis) eg, esophagitis, non-invasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc, the usual effective dose is 50-100 mg daily given for 14-30 days. For the prevention of relapse of oropharyngeal candidiasis in patients with AIDS, after patient receives a full course of primary therapy, fluconazole may be administered at a 150-mg once-weekly dose.
Treatment of Vaginal Candidiasis and Candida balanitis:
150 mg should be administered as a single oral dose.
Prevention of Candidiasis:
Recommended Dosage: 50-400 mg once daily, based on the patient's risk for developing fungal infection. For patients at high risk of systemic infection eg, patients who are anticipated to have profound or prolonged neutropenia, the recommended daily dose is 400 mg once daily. Fluconazole administration should start several days before the anticipated onset of neutropenia, and continue for 7 days after the neutrophil count rises >1000 cells/mm3
A higher dose of 100 mg once daily may be used in patients at risk of severe recurrent infections.
Dermal Infections Including Tinea Pedis, Corporis, Cruris and Candida Infections:
Recommended Dosage: 150 mg once weekly or 50 mg once daily. Duration of treatment is normally 2-4 weeks but tinea pedis may require treatment for up to 6 weeks. For tinea versicolor, the recommended dose is 50 mg once daily for 2-4 weeks. Duration of treatment should not exceed 6 weeks.
Use in children <16 years is not recommended. However, when the treating physician considers fluconazole therapy imperative, the following daily doses for children ≥1 year with normal renal function are recommended: 1-2 mg/kg for superficial candidal infections and 3-6 mg/kg for systemic candidal/cryptococcal infections.
These recommendations approximate the doses used in adults on a mg/kg basis. However, preliminary data in children 5-13 years indicate fluconazole elimination may be faster than in adults. Therefore, for serious or life-threatening infections, higher daily doses may be required. Daily doses up to 12 mg/kg have been used in a small number of children. The maximum approved adult daily dose of 400 mg should not be exceeded.
For children with impaired renal function, the daily dose should be reduced in accordance with the guidelines given for adults, depending on the degree of renal impairment.
When there is no evidence of renal impairment, normal dosage recommendations should be adopted. For patients with renal impairment (creatinine clearance <50 mL/min), the dosage schedule should be adjusted as follows:
Patients with Renal Impairment:
Fluconazole is predominantly excreted in the urine as unchanged drug. No adjustments in single-dose therapy are necessary. In patients with impaired renal function who will receive multiple doses of fluconazole, an initial loading dose of 50-400 mg should be given. After the loading dose, the daily dose (according to indication) should be based on the following table. (See table.)
Click on icon to see table/diagram/image
Patients on regular dialysis should receive 100% of the recommended dose after each dialysis; on non-dialysis days, patients should receive a reduced dose according to their creatinine clearance.
When serum creatinine is the only measure of renal function available, the following formula (based on sex, weight and age of the patients) should be based on the following equation:
Click on icon to see table/diagram/image
Fluconazole may be administered either orally or by IV infusion at a rate not exceeding 200 mg/hr given as a continuous infusion, the route being dependent on the clinical state of the patient. On transferring from the IV to the oral route or vice versa, there is no need to change the daily dosage. Capsules should be swallowed whole. Diflucan injection in glass containers is intended only for IV administration using sterile equipment. Fluconazole is formulated in 0.9 % sodium chloride solution, each 200 mg (100 mL bottle) containing 15 mmol each of Na+
. Because fluconazole is available as a dilute saline solution, in patients requiring sodium or fluid restriction, consideration should be given to the rate of fluid administration.