Fodisis Dosage/Direction for Use

The daily dose of FODISIS should be based on the nature and severity of the fungal infections. 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: For cryptococcal meningitis and cryptococcal infections at other sites, the usual dose is 400 mg on the first day followed by 200 mg to 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 patients receives a full course of primary therapy. FODISIS may be administered indefinitely at a daily dose of 200 mg.
For candidemia, disseminated candidiasis and other invasive candidal infections, the usual dose is 400 mg on the first 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.
For oropharyngeal candidiasis, the usual dose is 50 mg to 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 with denture.
For other candidal infections of mucosa except genital candidiasis (e.g. esophagitis, non-invasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc.) the usual effective dose is 50 to 100 mg daily, give for 14-30 days. For the prevention of relapse of oropharyngeal candidiasis in patients with AIDS, after the patient receives a full course of primary therapy. FODISIS may be administered at a 150 mg once weekly dose.
For Candida balanitis, FODISIS 150 mg should be administered as a single oral dose.
The recommended FODISIS dosage for the prevention of candidiasis is 50 to 400 mg once daily, based on patient's risk for developing fungal infection. For patients at high risk of systemic infection, e.g. patients who are anticipated to have profound or prolonged neutropenia, the recommended daily dose is 400 mg once daily. FODISIS administration should start several days before the anticipated onset of neutropenia, and continue for 7 days after the neutrophil count rises above 1000 cell per mm³.
A higher dose of 100 mg once dally may be used in patients at risk of severe recurrent infections.
For dermal infections including tinea pedis, corporis, cruris and candida infections, the recommended dosage is 150 mg once weekly or 50 mg once daily. Duration of treatment is normally 2 to 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 to 4 weeks. Duration of treatment should not exceed 6 weeks.
For the treatment of vaginal candidiasis, FODISIS 150 mg should be administered as a single dose.
Children: As stated in the precautions, use in children below the age of 16 years is not recommended. However, when the treating physician considers FODISIS therapy imperative, the following daily doses for children aged 1 year and older 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 aged 5-13, indicate FODISIS elimination may be faster than in adults. Therefore, for serious or life-threatening infections, higher daily doses used maybe 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, dependent on the degree of renal impairment.
Elderly: Where 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 described as follows.
Renal Impairment: FODISIS 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 FODISIS, an initial loading dose of 50 to 400 mg should be given. After the loading dose, the daily dose (according to indication) should be based on the following table: See table.


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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: See equation.


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