F-Zol IV Infusion

Indication

1. Cryptococcosis, including cryptococcal meningitis and infections of other sites (e.g. pulmonary, cutaneous). F-ZolTM IV Infusion can be used as maintenance therapy to prevent relapse of cryptococcal disease in patients with AIDS.
2. Systemic candidiasis including candidaemia, disseminated candidiasis and other forms of invasive candidal infection including infections of the peritoneum, endocardium and pulmonary and urinary tracts. Patients with malignancy, in intensive care units, receiving cytotoxic or immunosuppressive therapy, or with other factors predisposing to candidal infection may be treated.
3. Mucosal candidiasis. These include oropharyngeal, oesophageal, non-invasive bronchopulmonary infections, candiduria, mucocutaneous and chronic oral atrophic candidiasis (denture sore mouth).
4. Vaginal candidiasis, acute or recurrent.
5. Prevention of fungal infection in immunocompromised patients considered at risk as a consequence of HIV infections or neutropenia following cytotoxic chemotherapy, radiotherapy or bone marrow transplant


Dosage & Administration

The daily dose of F-ZolTM 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.
Adults:

  • Cryptococcal meningitis and cryptococcal infections at other sites: The usual dose is 400 mg (2 bags) on the first day followed by 200 to 400 mg (1-2 bags) 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.
  • Prevention of relapse of cryptococcal meningitis in AIDS patients: After the patient receives a full course of primary therapy, Fluconazole 0.2% may be administered indefinitely at a single daily dose of 200 mg (1 bag).
  • Candidaemia, disseminated candidiasis and other invasive candidal infections: The usual dose is 400 mg on the first day followed by 200 mg (1 bag) once daily. Depending on the clinical response, the dose may be increased to 400 mg (2 bags) once daily. Duration of treatment is based upon the clinical response.
  • Oropharyngeal candidiasis: The recommended dosage of Fluconazole IV for oropharyngeal candidiasis is 200 mg on the first day, followed by 100 mg once daily. Clinical evidence of oropharyngeal candidiasis generally resolves within several days, but treatment should be continued for at least 2 weeks to decrease the likelihood of relapse.
  • For other candidal infections of mucosa (except vaginal candidiasis), e.g. oesophagitis, candiduria, mucocutaneous candidiasis etc., the usual effective dose is 50 mg daily, given for 14-30 days. In unusually difficult cases of mucosal candidal infections the dose may be increased to 100 mg daily.
  • Prevention of fungal infections in immunocompromised patients: The dose should be 50 mg once daily while the patient is at risk as a consequence of receiving cytotoxic chemotherapy, radiotherapy or bone marrow transplant. A higher dose of 100 mg/day may be used in patients at risk of severe recurrent infections.
  • Dermatomycoses: The usual dosage is 50 mg once daily or 150 mg once weekly for two to four weeks. Tinea pedis may require treatment for up to six weeks.
Children: F-Zol IV Infusion is administered as a single dose each day.
  • Mucosal candidiasis: 3 mg/kg daily. A loading dose of 6 mg/kg may be used on the first day to achieve steady state levels more rapidly.
  • Systemic candidiasis and cryptococcal infection: 6-12 mg/kg daily, depending on the severity of the disease. Children 4 weeks of age and younger: Neonates excrete fluconazole slowly. In the first two weeks of life the same mg/kg dosing as in older children should be used but administered every 72 hours. During weeks 3 and 4 of life the same dose should be given every 48 hours.


Precautions

Anaphylaxis has been reported in rare instances. Patients who develop abnormal liver function tests during, Fluconazole IV Infusion therapy should be monitored for the development of more severe hepatic injury. Fluconazole IV Infusion should be discontinued if clinical signs and symptoms consistent with liver disease develop that may be attributable to fluconazole. If rash which is attributable to fluconazole develops in a patient treated for a superficial fungal infection, Fluconazole IV Infusion should be discontinued. If patients with

invasive/systemic fungal infections develop rashes, they should be monitored closely and Fluconazole IV Infusion discontinued if bullous lesions or erythema multiforme develop. Some azoles, including fluconazole, have been associated with prolongation of the QT interval on the electrocardiogram.

Use in Pregnancy & Lactation:
Use in pregnancy should be avoided except in patients with severe or potentially life-threatening fungal infections in whom fluconazole may be used if the anticipated benefit outweighs the possible risk to the fetus. Fluconazole IV Infusion is found in human breast milk at concentrations similar to plasma, hence its use in nursing mothers is not recommended.

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