Fluconazole for oral Suspension USP 50mg/5ml
Fluconazole has demonstrated activity against opportunistic mycoses, such as infections with Candida spp, including intracranial infections; with Microsporium spp; and with Trichophyton spp. Fluconazole has also been shown to be active in animal models of endemic mycoses, including infections with Blastomyces dermatitidis, with Coccidioides immitis, including intracranial infection and with Histoplasma capsulatum in normal and immunosuppressed animals.
Ficomed® contains fluconazole, a member of the triazole class of antifungal agents. It blocks the demethylation of lanosterol to ergosterol, the main sterol of fungal membranes, thereby potently inhibiting fungal sterolsynthesis.
After oral administration, fluconazole is well absorbed and plasma levels (and systemic bioavailability) are over 90% of the levels achieved after intravenous administration. Oral absorption is not affected by concomitant food intake.
Fluconazole achieves good penetration into all body fluids studied. Sputum and saliva levels of fluconazole are similar to plasma levels. In patients with fungal meningitis, fluconazole levels in the CSF are approximately 80% of corresponding plasma levels.
The major route of excretion is renally with approximately 80% of the administered dose appearing in the urine as unchanged drug.
INDICATIONS AND DOSAGE
Fluconazole is administered as a single dose each day.
Children 28 days to 17 years old
- Oropharyngeal Candidiasis: The recommended dosage for oropharyngeal candidiasis in children is 6mg/kg body weight on the first day of therapy, followed by 3mg/kg once daily. Treatment should be administered for at least 2 weeks to decrease the likelihood of relapse.
- Esophageal Candidiasis: The recommended dosage is 6mg/kg on the first day followed by 3mg/kg once daily. Dosage of up to 12mg/kg/day may be used based on patient’s response to therapy. Patients with esophageal candidiasis should be treated for a minimum of 3 weeks and for at least 2 weeks after the resolution of symptoms.
- Systemic Candida Infections: For the treatment of candidemia and disseminated candida infections, daily doses of 6-12mg/kg/day have been used in an open, noncomparative study of a small number of children.
- Cryptococcal meningitis: For the treatment of acute cryptococcal meningitis, the recommended dosage is 12mg/kg on the first day followed by 6mg/kg once daily. A dosage of 12mg/kg once daily may be used based on the medical judgement of the patient’s response to therapy. The recommended duration of treatment for initial therapy of cryptococcal meningitis is 10-12 weeks after the cerebrospinal fluid becomes culture negative. For suppression of relapse of cryptococcal meningitis in children with AIDS, the recommended dose of is 6mg/kg/once daily.
- Skin Infections(dermatomycosis): athlete’s foot, ringworm and jock itch. 6mg/kg on the first day followed by 3mg/kg once daily on subsequent days.
For the prevention of fungal infections in immunocompromised children considered at risk as a consequence of neutropenia following cytotoxic chemotherapy, the dose should be 3-12 mg/kg body weight daily, depending on the extent and duration of the induced neutropenia.
Children from birth to 28 days old
During the first 2 weeks of life, the same doses in mg/kg as for older children must be used, but administered every 72 hours. In children 3 to 4 weeks of age, the dose should be administered every 48 hours. The maximum dosage of 12mg/kg in the stated periods should not be exceeded.
Ficomed® is generally well tolerated, common side effects are symptoms related to gastrointestinal tracts: Mild to moderate nausea, vomiting, abdominal pain and diarrhea.
Others: Rash, headache, and in rare cases as with other azoles, anaphylaxis has been reported.
Before reconstitution, store dry powder at a temperature not exceeding 30°C. After reconstitution, immediately store suspension between 2 – 8° C in a refrigerator. Reconstituted suspension should be used within 2 weeks.
NOT TO BE FROZEN
Protect from light. SHAKE WELL BEFORE USE.
70ml HDPE bottle to be packed in carton along with pack insert.
Ficomed® Suspension is a registered trade mark of FilGap Healthcare Limited.