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TREFLUCAN
Composition Each capsule contains:
Fluconazole 150 mg
Properties and Mode of Action TREFLUCAN is a triazole antifungal agent. It inhibits cytochrome P-450 dependent enzymes resulting in impairment of ergosterol synthesis in fungal cell membranes.
Its activity has been demonstrated against Candida species, Dermatophytosis, Blastomyces dermatitidis, Coccidioides immitis, Cryptococcus neoformans, Histoplasma capsulatum, and Aspergillus spp..
Indications
For Adults:
Vaginal Candidiasis, Candidal Balanitis:
150 mg single dose.
Dermatophytosis including Tinea Corporis, Cruris, Pedis and Pityriasis Versicolor:
150 mg once weekly for 4-6 weeks.
Onychomycosis:
150 mg once weekly.
Treatment must be continued until the infected nail is replaced. This usually requires 3 - 6 months for finger nails and 6 - 12 months for toe nails.
Oropharyngeal and Oesophageal Candidiasis:
50 mg daily for 7 - 14 days in oropharyngeal and 14 - 30 days in oesophageal candidiasis or 200 mg initial dose followed by 100 mg daily for 2 weeks in oropharyngeal candidiasis, and a minimum of 3 weeks in oesophageal candidiasis.
Systemic Candidiasis and Cryptococcal Meningitis:
400 mg as initial dose followed by 200 mg daily.
Duration of treatment is based on the clinical and mycological response (may be up to 8 weeks in cryptococcal meningitis).)
As a Prophylaxis in Immunocompromised Patients with High Risk of Fungal Intections
50 - 400 mg daily.
Precautions Fluconazole has been associated with rare cases of hepatic reactions especially in patients with severe underlying diseases and hepatic dysfunction. This is usually reversible on discontinuation of therapy. Patients who develop abnormal liver function tests during fluconazole therapy should be monitored for the development of more severe hepatic injury, and fluconazole should be discontinued.
Patients with Impaired Renal Function:
Those who will receive multiple doses are given an initial dose of 50 - 400 mg. After that base the daily dose according to creatinine clearance as follows: | Creatinine clearance (ml / min.) | Percent of recommended dose | > 50 11 - 50 | 100 % 50 % |
Patients receiving regular dialysis:
One recommended dose after each dialysis.
Drug Interactions
TREFLUCAN may interfere with the metabolism of some drugs if given concomitantly through inhibition of cytochrome P-450. This may account for reported increase in plasma concentration of phenytoin, sulphonylurea hypoglycaemics and cyclosporins.
Concomitant administration of rifampicin and TREFLUCAN results in reduced plasma concentrations of TREFLUCAN.
The use of TREFLUCAN with astemizole, terfenadine and cisapride should be avoided because of the risk of cardiac arrhythmias.
Administration of hydrochlorothiazide and TREFLUCAN may result in increased serum TREFLUCAN concentrations.
Contra_indications Hypersensitivity to fluconazole.
Pregnancy (used only if the potential benefit justifies the possible risk). Lactation.
Side effects
Side effects with TREFLUCAN affect most commonly the gastrointestinal tract and include: nausea, vomiting, flatulence or diarrhoea.
Others include: headache, dizziness, leucopenia, thrombocytopenia, skin reactions and raised liver enzymes.
Presentation
Box of 1 strip of 1 capsule.
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