DOTARA
FLUCONAZOLE · by CONTINENTAL PHARMA
Composition
Cap/Tab 50 mg/100 mg/150 mg/200 mg: Fluconazole 50 mg/100 mg/150 mg/200 mg Inj Per ml: Fluconazole 2 mg; 50 ml, 100 ml vial. Susp: Per 5 ml: Fluconazole 50 mg; after reconstitution
Indications & Dosage
Candidalbalanitis, Vaginal candidiasis: ORAL: Adult & Children above 16yrs: 150 mg for 1 dose. Vulvovaginal candidiasis (recurrent): ORAL: Adult: Initially 150 mg every 72 hours for 3 doses, then 150 mg once weekly for 6 months. Mucosal candidiasis (except genital): ORAL, OR BY IV INF: Children 1 month-11 yrs: 3-6 mg/kg, dose to be given onfirst day, then 3 mg/kg daily (max. per dose 100 mg); Adult & Children above 12yrs: 50 mg (oral)daily, increased to 100 mg daily for unusually difficult infections. Doses to be taken for7-14 days in oropharyngeal candidiasis (max. 14 days except in severely immunocompromised patients); for14-30 days in other mucosal infections. Tineapedis, corporis, cruris, pityriasisversicolor, Dermal Candidiasis: ORAL: Adult: 50 mg daily for 2-4 weeks (for up to 6 weeks in tineapedis); max. duration of treatment 6 weeks. Invasive candidal infections including candidaemia, disseminated candidiasis; and cryptococcal infections including meningitis: ORAL OR BY IV INF: Adult: 400 mg, dose to be given on first day, then200-400 mg daily (max. per dose 800 mg once daily); Children: 6-12 mg/kg daily (max. per dose 800 mg) treatment continued according to response (at least8 weeks for crypto coccal meningitis). Prevention of fungal infections in immunocompromised patients: ORAL OR BY IV INF: Adult: 50-400 mg daily; Children: 3-12 mg/kg daily (max. per dose 400 mg) Start treatment before anticipated onset of neutropenia and continue for 7 days after neutrophil count in desirable range. Prevention of relapse of cryptococcal meningitis in HIVinfectedpatients after completion of primary therapy: ORAL OR BY IV INF: Adult: 200 mg daily.
Administration
Administered by IV Infusion over approx 1-2 hours; do not exceed 200 mg/hour when giving IV Infusion. Standard diluent: 200 mg/100 ml NS (premixed); 400 mg/200 ml NS (premixed).
Compatibility
Stable in 135W, LR, NS.
Stability
Store vial at 5-30 degree centigrade. Do not freeze. Do not unwrap until ready for use.
Contraindications
Acute porphyrias
Precautions
Susceptibility to QT interval prolongation, renal impairment; reduced dose, hepatic impairment; toxicity with related drugs. Monitor liver function with high doses or extended courses; discontinue if signs orsymptoms of hepatic disease (risk of hepatic necrosis).
Interactions
Anticoagulants, oral sulfonylureas, phenytoin, cisapride, rifampicin, rifabutin, cyclosporin, astemizole, zidovudine, other drugs metabolised by P450, benzodiazepines.
Pregnancy
Contraindicated
Lactation
Contraindicated
Side Effects
Abdominal discomfort, diarrhoea, flatulence, headache, nausea, rash, alopecia, anaphylaxis, angioedema (in children), dizziness, dyspepsia, hepatic disorders, hyperlipidaemia, pruritus, seizures, Stevens-Johnson syndrome, taste disturbance, toxic epidermal necrolysis, vomiting, hypokalaemia, leucopenia, thrombocytopenia