Product Details

Zolen ®
Fluconazole
Antifungal

Brief:
Fluconazole

Indication:
ZOLEN (Fluconazole) is indicated for the treatment of the following infections : •Vaginal candidiasis and candidal balanitis •Mucosal candidiasis including oropharyngeal candidiasis, atrophic oral candidiasis associated with dentures •Other mucosal infections (e.g. oesophagitis, candiduria, non-invasive bronchopulmonary infections) •Tenia pedis, corporis, cruris, pityriasis versicolor and dermal candidiasis •Systemic/Invasive candidal infections (including candidaemia and disseminated candidiasis) and cryptococcal infections (including meningitis) •Prevention of relapse of cryptococcal meningitis in AIDS patients •Prevention of fungal infections in immunocompromised patients •Urinary tract infection and peritonitis •Cutaneous leishmaniasis

Dosage and administration:
Adults
Infections Dose Treatment Duration
Vaginal candidiasis and candidal balanitis a single dose of 150 mg.
Oropharyngeal candidiasis * 50 mg once daily 7-14 days
Atrophic oral candidiasis associated with dentures 50 mg once daily 14 days
Other mucosal infections (e.g. oesophagitis*,candiduria, non-invasive bronchopulmonary infections) 50 mg once daily 14-30 days
Tenia pedis, corporis, cruris, pityriasis versicolor,and dermal candidiasis 50 mg once daily 2-4 weeks (for up to 6 weeks in tenia pedis
Systemic/Invasive candidal infections (including candidaemia, disseminated candidiasis, pneumonia) and
cryptococcal infections (including meningitis)
400 mg initially then 200 mg daily, increased if necessary to 400 mg daily Treatment continued according to response (at least 6-8 weeks for cryptococcal meningitis)**
Prevention of relapse of cryptococcal meningitis in AIDS patients 100 mg to 200 mg daily
Prevention of fungal infections in immunocompromised patients 50-400 mg daily adjusted according to risk; 400 mg daily if high risk of systemic infections e.g. following bone-marrow transplantation; commence treatment before anticipated onset of neutropenia and continue for 7 days after neutrophil count in desirable range.
Urinary tract infection and peritonitis 50-200 mg daily
Cutaneous leishmaniasis 200 mg daily 6 weeks
∗Higher doses are recommended in the USA where an initial dose of Fluconazole 200 mg is followed by 100 mg daily and doses up to 400 mg daily may be used if necessary.∗∗ In the USA 10-12 weeks. Children (over 4 weeks) : Mucosal candidiasis 6 mg/kg on first day then 3 mg/kg daily. Systemic/Invasive candidal infections (including candidaemia and disseminated candidiasis) and cryptococcal infections (including meningitis) :12 mg/kg on first day then 6 mg/kg daily. Prevention of fungal infections in immunocompromised patients : according to extent and duration of neutropenia, 3-12 mg/kg daily. Infant (2-4 weeks) :Same dose of older children (over 4 weeks) but every 48 hours. Infant (under 2 weeks) :Same dose of older children (over 4 weeks) but every 72 hours. A maximum dose of 400 mg daily should not be exceed in children or 12 mg/kg at appropriate intervals in infants. In renal impairment :Normal loading or initial doses of Fluconazole should be given on the first day of treatment and subsequent doses should be adjusted according to Creatinine Clearance (CC). CC >50 ml/min:standard dose; CC <50 ml/min and the patient is not receiving dialysis: ½ the standard dose; patients on regular haemodialysis: standard dose after every dialysis session. No dosage adjustment is needed in single-dose therapy.

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Tel: 9863026, 8856717
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