TYPE: Prescription

BRAND: Flucol

ACTIVE INGREDIENT: Fluconazole

STRENGTH & PACK SIZE & GMS CODES:

50 mg Capsules X 7 ~ 24817

150 mg Capsules X 1 ~ 24826

200 mg Capsules X 7 ~ 24840

2 mg/ml Solution for Infusion 100 ml x 1

 

INDICATION:

Flucol Capsules:

Flucol is indicated in adults for the treatment of:
 Cryptococcal meningitis (see section 4.4).
 Coccidioidomycosis (see section 4.4).
 Invasive candidiasis.
 Mucosal candidiasis including oropharyngeal, oesophageal candidiasis, candiduria and chronic mucocutaneous
candidiasis.
 Chronic oral atrophic candidiasis (denture sore mouth) if dental hygiene or topical treatment are insufficient.
 Vaginal candidiasis, acute or recurrent; when local therapy is not appropriate.
 Candidal balanitis when local therapy is not appropriate.
 Dermatomycosis including tinea pedis, tinea corporis, tinea cruris, tinea versicolor and dermal candida infections
when systemic therapy is indicated.
 Tinea unguinium (onychomycosis) when other agents are not considered appropriate.
Flucol is indicated in adults for the prophylaxis of:
 Relapse of cryptococcal meningitis in patients with high risk of recurrence.
 Relapse of oropharyngeal or oesophageal candidiasis in patients infected with HIV who are at high risk of
experiencing relapse.
 To reduce the incidence of recurrent vaginal candidiasis (4 or more episodes a year).
 Prophylaxis of candidal infections in patients with prolonged neutropenia (such as patients with haematological
malignancies receiving chemotherapy or patients receiving Haematopoietic Stem Cell Transplantation.

Flucol is indicated in term newborn infants, infants, toddlers, children, and adolescents aged from 0 to 17 years old:
Flucol is used for the treatment of mucosal candidiasis (oropharyngeal, oesophageal), invasive candidiasis, cryptococcal
meningitis and the prophylaxis of candidal infections in immunocompromised patients. Flucol can be used as maintenance
therapy to prevent relapse of cryptococcal meningitis in children with high risk of reoccurrence.

Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these
results become available, anti-infective therapy should be adjusted accordingly.
Consideration should be given to official guidance on the appropriate use of antifungals.

 

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