Form & Presentation

Single dose sachets.

Composition

Fluconazole.

Indications

FLUCAZOL is used to treat the following fungal infections:

In adults, for the treatment of:

• Cryptococcal meningitis (see section 4.4).
• Coccidioidomycosis (see section 4.4).
• Systemic candidiasis.
• Mucosal candidiasis, including oropharyngeal, esophageal, urinary, and chronic mucocutaneous candidiasis.
• Chronic atrophic oral candidiasis (denture pain) when oral care or topical treatment is inadequate.
• Acute or recurrent vaginal candidiasis when topical treatment is not possible.
• Penile candidiasis when topical treatment is not possible.
• Fungal skin infections, including tinea pedis, tinea corporis, tinea cruris, pityriasis versicolor, and candidal skin infections when systemic therapy is required.
• Nail fungus (onychomycosis) when other agents cannot be used.

In adults, for the prevention of:

• Recurrent cryptococcal meningitis in patients at risk of relapse.
• Recurrence of oropharyngeal or esophageal candidiasis in HIV patients at risk for relapse.
• Reduce the incidence of recurrent vaginal candidiasis (4 or more episodes per year).
• Prevention of Candida infections in patients with prolonged neutropenia (e.g. haematological oncology patients receiving chemotherapy or patients undergoing haematological stem cell transplantation) (see section 5.1).

FLUCAZOL is used in neonates, infants, children, and adolescents 0 to 17 years of age for:

• Treatment of mucosal candidiasis (oropharyngeal, esophageal).
• Treatment of systemic candidiasis and cryptococcal meningitis.
• Prevention of Candida infections in immunocompromised patients.
• FLUCAZOL may be used as prophylaxis to prevent recurrence of cryptococcal meningitis in children at risk of relapse (see section 4.4).

comments

Treatment may be initiated before the results of culture and other biological tests are known. However, once these results are available, anti-infective therapy should be adjusted accordingly.
Official recommendations for the appropriate use of antifungals should be followed.