Indications : התוויות

Therapeutic indications                                                                                         Patients have rarely developed exfoliative cutaneous reactions, such as Stevens-Johnson
syndrome and toxic epidermal necrolysis, during treatment with fluconazole. AIDS patients are
Fluconazole Baxter 2 mg/ml is indicated in the following fungal infections (see section 5.1).                   more prone to the development of severe cutaneous reactions to many medicinal products. If a
rash, which is considered attributable to fluconazole, develops in a patient treated for a superficial
Fluconazole Baxter 2 mg/ml is indicated in adults for the treatment of:                                         fungal infection, further therapy with this medicinal product should be discontinued. If patients with
invasive/systemic fungal infections develop rashes, they should be monitored closely and
•       Cryptococcal meningitis (see section 4.4).                                                              fluconazole discontinued if bullouslesions or erythema multiforme develop.
•       Coccidioidomycosis (see section 4.4).Invasive candidiasis.
•       Mucosal candidiasis including oropharyngeal candidiasis, oesophageal candidiasis,                       Hypersensitivity
candiduria and chronic mucocutaneous candidiasis.                                                       In rare cases anaphylaxis has been reported (see section 4.3).
•       Chronic oral atrophic candidiasis (denture sore mouth) if dental hygiene or topical treatment
are insufficient.                                                                                       Cytochrome P450
Fluconazole is a moderate CYP2C9 and CYP3A4 inhibitor. Fluconazole is also a strong inhibitor of
Fluconazole Baxter 2 mg/ml is indicated in adults for the prophylaxis of:                                       CYP2C19.Fluconazole treated patients who are concomitantly treated with medicinal products
with a narrow therapeutic window metabolised through CYP2C9, CYP2C19 and CYP3A4, should
•     Relapse of crytopcoccal meningitis in patients with high risk of recurrence.                              be monitored (see section 4.5).
•     Relapse of oropharyngeal or oesophageal candidiasis in patients infected with HIV who are
at high risk of experiencing relapse.                                                                     Terfenadine
•     Prophylaxis of candidal infections in patients with prolonged neutropenia (such as patients               The coadministration of fluconazole at doses lower than 400 mg per day with terfenadine should be
with haematological malignancies receiving chemotherapy or patients receiving                             carefully monitored (see sections 4.3 and 4.5).
Hematopoietic Stem Cell Transplantation (see section 5.1)).
Fluconazole q Baxter 2 mg/ml is indicated in term newborn infants, infants, toddlers, children and              Excipients
adolescents aged from 0 to 17 years old:                                                                        This medicinal product contains 0.154 mmol sodium per ml. To be taken into consideration by
patients on a controlled sodium diet.
Fluconazole Baxter 2 mg/ml is used for the treatment of mucosal candidiasis (oropharyngeal,
oesophageal), invasive candidiasis, cryptococcal meningitis and the prophylaxis of candidal               4.5   Interaction with other medicinal products and other forms of interaction
infections in immunocompromised patients. Fluconazole Baxter 2 mg/ml can be used as
maintenance therapy to prevent relapse of cryptococcal meningitis in children with high risk of                 Concomitant use of the following other medicinal products is contraindicated:
reoccurrence (see section 4.4).
Cisapride: There have been reports of cardiac events including torsades de pointes in patients to
Therapy may be instituted before the results of the cultures and other laboratory studies are known;            whom fluconazole and cisapride were coadministered. A controlled study found that concomitant
however, once these results become available, anti-infective therapy should be adjusted                         fluconazole 200 mg once daily and cisapride 20 mg four times a day yielded a significant increase
accordingly.                                                                                                    in cisapride plasma levels and prolongation of QTc interval. Concomitant treatment with
fluconazole and cisapride is contraindicated (see section 4.3).
Consideration should be given to official guidance on the appropriate use of antifungals.
Terfenadine: Because of the occurrence of serious cardiac dysrhythmias secondary to