Fluconazol-BP (tab)

Fluconazolum

Fluconazole-BP 50 mg tablets: each tablet contains fluconazole 50 mg. Fluconazole-BP 100 mg tablets: fluconazole 100 mg. Fluconazole-BP 150 mg tablets: fluconazole 150 mg.

Indication: Treatment of systemic and local fungal infections in adults (cryptococcal meningitis, coccidioidomycosis, invasive candidiasis, mucosal candidiasis — oropharyngeal, oesophageal, candiduria, chronic mucocutaneous candidiasis, chronic atrophic oral candidiasis, vaginal candidiasis and candidal balanitis, dermatomycoses incl. tinea pedis/corporis/cruris/versicolor and onychomycosis) and prevention of their relapse in high-risk patients; also indicated in neonates, infants, children and adolescents for similar indications.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications
Hypersensitivity to the active substance, to other related azole compounds, or to any of the excipients. Administration of terfenadine is contraindicated in patients being treated with Fluconazole-BP in multiple doses of 400 mg or more per day, based on the results of a drug interaction study using multiple doses. Concomitant administration of other medicinal products that prolong the QT interval and are metabolised via the cytochrome P450 (CYP) 3A4 pathway, such as cisapride, astemizole, pimozide, quinidine and erythromycin, is contraindicated in patients being treated with fluconazole (see sections 4.4 and 4.5).

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use
Candidiasis
Studies have shown an increased prevalence of infections with Candida species other than C. albicans. These are often inherently resistant (e.g. C. krusei and C. auris) or show reduced susceptibility to fluconazole (C. glabrata). Such infections may require alternative antifungal treatment following therapeutic failure. Prescribers are therefore advised to take into account the prevalence of fluconazole resistance among different Candida species.
Tinea capitis
Studies have been conducted on the use of fluconazole for the treatment of tinea capitis in children. It has been shown not to be superior to griseofulvin, and the overall success rate was below 20%. Fluconazole-BP should therefore not be used for the treatment of tinea capitis.
Cryptococcosis
The available data on the efficacy […]