Fluconazole 50mg/5ml oral suspension

Summary of Product characteristics

                                OBJECT 1
FLUCONAZOLE 50MG/5ML POWDER FOR ORAL
SUSPENSION
Summary of Product Characteristics Updated 18-Apr-2017 | Genus
Pharmaceuticals
1. Name of the medicinal product
Fluconazole 50mg/5ml Powder for Oral Suspension
2. Qualitative and quantitative composition
Each 5ml of oral suspension contains 50mg of fluconazole
For a full list of excipients see section 6.1.
3. Pharmaceutical form
Powder for oral suspension.
The powder is almost white. A whitish suspension is obtained after its
reconstitution with water.
4. Clinical particulars
4.1 Therapeutic indications
Fluconazole is indicated in the treatment of mycoses caused by
Candida, Cryptococcus and other
susceptible yeast, in particular:
1. Mucosal candidiasis: These include oropharyngeal candidiasis,
oesophageal, non-invasive
bronchopulmonary infections, candiduria, mucocutaneous candidiasis and
chronic atrophic oral
candidiasis (denture sore mouth). Both normal hosts and
immunocompromised patients may be treated.
2 Systemic candidiasis (including disseminated deep infections and
peritonitis).
3. Acute cryptococcal meningitis in adults, including patients with
AIDS, transplanted patients or other
patients with other causes of immunosuppression.
4. Genital candidiasis. Acute or recurrent vaginal candidiasis.
Candida balanitis. The treatment of partners
who present with symptomatic genital candidiasis should be considered.
5. Prevention of fungal infections in patients predisposed to such
infections as a result of chemotherapy or
radiotherapy, including bone transplant patients.
6. Dermatomycosis, including infections such as Tinea pedis, Tinea
corporis, Tinea cruris, Tinea
versicolor. Fluconazole is not indicated for nail infections and tinea
capitis.
Use in children
Fluconazole should not be used for tinea capitis.
Consideration should be given to official guidance on the appropriate
use of antimycotic agents. Before
initiating treatment, samples should be taken for microbiological
analysis and the suitability of the
therapy should be subsequently confirmed (see s
                                
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