GMP certified Fluconazole capsules 150mg antifungal infections
drugs treatment of vaginal thrush,mucosal candidiasis
Each capsule contains fluconazole 150mg
Fluconazole capsule is indicated in the following fungal infections
Fluconazole capsule is indicated in adults for the treatment of:
• Cryptococcal meningitis
• 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
• 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
Fluconazole capsule is indicated in adults for the prophylaxis of:
• Relapse of cryptococcal meningitis in patients with high risk of
• 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 Hematopoietic Stem
Cell Transplantation ).
Fluconazole capsule is used for the treatment of mucosal
candidiasis (oropharyngeal, oesophageal), invasive candidiasis,
cryptococcal meningitis and the prophylaxis of candidal infections
in immunocompromised patients. Fluconazole capsule 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
Consideration should be given to official guidance on the
appropriate use of antifungals.
The dose should be based on the nature and severity of the fungal
infection. Treatment of infections requiring multiple dosing should
be continued until clinical parameters or laboratory tests indicate
that active fungal infection has subsided. An inadequate period of
treatment may lead to recurrence of active infection.
Infants, toddlers and children (from 28 days to 11 years old):
|- Mucosal candidiasis||Initial dose: 6 mg/kg Subsequent dose: 3 mg/kg daily||Initial dose may be used on the first day to achieve steady state
levels more rapidly|
|- Invasive candidiasis||Dose: 6 to 12 mg/kg daily||Depending on the severity of the disease|
|- Cryptococcal meningitis|
|- Maintenance therapy to prevent relapse of cryptococcal meningitis
in children with high risk of recurrence||Dose: 6 mg/kg daily||Depending on the severity of the disease|
|- Prophylaxis of Candida in immunocompromised patients||Dose: 3 to 12 mg/kg daily||Depending on the extent and duration of the induced neutropenia
(see Adults posology)|
Method of administration
Fluconazole capsule may be administered either orally or by
intravenous infusion, the route being dependent on the clinical
state of the patient. On transferring from the intravenous to the
oral route, or vice versa, there is no need to change the daily
The capsules should be swallowed whole and independent of food
Hypersensitivity to the active substance, to related azole
substances, or to any of the excipients.
Coadministration of terfenadine is contraindicated in patients
receiving Fluconazole capsule at multiple doses of 400 mg per day
or higher based upon results of a multiple dose interaction study.
Coadministration of other medicinal products known to prolong the
QT interval and which are metabolised via the cytochrome P450 (CYP)
3A4 such as cisapride, astemizole, pimozide, quinidine and
erythromycin are contraindicated in patients receiving fluconazole.
Special precautions for storage
Do not store above 25°C. Store in the original package.
Nature and contents of container
Blister PVC/Aluminium foil, Pack of 1 capsule in a carton