Active Member
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[China]
Address: Room 1307,Unit 4,St Honest Sunshine Regency, Happiness Street, Houhu Avenue,. Jiang an Dist, Hubei province ,P.R.OF CHINA.
Contact name:
Wuhan uni-pharma bio-tech co.,ltd |
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GMP certified Fluconazole capsules 150mg antifungal infections drugs treatment of vaginal thrush,mucosal candidiasis
Composition
Each capsule contains fluconazole 150mg
Therapeutic indications
Fluconazole capsule is indicated in the following fungal infections .
Fluconazole capsule is indicated in adults for the treatment of:
• Cryptococcal meningitis
• Coccidioidomycosis
• 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 not appropriate.
• 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 considered appropriate.
Fluconazole capsule is indicated in adults for the prophylaxis of:
• Relapse of cryptococcal meningitis in patients with high risk of recurrence.
• 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 accordingly.
Consideration should be given to official guidance on the appropriate use of antifungals.
Dosage
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):
| Indication | Posology | Recommendations |
| - 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 dose.
The capsules should be swallowed whole and independent of food intake.
Contraindications
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.
Blister PVC/Aluminium foil, Pack of 1 capsule in a carton
