Home » Anti Fungal & Antiviral » Biozole (Diflucan)
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Brand names: Biozole, Diflucan
Generic name: Fluconazole
Biozole Capsule 200 mg. Each capsule contain Fluconazole 200mg
Fluconazole is indicated for the treatmen of the folowing conditions.
1. Cryptococcosis including cryptococcal meningitis and infection of other sites (eg pulmonary, cutaneous). Normal hosts, and patients with AIDs, organ transplants or other causes of immunosuppression may be treated. Fluconazole can be used as maintainance therapy to prevent relapse of cryptococcal disease in patients with AIDs.
2. Systemic candidiasis including candidemia, disseminated candidiasis and other forms of invasive candidal infection including infections of the peritoneum, endocardium and pulmonary and urinary tracts. Patients with malignancy, in intensive care utits, receiving cytotoxic or immunosuppressive therapy, or with other factors predisposing to candidal infection may be treated.
3. Mucosal Candidiasis These include oropharyngeal, esophageal, noninvasive bronchopulmonary infections, condiduria, mucocutaneous and chronic oral atrophic candidiasis (denture sore mouth) Normal hosts and patents with compromised immune function may be treated.
4. Vaginal candidiasis acute or recurrent.
5. Prevention of fungal infection in patients with malignancy who are predisposed to such infections as a result of cytotoxic chemotherapy or radiotherapy.
6. Dematomycosis including tinea pedis, tinea corporis, tinea cruris, tinea versicolor and candida infections.
Dosage and administration
1. For cryptococcal menngitis and cryptococcal infections at other sites, the usual dose is 400mg on the first day followed by 200mg once daily. Depending on the clinical response of the patient this dose may be increased to 400mg daily. Usually, duration of treatment for cryptococcal meningtis is 6-8 weeks.
For prevention of Relapse of cryptococcal meningitis in patients with AIDs. after the patient receives a full course of primary therapy. Fluconazole may be administered indefinitely at a daily dose of at least 200mg.
2. For candidemia, disseminated candidiasis and other incasive candidal infections, the usual dose is 400mg on the first day followed by 200mg daily. Depending on the clinical response, the dose may be increased to 400mg daily. Duration of treatment is based upson the clinical response.
3. For oropharyngeal candidiasis, the usual dose is 50mg once daily for 7-14 days. If ecessary, treatment can be continued for longer periods in patients with severely compromised immune function.
For atrophic oral candidiasis associated with dentures, the usual dose is 50mg once daily for 14 days administered concurrently with local antiseptic measure to the denture.
For other candidal infections of mucosa, (except vaginal candidiasis, see the following), eg esophagitis, non-incasive bromchopulmonary infections, candiduria, mucocutaneous candidiasis, etc, the usual effective dose is 50mg dailym given for 14-30 days. In unusually difficult cases of mucosal candidal infections, the dose may be increased to 100mg daily.
4. For vaginal candidiasis, fluconazole 150mg should be administered as a single oral dose.
5. For the prevention of cungal infections in patients with malignancy. the dose should be 50mg once daily while the patient is at risk as a consequence of receiving cytotoxic chemotherapy or radiotherapy.
6. For dermal infections including tinea pedis, tinea corporis, tinea cruris and candida infections the recommended dosage is 150mg once weekly or 50mg once daily Duration of treatment is normally for 2-4 weeks but tinea pedis may require treatment for up to 6 weeks. For tinea vesicolor, the recommended dose is 50mg once daily for 2-4 weeks.
Use in children below the age of 16 is not recommended, where the treating physician considers. Fluconazole therapy imperative, the following doses are proposed :
For children age >1 year with normal renal function, the recommended daily doses is 1-2mg/kg for superficial candidal infection, and 3-6mg/kg for systemic candidak/cryptococal infections.
For children with impaired renal unction, the daily doses should be reduced in accordance with the guidelines given for adults, dependent on the degree of renal impairment.
Where ther is no evidence of renal impairment, normal dosage recommendations should be adopted. For patients with renal impaiment (creatinineclearance < 40ml/min) the dosage schedule should be adjusted as described in the following table.
Creatinine clearance (ml/min) Dosage intervals/Daily dose
> 40 24 hrs. (normal dosage regimen)
21 - 40 48 hrs. or half normal faily dose
10 - 20 72 hrs. or one-third normal daily dose
Patients receiving regular dialysis One dose after every dialysis session
Fluconazole should not be used in patients with known sensitivity to the drugs or to related azole compounds.
Use in pregnancy & Lactation
Use in pregnancy should be avoided except in patients with severe or potentially life - threatening fungal infections in whom flucanazole may be used if the anticipated benefit outweighs the possible risk ti the fetus.
Fluconazole is found in human breast milk, hence its use in nursing mothers is not recommended.
The most common side effects associated with fluconazole are symptoms related to the gastrointestinal tract. These include nausea, abdominal pain diarrhea to the gastrointestinal tract. These include nausea, abdominal pain diarrhea and flatilence, the second most commonly observed side effect was rash. In some patients particularly those with serious underlying diseases eg AIDs and cancer, changes in renal and hematological functicntest results and hepatic abnormalities have been observed during treatment with fluconazole and comparative agents, but the clinical significance and relationship to treatment is uncertain.
Patients with AIDS are more prone to the development of servere cutaneous reactions to many drugs. A small number of AIDS patients have developed such reaction, usually while receiving fluconazole concomitantly with other agents know to be associated with exfoliative cutaneous reactions. If a rash develops in a patient treated for a superficial fungal infection which is considered attributable to fluconazole, further therapy with this agent should be discontinued. If patients with invasive/systemic fungal infections develop rashes, they should be monitored closely and fluconazole discontinued if bullous lesions or erythema multiform develop. In rare cases, as with other azoles anaphylaxis has been reported.