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Diflucan

1. NAME OF THE MEDICINAL PRODUCT

DIFLUCAN

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
DIFLUCAN contains as its active ingredient fluconazole 50 mg, 100 mg and 150 mg as capsules, and as 2 mg/ml in a saline solution for intravenous infusion.

Fluconazole is a bis-triazole, having the following chemical name : 2-(2, 4-difluorophenyl)-1, 3-bis (1 H, 2, 4-triazol-1-yl)2-propanol. It has a molecular weight of 306.3.

3. PHARMACEUTICAL FORM
Capsule and solution for intravenous infusion.

4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
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.
1. Cryptococcosis, including cryptococcal meningitis and infections of other sites (e.g., pulmonary, cutaneous). Normal hosts and patients with AIDS, organ transplants or other causes of immunosuppression may be treated. Fluconazole can be used as maintenance 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. These include infections of the peritoneum, endocardium, eye, and pulmonary and urinary tracts. Patients with malignancy, in intensive care units, receiving cytotoxic or immunosuppressive therapy, or with other factors predisposing to candidal infection may be treated.

3. Mucosal candidiasis. These include oropharyngeal, esophageal, non-invasive bronchopulmonary infections, candiduria, mucocutaneous and chronic oral atrophic candidiasis (denture sore mouth). Normal hosts and patients with compromised immune function may be treated. Prevention of relapse of oropharyngeal candidiasis in patients with AIDS.

4. Genital candidiasis. Vaginal candidiasis, acute or recurrent; and prophylaxis to reduce the incidence of recurrent vaginal candidiasis (3 or more episodes a year). Candidal balanitis.

5. Prevention of fungal infections in patients with malignancy who are predisposed to such infections as a result of cytotoxic chemotherapy or radiotherapy.

6. Dermatomycosis including tinea pedis, tinea corporis, tinea cruris, tinea versicolor, and dermal candida infections.

4.2 Posology and Method of Administration
The daily dose of fluconazole should be based on the nature and severity of the fungal infection. Most cases of vaginal candidiasis respond to single dose therapy. Therapy for those types of infections requiring multiple dose treatment 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. Patients with AIDS and cryptococcal meningitis or recurrent oropharyngeal candidiasis usually require maintenance therapy to prevent relapse.

Use In Adults
1. For cryptococcal meningitis and cryptococcal infections at other sites, the usual dose is 400 mg on the first day followed by 200 to 400 mg once daily. Duration of treatment for cryptococcal infections will depend on the clinical and mycological response, but is usually at least 6-8 weeks for cryptococcal meningitis.
For the 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 200 mg.

2. For candidemia, disseminated candidiasis and other invasive candidal infections, the usual dose is 400 mg on the first day followed by 200 mg daily. Depending on the clinical response, the dose may be increased to 400 mg daily. Duration of treatment is based upon the clinical response.

3. For oropharyngeal candidiasis, the usual dose is 50 to 100 mg once daily for 7-14 days. If necessary, 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 50 mg once daily for 14 days administered concurrently with local antiseptic measures to the denture.
For other candidal infections of mucosa except genital candidiasis [see below] (e.g., esophagitis, non-invasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc.) the usual effective dose is 50 to 100 mg daily, given for 14-30 days.
For the prevention of relapse of oropharyngeal candidiasis in patients with AIDS, after the patient receives a full course of primary therapy, fluconazole may be administered at a 150 mg once weekly dose.

4. For the treatment of vaginal candidiasis, fluconazole 150 mg should be administered as a single oral dose.
To reduce the incidence of recurrent vaginal candidiasis, a 150 mg once monthly dose may be used. The duration of therapy should be individualized, but ranges from 4-12 months. Some patients may require more frequent dosing.
For Candida balanitis, fluconazole 150 mg should be administered as a single oral dose.

5. The recommended fluconazole dosage for the prevention of candidiasis is 50 to 400 mg once daily, based on the patient's risk for developing fungal infection. For patients at high risk of systemic infection, e.g., patients who are anticipated to have profound or prolonged neutropenia, the recommended daily dose is 400 mg once daily. Fluconazole administration should start several days before the anticipated onset of neutropenia and continue for 7 days after the neutrophil count rises above 1000 cells per mm³.

6. For dermal infections including tinea pedis, corporis, cruris and candida infections the recommended dosage is 150 mg once weekly or 50 mg once daily. Duration of treatment is normally 2 to 4 weeks but tinea pedis may require treatment for up to 6 weeks.
For tinea versicolor, the recommended dose is 300 mg once weekly for 2 weeks; a third weekly dose of 300 mg may be needed in some patients, whereas, in some patients, a single dose of 300 to 400 mg may be sufficient. An alternate dosing regimen is 50 mg once daily for 2 to 4 weeks.

Use In Children
As with similar infections in adults, the duration of treatment is based on the clinical and mycological response. The maximum adult daily dosage should not be exceeded in children. Fluconazole is administered as a single dose each day.

The recommended dosage fluconazole for mucosal candidiasis is 3 mg/kg daily. A loading dose of 6 mg/kg maybe
used on the first day to achieve steady state levels more rapidly.

For the treatment of systemic candidiasis and cryptococcal infections, the recommended dosage is 6 to 12 mg/kg daily, depending on the severity of the disease.

For the prevention of fungal infections in immunocompromised patients considered at risk as a consequence of neutropenia following cytotoxic chemotherapy or radiotherapy, the dose should be 3 to 12 mg/kg daily, depending on the extent and duration of the induced neutropenia (see Use In Adults). (For children with impaired renal functions, see Use In Renal Impairment).

Use In Children below 4 weeks of age and younger
Neonates excrete fluconazole slowly. In the first two weeks of life, the same mg/kg dosing as in older children should be used but administered every 72 hours. During weeks 2-4 of life, the same dose should be given every 48 hours.

Use In Elderly
Where there is no evidence of renal impairment, normal dosage recommendations should be adopted. For patients with renal impairment (creatinine clearance <50 ml/min) the dosage schedule should be adjusted as described below.

Use In Renal Impairment
Fluconazole is predominantly excreted in the urine as unchanged drug. No adjustments in single-dose therapy are necessary. In patients (including children) with impaired renal function who will receive multiple doses of fluconazole, an initial loading dose of 50 to 400 mg should be given. After the loading dose, the daily dose (according to indication) should be based on the following table:

These are suggested dose adjustments based on pharmacokinetics following administration of single doses. Further adjustment may be needed depending on clinical condition.

Administration
Fluconazole maybe administered either orally or by intravenous infusion at a rate not exceeding 10 ml/minute, 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 dosage. Fluconazole is formulated in 0.9% sodium chloride solution, each 200 mg (100 ml bottle) containing 15 mmol each of Na+ and C1-. Because fluconazole is available as a dilute saline solution, in patients requiring sodium or fluid restriction, consideration should be given to the rate of fluid administration.