CANDIVAST 150MG CAP 1'S

CANDIVAST 150MG CAP 1'S
Page 1 of 18 NEW ZEALAND DATA SHEET FLUCONAZOLE 1. Product Name Fluconazole, 50 mg, 100 mg, 150 mg and 200 mg, capsule. 2. Qualitative and Quantitative Composition Each capsule contains 50 mg, 100 mg, 150 mg or 200 mg of fluconazole. Fluconazole capsules contain lactose. For the full list of excipients, see section 6.1. 3. Pharmaceutical Form Fluconazole 50 mg: Size 4 hard gelatin capsule with white opaque body and dark blue opaque cap. The body has "FC 50" and the cap has "G" printed in black. The capsule contains white to off-white powder. Fluconazole 100 mg: Size 2 hard gelatin capsule with white opaque body and blue opaque cap. The body has “FC 100” and the cap has “G” printed in black. The capsule contains white to offwhite powder. Fluconazole 150 mg: Size 1 hard gelatin capsule with white opaque body and white opaque cap. The body has "FC 150" and the cap has "G" printed in black. The capsule contains white to offwhite powder. Fluconazole 200 mg: Size 0 hard gelatin capsule with white opaque body and blue opaque cap. The body has "FC 200" and the cap has "G" printed in black. The capsule contains white to offwhite powder. 4. Clinical Particulars 4.1 Therapeutic indications Fluconazole is indicated for the treatment of the following conditions: 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 candidaemia, disseminated candidiasis and other forms of invasive candida infection including infections of the peritoneum, endocardium and pulmonary and urinary tracts. Patients with malignancy, in intensive care units, receiving cytotoxic or immunosuppressive therapy, or with other factors predisposing to candida infections may be treated. Page 2 of 18 3. Mucosal candidiasis. These include oropharyngeal, oesophageal, 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. 4. Vaginal candidiasis, acute or recurrent. 5. Prevention of fungal infection in immunocompromised patients considered at risk as a consequence of HIV infections or neutropenia following cytotoxic chemotherapy, radiotherapy or bone marrow transplant. 6. Fluconazole 50 mg & 150 mg capsules are also indicated for the treatment of dermatomycoses including tinea pedis, tinea corporis, tinea cruris, pityriasis versicolor & candidiasis. 4.2 Dose and method of administration Dose 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. 1. (a). Cryptococcal meningitis and cryptococcal infection 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. (b). Prevention of relapse of cryptococcal meningitis in AIDS patients: After the patient receives a full course of primary therapy, fluconazole may be administered indefinitely at a once daily dose of 200 mg. 2. Candidaemia, disseminated candidiasis and other invasive candida infections: The usual dose is 400 mg on the first day followed by 200 mg once daily. Depending on the clinical response, the dose may be increased to 400 mg once daily. Duration of treatment is based upon the clinical response. 3. Oropharyngeal candidiasis: The usual dose is 50 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 vaginal candidiasis, see below), e.g. oesophagitis, candiduria, mucocutaneous candidiasis etc., the usual effective dose is 50 mg once daily, given for 14-30 days. In unusually difficult cases of mucosal candidal infections the dose may be increased to 100 mg daily. 4. Vaginal candidiasis: Fluconazole 150 mg should be administered as a single oral dose. Median time to onset of symptom relief following a 150 mg single oral dose for the treatment of vaginal candidiasis is one day. The range of time to onset of symptom relief is one hour to nine days. 5. Prevention of fungal infections in immunocompromised patients: The dose should be 50 mg once daily while the patient is at risk as a consequence of receiving cytotoxic Page 3 of 18 chemotherapy, radiotherapy or bone marrow transplant. A higher dose of 100 mg/day may be used in patients at risk of severe recurrent infections. 6. Dermatomycoses: The usual dosage is 50 mg once daily or 150 mg once weekly for two to four weeks. Tinea pedis may require treatment for up to six weeks. Special populations ChildrenAs with similar infections in adults, the duration of treatment is based on the clinical and mycological response. Fluconazole is administered as a single dose each day. 1. Mucosal candidiasis: 3 mg/kg once daily. A loading dose of 6 mg/kg may be used on the first day to achieve steady state levels more rapidly. 2. Systemic candidiasis and cryptococcal infection: 6-12 mg/kg once daily, depending on the severity of the disease. 3. Prevention of fungal infections in immunocompromised patients considered at risk as a consequence of neutropenia following cytotoxic chemotherapy or radiotherapy: 3 - 12 mg/kg once daily, depending on the extent and duration of the induced neutropenia (see adult dosing). For children with impaired renal function the daily dose should be reduced in accordance with the guidelines given for adults. Children 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 3 and 4 of life the same dose should be given every 48 hours. 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. Renal impairment Fluconazole is predominantly excreted in the urine as unchanged drug. No adjustments in single dose therapy are necessary. In patients with impaired renal function who will receive multiple doses of fluconazole, an