el-GRen-US

 

Name of the medicinal product: FARVIRON

Content: Each tablet contains 150mg Fluconazole

Pharmaceutical form: Capsule

Pharmacotherapeutic group: Antimycotics

Packaging description: Cardboard box of 14 capsules, packaged with blisters of PVC / PVDC-aluminium foil

Fluconazole is an antifungal drug used to treat infections caused by fungi.
  • Cryptococcal infections including cryptococcal meningitis and infections of other sites (eg, lungs, skin). Normal hosts and patients with AIDS, and patients with organ transplants or other causes of immunosuppression may be treated. Fluconazole can be used to prevent relapse of cryptococcal disease in patients with AIDS
  • Disseminated candidiasis, including candidemia in clinically stable and non-neutropenic patients, the disseminated candidiasis and focal candidiasis (infections of the peritoneum, endocardium, lungs and urinary tract). Also can be treated with the medication, patients with malignant neoplasms or intensive care units patients and patients receiving cytotoxic or immunosuppressive drugs
  • It goes without saying, that for the first two indications, prior to initiation of treatment, samples should be take or to make appropriate laboratory tests (direct microscopy, biopsies, serology) to isolate and identify the causative agent
  • Mucosal candidiasis: Oropharyngeal, oesophageal candidiasis (as an alternative to topical treatment), non-invasive bronchopulmonary candidiasis. Candiduria, chronic mucocutaneous candidiasis. Chronic oral atrophic candidiasis (denture stomatitis), as an alternative to topical treatment. Patients especially with impaired immune function can be treated with medicine
  • Candidiasis Genital: Vaginal candidiasis, as an alternative to topical treatment (only one-off grant of capsules 150 mg)
    • acute
    • relapsing, as long as the disease is confirmed by culturing
    • Candidal valanitis
  • Dermatomycosis involving tinea pedis, tinea corporis, tinea cruris, tinea versicolor and dermal candida infections when systemic therapy is indicated. Note: Systemic treatment in the above indications it is preferred when the infection extends to a large area of skin, refers to the scalp or patients with impaired defense mechanisms, poor response of topical treatment and persistence of fungal infection despite treatment
  • Prevention of fungal infections in patients with neutropenia and malignant diseases that predispose to the development of these infections, as a result in chemotherapy with cytostatic drugs or radiotherapy and following marrow transplant. Attention is drawn to the fact that chronic administration of azoles increases the likelihood of developing C.krusei, Aspergilus, Mucorales, Fusarium, C.glabrata, which often have natural resistance to azoles
  • Treatment may begin before notification of the results of the cultures and other laboratory tests. However, upon receipt of the above results, anti-infective therapy should be adjusted accordingly.
Fluconazole should not be used in patients with known hypersensitivity to the drug or excipients or related azole compositions. Not to be given concomitantly with cisapride. Do not co-administered with terfenadine in patients receiving multiple doses equal to or greater than 400 mg fluconazole daily.
Ενήλικες
1a. For the treatment of cryptococcal meningitis and cryptococcal infection of other areas of the body, the usual dose is 400 mg on the first day of treatment followed by a dose of 200-400 mg daily. The duration of treatment for cryptococcal infections depends on the clinical and mycological response to treatment, but is usually at least 6-8 weeks for cryptococcal meningitis, or from 10 to 12 weeks after the sputum of CSF culture.
1b. For the prevention of relapse of cryptococcal meningitis in patients with AIDS, after the completion of comprehensive initial therapy may be administered fluconazole indefinitely at a daily dose of 100-200 mg.

2. Treatment of candidemia, generalized candidiasis and other heavy candidiasis, the usual dose of the drug is 400 mg on the first day of treatment, followed by a dose of 200 mg daily. If needed, for response that is inadequate, the dose may be increased to 400 mg daily. The duration of treatment depends on the clinical response of patients.

3. For invasive candidiasis infections may require doses of 200-400 mg daily for lasting up to 2 years. The duration of treatment should be individualized.

4. For treatment of oropharyngeal candidiasis the usual dose is 50-100 mg once a day for 7-14 days. If necessary, in patients with severe disorders of immune system's function, treatment can be continued for a longer period. For the treatment of atrophic oral candidiasis observed for dentures, the usual dose is 50 mg once a day for 14 days. administered simultaneously with the implementation of local antiseptic measures to the denture. For treatment of other candidal infection of mucous (except vaginal candidiasis, see below), e.g. esophagitis, non-invasive bronchopulmonary infections, candiduria, chronic mucocutaneous candidiasis, etc., the usual effective dose is 50-100 mg daily administered for 14-30 days

5. For treatment of vaginal candidosis and candidal balanitis 150 mg administered as a single dose.

6. Cutaneous infections include dermatofytiasi of the legs and the thin skin and as those due to Candida, the recommended dose is 150 mg once weekly or 50 mg once daily. The duration term treatment varies from 2 to 4 weeks, but especially dermatomycosis of the feet may require treatment for up to 6 weeks. For tinea versicolor, the recommended dose is 50 mg once daily for 2 to 4 weeks. For dermatomycosis of nail the recommended dose is 150 mg once weekly. Treatment should be continued until the diseased nail replace healthy. The growth of a healthy nail of the fingers and toes normally requires 3 to 6 months and 6 to 1 2 months respectively. However, the growth rate can vary significantly from person to person and also depends upon the age of the individual. Occasionally, after successful treatment of long-term infections, nails may remain deformed.

7. For the prevention of fungal infections in patients at high risk of developing generalized infection e.g. Patients are expected to have a heavy or prolonged neutropenia, such as patients with bone marrow transplantation, the recommended dose is 400 mg once daily, and for the prevention of fungal infections in patients with neutropenia and malignant diseases that predispose to the development of these infections result in chemotherapy with cytostatic drugs or radiation dose range of 50-400 mg once daily. The administration should start several days before the anticipated onset of neutropenia and continue for 7 days after the increase in the number of neutrophil cells.