COMPOSITION :
Fludis® Infusion 200 mg/100 ml, each 100 ml contains : Fluconazole 200 mg.
DESCRIPTIONS :
Fludis® contains Fluconazole as active ingredient is available in infusion 200 mg/100 ml.
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.
- Cryptococcosis, including cryptococcal meningitis and infections of other sites (e.g., pulmonary and cutaneous). Normal hosts, and patients with AIDS, organ transplants or other causes of immunosuppression may be treated. Fludis® can be used as maintenance therapy to prevent relapse of cryptococcal disease in patients with AIDS.
- 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 units, receiving cytotoxic or immunosuppressive therapy or with other factors predisposing to candidal infection may be treated.
- Mucosal candidiasis. These include oropharyngeal, esophageal, non-invasive bronchopulmonary infections, candiduria, mucocutaneous and chronic oral atropic 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.
DOSAGE AND ADMINISTRATIONS :
Dosage :
The daily dose of Fludis® should be based on the nature and severity of the fungal infection. Patients with AIDS and cryptococcal meningitis or recurrent oropharyngeal candidiasis usually require maintenance therapy to prevent relapse.
Adults :
- Cryptococcal meningitis and cryptococcal infections at other sites :
The usual dose is 400 mg on the first day followed by 200 mg – 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, Fludis® may be administered indefinitely at a daily dose of 200 mg.
- 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.
- Oropharyngeal candidiasis :
The usual dose is 50 mg – 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 atropic 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 candida infections of mucosa (except genital candidiasis) e.g., esophagitis, non-invasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., the usual effective dose is 50 – 100 mg daily, given for 14 – 30 days.
For the prevention of relapse of oropharyngeal candidiasis in patient with AIDS, after patient receives a full course of primary therapy, Fludis® may be administered at a 150 mg once weekly dose.
- Prevention of candidiasis :
50 to 400 mg once daily, based on the patients 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. Fludis® administration should start several days before the anticipated onset of neutropenia and continue for 7 days after the neutrophil count rises > 1000 cells/mm3.
A higher dose of 100 mg once daily may be used in patients at risk of severe recurrent infections.
Children :
Use in children below the age of 16 years is not recommended. However, when the treating physician considers Fludis® therapy imperative, the following daily doses for children aged 1 year and older with normal renal function are recommended :
- Superficial candida infections : 1 – 2 mg/kg.
- Systemic candida/cryptococcal infections : 3 – 6 mg/kg.
These recommendations approximate the doses used in adults on a mg.kg basis. However, preliminary data in children aged 5 – 13 years, indicate Fludis® elimination may be faster than in adults. Therefore, for serious or life-threatening infections, higher daily doses may be required. Daily doses up to 12 mg/kg have been used in a small number of children. The maximum approved adult daily dose of 400 mg should not be exceeded.
For children with impaired renal function the daily doses should be reduced in accordance with the guidelines given for adults, depending on the degree of renal impairment.
Elderly :
Where there is no evidence of renal impairment, normal dosage recommendations should be adopted. For patients with renal impairment (creatinine clearance < 50 ml/minute) the dosage schedule should be adjusted as described below.
Patients with renal impairment :
Fludis® 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 Fludis®, an initial loading dose of 50 – 400 mg should be given. After the loading dose, the daily dose (according to indication) should be based on the following table :
| Creatinine clearance (ml/minute) | Percent of recommended dose |
| > 50 | 100% |
| 11 – 50 | 50% |
| Patients receiving regular dialysis | 100% after every dialysis session |
When serum creatinine is the only measure of renal function available, the following formula (based on sex, weight and age of the patient) should be based on the following equation :
| Male : | Body weight (kg) x (140 – Age) |
| 72 x Serum creatinine (mg/100 ml) | |
| Female : | 0.85 x value above |
Administrations :
Fludis® may be administered either orally or by IV infusion at a rate not exceeding 200 mg/hour given as a continuous infusion, the route being dependent on the clinical state of the patient. On transferring from the IV to the oral route or vice versa, there is no need to change the daily dosage. Fludis® infusion is intended only for IV administration using sterile equipment.
OVERDOSAGE :
There has been a reported case of overdosage with Fluconazole. A 42 years-old patient infected with human immunodeficiency virus developed hallucinations and exhibited paranoid behavior after reportedly ingesting 8200 mg of Fluconazole. The patient was admitted to the hospital and his condition resolved within 48 hours.
In the event of overdosage, symptomatic treatment (with supportive measures and gastric lavage if necessary) may be adequate.
Fluconazole is largely excreted in urine; forced volume diuresis would probably increase the elimination rate. A three hours hemodialysis session decreases plasma levels by approximately 50%.
CONTRAINDICATIONS :
Fluconazole should not be used in patients with known sensitivity to the drug or to related Azole compounds.
WARNINGS AND PRECAUTIONS :
- Fluconazole has been associated with rare cases of serious hepatic toxicity including fatalities, primarily in patients with serious underlying medical conditions. In cases of Fluconazole-associated hepatotoxicity, no obvious relationship to total daily dose, duration of therapy, sex or age of the patient has been observed. Fluconazole hepatotoxicity has usually been reversible on discontinuation of therapy.
- Patients who develop abnormal liver function tests during Fluconazole therapy should be monitored for the development of more serious hepatic injury. Fluconazole should be discontinued if clinical signs or symptoms consistent with liver disease develop that may be attributable to Fluconazole.
- Patients have rarely developed exfoliative cutaneous reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, during treatment with Fluconazole. AIDS patients are more prone to the development of severe cutaneous reactions to many drugs. If a rash develops in patients 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 multiforme develop.
- In rare cases, as with other Azoles, anaphylaxis has been reported.
- Effects on ability to drive and use machines :
Experience with Fluconazole indicates that therapy is unlikely to impair a patient ability to drive or use machinery.
- Use during pregnancy :
Fluconazole in pregnant women should be avoided except in patients with severe or potentially life-threatening fungal infections in whom Fluconazole may be used if the anticipated benefit outweighs the possible risk of the fetus.
- Use during lactation :
Fluconazole is found in human breast milk at concentrations similar to plasma, therefore use in nursing mothers is not recommended.
- Use in children :
Limited data are available on the use of Fluconazole in children below the age of 16 years; therefore, use at present is not recommended in these patients unless antifungal treatment is imperative and no suitable alternative agents exist. There are only limited data on the use of Fluconazole in neonates and its use in children below the age of 1 year is therefore not recommended.
PRESENTATION :
Fludis® Infusion 200 mg/100 ml Box, 1 bottle @ 100 ml Reg. No. DKL1002342749A1
STORAGE :
STORE BELOW 30°C, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
PT. BERNOFARM
Sidoarjo – Indonesia
