FLUCORIC Capsule Ref.[50943] Active ingredients: Fluconazole

Posology

The daily dose of FLUCORIC should be based on the nature and severity of the fungal infection.

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 the usual dose is 400 mg on the first day followed by 200 mg once daily. Depending on the clinical response of the patient this dose may be increased to 400 mg daily. Usually, duration of treatment for cryptococcal meningitis is 6 to 8 weeks.

For the prevention of relapse of cryptococcal meningitis in patients with AIDS, after the patient receives a full course of primary therapy, FLUCORIC may be administered at a daily dose of 100 mg to 200 mg until the CD4 count has stabilised at more than 250 cells/mm³.

2. For systemic candidiasis, 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 mg to 100 mg once daily for 7 to 14 days. If necessary, treatment can be continued for longer periods in patients with severely compromised immune function.

For the prevention of relapse of oropharyngeal candidiasis in patients with AIDS, after the patient receives a full course of primary therapy, FLUCORIC may be administered at a 150 mg once weekly dose.

For oesophageal candidiasis, the recommended dose is 200 mg on the first day, followed by 100 mg to 200 mg once daily. Doses up to 400 mg/day may be used, based on medical judgment of the patient’s response to therapy. Patients with oesophageal candidiasis should be treated for a minimum of 3 weeks and for at least 2 weeks following resolution of symptoms.

4. The recommended FLUCORIC dosage for the prevention of candidiasis is 50 mg 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, a dose of 400 mg once daily has been used. FLUCORIC administration should start several days before the anticipated onset of neutropenia and continue for 7 days after the neutrophil count rises above 1 000 cells per mm³.

FLUCORIC 150 CAPSULES

For vaginal candidiasis FLUCORIC 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 individualised but ranges from 4 to 12 months. Some patients may require more frequent dosing.

For Candida balanitis, FLUCORIC 150 mg should be administered as a single oral dose.

For dermal infections including tinea pedis, corporis, cruris and Candida infections the recommended dosage is 150 mg once weekly. Duration of treatment is normally 2 to 4 weeks but tinea pedis may require treatment for up to 6 weeks.

For tinea unguium, the recommended dosage is 150 mg once weekly. Treatment should be continued until infected nail is replaced (uninfected nail grows in). Regrowth of fingernails and toenails normally require 3 to 6 months and 6 to 12 months, respectively. However, growth rates may vary widely in individuals and by age. After successful treatment of long-term chronic infections, nails occasionally remain disfigured.

Special populations

Use in elderly patients

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 patients with impaired renal function

FLUCORIC is cleared primarily by renal excretion as unchanged medicine. No adjustments in single dose therapy are necessary. Multiple-dose therapy should be carefully monitored in patients with renal impairment.

In patients (including children) with impaired renal function, an initial dose of 50 mg to 400 mg should be given. After the loading dose, the daily dose (according to indication) should be based on the following table:

Patients on haemodialysis should receive 100% of the recommended dose after each haemodialysis; on non-dialysis days, patients should receive a reduced dose according to their creatinine clearance.

These are suggested dose adjustments based on pharmacokinetics following administration of multiple doses. Further adjustment may be needed depending upon clinical condition. 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 used to estimate the creatinine clearance:

Males:

[140 – age] x Wt (kg) x constant
Scr (mmol/L)

Constant = 1,23 for males

Females:

[140 – age] x Wt (kg) x constant
Scr (mmol/L)

Constant = 1,04 for females (0,85 × 1,23 = 1,04)

Scr = serum creatinine

Paediatric population

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. FLUCORIC is administered as a single daily dose.

1. The recommended dosage of FLUCORIC for oropharyngeal candidiasis in children is 6 mg/kg on the first day, followed by 3 mg/kg once daily.

Treatment should be administered for at least 2 weeks to decrease the likelihood of relapse.

2. For the treatment of oesophageal candidiasis, the recommended dosage of FLUCORIC in children is 6 mg/kg on the first day, followed by 3 mg/kg once daily. Doses up to 12 mg/kg/day may be used based on medical judgment of the patient’s response to therapy. Patients with oesophageal candidiasis should be treated for a minimum of 3 weeks and for at least 2 weeks following the resolution of symptoms.

3. For the treatment of systemic candidiasis and cryptococcal infection, the recommended dosage is 6 mg/kg/day – 12 mg/kg/day, depending on the severity of the disease.

4. 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 mg/kg/day – 12 mg/kg daily, depending on the extent and duration of the induced neutropenia.

For children with impaired renal function the daily dose should be reduced in accordance with the guidelines given for adults, dependent on the degree of renal impairment.

Use in children 4 weeks of age and younger

Neonates excrete FLUCORIC slowly. In the first 2 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.

Method of administration

For oral use.

There have been reports of overdose with FLUCORIC accompanied by hallucinations and paranoid behaviour.

In the advent of overdosage, symptomatic treatment (with supportive measures and gastric lavage if necessary) may be adequate.

FLUCORIC is largely excreted in the urine; forced volume diuresis would probably increase the elimination rate. A three-hour haemodialysis session decreases plasma levels by approximately 50%.

24 months.

Store at or below 25°C, protected from moisture.

Flucoric 50 Capsules: Cartons containing blister strips consisting of white, opaque PVC (PVdC coated) film with an aluminium foil backing containing 14 capsules each.

Flucoric 100 Capsules: Cartons containing blister strips consisting of white, opaque PVC (PVdC coated) film with an aluminium foil backing containing 14 capsules each.

Flucoric 150 Capsules: Cartons containing blister strips consisting of white, opaque PVC (PVdC coated) film with an aluminium foil backing containing 1 or 4 capsules each.

Flucoric 200 Capsules: Cartons containing blister strips consisting of white, opaque PVC (PVdC coated) film with an aluminium foil backing containing 28 capsules each.

No special requirements.