Posology : מינונים

4.2      Posology and method of administration

For optimal absorption, SPORANOX Oral Solution should be taken without food (patients are advised to refrain from eating or drinking for at least 1 hour after intake).

For the treatment of oral and/or oesophageal candidosis, the oral solution should be swished around the oral cavity (approx. 20 seconds) and swallowed. There should be no rinsing after swallowing.

Treatment of oral and/or oesophageal candidosis200 mg (2 measuring cups) per day in two intakes, or alternatively in one intake, for 1 week. If there is no response after 1 week, treatment should be continued for another week.


Treatment of fluconazole resistant oral and/or oesophageal candidosis: 100 to 200 mg (1-     2 measuring cups) twice daily for 2 weeks. If there is no response after 2 weeks, treatment should be continued for another 2 weeks. The 400 mg daily dose should not be used for longer than 14 days if there are no signs of improvement.

Prophylaxis of fungal infections

−       5 mg/kg per day administered in two intakes. In clinical trials, prophylaxis treatment was started immediately prior to the cytostatic treatment and generally one week before transplant procedure.
Treatment was continued until recovery of neutrophils (i.e. > 1 000 cells/µL).
Empiric therapy of febrile neutropenic patients with suspected systemic mycoses Treatment should be started with SPORANOX IV. The recommended dose of SPORANOX IV is 200 mg b.i.d. for four doses, followed by 200 mg once daily for up to 14 days. Each intravenous dose should be infused over 1 hour. Treatment should be continued with SPORANOX oral solution 200 mg (20 ml) b.i.d.
until resolution of clinically significant neutropenia. The safety and efficacy of SPORANOX use exceeding 28 days in empiric therapy of febrile patients with suspected systemic mycoses is not known.

Use in pediatric patients
Clinical data on the use of SPORANOX Oral Solution in pediatric patients are limited. The use of SPORANOX Oral Solution in paediatric patients is not recommended unless it is determined that the potential benefit outweighs the potential risks (see section 4.4).

Prophylaxis of fungal infections: there are no efficacy data available in neutropenic children. Limited safety experience is available with a dose of 5 mg/kg per day administered in two intakes. The incidence of adverse events such as diarrhea, abdominal pain, vomiting, fever, rash and mucositis was higher than in adults.
However, it is not clear to what extent this is attributable to SPORANOX oral solution or the chemotherapy.(see section 4.8).

Use in elderly
Clinical data on the use of SPORANOX Oral Solution in elderly patients are limited, it is advised to use SPORANOX Oral Solution in these patients only if it is determined that the potential benefit outweighs the potential risks. In general, it is recommended that the dose selection for an elderly patient should be taken into consideration, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see section 4.4).

Use in patients with hepatic impairment
Limited data are available on the use of oral itraconazole in patients with hepatic impairment. Caution should be exercised when this drug is administered in this patient population. (see section 5.2) 
Use in patients with renal impairment
Limited data are available on the use of oral itraconazole in patients with renal impairment. The exposure of itraconazole may be lower in some patients with renal insufficiency Caution should be exercised when this drug is administered in this patient population and adjusting the dose may be considered.