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The capsules must be swallowed whole. (See Table 1, Table 2 and Table 3.)
Click on icon to see table/diagram/image
Click on icon to see table/diagram/image
Click on icon to see table/diagram/imageElimination of itraconazole from skin and nail tissue is slower than from plasma. Optimal clinical and mycological response is thus reached 2 to 4 weeks after the cessation of treatment for skin infections and 6 to 9 months after the cessation of treatment for nail infections. (See Table 4.)
Click on icon to see table/diagram/imageOral solution: For optimal absorption, SPORANOX Oral Solution should be taken without food (patients are advised to refrain from eating for at least 1 hour after intake).
For the treatment of oral and/or esophageal 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 candidiasis: 200 mg (2 measuring cups, i.e. 20 mL) 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 esophageal candidosis: 100 mg (1 measuring cup, i.e. 10 mL) daily for a minimum treatment of three weeks. Treatment should continue for 2 weeks following resolution of symptoms. Doses up to 200 mg (2 measuring cups, i.e. 20 mL) per day may be used based on the clinical response of the patient.
Treatment of fluconazole resistant oral and/or esophageal 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., > 1000 cells/μL).
Special Populations: Pediatrics: Capsule: Clinical data on the use of SPORANOX capsules in pediatric patients are limited. The use of SPORANOX capsules in pediatric patients is not recommended unless it is determined that the potential benefit outweighs the potential risks. (See Precautions.)
Oral solution: 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.
Elderly: Clinical data on the use of SPORANOX in elderly patients are limited. It is advised to use SPORANOX 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 Precautions.)
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 Pharmacology: Pharmacokinetics: Special Populations: Hepatic impairment under Actions).
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.
