JAMP ITRACONAZOLE ORAL SOLUTION 10MG/ML

GOLDPLUS UNIVERSAL PTE LTD

GOLDPLUS UNIVERSAL PTE LTD

Therapeutic

Prescription Only

SOLUTION

**Dosage and Administration** For optimal absorption, JAMP Itraconazole 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 candidosis** 200 mg (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 (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 (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 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/mcL). **Empiric therapy of febrile neutropenic patients with suspected systemic mycoses** Treatment should be started with itraconazole IV. The recommended dose of itraconazole 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 JAMP Itraconazole Oral Solution 200 mg (20 mL) b.i.d. until resolution of clinically significant neutropenia. The safety and efficacy of itraconazole use exceeding 28 days in empiric therapy of febrile patients with suspected systemic mycoses is not known. **Special populations** _**Pediatrics**_ Clinical data on the use of itraconazole oral solution in pediatric patients are limited. The use of JAMP Itraconazole Oral Solution in pediatric patients is not recommended unless it is determined that the potential benefit outweighs the potential risks (see _Warnings and Precautions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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 itraconazole oral solution or the chemotherapy. _**Elderly**_ Clinical data on the use of itraconazole oral solution in elderly patients are limited. It is advised to use itraconazole 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 _Warnings and Precautions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _**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 _Pharmacokinetic Properties - Special populations, Hepatic impairment_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _**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 (see _Pharmacokinetic Properties - Special populations, Renal impairment_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).