ITRACONAZOLE Oral solution Ref.[6946] Active ingredients: Itraconazole

For optimal absorption, Itraconazole oral solution should be taken without food (patients are advised to refrain from eating for at least 1 hour after intake).

A graduated measuring cup is provided to measure out the correct dose.

For the treatment of oral and/or oesophageal candidosis, the liquid 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 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 fluconazole resistant oral and/or oesophageal candidosis: 100 to 200 mg (10-20 ml) twice daily for 2 weeks. If there is no response after 2 weeks, treatment should be continued for another 2 weeks. The 400mg 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. Almost all proven deep fungal infections occurred in patients reaching neutrophil counts below 100 cells/µl. Treatment was continued until recovery of neutrophils (i.e. >1000 cells/µl).

Pharmacokinetic parameters from clinical studies in neutropenic patients demonstrate considerable intersubject variation. Blood level monitoring should be considered particularly in the presence of gastrointestinal damage, diarrhoea and during prolonged courses of Itraconazole oral solution.

Use in patients with gastro-intestinal motility impairment

When treating patients with severe fungal infections or when administering it as fungal prophylaxis to those with abnormal gastro-intestinal motility, patients should be carefully monitored and where appropriate drug therapeutic monitoring should be considered, where available.

Use in children

Since clinical data on the use of itraconazole oral solution in paediatric patients is limited, its use in children is not recommended unless the potential benefit outweighs the potential risks (See section 4.4 Special warnings and special precautions for use and section 4.8 Undesirable effects).

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 (See section 4.8 Undesirable effects).

Use in elderly

Since clinical data on the use of Itraconazole oral solution in elderly patients is limited, it is advised to use Itraconazole oral solution in these patients only if the potential benefit outweighs the potential risks (See section 4.4 Special warnings and special precautions for use).

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 4.8 Undesirable effects and 5.2 Pharmacokinetic properties, Special populations, Hepatic impairment).

Use in patients with renal impairment

Limited data are available on the use of oral itraconazole in patients with renal impairment. Caution should be exercised when this drug is administered in this patient population (See section 4.8 Undesirable effects).

Symptoms

In general, adverse events reported with overdose have been consistent with adverse drug reactions already listed in this SmPC for itraconazole (see section 4.8).

Treatment

In the event of an overdose, supportive measures should be employed. Activated charcoal may be given if considered appropriate. Itraconazole cannot be removed by haemodialysis. No specific antidote is available.

Shelf life:

• 18 months as packaged for sale.
• 1 month after first opening the container.

Do not store above 25°C.

Type III 150 ml amber glass bottle, with child resistant polyethylene screw cap and LDPE internal coating, in a cardboard carton.

A graduated measuring cup is provided. Graduation is from 2.5-30ml, initially in 2.5ml and then 5ml intervals.

Any unused product or waste material should be disposed of in accordance with local requirements.