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Qualitative and quantitative composition 1 ml Itraconazole oral solution contains 10mg itraconazole. Sorbitol E microlitre per ml , ethanol. For a full list of excipients, see section 6. Pharmaceutical form Oral solution. Itraconazole oral solution is a clear, yellow solution. At present there are insufficient clinical efficacy data in the prevention of aspergillosis.
Itraconazole oral solution is indicated for use in adults. A graduated measuring cup is provided to measure out the correct dose. There should be no rinsing after swallowing. If there is no response after 1 week, treatment should be continued for another week. If there is no response after 2 weeks, treatment should be continued for another 2 weeks.
The mg daily dose should not be used for longer than 14 days if there are no signs of improvement. Prophylaxis of fungal infections: 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. 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.
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. 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. 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. Limited data are available on the use of oral itraconazole in patients with renal impairment. Co-administration of the following drugs is contraindicated with Itraconazole oral solution see also 4.
Co-administration may result in increased plasma concentrations of these substrates, which can lead to QT prolongation and rare occurrences of torsade de pointes. Itraconazole oral solution should not be used during pregnancy for non life-threatening indications see section 4.
There is no information regarding cross hypersensitivity between itraconazole and other azole antifungal agents. Caution should be used in prescribing Itraconazole Oral Solution to patients with hypersensitivity to other azoles. In a healthy volunteer study with Itraconazole IV, a transient asymptomatic decrease of the left ventricular ejection fraction was observed. Itraconazole has been shown to have a negative inotropic effect and has been associated with reports of congestive heart failure.
Heart failure was more frequently reported among spontaneous reports of mg total daily dose than among those of lower total daily doses, suggesting that the risk of heart failure might increase with the total daily dose of itraconazole. Itraconazole oral solution should not be used in patients with congestive heart failure or with a history of congestive heart failure unless the benefit clearly outweighs the risk. Such patients should be informed of the signs and symptoms of congestive heart failure, should be treated with caution, and should be monitored for signs and symptoms of congestive heart failure during treatment; if such signs or symptoms do occur during treatment, Itraconazole oral solution should be discontinued.
Caution should be exercised when co-administering itraconazole and calcium channel blockers see section 4. Interaction with other medicinal products. Very rare cases of serious hepatotoxicity, including some cases of fatal acute liver failure, have occurred with the use of Itraconazole. Some of these cases involved patients with no pre-existing liver disease.
Some of these cases have been observed within the first month of treatment, including some within the first week. Liver function monitoring should be considered in patients receiving itraconazole treatment. Patients should be instructed to promptly report to their physician signs and symptoms suggestive of hepatitis such as anorexia, nausea, vomiting, fatigue, abdominal pain or dark urine. In these patients treatment should be stopped immediately and liver function testing should be conducted.
In patients with raised liver enzymes or active liver disease, or who have experienced liver toxicity with other drugs, treatment should not be started unless the expected benefit exceeds the risk of hepatic injury.
In patients with impaired hepatic function liver enzyme should be carefully monitored when taking itraconazole. 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. Caution should be exercised when the drug is administered in this patient population. Prophylaxis in neutropenic patients. In clinical trials diarrhoea was the most frequent adverse event.
This disturbance of the gastrointestinal tract may result in impaired absorption and may alter the microbiological flora potentially favouring fungal colonisation. Consideration should be given to discontinuing Itraconazole oral solution in these circumstances. Treatment of severely neutropenic patients. Due to the pharmacokinetic properties See 5. Transient or permanent hearing loss has been reported in patients receiving treatment with itraconazole.
Several of these reports included concurrent administration of quinidine which is contraindicated see sections 4. The hearing loss usually resolves when treatment is stopped, but can persist in some patients. If neuropathy occurs that may be attributable to Itraconazole oral solution, the treatment should be discontinued.
In systemic candidosis, if fluconazole-resistant strains of Candida species are suspected, it cannot be assumed that these are sensitive to itraconazole, hence their sensitivity should be tested before the start of itraconazole therapy Interaction potential.
Itraconazole Oral Solution has a potential for clinically important drug interactions see section 4. Itraconazole should not be used within 2 weeks after discontinuation of treatment with CYP 3A4 inducing agents rifampicin, rifabutin, phenobarbital, phenytoin, carbamazepine, Hypericum perforatum St. The use of itraconazole with these drugs may lead to subtherapeutic plasma levels of itraconazole and thus treatment failure.
Itraconazole oral solution contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. Also contains ethanol less than mg per dose. Drugs affecting the metabolism of itraconazole: Itraconazole is mainly metabolised through the cytochrome CYP3A4.
Interaction studies have been performed with rifampicin, rifabutin and phenytoin, which are potent enzyme inducers of CYP3A4. Since the bioavailability of itraconazole and hydroxy-itraconazole was decreased in these studies to such an extent that efficacy may be largely reduced, the combination of itraconazole with these potent enzyme inducers is not recommended.
No formal study data are available for other enzyme inducers, such as carbamazepine, Hypericum perforatum St John's Wort , phenobarbital and isoniazid, but similar effects should be anticipated. Potent inhibitors of this enzyme such as ritonavir, indinavir, clarithromycin and erythromycin may increase the bioavailability of itraconazole.
Effect of itraconazole on the metabolism of other drugs: When using concomitant medication, the corresponding label should be consulted for information on the route of metabolism. After stopping treatment, itraconazole plasma levels decline gradually, depending on the dose and duration of treatment See Section 5. This should be taken into account when the inhibitory effect of itraconazole on co-medicated drugs is considered.
The following drugs are contraindicated with itraconazole: In addition to possible pharmacokinetic interactions involving the drug metabolising enzyme CYP3A4, calcium channel blockers can have negative inotropic effects which may be additive to those of itraconazole. The following drugs should be used with caution, and their plasma concentrations, effects or side effects should be monitored. Their dosage, if co-administered with itraconazole, should be reduced if necessary: The importance of the concentration increase and the clinical relevance of these changes during the co-administration with itraconazole remain to be established.
No inducing effects of itraconazole on the metabolism of ethinyloestradiol and norethisterone were observed. Effect on protein binding: In vitro studies have shown that there are no interactions on the plasma protein binding between itraconazole and imipramine, propranolol, diazepam, cimetidine, indometacin, tolbutamide and sulfamethazine.
Itraconazole oral solution must not be used during pregnancy except for life-threatening cases where the potential benefit to the mother outweighs the potential harm to the foetus see 4. In animal studies itraconazole has shown reproduction toxicity see 5. Women of child-bearing potential: Women of childbearing potential taking Itraconazole oral solution should use contraceptive precautions. Effective contraception should be continued until the next menstrual period following the end of Itraconazole therapy.
In the rat, itraconazole had no effect on male or female fertility at doses which exhibited signs of general toxicity. The effect in humans is unknown. A very small amount of itraconazole is excreted in human milk. Itraconazole Oral Solution must not be used during lactation. When driving vehicles and operating machinery the possibility of adverse reactions such as dizziness, visual disturbances and hearing loss see Section 4. The most frequently reported adverse experiences have been of gastrointestinal, hepatic and dermatological origin.
The table below presents adverse drug reactions by System Organ Class. Within each System Organ Class, the adverse drug reactions are presented by incidence, using the following convention: Toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalised exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, urticaria, alopecia, photosensitivity.
The safety of Itraconazole oral solution was evaluated in paediatric patients aged 6 months to 14 years who participated in five open-label clinical trials. These patients received at least one dose of itraconazole for prophylaxis of fungal infections or for treatment of oral thrush or systemic fungal infections and provided safety data. Based on pooled safety data from these clinical trials, the very common reported ADRs in paediatric patients were Vomiting The nature of ADRs in paediatric patients is similar to that observed in adult subjects, but the incidence is higher in the paediatric patients.
Reporting of suspected adverse reactions.