Spyrocon Special Precautions

Since clinical data of the use of Itraconazole in paediatric patients is limited, it is advised that Itraconazole should not be used in these patients unless the potential benefits outweigh the potential risks.
If during treatment patients develop symptoms, e.g. fatigue, nausea, vomiting, anorexia, abdominal pain or dark urine, liver enzymes should be monitored promptly and if abnormal, treatment should be stopped.
In patients with raised liver enzymes, treatment should not be started unless the expected benefit exceeds the risk of hepatic injury. In this instance, liver enzymes monitoring is required. Itraconazole is predominantly metabolized in the liver.
The oral bioavailability in cirrhotic patients is somewhat decreased. It is advised to monitor the Itraconazole plasma concentrations and to adapt the dose when necessary.
If neuropathy occurs that may be attributable to Itraconazole, the treatment should be discontinued.
Renal impaired patients: the oral bioavailability of Itraconazole may be lower in patients with renal insufficiency. Monitoring of the Itraconazole plasma concentrations and a dose adaptation are advisable.
Use in Pregnancy & Lactation: See USE IN PREGNANCY & LACTATION section for further information.