Sporal is predominantly metabolised in the liver. The oral bioavailability in cirrhotic patient is somewhat increased. It is advised to monitor the Sporal plasma concentrations and to adapt the dose when necessary.
Although with short courses, Sporal has not been associated with hepatic dysfunction, it is advisable not to give this drug to patients with a known history of liver disease or to patients who have experienced liver toxicity with other drugs. For therapy >30 days, liver function tests should be carried out monthly.
Renal Impairment: The oral bioavailability of Sporal was lower in patients with renal insufficiency. Monitoring of the Sporal plasma concentrations and a dose adaption is advisable.
Use in children: Since clinical data of the use of Sporal in paediatric patients is limited, it is advised that Sporal should not be used in these patients unless the potential benefit outweighs the potential risks.