The therapeutic response to Oratane and its adverse events are dose-related and varies between patients. This necessitates individual dosage adjustment during therapy. Oratane therapy should be started at a dose of 0.5 mg/kg daily. For most patients the dose ranges from 0.5-1.0 mg/kg per day. Patients with very severe disease or with truncal acne may require higher daily doses up to 2.0 mg/kg.
A cumulative dose of 120 mg/kg per treatment has been documented to increase remission rates and prevent relapse. The therapy duration in individual patients therefore varies as a function of the daily dose. Complete remission of the acne is often achieved by a therapy course of 16-24 weeks. In patients who show severe intolerance to the recommended dose, treatment may be continued at a lower dose with the consequence of a longer therapy duration.
In the majority of patients complete clearing of the acne is obtained with a single treatment course. In case of a definite relapse, a renewed course of Oratane therapy should be given with the same daily dose and cumulative treatment dose as previously. Since further improvement of the acne can be observed up to 8 weeks after discontinuation of treatment, retreatment should not be initiated until after this period.
The capsules should be taken with food once or twice daily.