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No cases of delamanid overdose have been observed in clinical trials. However, additional clinical data showed that in patients receiving 200 mg twice daily, i.e. total 400 mg delamanid per day, the overall safety profile is comparable to that in patients receiving the recommended dose of 100 mg twice daily. Albeit, some reactions were observed at a higher frequency and the rate of QT prolongation increased in a dose-related manner.
Treatment of overdose should involve immediate measures to remove delamanid from the gastrointestinal tract and supportive care as required. Frequent ECG monitoring should be performed.
