Duodart Overdosage

No data are available with regard to overdosage of DUODART. The following statements reflect the information available on the individual components.
Dutasteride: In volunteer studies single doses of dutasteride up to 40 mg/day (80 times the therapeutic dose) for 7 days have been administered without significant safety concerns. In clinical studies doses of 5 mg daily have been administered to patients for 6 months with no additional adverse effects to those seen at therapeutic doses of 0.5 mg.
There is no specific antidote for dutasteride therefore, in cases of suspected overdosage, symptomatic and supportive treatment should be given as appropriate.
Tamsulosin: In case of acute hypotension occurring after overdosage with tamsulosin hydrochloride cardiovascular support should be given. Restoration of blood pressure and normalization of heart rate may be accomplished by lying the patient down. If this is inadequate, administration of volume expanders and if necessary vasopressors should then be used and renal function should be monitored and supported as needed. Laboratory data indicate that tamsulosin hydrochloride is 94% to 99% protein bound; therefore, dialysis is unlikely to be of benefit in removing tamsulosin from the body.