Durotam Overdosage

No data are available with regard to overdosage of Dutasteride + Tamsulosin HCl (Durotam). The following statements reflect the information available on the individual components.
Dutasteride: In volunteer studies, single daily doses of Dutasteride up to 40 mg/day (80 times the therapeutic dose) have been administered for 7 days without significant safety concerns. In clinical studies, doses of 5 mg daily have been administered to subjects 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 suspected overdosage symptomatic and supportive treatment should be given as appropriate.
Tamsulosin: Acute overdose of 5 mg Tamsulosin hydrochloride has been reported. Acute hypotension (systolic blood pressure 70 mmHg), vomiting, and diarrhea were observed which were treated with fluid replacement and the patient could be discharged the same day. In case of acute hypotension occurring after overdosage cardiovascular support should be given. Blood pressure can be restored and heart rate brought back to normal by lying the patient down. If this does not help then volume expanders, and when necessary, vasopressors could be employed. Renal function should be monitored and general supportive measures applied. Dialysis is unlikely to be of help as Tamsulosin is very highly bound to plasma proteins.