No data are available with regard to overdosage with Duodart. The following statements reflect the information available on the individual components.
Dutasteride: In studies, volunteers were given single daily doses of dutasteride up to 40 mg (equivalent to 80 times the therapeutic dose) for 7 days without any major problems as regards safety. In clinical trials, volunteers were given daily doses of 5 mg for 6 months without any additional adverse effects occurring compared with the recommended dose. There is no specific antidote for dutasteride. Therefore, if an overdosage is suspected appropriate symptomatic treatment should be initiated.
Tamsulosin: Cases of acute overdosage with tamsulosin 5mg have been reported. Acute hypotension (systolic blood pressure 70 mmHg), vomiting and diarrhoea were observed in these patients.
In cases of acute hypotension occurring after overdosage with tamsulosin hydrochloride cardiovascular support should be given. Normalisation of blood pressure and heart rate may be accomplished by lying the patient down. If this is inadequate, volume expanders and if necessary vasopressors can then be administered. Since tamsulosin exhibits strong plasma protein-binding, dialysis is unlikely to be of benefit in removing tamsulosin from the body. Vomiting may be induced to reduce absorption. If a large dose has been taken, administration of activated charcoal and osmotic laxatives may be useful.