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JALYN (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE): OVERDOSAGE

No data are available with regard to overdosage with Dutasteride and Tamsulosin Hydrochloride (Jalyn). The following text reflects information available for the individual components.

Dutasteride

In volunteer studies, single doses of dutasteride up to 40 mg (80 times the 427 therapeutic dose) for 7 days have been administered without significant safety concerns. In a clinical study, daily doses of 5 mg (10 times the therapeutic dose) were administered to 60 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 cases of suspected overdosage symptomatic and supportive treatment should be given as appropriate, taking the long half-life of dutasteride into consideration.

Tamsulosin

Should overdosage of tamsulosin lead to hypotension, support of the cardiovascular system is of first importance. Restoration of blood pressure and normalization of heart rate may be accomplished by keeping the patient in the supine position. If this measure is inadequate, then administration of intravenous fluids should be considered. If necessary, vasopressors should then be used and renal function should be monitored and supported as needed. Laboratory data indicate that tamsulosin is 94% to 99% protein bound; therefore, dialysis is unlikely to be of benefit.


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