UROMAX D Film-coated tablet Ref.[50496] Active ingredients: Dutasteride Tamsulosin

The recommended dose of URIMAX D is one tablet once daily with or without food. The tablet should be swallowed whole and should not be crushed or chewed. No dosage adjustment is required for subjects with renal impairment or for the elderly.

Overdosage with URIMAX D tablets could potentially lead to hypotension due to the tamsulosin hydrochloride component. In case of 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 be used and renal function should be monitored and supported as needed. Laboratory data indicate that tamsulosin hydrochloride is 94-99% protein bound; therefore, dialysis is unlikely to be of benefit.

In volunteer studies, single doses of dutasteride up to 40 mg (80 times the 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.

Store in a cool, dry place.

URIMAX D Tablets: Pack of 10 tablets.