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.

AVODART is contraindicated for use in:

• Pregnancy. Dutasteride inhibits the activity of 5α-reductase, which prevents conversion of testosterone to dihydrotesterone, a hormone necessary for normal development of male genitalia. In animal reproduction and developmental toxicity studies, dutasteride inhibited development of male fetus external genitalia. Therefore, AVODART may cause fetal harm when administered to a pregnant woman. If AVODART is used during pregnancy or if the patient becomes pregnant while taking AVODART, the patient should be apprised of the potential hazard to the fetus [see WARNINGS AND PRECAUTIONS, Use in Specific Populations].
• Women of childbearing potential [see WARNINGS AND PRECAUTIONS, Use in Specific Populations].
• Pediatric patients [see Use in Specific Populations].
• Patients with previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angioedema) to AVODART or other 5α-reductase inhibitors.

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