Treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.

5 Alpha-Reductase Inhibitor; Alpha 1 Blocker

1. Clinically significant hypersensitivity (eg, serious skin reactions, angioedema, urticaria, pruritus, respiratory symptoms) to dutasteride, tamsulosin, other 5-alpha-reductase inhibitors, or any component of the formulation.
2.Pregnancy.

Use is contraindicated during pregnancy. (Dutasteride may negatively impact the development of a male fetus.)

It is not known if dutasteride or tamsulosin are present in breast milk.

Ejaculatory disorder, Impotence, Decreased libido, Dizziness, Breast changes (including breast hypertrophy, breast swelling, breast tenderness, gynecomastia, mastalgia, nipple pain, nipple swelling)

Benign prostatic hyperplasia: Oral One capsule QD 30 minutes after the same meal.

CrCl >10: No dosage adjustment necessary.
CrCl <10: Has not been studied.

There are no dosage adjustments provided in the manufacturer's labeling.