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These highlights do not include all the information needed to use Dutasteride Capsules safely and effectively. See full prescribing information for Dutasteride Capsules. DUTASTERIDE capsules, for oral use Initial U.S. Approval: 2001
Medication labelWhy this: Advisory · dailymed-prescription
1.1 Monotherapy Dutasteride Capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: · improve symptoms, · reduce the risk of acute urinary retention (AUR), and · reduce the risk of the need for BPH-related surgery. 1.2 Combination with Alpha-adrenergic Antagonist Dutasteride Capsules in combination with the alpha-adrenergic antagonist, tamsulosin, is indicated for the treatment of symptomatic BPH in men with an enlarged prostate. 1.3 Limitations of Use Dutasteride Capsules are not approved for the prevention of prostate cancer.
- generic_name
- dutasteride
- product_names
- Dutasteride
- ndc
- 25000-011, 25000-011-03, 25000-011-07, 25000-011-27
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en