Dutasteride and Tamsulosin Hydrochloride Capsules
Drug Details
- Generic Name
- Dutasteride and Tamsulosin Hydrochloride Capsules
- Brand Names
- Dutasteride and Tamsulosin Hydrochloride
- Application Number
- ANDA202509
- Sponsor
- AvKARE
- NDC Codes
- 1
- Dosage Forms
- CAPSULE
- Routes
- ORAL
- Active Ingredients
- DUTASTERIDE, TAMSULOSIN HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE Dutasteride and tamsulosin hydrochloride capsules are a combination of dutasteride, a 5-alpha-reductase inhibitor, and tamsulosin, an alpha-adrenergic antagonist, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. ( 1.1 ) Limitations of Use: Dutasteride-containing products, including dutasteride and tamsulosin hydrochloride capsules, are not approved for the prevention of prostate cancer. ( 1.2 ) 1.1 Benign Prostatic Hyperplasia (BPH) Treatment Dutasteride and tamsulosin hydrochloride capsules are indicated for the treatment of symptomatic BPH in men with an enlarged prostate. 1.2 Limitations of Use Dutasteride-containing products, including dutasteride and tamsulosin hydrochloride capsules, are not approved for the prevention of prostate cancer.