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Dutasteride 0.5 MG Tamsulosin hydrochloride 0.4 MG Oral Capsule

1 INDICATIONS AND USAGE Dutasteride and tamsulosin hydrochloride capsules is 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.

Actavis Pharma, Inc.


4 years ago CAPSULE WHITE WPI 3771 Dutasteride 0.5 MG  Tamsulosin hydrochloride 0.4 MG Oral Capsule

CAPSULE WHITE WPI 3771

16 HOW SUPPLIED/STORAGE AND HANDLING Dutasteride and tamsulosin hydrochloride capsules, containing 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride, are size “00”, hard capsule, white opaque cap and body, containing white to off-white pellets and one yellow colored soft gelatin capsule. The hard capsule is imprinted with “ WPI 3771 ” in black ink. They are available in bottles with child-resistant closures as follows: Bottle of 30 (NDC 0591-3771-30). Bottle of 90 (NDC 0591-3771-19). Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. capsules may become deformed and/or discolored if kept at high temperatures. Dutasteride is absorbed through the skin. Dutasteride and tamsulosin hydrochloride capsules should not be handled by women who are pregnant or who could become pregnant because of the potential for absorption of dutasteride and the subsequent potential risk to a developing male fetus [see Warnings and Precautions ( 5.6 )] .


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