dutasteride

　　【Indications】

　　This product is a 5α-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia(BPH)in men with an enlarged prostate to:

　　•Improve lower urinary tract symptoms;

　　•Reduce the risk of acute urinary retention;

　　•Reduce the risk of BPH-related surgery.

　　This product may be used in combination with tamsulosin,an alpha-adrenergic antagonist,for the treatment of symptomatic BPH in men with an enlarged prostate.

　　Limitation of Use:

　　This product is not approved for the prevention of prostate cancer.

　　【Recommended Dosage】

　　Monotherapy:

　　0.5 mg taken orally once daily,with or without food.

　　Combination Therapy with Tamsulosin:

　　0.5 mg of this product plus 0.4 mg of tamsulosin,each taken orally once daily,with or without food.

　　【Adverse Reactions】

　　The most common adverse reactions(incidence≥1%)include erectile dysfunction,decreased libido,ejaculation disorders,and breast-related disorders(such as gynecomastia and breast tenderness).

　　【Pharmacological Action】

　　Dutasteride inhibits the conversion of testosterone to dihydrotestosterone(DHT).DHT is the primary androgen responsible for initial prostate development and subsequent enlargement.Testosterone is converted to DHT by 5α-reductase,which exists as two isoenzymes:type 2 is predominantly active in reproductive tissues,while type 1 also mediates testosterone conversion in the skin and liver.Dutasteride is a competitive and specific inhibitor of both type 1 and type 2 5α-reductase isoenzymes,forming a highly stable enzyme-inhibitor complex that dissociates extremely slowly under both in vitro and in vivo conditions.Dutasteride does not bind to the human androgen receptor.

　　【Storage】

　　Store at room temperature of 25°C,with excursions permitted between 15°C and 30°C.