Urodart Capsule

Benign prostatic hyperplasia (BPH)

Oral Benign prostatic hyperplasia Adult: 500 mcg once daily for at least 6 mth. Hepatic impairment: Severe: Contraindicated.

Renal impairment: Dose adjustment not necessary

May be taken with or without food.

Severe liver impairment; pregnant women, children, adolescent.

Excreted in semen therefore use of condom is recommended. Women of childbearing potential should avoid handling dutasteride capsules. Advisable to exclude other causes of benign prostatic hypertrophy (e.g. prostate cancer, infection) before initiating therapy. Lactation: Excretion in milk unknown/contraindicated

X Pregnancy category: X Lactation: Excretion in milk unknown/contraindicated

Plasma concentrations may be increased when used concomitantly w/ moderate or potent CYP3A4 inhibitors.

1-10% Impotence,Decreased libido,Ejaculation disorder,Breast disorders/gynecomastia <1% Dizziness Frequency Not Defined Cardiac failure,Prostate cancer (high grade)

Dutasteride has antiandrogenic properties. It inhibits 5alpha-reductase, thus preventing the conversion of testosterone to 5?-dihydrotestosterone which is the main androgen involved in causing prostate enlargement.

Urodart 500mcg Capsule manufactured by UniMed UniHealth Pharmaceuticals Ltd.. Its generic name is Dutasteride.