- Active ingredient
- dutasteride
- Strength
- 0.5mg
- Form
- capsule
- Manufacturer
- sigma
- Route
- oral.solid
Uses
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, and reduce the need for BPH-related surgery. Not approved for prevention of prostate cancer.
Do not use if
Contraindicated in women who are pregnant or of childbearing potential due to risk of fetal harm (feminization of male fetus). Contraindicated in pediatric patients. Women should not handle crushed or broken capsules due to dermal absorption risk.
Side effects
Common adverse effects include ejaculation disorders, erectile dysfunction, decreased libido, and breast tenderness or enlargement (gynecomastia). These are related to the hormonal mechanism of action. Effects on libido and sexual function may persist after discontinuation.
Warnings
Associated with increased risk of high-grade prostate cancer in some studies; discuss with patients before initiating therapy. Reduces serum PSA levels by approximately 50%, which must be considered when interpreting PSA values for prostate cancer screening. Pregnant women must avoid exposure.
How it works
Dutasteride inhibits both type 1 and type 2 isoforms of 5-alpha-reductase, the enzyme responsible for converting testosterone to the more potent androgen dihydrotestosterone (DHT). Reduction of DHT levels leads to shrinkage of the enlarged prostate gland.
Storage
Store at room temperature below 30°C. Protect from light and moisture. Keep out of reach of children.