Classifications: antiandrogen; 5-alpha reductase inhibitor; benign prostatic hyperplasia (bph) agent; Therapeutic:bph agent
Pregnancy Category: X
0.5 mg capsules
Specific inhibitor of the steroid 5-alpha-reductase, an enzyme necessary to convert testosterone into the potent androgen
5-alpha-dihydrotestosterone (DHT) in the prostate gland.
Decreases the production of testosterone in the prostate gland.
Treatment of benign prostatic hypertrophy (BPH).
Treatment of male pattern baldness.
Hypersensitivity to dutasteride or finasteride; pregnancy (category X), lactation, and children <18 y.
Hepatic impairment, obstructive uropathy.
Route & Dosage
Adult: PO 0.5 mg once daily
Male Pattern Baldness
Adult: PO 0.250.5 mg once daily
- Do not handle capsules if you are or may become pregnant because of the potential for absorption of dutasteride and the
subsequent risk to a developing male fetus.
- Do not open or crush capsules. They must be swallowed whole.
- Store at 15°30° C (59°86° F).
Adverse Effects (≥1%)Endocrine:
Ejaculation dysfunction, impotence, decreased libido.
InteractionsDrug: Diltiazem, verapamil
may decrease clearance of dutasteride. Herbal:
May see exaggerated effects with saw palmetto.
Rapidly absorbed. 60% bioavailability. Peak:
23 h. Distribution:
99% protein bound. Metabolism:
Metabolized in liver by CYP3A4 to one active and 2 inactive metabolites. Elimination:
Primarily in feces. Half-Life:
Assessment & Drug Effects
- Monitor voiding patterns, assessing for ease of starting a stream, frequency, and urgency.
- Lab tests: Monitor baseline PSA and again at 36 mo to establish new baseline to use to assess potentially cancer-related
changes in PSA. After 6 mo of treatment, obtained PSA values should be doubled for comparison with normal values in untreated
Patient & Family Education
- Do not donate blood until at least 6 mo following last dose to prevent administration of dutasteride to a pregnant female
- Ejaculate volume might be decreased during treatment but this does not seem to interfere with normal sexual function.
- Note that the incidence of most drug-related sexual adverse events (impotence, decreased libido, and ejaculation disorder)
typically decrease with duration of treatment.