Usual Adult Dose for Benign Prostatic Hyperplasia

0.5 mg orally once a day

Use: Treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to reduce the risk of acute urinary retention (AUR) and BPH-related surgery.

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Dose adjustment may be required as drug exposure could be higher in hepatically-impaired patients due to this drug being extensively metabolized; however, no specific guidelines have been suggested. Caution is recommended.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available.

Other Comments

Administration Advice:

• This drug may be taken with or without food.
• Drug capsules should be swallowed whole and not chewed or opened as contact with the capsule contents may result in irritation of the oropharyngeal mucosa.

• This drug is not approved for the prevention of prostate cancer.
• It may take up to 6 months before a treatment response with this drug can be achieved.
• Serum levels of this drug are detectable for 4 to 6 months after treatment cessation.
• Hair loss reduction and induction of hair growth in patients with male pattern hair loss may occur with the use of 5 alpha-reductase inhibitors.
• Overdosage: There is no specific antidote; symptomatic and supportive treatment should be given as appropriate and the long half-life of this drug should be taken into consideration.