Uses
Benign Prostatic Hypertrophy (BPH)
Treatment of symptomatic BPH to improve symptoms and reduce the risk of acute urinary retention and the need for surgery. Ineffective in patients who do not have evidence of prostatic enlargement.
Used alone or in combination with an α1-adrenergic blocking agent (e.g., doxazosin). Combination therapy with a 5α-reductase inhibitor and an α1-blocker has been more effective than therapy with either drug alone in preventing long-term BPH symptom progression. Men at risk for BPH progression are most likely to benefit from combination therapy.
Steroid 5α-reductase inhibitors may be a useful alternative to surgery in patients with obstructive manifestations who are awaiting or unwilling to undergo surgical correction of BPH; may aid those who are at increased risk from or are not candidates for prostate surgery. Also may be considered in patients who have symptomatic prostatic enlargement but whose symptoms are not bothersome (i.e., do not interfere with activities of daily living) in order to prevent progression of the disease.
Although drug therapy usually is not as effective as surgical therapy, it may provide adequate symptomatic relief with fewer and less serious adverse effects compared with surgery.
Androgenetic Alopecia
Stimulates regrowth of hair in men with mild to moderate androgenetic alopecia (male pattern alopecia, hereditary alopecia, common male baldness).
Effective in promoting hair regrowth in young and middle-aged men (18–41 years of age) with mild to moderate androgenetic alopecia and hair loss on the vertex of the scalp and/or anterior mid-scalp area; the effects on bitemporal recession are not established.
Recommended only for use in men; not indicated for use in women or children. Ineffective for treatment of hair loss in postmenopausal women with androgenetic alopecia.
Withdrawal of the drug leads to reversal of clinical benefit within 1 year. Therapy must be continued to sustain initial regrowth and subsequent slowing of hair loss. Maximum improvement in hair count occurs during first 2 years of therapy.
Dosage and Administration
Administration
Administer orally without regard to meals.
Dosage
Adults
BPH
Oral
5 mg once daily, alone or in combination with doxazosin mesylate.
While early symptomatic improvement may occur, ≥6 months of therapy may be necessary to determine clinical benefit.
Androgenetic Alopecia
Oral
1 mg once daily.
Generally administered for ≥3 months before benefit is observed. If improvement does not occur within 1 year, further treatment with the drug is unlikely to provide benefit.
Continued use recommended to sustain benefit, which should be re-evaluated periodically.
Discontinuance leads to reversal of effect within 12 months.
Special Populations
Dosage in Hepatic Impairment
No specific dosage recommendations for hepatic impairment. (See Hepatic Impairment under Cautions.)
Dosage in Renal Impairment
Dosage adjustment not required.
Geriatric Patients
Dosage adjustment not required.
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