Usual Adult Dose for Benign Prostatic Hyperplasia

8 mg orally once a day with a meal

Comments: Patients who have difficulty swallowing may open the capsule and sprinkle the powder on a tablespoonful of applesauce. The applesauce should not be hot, and should be soft enough to be swallowed within 5 minutes without chewing and followed with 8 ounces of cool water.

Renal Dose Adjustments

Mild renal dysfunction (CrCl 50 to 80 mL/min): No adjustment recommended
Moderate renal dysfunction (CrCl 30 to 50 mL/min): 4 mg orally once a day with a meal
Severe renal dysfunction (CrCl less than 30 mL/min): Contraindicated

Liver Dose Adjustments

Mild to moderate liver dysfunction: No adjustment recommended
Severe liver dysfunction (Child-Pugh 10 or greater): Contraindicated

Precautions

US FDA requires a medication guide to assure safe use. For additional information: www.fda.gov/drugs/drug-safety-and-availability/medication-guides

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients
• Severe renal impairment (CrCl less than 30 mL/min)
• Severe hepatic impairment (Child-Pugh 10 or greater)
• Concomitant use of strong CYP450 3A4 inhibitors (e.g., ketoconazole, clarithromycin, itraconazole, ritonavir)

Dialysis

Data not available

Other Comments

Patient advice:

• Inform patients regarding postural hypotension and related symptoms such as dizziness. Caution patients about driving, operating machinery, or performing hazardous tasks when initiating therapy.
• Inform patients that the most common adverse reaction, orgasm with reduced or no semen, does not pose a safety concern and is reversible upon discontinuation of this drug.
• Advise patients planning cataract surgery or other eye procedures to inform their ophthalmologist regarding use of this drug, even if they are no longer taking it.