Dutasteride 0.5 mg-Tamsulosin 0.4 mg orally once a day approximately 30 minutes after the same meal each day
Use: Treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.
Renal Dose Adjustments
CrCl 10 mL/min or more: No adjustment recommended
CrCl less than 10 mL/min: Data not available
Liver Dose Adjustments
Mild to moderate liver dysfunction: No adjustment recommended
Severe liver dysfunction: Data not available
Precautions
CONTRAINDICATIONS:
Previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angioedema, urticaria, pruritus, respiratory symptoms) to either active component, any of the ingredients, or other 5-alpha-reductase inhibitors
Pregnancy
Women of childbearing potential
Pediatric patients
Safety and efficacy have not been established in pediatric patients.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice: This drug should be swallowed whole and not chewed or opened.
General: This drug should not be handled by women who are pregnant or who could become pregnant.
Monitoring:
Genitourinary: Prostate-specific antigen (PSA) (to interpret serial PSA values, baseline PSA should be established at least 3 months after starting treatment and PSA monitored periodically thereafter)
Patient advice:
Advise patients starting this drug to avoid situations where syncope could result in injury.
Advise patients to tell their ophthalmologists that they take or have taken this drug.
Advise patients regarding the possibility and seriousness of priapism.
Advise patients to avoid blood donation for at least 6 months after their final dose.
