Drug Detail:Dutasteride and tamsulosin (Dutasteride and tamsulosin [ doo-tas-ter-ide-and-tam-soo-loe-sin ])
Drug Class: 5-alpha-reductase inhibitors
Usual Adult Dose for Benign Prostatic Hyperplasia
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.