Indication
Tamsulosin & Dutasteride combination capsules are indicated for the treatment of
symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.
Dosage & Administration
The recommended dose is 1 capsule (0.5 mg Dutasteride and 0.4 mg Tamsulosin
Hydrochloride) taken once daily approximately 30 minutes after the same meal
each day.
The capsules should be swallowed whole and not chewed or opened. Contact with
the contents of the capsule may result in irritation of the oropharyngeal mucosa.
Dose adjustment for renal & hepatic impaired patients
Renal impairment: Patients with renal impairment do not require an adjustment in
Tamsulosin dosing. Patients with end stage renal disease (CrCl < 10 ml/min) have
not been studied.
Hepatic impairment: Patients with mild to moderate hepatic dysfunction do not
require an adjustment. Tamsulosin has not been studied in patients with severe
hepatic dysfunction.
Precautions
Use in Pregnancy and Lactation
Pregnancy: Combination of Tamsulosin & Dutasteride is contraindicated for use in
women.
Lactating Mother: This combination is contraindicated for use in women. It is not
known whether Tamsulosin or Dutasteride are excreted in breast milk.
Use in Pediatric Patient
This combination is contraindicated for use in children. BPH is not a disease of
childhood. Safety and effectiveness of Tamsulosin or Dutasteride in children have
not been established.
