Important
THIS IS A PRESCRIPTION DRUG. Caution: Foods, Drugs, Devices, and Cosmetics Act prohibits dispensing without prescription. The contents of this page are provided for information purposes only. It should not be construed as a substitute for a professional medical advice. Please consult your physician and other healthcare providers before taking any medicines found in this page.
Regulatory Classification
Rx
Unit of Measure
Box of 30's
Pharmacologic Category
Benign Prostatic Hypertrophy Drug
Contents & Formulation
Each hard gelatin capsule contains:
Dutasteride EP .................................. 0.5 mg
(As immediate-release pellets)
Tamsulosin Hydrochloride USP ….............0.4 mg
(as sustained-release pellets)
Excipients…......................................q.s.
Indications and Usage
Treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH).
Reduction in the risk of acute urinary retention (AUR) and surgery in patients with moderate to severe symptoms of BPH.
Dosage & Administration
Adults (including elderly)
— The recommended dose of Dutasteride + Tamsulosin HCl (Durotam) is one capsule (0.5 mg/ 0.4 mg) once daily.
— Where appropriate, Dutasteride + Tamsulosin HCl (Durotam) may be used to substitute concomitant Dutasteride and Tamsulosin hydrochloride in existing dual therapy to simplify treatment.
— Where clinically appropriate, direct change from Dutasteride or Tamsulosin hydrochloride monotherapy to Dutasteride + Tamsulosin HCl (Durotam) may be considered.
Method of administration
For oral use.
Patients should be instructed to swallow the capsules whole, approximately 30 minutes after the same time of meal each day. The capsules should not be chewed or opened. Contact with the contents of the Dutasteride capsule contained within the hard-shell capsule may result in irritation of the oropharyngeal mucosa.
