Duodart Dosage/Direction for Use

Posology: Adults (including elderly): The recommended dose of Duodart is one capsule (0.5 mg/ 0.4 mg) once daily.
Where appropriate, Duodart 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 Duodart may be considered.
Renal impairment: The effect of renal impairment on dutasteride-tamsulosin pharmacokinetics has not been studied. No adjustment in dosage is anticipated for patients with renal impairment (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: The effect of hepatic impairment on dutasteride-tamsulosin pharmacokinetics has not been studied so caution should be used in patients with mild to moderate hepatic impairment (see Precautions and Pharmacology: Pharmacokinetics under Actions). In patients with severe hepatic impairment, the use of Duodart is contraindicated (see Contraindications).
Paediatric population: Dutasteride-tamsulosin is contraindicated in the paediatric population (under 18 years of age) (see Contraindications).
Method of administration: For oral use.
Patients should be instructed to swallow the capsules whole, approximately 30 minutes after the same 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.