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Dosing1
Important
- The capsules should be swallowed whole and not 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.
- The effect of renal impairment on dutasteride-tamsulosin pharmacokinetics has not been studied. However, no adjustment in dosage is anticipated for patients with renal impairment.
Duodart safety information1
Contraindications:
Duodart is contraindicated in women, children, adolescents and in patients with hypersensitivity to dutasteride, other 5-alpha reductase inhibitors, tamsulosin or any of the other excipients; patients with history of orthostatic hypotension; patients with severe hepatic impairment.
Special warnings and precautions:
Combination therapy should be prescribed after careful benefit-risk assessment due to the potential increased risk of adverse events (including cardiac failure) and after consideration of alternative treatment options including monotherapies.
Alpha blockers have been associated with risk of orthostatic hypotension and intraoperative floppy iris syndrome.
Men taking Duodart should be regularly evaluated for prostate cancer risk including PSA testing.
Any confirmed increase from lowest PSA level while on Duodart may signal the presence of prostate cancer or noncompliance to therapy with Duodart and should be carefully evaluated.
Adverse events:
Ejaculation disorders, Impotence, Altered (decreased) Libido, Breast disorders, Dizziness and Priapism.
References
- Duodart Prescribing Information
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Department of Pharmacovigilance & Drug Information |
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PM-RCH-DTT-WCNT-250001 | Date of Preparation May 2025
