Superior and sustained symptom improvement at 4 years vs both tamsulosin and dutasteride monotherapy 3
Start with Duodart..... reducing symptoms and preventing disease progression # in men with
moderate to severe BPH symptoms 1, 2.
# as measured by reductions in acute urinary retention and need for BPH related surgery 2
Superior and sustained symptom improvement at 4 years vs both tamsulosin and dutasteride monotherapy 3
AUS / DUTT / 0001 / 13
PBS Information: Authority Required( STREAMLINED). Treatment of LUTS due to BPH where treatment has been initiated by a urologist.
Tamsulosin containing products in Australia are not bioequivalent. They have similar clinical efficacy with small differences in some adverse events. PLEASE REVIEW PRODUCT INFORMATION BEFORE PRESCRIBING. To have a copy of the Product Information sent to you telephone 1800 033 109. The Product Information can be accessed at http:// www. gsk. com. au
Duodart( dutasteride / tamsulosin hydrochloride) Minimum PI: Indications: For the management of moderate to severe symptomatic benign prostatic hyperplasia( BPH). Contraindications: Hypersensitivity to dutasteride, other 5-alpha reductase inhibitors, tamsulosin hydrochloride, or any component of the preparation; use in women and children; pregnancy( Category X); lactation; history of orthostatic hypotension; severe hepatic impairment; severe renal impairment; combination with another alpha-blocker. Precautions: Contact with leaking capsules; hepatic impairment; renal impairment; predictable decrease in serum PSA levels after 6 months – any sustained increase after this should be evaluated; cataract surgery( risk of Intraoperative Floppy Iris Syndrome); do not donate blood. Use with caution in those reporting a serious or life-threatening sulphur allergy *. Composite term“ cardiac failure” increased in patients taking combination of dutasteride and an alpha-blocker( ≤1 %) vs monotherapy *. In a study of men at high risk of developing prostate cancer, an increased incidence of high grade prostate cancer in the dutasteride versus placebo arm was seen *. Interactions: No drug interaction studies have been conducted with the Duodart capsule. Co-administration of Duodart with alpha-blockers is contraindicated. Based on information available on the individual components, caution is required with co-administration of the following: cimetidine, PDE-5 inhibitors and warfarin. Adverse Effects: No clinical trials have been conducted with the Duodart capsule. The CombAT( Combination of Avodart and Tamsulosin) study found the occurrence of the following in ≥1 % of patients: impotence, altered( decreased) libido, ejaculation disorders, breast disorders( includes breast tenderness and enlargement). Dizziness and syncope have also been reported. Dosage: Adult males( including elderly) – one 500mcg dutasteride / 400mcg tamsulosin hydochloride capsule daily, swallowed whole, 30 minutes after food at the same time each day. PBS dispensed price $ 35.50. Based on TGA approved date 19 August 2011. References: 1. Approved Duodart Product Information, 2010. 2. Oelke M et al. Guidelines on management of male lower urinary tract symptoms( LUTS), including Benign Prostatic Obstruction( BPO). European Association of Urology, 2012. 3. Roehrborn CG et al. Eur Urol 2010; 57: 123-131. Full Disclosure Product Information is available from GlaxoSmithKline Australia Pty Ltd. ABN: Level 4, 436 Johnston Street, Abbotsford VIC 3067 47 100 162 481. Contact us on www. gsk. com. au or Ph: 1800 033 109. A2. Duodart ® is a registered trade mark of the GlaxoSmithKline Group of Companies. For information on GSK products or to report an adverse event involving a GSK product, please contact GSK Medical Information on 1800 033 109. Date of approval: 4 / 02 / 2013. AUS / DUTT / 0001 / 13
* Please note change in Product Information
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