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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