Australian Doctor Australian Doctor 2 June 2017 | Page 13

Start with Duodart to improve
symptoms* and reduce the risk of
AUR and BPH related surgery # in
men with moderate to severe BPH 1,2
*p<0.001 vs. both tamsulosin and dutasteride monotherapies. # 66% RRR (ARR = 7.7%)
vs tamsulosin monotherapy (not significant vs. dutasteride monotherapy p= 0.18)
BPH=Benign Prostatic Hyperplasia AUR=Acute Urinary Retention
Duodart may now be initiated on the PBS by a GP
Duodart is generally well tolerated. Sexual side effects may be reported 2 .
See full PI for further information. LUTS= lower urinary tract symptoms
PBS Information: Authority Required (STREAMLINED 6189).
Treatment of LUTS in patients with moderate to severe BPH.
Please Review Duodart ® Product Information Before Prescribing.
The Product Information can be accessed at au.gsk.com
Duodart® (dutasteride/tamsulosin hydrochloride) Minimum Product Information
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; 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. Breast Cancer has been reported in men taking dutasteride in clinical
trials and during the post-marketing period. 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 hydrochloride
capsule daily, swallowed whole, 30 minutes after food at the same time each day. Duodart Min PI v2. For further details, please refer to the Full PI.
References: 1. Roehrborn CG et al. European Urology 2010 (57): 123-131. 2. Duodart Approved Product Information v11
For full product information, information on GSK products or to report an adverse event involving a GSK product, please contact GSK Medical Information on 1800 033
109. GlaxoSmithKline Australia Pty Ltd. ABN 47 100 162 481. Level 3, 436 Johnston street, Abbotsford VIC 3067. Melbourne, VIC. Duodart ® is a registered trade
mark of the GSK group of companies. AUS/Pharma/0013/17; Date of Approval April 2017