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 What is UROREC?

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UROREC (silodosin) is a highly selective α1A receptor blocker indicated for the relief of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia in adult men alleviating a range of BPH symptoms.1,2

Why choose UROREC?

UROREC has the highest selectivity for α1A receptors located in the prostate and bladder.
It is 162 x more selective for α1A receptors than for α1B so it works where you need it.1,2†

In vitro data does not necessarily predict human clinical effects

URO-Icon_min cardiovascular impact_website

 

Minimal cardiovascular impact2*

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Highest improvement in bladder outlet obstruction among alpha blockers3

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Improvement in nocturia4

*Minimal effect on supine blood pressure; no effect on ECG intervals or cardiac repolarisation;
orthostatic hypotension similar to placebo (more common in elderly although usually mild and resolves with continued treatment);
can be co-administered with antihypertensives while monitoring for possible adverse reactions.2

Based on alpha 1a/alpha 1b affinity ratio; study used indirect comparisons­.3

 

 

How does UROREC work differently from other alpha blockers?

UROREC has high affinity for the α1A adrenergic receptors in the prostate, the bladder, and the prostatic urethra. By this mechanism, it relaxes the smooth muscle in these organs, easing urinary flow and other symptoms of BPH.2

There are three known subtypes of α1 receptors: α1A, α1B and α1D

α1 Subtype

Predominant location

Physiologic function

α1A

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α1A regulates smooth muscle tone in the bladder neck, prostate, and prostatic urethra2,5

Blockade of α1A receptors relieves LUTS via relaxation of the lower urinary tract5

α1B

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α1B regulates vascular smooth muscle5

Blockade of α1B receptors can cause orthostatic hypotension5

α1D

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α1D is found in the central nervous system6 and the coronary arteries5

Blockade of the α1D receptor may mediate coronary vasodilation5

Table adapted from Rossi M, et al. 2010; Kaplan SA, et al. 2005.5,6

α1-adrenoreceptor selectivity of current alpha blockers used to treat lower urinary tract symptoms

Alfuzosin

Nonsubtype-selective

Doxazosin

Nonsubtype-selective

UROREC (silodosin)

α1A1D1B

Tamsulosin

α1A1D1B

Terazosin

Nonsubtype-selective

Table adapted from Rossi, M. et al. 20105

IPSS Sheet

Bladder Diary

Urorec Patient Sheets

 

UROREC RPBS information7

 

silodosin 8 mg capsule, 30

silodosin 4 mg capsule, 30

Item Code

12077P

12079R

General Patient Charge

$6.60

$6.60

 

Max. quantity of packs - 1; max. number of repeats - 5
Authority required – Benign prostatic hyperplasia. Clinical criteria: Patient must have lower urinary tract symptoms.

8 mg starting dose. No dose adjustment required in elderly.2‡
4 mg starting dose recommended in patients with moderate renal impairment; please see PI for full information.

 

UROREC provides effective relief of LUTS in BPH8

The efficacy of UROREC in the relief of LUTS (as measured by IPSS total score) was:

  • Superior to placebo (p<0.001)
  • Non-inferior to tamsulosin (p = NS)

CHANGES IN IPSS TOTAL SCORE AT 12 WEEKS (PRIMARY ENDPOINT)

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Figure adapted from Chapple, CR. et al. 20118

The study was not designed to detect a difference in efficacy between UROREC and tamsulosin8

Learn more about this study

 

PBS Information: This product is not listed on the PBS. For RPBS Information refer to PBS Schedule
Please review the Full Product Information before prescribing.

 

Abbreviations: LUTS = lower urinary tract symptoms; BPH = benign prostatic hyperplasia; RPBS = Repatriation Schedule of Pharmaceutical Benefits; IPSS = International Prostate Symptom Score; vs = versus; ITT = intent-to-treat (all subjects who had a baseline IPSS assessment and at least one valid post baseline IPSS assessment); vs. = versus; PP = per-protocol (all subjects who completed the study without any major protocol violation); NS = non-significant.

References: 1. Roehrborn CG, et al. Adv Ther (2016) 33: 2110–2121. 2. UROREC Approved Product Information. 3. Fusco F et al. Adv Ther 2017; 24:773–783.  4. Eisenhardt A, et al. World J Urol 2014; 32:1119–1125. 5. Rossi M, et al. Drug Des Devel Ther. 2010; 4: 291–7. 6. Kaplan SA, et al. Alpha-blocker therapy: current update. Rev Urol. 2005; 7(Suppl 8): S34–42. 7. https://www.pbs.gov.au/browse/rpbs [Accessed 3 May 2022]. 8. Chapple CR, et al. Silodosin Therapy for Lower Urinary Tract Symptoms in Men with Suspected Benign Prostatic Hyperplasia: Results of an International, Randomized, Double-Blind, Placebo- and Active-Controlled Clinical Trial Performed in Europe. Eur Urol. 2011; 59: 342–52.

UROREC® is sold by Mayne Pharma International Pty Ltd under license from Recordati Ireland, Ltd., Ringaskiddy, Ireland and Kissei Pharmaceutical Co., Ltd., Matsumoto, Japan. Mayne Pharma International Pty Ltd. ABN 88 007 870 984. 1538 Main North Road, Salisbury South, SA 5106. T: 1300 081 849. URO0091. Date of preparation: May 2022.