Safety in Lactation: Drugs for urinary frequency, enuresis, and incontinence

25 September 2020This group of drugs have varied mechanisms of action in treating urinary control conditions. Indications are broadly similar for all drugs, although there are small…

Drugs for urinary disorders – are any lactose-free?

5 February 2020This Medicine Q&A gives details of available urinary frequency, enuresis, incontinence and urinary retention preparations that do not contain lactose. There is a lactose-free preparation…
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Medicine Compliance Aid Stability

VesicareAstellas Pharma Ltd

Astellas Pharma Ltd
Tablets f/c 5mg, 10mg
A2 · Amber 2No stability data is available, the manufacturer does not, or cannot recommend use in CAs but there are no theoretical concerns with the product.
No special precautions for storage
No special precautions for storage
21 September 2015

Lactation Safety Information

No published evidence of safety
Low levels anticipated in milk due to the drug’s properties although very long half-life increases risk of accumulation in breastfed infants
Monitor infant for anticholinergic effects, e.g. urinary retention, colic and constipation
18 September 2020

New Medicines

VesicareNeurogenic detrusor overactivity in children - oral suspension formulation


Licence extension / variation and New formulation

Development and Regulatory status

Approved (Licensed)
October 2018
May 20Approved in US for NDO in children aged 2 years and older [13].
Oct 18Launched in UK. Licence is for symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder (OAB) syndrome, plus treatment of NDO in children aged 2 to 18 years. Price 1mg/ml oral susp, 150ml=£27.62 [12].
Feb 18 Approved in EU for neurogenic detrusor overactivity in children [11].
Apr 17Filed in EU [8].
Feb 17Filed in US [8].
Oct 16Remains PIII [6].
Oct 15PIII study in EU & US continues [5].
Mar 12PIII study started Mar 12 [1].


Muscarinic M3 receptor anatgonist in an oral 5mg/5ml suspension formulation.
It is estimated that 46% of women and 34% of men aged over 80 years have urinary incontinence. In a recent cohort study of individuals aged over 85 years, severe or profound urinary incontinence was reported by 21%. In general, urinary incontinence is twice as common in women as in men [2]. Neurogenic Detrusor Overactivity (NDO) is Detrusor Overactivity associated with a neurological condition. There is an incidence of 1.8 per 10, 000 births in the EU [10].
Neurogenic detrusor overactivity in children - oral suspension formulation

Trial or other data

Apr 16Astellas complete PIII study NCT01565694 [7].
Mar 15The NCT01565694 PIII study in children aged 5-18 is continuing and is expected to complete Aug 16. The second PIII study in children less than 5 has suspended recruitment [5].
Mar 14In April 2013 a PIII trial initiated to investigate the long-term efficacy, safety, quality-of-life effects and pharmacokinetics of oral solifenacin, in children aged 2-5 years with neurogenic detrusor overactivity. It is being conducted under an EMA Paediatric Investigation Plan (Decision no. P314-2011). Recruitment of approximately 24 pts has begun in the UK, Netherlands and Denmark and is expected to expand to other sites in the EU as well as South Korea and the Philippines. [4]
Mar 14NCT01565694 estimated to complete October 2015 [3]
Apr 12NCT01565694 A 52-week PIII, open-label, baseline-controlled, multicentre, sequential dose titration study to assess the long-term efficacy and safety, and the pharmacokinetics of solifenacin succinate suspension in 90 children from 5 to <18 years of age with neurogenic detrusor overactivity (NDO). The primary outcome is change from baseline in maximum cystometric capacity (MCC) at 24 weeks. The study started Mar 12 and is due to complete Nov 14 [1]