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…
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Medicine Compliance Aid Stability


Tablets 2.5mg, 5mg
R2 · Red 2Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Protect from light
29 September 2015

Lactation Safety Information

Low levels anticipated in milk due to the drug's properties
No published evidence of safety
Monitor infant for anticholinergic effects, e.g. urinary retention, colic and constipation
3 August 2020

New Medicines

Vesoxx Neurogenic detrusor overactivity - second-line after failure of oral anticholinergics in patients managing bladder emptying by clean intermittent catheterisation (intravesical formulation)


New formulation

Development and Regulatory status

Approved (Licensed)
Approved (Licensed)
Jan 21Licensed in the UK for suppression of detrusor overactivity due to spinal cord injury or myelomeningocele (spina bifida) in children from 6 years of age and adults, who are managing bladder emptying by clean intermittent catheterisation, not adequately managed with oral anticholinergics [2].
Sep 18Licensed in the EU using the decentralised procedure [2].


Anticholinergic agent, which also exerts a direct antispasmodic effect on smooth muscle. Available in a pre-filled syringe, dosed between 1-4 times daily.
Any condition that impairs bladder and bladder outlet afferent and efferent signalling can cause neurogenic bladder. Causes are many and include spinal cord injury, spina bifida, diabetes, AIDS, multiple sclerosis and tumours. Immediate continuous or intermittent catheterisation is needed for a flaccid bladder, especially if the cause is an acute spinal cord injury. Clean intermittent self-catheterisation is a technique used to empty the bladder at regular intervals [1].
Neurogenic detrusor overactivity - second-line after failure of oral anticholinergics in patients managing bladder emptying by clean intermittent catheterisation (intravesical formulation)

Further information


Trial or other data

Jun 16Open-label PIII study investigating the efficacy, safety, and tolerability of intravesically administered 0.1% oxybutynin hydrochloride solution in 35 adults with neurogenic bladder published in Neurourology and Urodynamics. NDO was confirmed within the previous 24 months by urodynamic studies (UDS). Group 1 (n = 18) received 10 ml 0.1% oxybutynin hydrochloride intravesically three times per day and group 2 (n = 17) 5 mg oxybutynin hydrochloride orally three times per day for a period of 28 days. Primary efficacy criterion was the change in the maximum bladder capacity between the beginning of the study and after 4 weeks as assessed by UDS. Adverse drug reactions (ADR) were collected and an evaluation of anticholinergic effects was conducted. The increase in maximum bladder capacity was 117 ml with intravesical application (P = 0.0002) versus 18 ml with the oral application (P = 0.51). The difference was statistically significant (P = 0.0086). ADR were reported by 10 (55.6%) of patients with intravesical administration, and by 14 (82.4%) of patients with oral administration. Significant differences in favor of the intravesical application were observed in ADR affecting vision (1/10 vs. 9/14), gastrointestinal tract (8/10 vs. 14/14), nervous system (2/10 vs. 8/14), and skin and subcutis (1/10 vs. 6/14). No serious adverse drug reactions were reported [3].

Evidence based evaluations