- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
Kinetic parameters determined in 33 children aged 5-10 yrs
Tmax = 1.2-1.4 hours
T½ = 1.4-2 hours
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
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Available formulations
No information is present at this moment.
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Dosages
| Urinary incontinence, overactive bladder syndrome, neurogenic bladder |
|---|
|
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Renal impaiment in children > 3 months
6 mnd-10 years:
- GFR ≥ 30: No dose adjustment needed
- GFR 10-30: 50% of normal reversal dose, max 1 mg/day, interval between 2 doses: 12 hours.
- GFR <10: general advice is not given.
10-18 years:
- GFR ≥ 30: no dose adjustment needed
- GFR 10-30: 50% of normal reversal dose, max 2 mg/day, interval between 2 doses: 12 hours.
- GFR <10: general advice is not given
Clinical consequences
With severely impaired renal function, the AUC of tolterodine and its pharmacologically active 5-hydroxymethyl metabolite may increase. This increases the risk of adverse reactions.
Clinical implications:
Dose-dependent adverse reactions due to the pharmacological effect include dry mouth, dry eyes, abnormal accommodation, vision disturbances, dry skin, constipation, urinary retention, tachycardia, and palpitations. Prolongation of the QTc interval has been reported at high doses.
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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Side effects
No information is present at this moment.
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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
Contra-indications
No information available on specific contra indications in children.
The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here
Warnings & precautions
No information available on specific warnings and precautions in children.
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| Acidifiers | ||
|---|---|---|
| G04BA01 | ||
| Drugs for urinary frequency and incontinence | ||
|---|---|---|
| G04BD04 | ||
| G04BD04 | ||
| G04BD06 | ||
| G04BD08 | ||
| G04BD09 | ||
| Drugs used in erectile dysfunction | ||
|---|---|---|
| G04BE03 | ||
| G04BE08 | ||
| Other urologicals | ||
|---|---|---|
| G04BX16 | ||
| OTHER UROLOGICALS | ||
|---|---|---|
| G04BX16 | ||
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References
- Hjalmas K, et al, The overactive bladder in children: a potential future indication for tolterodine, BJU Int., 2001, Apr;87(6), 569-74
- Deng YJ, et al, Comparisons of efficacy and safety of tolterodine and oxybutynin in children with idiopathic overactive bladder, Zhongguo Dang Dai Er Ke Za Zhi., 2011, Jan;13(1):, 26-8
- Reddy PP, et al, Long-term efficacy and safety of tolterodine in children with neurogenic detrusor overactivity, J Pediatr Urol, 2008, Dec;4(6), 428-33
- Mahanta K, et al, Comparative efficacy and safety of extended-release and instant-release tolterodine in children with neural tube defects having cystometric abnormalities, J Pediatr Urol, 2008, Apr;4(2), 118-23
- Kilic N, et al, Comparison of the effectiveness and side-effects of tolterodine and oxybutynin in children with detrusor instability, Int J Urol, 2006, Feb;13(2), 105-8
- Bolduc S, et al, Double anticholinergic therapy for refractory overactive bladder. , J Urol., 2009, Oct;182(4 Suppl), 2033-8
- Christoph F, et al, Long-term efficacy of tolterodine and patient compliance in pediatric patients with neurogenic detrusor overactivity, Urol Int.;, 2007, 79(1):, 55-9
- Raes A, et al, Retrospective analysis of efficacy and tolerability of tolterodine in children with overactive bladder., Eur Urol., 2004, Feb;45(2), 240-4
- Nijman RJ, et al, Long-term tolerability of tolterodine extended release in children 5-11 years of age: results from a 12-month, open-label study, Eur Urol, 2007, Nov;52(5), 1511-6
- Ayan S, et al, Efficacy of combined anticholinergic treatment and behavioral modification as a first line treatment for nonneurogenic and nonanatomical voiding dysfunction in children: a randomized controlled trial, J Urol, 2007, Jun;177(6), 2325-8; discussion 8-9
- Ellsworth PI, et al, Use of tolterodine in children with neurogenic detrusor overactivity: relationship between dose and urodynamic response, J Urol, 2005, Oct;174(4 Pt 2), 1647-51; discussion 51
- Nijman RJ, et al, Tolterodine treatment for children with symptoms of urinary urge incontinence suggestive of detrusor overactivity: results from 2 randomized, placebo controlled trials, J Urol., 2005, Apr;173(4), 1334-9
- NKFK Workinggroup Acute Kidney Impairment, Extrapolation of KNMP risk analysis "Impaired renal function" for adults to children, 20 Dec 2021
- Bolduc S, et al, Double anticholinergic therapy for refractory overactive bladder., J Urol., 2009, Oct;182(4 Suppl), 2033-8
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Changes
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