BNF for Children (BNFC) 2018-2019

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Oral solution
CAUTIONARY AND ADVISORY LABELS 3
▶Oxybutynin hydrochloride (Non-proprietary)
Oxybutynin hydrochloride 500 microgram per 1 mlOxybutynin
2. 5 mg/ 5 ml oral solution sugar free sugar-free| 150 mlP
£ 154. 50 – £ 214. 85 DT = £ 184. 68
Oxybutynin hydrochloride 1 mg per 1 mlOxybutynin 5 mg/ 5 ml oral
solution sugar free sugar-free| 150 mlP£ 199. 20 DT = £ 199. 20

eiiiiF 489

Trospium chloride 11-May-2018


lINDICATIONS AND DOSE
Urinary frequency|Urinary urgency|Urge incontinence
▶BY MOUTH USING IMMEDIATE-RELEASE MEDICINES
▶Child 12–17 years: 20 mg twice daily, to be taken before
food

lINTERACTIONS→Appendix 1 : trospium
lSIDE-EFFECTS
▶Common or very commonAbdominal pain
▶UncommonChest pain.diarrhoea.flatulence
▶Rare or very rareArthralgia.asthenia.dyspnoea.myalgia
.urinary disorder.vision disorder
▶Frequency not knownAgitation.anaphylactic reaction.
hallucination.severe cutaneous adverse reactions (SCARs)
lPREGNANCYManufacturer advises caution.
lBREAST FEEDINGManufacturer advises caution.
lHEPATIC IMPAIRMENTManufacturer advises caution in
mild to moderate impairment. Avoid in severe
impairment.
lRENAL IMPAIRMENTUse with caution. AvoidRegurin®XL.
Dose adjustmentsReduce dose to 20 mg once daily or
20 mg on alternate days if eGFR 10 – 30 mL/minute/ 1. 73 m

2
.
lPRESCRIBING AND DISPENSING INFORMATIONThe need for
continuing therapy for urinary incontinence should be
reviewed every 4 – 6 weeks until symptoms stabilise, and
then every 6 – 12 months.

lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug. Forms available from special-order
manufacturers include: oral solution
Tablet
CAUTIONARY AND ADVISORY LABELS 23
▶Trospium chloride (Non-proprietary)
Trospium chloride 20 mgTrospium chloride 20 mg tablets|
60 tabletP£ 9. 00 DT = £ 8. 26
▶Flotros(Galen Ltd)
Trospium chloride 20 mgFlotros 20 mg tablets| 60 tabletP
£ 18. 20 DT = £ 8. 26
▶Regurin(Speciality European Pharma Ltd)
Trospium chloride 20 mgRegurin 20 mg tablets| 60 tabletP
£ 26. 00 DT = £ 8. 26
▶Uraplex(Speciality European Pharma Ltd)
Trospium chloride 20 mgUraplex 20 mg tablets| 60 tabletP
£ 26. 00 DT = £ 8. 26

eiiiiF 489

Tolterodine tartrate


lINDICATIONS AND DOSE
Urinary frequency|Urinary urgency|Urinary incontinence
▶BY MOUTH USING IMMEDIATE-RELEASE MEDICINES
▶Child 2–17 years: 1 mg once daily, then increased if
necessary up to 2 mg twice daily, adjusted according to
response
▶BY MOUTH USING MODIFIED-RELEASE CAPSULES
▶Child 2–17 years: 4 mg once daily

Nocturnal enuresis associated with overactive bladder
▶BY MOUTH USING IMMEDIATE-RELEASE MEDICINES
▶Child 5–17 years: 1 mg once daily, dose to be taken at
bedtime, then increased if necessary up to 2 mg twice
daily, adjusted according to response
DOSE EQUIVALENCE AND CONVERSION
▶Children stabilised on immediate-release tolterodine
tartrate 2 mg twice daily may be transferred to
modified-release tolterodine tartrate 4 mg once daily.

lUNLICENSED USENot licensed for use in children.
lCAUTIONSHistory of QT-interval prolongation
lINTERACTIONS→Appendix 1 : tolterodine
lSIDE-EFFECTS
▶Common or very commonAbdominal pain.bronchitis.
chest pain.diarrhoea.dry eye.fatigue.gastrointestinal
disorders.paraesthesia.peripheral oedema.vertigo.
visual impairment.weight increased
▶UncommonArrhythmia.heart failure.memory loss.
nervousness
▶Frequency not knownDisorientation.hallucination
lPREGNANCYManufacturer advises avoid—toxicity in
animalstudies.
lBREAST FEEDINGManufacturer advises avoid—no
information available.
lHEPATIC IMPAIRMENTAvoid modified-release
preparations.
Dose adjustmentsReduce dose.
lRENAL IMPAIRMENTAvoid modified-release preparations
if estimated glomerularfiltration rate less than
30 mL/minute/ 1. 73 m^2.
Dose adjustmentsReduce dose if estimated glomerular
filtration less than 30 mL/minute/ 1. 73 m^2.
lPRESCRIBING AND DISPENSING INFORMATIONThe need for
therapy for urinary indications should be reviewed soon
after it has been commenced and then at regular intervals;
a response usually occurs within 6 months but may take
longer.

lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug. Forms available from special-order
manufacturers include: oral suspension, oral solution, powder
Tablet
CAUTIONARY AND ADVISORY LABELS 3
▶Tolterodine tartrate (Non-proprietary)
Tolterodine tartrate 1 mgTolterodine 1 mg tablets| 56 tabletP
£ 29. 03 DT = £ 1. 79
Tolterodine tartrate 2 mgTolterodine 2 mg tablets| 56 tabletP
£ 30. 56 DT = £ 2. 09
▶Detrusitol(Pfizer Ltd)
Tolterodine tartrate 1 mgDetrusitol 1 mg tablets| 56 tabletP
£ 29. 03 DT = £ 1. 79
Tolterodine tartrate 2 mgDetrusitol 2 mg tablets| 56 tabletP
£ 30. 56 DT = £ 2. 09
Modified-release capsule
CAUTIONARY AND ADVISORY LABELS3, 25
▶Tolterodine tartrate (Non-proprietary)
Tolterodine tartrate 2 mgTolterodine 2 mg modified-release
capsules| 28 capsulePsDT = £ 11. 60
▶Blerone XL(Zentiva)
Tolterodine tartrate 4 mgBlerone XL 4 mg capsules|
28 capsuleP£ 25. 78 DT = £ 25. 78
▶Detrusitol XL(Pfizer Ltd)
Tolterodine tartrate 4 mgDetrusitol XL 4 mg capsules|
28 capsuleP£ 25. 78 DT = £ 25. 78
▶Efflosomyl XL(Mylan)
Tolterodine tartrate 4 mgEfflosomyl XL 4 mg capsules|
28 capsuleP£ 20. 62 DT = £ 25. 78
▶Inconex XL(Sandoz Ltd)
Tolterodine tartrate 4 mgInconex XL 4 mg capsules|
28 capsuleP£ 21. 91 DT = £ 25. 78

490 Bladder and urinary disorders BNFC 2018 – 2019


Genito-urinary system

7

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