BNF for Children (BNFC) 2018-2019

Loperamide hydrochloride 11-Oct-2017

lINDICATIONS AND DOSE

Symptomatic treatment of acute diarrhoea

▶BY MOUTH

▶Child 4–7 years: 1 mg 3 – 4 times a day for up to 3 days

only

▶Child 8–11 years: 2 mg 4 times a day for up to 5 days

▶Child 12–17 years:Initially 4 mg, followed by 2 mg for up

to 5 days, dose to be taken after each loose stool; usual

dose 6 – 8 mg daily; maximum 16 mg per day

Chronic diarrhoea

▶BY MOUTH

▶Child 1–11 months: 100 – 200 micrograms/kg twice daily,

to be given 30 minutes before feeds; increased if

necessary up to 2 mg/kg daily in divided doses

▶Child 1–11 years: 100 – 200 micrograms/kg 3 – 4 times a

day (max. per dose 2 mg), increased if necessary up to

1. 25 mg/kg daily in divided doses; maximum 16 mg per

day

▶Child 12–17 years: 2 – 4 mg 2 – 4 times a day; maximum

16 mg per day

lUNLICENSED USENot licensed for use in children for
chronic diarrhoea.Capsulesnot licensed for use in children
under 8 years.Syrupnot licensed for use in children under
4 years.

IMPORTANT SAFETY INFORMATION

MHRA/CHM ADVICE: REPORTS OF SERIOUS CARDIAC ADVERSE

REACTIONSWITHHIGHDOSESOFLOPERAMIDEASSOCIATEDWITH

ABUSE OR MISUSE (SEPTEMBER 2017)

Serious cardiovascular events (such as QT prolongation,

torsades de pointes, and cardiac arrest), including

fatalities, have been reported in association with large

overdoses of loperamide.

Healthcare professionals are reminded that if

symptoms of overdose occur, naloxone can be given as

an antidote. The duration of action of loperamide is

longer than that of naloxone ( 1 – 3 hours), so repeated

treatment with naloxone might be indicated; patients

should be monitored closely for at least 48 hours to

detect possible CNS depression.

Pharmacists should remind patients not to take more

than the recommended dose on the label.

lCONTRA-INDICATIONSActive ulcerative colitis.antibiotic-
associated colitis.conditions where abdominal distension
develops.conditions where inhibition of peristalsis should
be avoided

lCAUTIONSNot recommended for children under 12 years

lINTERACTIONS→Appendix 1 : loperamide

lSIDE-EFFECTS
▶Common or very commonGastrointestinal disorders.
headache.nausea
▶UncommonDizziness.drowsiness.dry mouth.
gastrointestinal discomfort.skin reactions.vomiting
▶Rare or very rareAngioedema.consciousness impaired.
coordination abnormal.fatigue.miosis.muscle tone
increased.severe cutaneous adverse reactions (SCARs).
urinary retention

lPREGNANCYManufacturers advise avoid—no information
available.

lBREAST FEEDINGAmount probably too small to be
harmful.
lHEPATIC IMPAIRMENTRisk of accumulation—
manufacturer advises caution.

lPRESCRIBING AND DISPENSING INFORMATION

Palliative careFor further information on the use of

loperamide in palliative care, seewww.palliativedrugs.com/

formulary/en/loperamide.html

lPATIENT AND CARER ADVICE

Medicines for Children leaflet: Loperamide for diarrhoea

http://www.medicinesforchildren.org.uk/loperamide-for-diarrhoea

lEXCEPTIONS TO LEGAL CATEGORYLoperamide can be sold

to the public, for use in adults and children over 12 years,

provided it is licensed and labelled for the treatment of

acute diarrhoea.

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

Tablet

▶Loperamide hydrochloride (Non-proprietary)

Loperamide hydrochloride 2 mgLoperamide 2 mg tablets|

30 tabletP£ 2. 93 DT = £ 2. 93

▶Norimode(Tillomed Laboratories Ltd)

Loperamide hydrochloride 2 mgNorimode 2 mg tablets|

30 tabletP£ 2. 15 DT = £ 2. 93

Oral solution

▶Imodium(Janssen-Cilag Ltd)

Loperamide hydrochloride 200 microgram per 1 mlImodium

1 mg/ 5 ml oral solution sugar-free| 100 mlP£ 1. 17 DT = £ 1. 17

Capsule

▶Loperamide hydrochloride (Non-proprietary)

Loperamide hydrochloride 2 mgLoperamide 2 mg capsules|

30 capsuleP£ 2. 99 DT = £ 0. 68

Orodispersible tablet

▶Imodium(McNeil Products Ltd)

Loperamide hydrochloride 2 mgImodium Instant Melts 2 mg

orodispersible tablets sugar-free| 12 tabletp£ 4. 38 sugar-free|

18 tabletp£ 5. 85 DT = £ 5. 39

Loperamide with simeticone

The properties listed below are those particular to the

combination only. For the properties of the components

please consider, loperamide hydrochloride above,

simeticone p. 52.

lINDICATIONS AND DOSE

Acute diarrhoea with abdominal colic

▶BY MOUTH

▶Child 12–17 years:Initially 1 tablet, then 1 tablet, after

each loose stool, for up to 2 days; maximum 4 tablets

per day

lINTERACTIONS→Appendix 1 : loperamide

lMEDICINAL FORMS

There can be variation in the licensing of different medicines

containing the same drug.

Tablet

▶Imodium Plus(McNeil Products Ltd)

Loperamide hydrochloride 2 mg, Dimeticone (as Simeticone)

125 mgImodium Plus caplets| 12 tabletp£ 4. 21

ANTIDIARRHOEALS›ENKEPHALINASE

INHIBITORS

Racecadotril 11-Feb-2016

lINDICATIONS AND DOSE

Adjunct to rehydration, for the symptomatic treatment of

uncomplicated acute diarrhoea

▶BY MOUTH USING GRANULES

▶Child 3 months–17 years (body-weight up to 9 kg): 10 mg

3 times a day until diarrhoea stops; maximum duration

of treatment 7 days

▶Child 3 months–17 years (body-weight 9–12 kg): 20 mg

3 times a day until diarrhoea stops; maximum duration

of treatment 7 days continued→

BNFC 2018 – 2019 Diarrhoea 49

Gastro-intestinal system

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