Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Loperamide (hydrochloride)

Generic name
Loperamide (hydrochloride)
Brand name
ATC Code
A07DA03

Pharmacokinetics in children

No pharmacokinetic data known for children.

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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

Diarrhoea
  • Oral
    • 3 years up to 8 years
      • 0.1 mg/kg/dose, as required, max. 3x daily. Max: 0.3 mg/kg/day.

      • Once a normal bowel movement has taken place or in the event of no defecation has taken place for more than 12 hours, the treatment with Imodium must be interrupted.

    • 8 years up to 18 years
      • 2 mg/dose, as required. This starting dose must be adjusted until 1 to 2 solid bowel movements per day are obtained, which is usually achieved with a maintenance dose of 1 to 6 capsules or tablets (2 to 12 mg) per day.

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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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 in children

Obstipation, nausea, dry mouth, dizziness, headache, distended abdomen, ileus, drowsiness and lethargy. Young children are particularly susceptible to central side effects, because the blood-brain barrier is still not functioning sufficiently in them

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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 in children

Acute dysentery with blood in the faeces and other bacterial intestinal infections, children under 3 years of age because of the risk of central side effects and paralytic ileus.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Because of the high risk of side effects, such as constipation, ileus or subileus and central side effects, caution is needed when administering loperamide to children between 3 and 8 years old. Use should then only be on medical prescription and under medical supervision.
Fluid and electrolyte depletion can occur in patients with diarrhoea, especially young children. Administration of appropriate fluid and electrolyte replacement therapy (oral rehydration solution, ORS) is then the most important measure. A dry mouth can also be a sign of dehydration. In the event of dehydration, a child can become dizzy and vomit. Administration of appropriate fluid and electrolyte replacement therapy (oral rehydration solution, ORS) is then also the most important measure. 
 

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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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References

  1. Johnson & Johnson, SmPC Imodium® akut lingual (34564.00.00), 09/2015
  2. Hexal AG, SmPC Lopedium (11915.00.00), 05/2017
  3. Hexal AG, SmPC Lopedium® akut bei akutem Durchfall, Lopedium® T akut bei akutem Durchfall, Lopedium® akut ISO bei akutem Durchfall (27743.00.01/ 49154.00.00/ 43827.00.00), 05/2017
  4. Ratiopharm, SmPC Loperamid-ratiopharm® akut 2 mg Filmtabletten (15370.00.00), 04/2017
  5. Ratiopharm, SmPC Loperamid-ratiopharm® 2 mg Filmtabletten (10648.00.00), 04/2017
  6. Aristo Pharma, SmPC Loperamid akut Aristo 2 mg Tabletten (49152.00.00), 08/2017
  7. Johnson & Johnson, SmPC Imodium akut (14373.00.00), 09/2015
  8. Motala C, et al, Effect of loperamide on stool output and duration of acute infectious diarrhea in infants, J Pediatr, 1990, 117, 467-71
  9. Bowie MD, et al, Loperamide for treatment of acute diarrhoea in infants and young children. A double-blind placebo-controlled trial, S Afr Med J, 1995, 85, 885-7
  10. Li ST, et al, Loperamide therapy for acute diarrhea in children: systematic review and meta-analysis, PLoS Med, 2007, 4, e98
  11. Johnson&Johnson Consumer B.V., SPC Imodium RVG (06945/08423/ 33724), www.cbg-meb.nl, Geraadpleegd 8 maart 2013, http://db.cbg-meb.nl/IB-teksten/h06945.pdf
  12. NHG, Standaard Acute diarree (Tweede herziening), Huisarts Wet, 2007, 50(3), 103-13
  13. Janssen-Cilag, SmPC Imodium (6761963.00.01/ 34563.00.00/ 6761963.00.00), 05/2017
  14. STADApharm, SmPC Loperamid STADA (11923.00.00/ 11923.00.01), 04/2017

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Changes

Changes