Pharmacokinetics in children

The study by Bateman et al. (N=9) shows that the pharmacokinetics of metoclopramide in children (aged 7–14 years) are similar to those in adults. This study found the following pharmacokinetic parameters for children: (average + SEM): t½ = 4.4 ± 0.56 hours, Vd = 3.0 ± 0.38 l/kg and Cl = 0.56 ± 0.10 l/hour/kg.

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

CAUTION:
Route of administration not applicable 1 year up to 18 years [9] The need to use metoclopramide in children should be carefully weighed against the risk of extrapyramidal side effects, as well as the availability of alternative products. Because of the risk of extrapyramidal side effects, oral and rectal application is not recommended in the home situation.

Severe nausea and vomiting with a known cause and where treatment with other agents has not proved sufficiently effective

Oral 1 year up to 18 years 0.3 - 0.5 mg/kg/day in 2 - 4 doses. Max: 30 mg/day. Duration of treatment: Only for short-term use, maximum 5 days Rectal 1 year up to 18 years 0.5 mg/kg/day in 3 doses. Max: 30 mg/day. Duration of treatment: Only for short-term use, maximum 5 days. No studies have been carried out into rectal administration in children.   Intravenous 1 year up to 18 years 0.3 - 0.5 mg/kg/day in 2 - 4 doses. Max: 30 mg/day. Slow injection over at least 3 min. Duration of treatment: Only for short-term use, maximum 5 days

Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2

Adjustment not necessary.

GFR 30-50 ml/min/1.73 m2

50% of the standard dose

GFR 10-30 ml/min/1.73 m2

50% of the standard dose

GFR < 10 ml/min/1.73 m2

No generalized dose recommendations are given.

Clinical consequences

This recommendation applies to all formulations.

The half-life of metoclopramide is lengthened in cases of reduced renal function. The risk of side effects is elevated as a result:  Extrapyramidal side effects can occur in children, even at therapeutic doses.

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

Extrapyramidal symptoms (acute dystonia and dyskinesia, parkinsonism, akathisia), especially in children and young adults and/or at high doses. Sleepiness, tiredness, obstipation, diarrhoea and tardive dyskinesia. . Furthermore, especially in neonates, methaemoglobinaemia has been reported that could be related to a NADH cytochrome B5 reductase deficiency.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications in children

Children under 1 year of age. Gastrointestinal bleeding, mechanical obstruction or gastrointestinal perforation where stimulation of gastrointestinal motility is a risk. A history of tardive dyskinesia induced by neuroleptics or metoclopramide.

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

In children, due to the high risk of extrapyramidal side effects, metoclopramide is only indicated in severe nausea and vomiting with known cause for which treatment with other drugs has not proved sufficiently effective or has proved to be impossible.
It should be noted that extrapyramidal side effects can occur at therapeutic doses and in children of all ages, although extrapyramidal side effects have in particular been reported in children aged under 1 year. Extrapyramidal side effects usually disappear completely after discontinuation of the therapy.
Symptomatic therapy can be necessary. The occurrence of extrapyramidal side effects was not a relevant issue in studies into short-term use.

The need to use metoclopramide in children should be carefully weighed against the risk of extrapyramidal side effects, as well as the availability of alternative products. Because of the risk of extrapyramidal side effects, oral and rectal application is not recommended in the home situation.

An interval of at least 6 hours between each administration should be taken into account. This also applies in cases of vomiting and regurgitation of the dose in order to prevent overdoses. To reduce the risk of severe hypotension, intravenous administration should be done slowly (over at least 3 minutes). If fever occurs after or during use of metoclopramide, malignant neuroleptic syndrome should be considered in the differential diagnosis. In the event of methaemoglobinaemia, the treatment must be stopped immediately and permanently and appropriate measures taken.
 

Interactions

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

• ALIMENTARY TRACT AND METABOLISM
• DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS

PROPULSIVES

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

References

1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
2. Bateman DN, et al, Dystonic reactions and the pharmacokinetics of metoclopramide in children, Br J Clin Pharmacol, 1983, 15, 557-9
3. Bolton CM, et al, Randomized, double-blind study comparing the efficacy of moderate-dose metoclopramide and ondansetron for the prophylactic control of postoperative vomiting in children after tonsillectomy, Br J Anaesth, 2007, 99, 699-703
4. Domino KB, et al, Comparative efficacy and safety of ondansetron, droperidol, and metoclopramide for preventing postoperative nausea and vomiting: a meta-analysis, Anesth Analg, 1999, 88, 1370-9
5. Roila F, et al, Optimal selection of antiemetics in children receiving cancer chemotherapy, Support Care Cancer., 1998, 6, 215-20
6. Henzi I, et al, Metoclopramide in the prevention of postoperative nausea and vomiting: a quantitative systematic review of randomized, placebo-controlled studies, Br J Anaesth, 1999, 83, 761-71
7. Lin DM, et al, A doubleblinded comparison of metoclopramide and droperidol for prevention of emesis following strabismus surgery, Anesthesiology, 1992, 76, 357–361
8. Sanofi-Aventis Netherlands BV, SPC Primperan RVG 06013/06014, www.cbg-meb.nl, Geraadpleegd 08 april 2014, http://db.cbg-meb.nl/IB-teksten/h06014.pdf
9. EMA, METOCLOPRAMIDE: Rapporteur’s Public Paediatric Assessment Report for paediatric studies submitted in accordancewith Article 45 of Regulation (EC) No1901/2006, as amended , www.hma.eu, Nov 2011, Geraadpleegd 13 maart 2013, http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Article_45_work-sharing/Metoclopramid_Art.45_PdAR_Update.pdf
10. Ratiopharm, SmPC MCP-ratiopharm® 10 mg Zäpfchen, 3129.00.01, 08/2016
11. Ratiopharm, MCP-ratiopharm® SF 10 mg/2 ml Injektionslösung, 3129.00.00, 08/2016
12. Mylan Healthcare GmbH, SmPC Paspertin® 10 mg/2 ml Ampullen (6168.00.00), 04/2022
13. HEXAL, SmPC MCP HEXAL® injekt, 7552.00.01, 08/2016
14. Ratiopharm, SmPC MCP-ratiopharm Lösung zum Einnehmen, 92719.00.00, 08/2016
15. Aliud Pharma, SmPC MCP AL Lösung zum Einnehmen, 93083.00.00, 10/2016
16. Ratiopharm, SmPC Metoclopramid-ratiopharm 30mg Retardkapsel, 3129.00.02, 08/2016
17. STADApharm, SmPC MCP STADA 10mg, 11303.00.00, 08/2016
18. Ratiopharm, SmPC MCP- ratiopharm 10mg, 6058726.00.00, 08/2016
19. MylanHealthcare, SmPC Paspertin Filmtabletten, 6168.00.01, 09/2016
20. Cornelia Bruns, Individuell für Kinder, Accessed March 13, 2018

Changes

Therapeutic Drug Monitoring

Overdose