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

Interactions
PK
Renal impairment
References

Lactulose

Generic name
Lactulose
Brand name
ATC Code
A06AD11

Pharmacokinetics in children

Only takes effect after a few days.

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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

Constipation
  • Oral
    • Preterm and Term neonate
      [1] [18]
      • 350 - 700 mg/kg/day in 1 - 2 doses.

      • The dosage depends on the patient and it is best to adapt it to the individual’s needs.

    • 1 month up to 7 months
      [17]
      • 350 - 700 mg/kg/day in 1 - 2 doses.
    • 7 months up to 18 years
      [2] [3] [4] [5] [6] [7]
      • 600 - 2.000 mg/kg/day in 1 - 2 doses. Max: 66 g/day.

      • In practice, higher doses can sometimes also be given. In general, the dosage can be reduced after just a few days and adapted to the patient's needs.
Hepatic coma / pre-coma
  • Oral
    • 1 month up to 18 years
      [1]
      • 1.000 mg/kg/day in 3 doses. Max: 100 g/day.

      • 1000 mg/kg/day = 1.5 ml/kg/day of the syrup of 667 mg/ml
Hyperammoniaemia
  • Oral
    • 0 years up to 18 years
      [1]
      • 1.000 mg/kg/day in 3 doses. Max: 100 g/day.

      • 1000 mg/kg/day = 1.5 ml/kg/day of the syrup of 667 mg/ml

        Treatment in hyperammonaemia in order to eliminate bacteria (possible ammonia source) from the digestive tract.

        Treatment in consultation with a paediatric specialist (metabolic disorders) who has experience of using lactulose for this indication.

         

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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

Flatulence, nausea and vomiting. Abdominal pain and diarrhoea if the dosage is too high. Chronic use may disrupt the electrolyte balance.

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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 in children

In cases of lactase deficiency, the lactose content must be taken into account. Chronic use may disrupt the electrolyte balance. In the event of abdominal pain or diarrhoea, the dose should be lowered.

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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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Contact laxatives
A06AB06
Enemas
A06AG
A06AG10

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References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Baker SS, et al., Constipation in infants and children: evaluation and treatment. A medical position statement of the North American Society for Pediatric Gastroenterology and Nutrition, J Pediatr Gastroenterol Nutr, 1999, 612-26
  3. Dupont C, et al, Double-blind randomized evaluation of clinical and biological tolerance of polyethylene glycol 4000 versus lactulose in constipated children., J Pediatr Gastroenterol Nutr, 2005, 41, 625-33
  4. Voskuijl W, et al., PEG 3350 (Transipeg) versus lactulose in the treatment of childhood functional constipation: a double blind, randomised, controlled, multicentre trial., Gut, 2004;, 53, 1590-4
  5. Gremse DA, et al., Comparison of polyethylene glycol 3350 and lactulose for treatment of chronic constipation in children., Clin Pediatr (Phila), 2002, 4, 225-9
  6. Candy DC, et al, Treatment of faecal impaction with polyethelene glycol plus electrolytes (PGE + E) followed by a double-blind comparison of PEG + E versus lactulose as maintenance therapy., J Pediatr Gastroenterol Nutr, 2006, 43, 65-70
  7. Rendeli C, et al, Polyethylene glycol 4000 vs. lactulose for the treatment of neurogenic constipation in myelomeningocele children: a randomized-controlled clinical trial., Aliment Pharmacol Ther 2006;;:, 2006, 15, 23:1259-65.
  8. T & D Pharma GmbH , SmPC Laevolac Pflaumenaroma 10g/15ml, (92212.00.00), 08/2016
  9. Aliud Pharma, SmPC Lactulose-AL 66,7g, 37144.00.00, 02/2014
  10. Fresenius/T&D Pharma?, SmPC Lactulose AIWA/Fresenius 10g/15ml, 88939.00.00, 02/2017
  11. MylanHealthcare, SmPC Bifiteral Beutel, 28216.00.00, 10/2015
  12. HEXAL, SmPC Lactulose-HEXAL, 39229.00.00, 07/2016
  13. MylanHealthcare, SmPC Bifiteral Sirup, 6424869.00.00, 05/2016
  14. Diamed, SmPC Florolac 670 Sirup, 83927.00.00 , 07/2014
  15. Genericon, SmPC Lactulose Genericon Konz. orale Lsg. (1-19912), 03/2019
  16. Riskin A, et al., The effects of lactulose supplementation to enteral feedings in premature infants: a pilot study., J Pediatr., 2010, 156(2), 209-14
  17. Abbott B.V., SmPC Duphalac Fruit (RVG 102976) 28-04-2022, www.geneesmiddeleninformatiebank.nl
  18. Werkgroep Neonatale Farmacologie NVK sectie Neonatologie., Expert opinie on use of lactulose in term and preterm neonates, 22-11-2024

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Changes

Changes