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

Interactions
PK
Renal impairment
References

Macrogol 4000

Generic name
Macrogol 4000
Brand name
ATC Code
A06AD15

Pharmacokinetics in children

Macrogol 4000 has a high molecular weight and so it does not get absorbed nor metabolised.

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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

Faecal impaction
  • Oral
    • 1 month up to 18 years
      • 1 - 1.5 g/kg/day in 1 dose

      • Treatment of fecal impaction for up to 6 days. After elimination of fecal impaction, it is necessary to continue treatment to prevent recurrence. Dosage according to indication of obstipation.

    • 1 month up to 18 years
      [4] [8] [9] [10] [12] [14]
      • 1 - 1.5 g/kg/day in 1 dose

      • Treatment of fecal impaction for up to 6 days. After elimination of fecal impaction, it is necessary to continue treatment to prevent recurrence. Dosage according to indication of obstipation.
Constipation
  • Oral
    • Premature neonates Postmenstrual age ≥ 32 weeks
      • 0.2 - 0.8 g/kg/day in 1 dose

      • Adjust the maintenance dose on clinical response

    • Term neonate
      • 0.2 - 0.8 g/kg/day in 1 dose

      • Adjust the maintenance dose on clinical response

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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

Gastrointestinal side effects such as diarrhoea, abdominal pain, bloated sensation, vomiting and nausea. Electrolyte disturbances. (Boles 2015).

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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

When using macrogol, one should drink sufficiently, otherwise there is a risk of increased constipation (NVK 2015).

Organic disorders must be excluded prior to the start of treatment, especially in children under 2 years of age. The recovery of intestinal peristalsis that the treatment initiates can be maintained by a healthy lifestyle and dietary measures. In the case of diarrhoea, caution should be exercised in patients with a predisposition towards water and electrolyte imbalances (patients with impaired liver or kidney function or patients who are on diuretics). Checks of the electrolytes should be considered.


Caution is advised in patients with impaired gag reflex and those predisposed to regurgitation or aspiration. Cases of aspiration have been reported after administration of excessive volumes of polyethylene glycol and electrolytes through a nasogastric tube [SmPC Forlax]. Children with oromotoric dysfunction who are neurologically impaired are particularly at risk.

Be aware of the risk of hyperosmalarity in preterm neonates [Expert Opinion Neodose workinggroup]

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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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Softeners, emollients
A06AA01
Contact laxatives
A06AB02
A06AB08
A06AB06
A06AB06
A06AB58
Bulk-forming laxatives
A06AC01
Osmotically acting laxatives
A06AD12
A06AD11
A06AD65
A06AD65
A06AD65
Enemas
A06AG
A06AG10
A06AG10
A06AG04
A06AG11
A06AG01
Other drugs for constipation
A06AX01
A06AX02

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References

  1. Dupont C, et al., A dose determination study of polyethylene glycol 4000 in constipated children: factors influencing the maintenance dose., J Pediatr Gastroenterol Nutr., 2006, 42, 178-85
  2. 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
  3. IPSEN Farmaceutica BV, SmPC Forlax junior (RVG 28913) 04-06-2021, www.geneesmiddeleninformatiebank.nl
  4. Nederlandse Vereniging voor Kindergeneeskunde, Obstipatie bij kinderen van 0-18 jaar , www.nvk.nl, Last Modified 1-12-2015, accessed 26-8-2021
  5. Ipsen, SmPC Forlax 4 g Plv. z. Herst. e. Lsg. z. Einn. (1-24988), 07/2019
  6. Gomes, P. B., et al, Comparison of the effectiveness of polyethylene glycol 4000 without electrolytes and magnesium hydroxide in the treatment of chronic functional constipation in children., J Pediatr (Rio J), 2011, 87 (1), 24-8
  7. Bekkali, N. L. H., et al, Polyethylene Glycol 3350 With Electrolytes Versus Polyethylene Glycol 4000 for Constipation: A Randomized, Controlled Trial, J Pediatr Gastroenterol Nutr, 2018, 66 (1), 10-15
  8. Boles, E. E., et al., Comparison of Polyethylene Glycol-Electrolyte Solution vs Polyethylene Glycol-3350 for the Treatment of Fecal Impaction in Pediatric Patients, J Pediatr Pharmacol Ther, 2015, 20 (3), 210-6
  9. Savino, F. et al, Efficacy and tolerability of peg-only laxative on faecal impaction and chronic constipation in children. A controlled double blind randomized study vs a standard peg-electrolyte laxative. 12:178, BMC Pediatr, 2012, 12, 178
  10. Tabbers, M. M., et al, Evaluation and treatment of functional constipation in infants and children: evidence-based recommendations from ESPGHAN and NASPGHAN., J Pediatr Gastroenterol Nutr, 2014, 58 (2), 258-74
  11. Dziechciarz, P., et al., Polyethylene glycol 4000 for treatment of functional constipation in children., J Pediatr Gastroenterol Nutr, 2015, 60 (1), 65-8
  12. Miller, M. K., et al., A randomized trial of enema versus polyethylene glycol 3350 for fecal disimpaction in children presenting to an emergency department., Pediatr Emerg Care, 2012, 28 (2), 115-9
  13. Ratanamongkol, Panjachat, et al, Polyethylene glycol 4000 without electrolytes versus milk of magnesia for the treatment of functional constipation in infants and young children: a randomized controlled trial., Asian Biomedicine, 2009, 3, 391-9
  14. Youssef, N. N., et al., Dose response of PEG 3350 for the treatment of childhood fecal impaction, J Pediatr, 2002, 141 (3), 410-4
  15. Nederlandse Vereniging voor Kindergeneeskunde, Obstipatie bij kinderen van 0-18 jaar, www.nvk.nl, Last Modified 1-12-2015, accessed 26-8-2021

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Changes

Changes