Macrogol 3350/electrolytes

Generic name
Macrogol 3350/electrolytes
Brand name
ATC Code
A06AD65
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Macrogol 3350/electrolytes

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

Macrogol 3350 is not metabolized in the gastrointestinal tract. Because of the high molecular weight, ≤ 0.1% is absorbed from the gastrointestinal tract; this fraction is then excreted via the urine. After reconstitution, the electrolytes in the solution prevent the electrolyte balance between the intestines and the plasma from being disrupted.

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

Distal intestinal obstruction syndrome (DIOS) in cystic fibrosis patients
  • Oral
    • 1 month up to 18 years
      • 2 g/kg/day in 1 dose. Max: 100 g/day.
    • 1 month up to 18 years
      [14]
      • 2 g/kg/day in 1 dose. Max: 100 g/day.
Faecal impaction
  • Oral
    • 1 month up to 18 years
      [3] [13] [15] [17] [19]
      • 1 - 1.5 g/kg/day in 1 or multiple divided doses.
      • Duration of treatment:

        maximum 6 days

      • After defecation it is recommended to take appropriate measures to regulate the intestine in order to prevent the recurrence of coprostasis (the dose is given according to the treatment of chronic constipation).
Colonic lavage
  • Oral
    • < 5 years
      • 5.4 g/kg/day in 2 doses.
      • Directions for administration:
        • Do not administer faster than 30 ml/kg/hour.
        • Take in the evening before the examination in 2 half doses with an interval of at least 2 hours.
    • 5 years up to 9 years
      • 4.8 g/kg/day in 2 doses.
      • Directions for administration:
        • Do not administer faster than 30 ml/kg/hour.
        • Take in the evening before the examination in 2 half doses with an interval of at least 2 hours.
    • ≥ 10 years
      • 4.2 g/kg/day in 2 doses.
      • Directions for administration:
        • Do not administer faster than 30 ml/kg/hour.
        • Take in the evening before the examination in 2 half doses with an interval of at least 2 hours.

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.

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, lower abdominal pain, abdominal cramps, nausea, vomiting, a bloated sensation, flatulence. Faecal incontinence with faecal impaction. Perianal pain on colonic lavage. Additionally, headaches, anal pruritus, anal irritation and hypersensitivity reactions have been reported. Electrolyte disturbances (Boles 2015)

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 abdominal pain and obstruction or perforation of the intestinal wall. Chronic inflammatory bowel diseases such as Morbus Crohn or Colitis ulcerosa. Ileus. Toxic megacolon.

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).

Movicolon Liquid contains 74.5 mg ethanol and 45.6 mg benzyl alcohol per 25 ml. Movicolon liquid is therefore only authorized for children from 12 years upwards for application in obstipation (not for treating faecal impaction). Movicolon Liquid must not be used undiluted and must only be diluted with water.
If a child has symptoms as a result of an electrolyte imbalance, discontinue use of the product immediately. Risk groups for an imbalance in water and electrolyte balance are patients with impaired hepatic or renal function or patients taking diuretics (SmPC Forlax). The electrolyte levels must be determined and imbalances should be treated appropriately.
Children aged 2 to 4 years with impaired cardiovascular function should not take more than 2 sachets of Junior macrogol/electrolytes per hour.(Colombo 2011). Children aged 5 to 11 years with impaired cardiovascular function should not take more than 3 sachets of Junior macrogol/electrolytes per hour [16]. For treating faecal impaction in children aged ≥ 12 years, the doses must be spread in cases of reduced heart function so that a maximum of 2 sachets per hours are taken.
Macrogol/electrolytes (Junior) should not be used by patients with faecal impaction who are chronically bedridden or who may potentially have impaired intestinal motility. Klean-Prep should be administered under medical supervision to elderly patients, vulnerable or weakened patients and young children.

In children, administration of solutions containing polyethylene glycol and electrolytes for intestinal lavage may be difficult. This is because proper cleansing requires a relatively large quantity of fluid to be taken; administration must be spread over a number of hours to prevent nausea and vomiting. In cases where children are unable to drink the fluid, it must be administered through a nasogastric tube under medical supervision. This requires clinical admission. However, lower doses are also applied in practice and deemed sufficiently effective, as a higher dose (large volume) is often not tolerated.
Unconscious or semi-conscious patients or those with a tendency towards aspiration or regurgitation should be observed during the administration of Klean-Prep, especially when this is done via the nasogastric route. Cases of pulmonary oedema have been reported due to aspiration of macrogol lavage solutions requiring immediate treatment.

The treatment of children with chronic obstipation should be carried out over a longer period of time (for at least  6 - 12 months). [SmPC]

Interactions

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

DRUGS FOR CONSTIPATION

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

Softeners, emollients
A06AA01
Contact laxatives
A06AB02
A06AB08
A06AB06
A06AB06
A06AB58
Bulk-forming laxatives
A06AC01
Osmotically acting laxatives
A06AD12
A06AD11
A06AD65
A06AD15
A06AD65
Enemas
A06AG
A06AG10
A06AG10
A06AG04
A06AG11
A06AG01
Other drugs for constipation
A06AX01
A06AX02

References

  1. Arora R, et al., Is polyethylene glycol safe and effective for chronic constipation in children?, Arch Dis Child, 2005, 90, 643-6
  2. Bell EA, et al, Pediatric constipation therapy using guidelines and polyethylene glycol 3350., Ann Pharmacother, 2004, 38, 686-93
  3. 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
  4. Kinservik MA, et al., The efficacy and safety of polyethylene glycol 3350 in the treatment of constipation in children., Pediatr Nurs, 2004, 30, 232-7
  5. Pashankar DS, et al, Long-term efficacy of polyethylene glycol 3350 for the treatment of chronic constipation in children with and without encopresis., Clin Pediatr (Phila), 2003, 42, 815-9
  6. Pashankar DS, et al., Safety of polyethylene glycol 3350 for the treatment of chronic constipation in children., Arch Pediatr Adolesc Med, 2003, 157, 661-4
  7. Norgine B.V., SPC Movicolon Junior., 2 juni 2004., h29318.pdf. CBG webiste Geraadpleegd 6 mei 2008.
  8. Thomson MA, et al., Polyethylene glycol 3350 plus electrolytes for chronic constipation in children: a double blind, placebo controlled, crossover study, Arch Dis Child, 2007, 92, 996-1000
  9. Loening-Baucke V, et al., Pashankar DS. Polyethylene glycol 3350 without electrolytes for the treatment of functional constipation in infants and toddlers.., J Pediatr Gastroenterol Nutr, 2004, 536-9
  10. Michail S, et al., Polyethylene glycol for constipation in children younger than eighteen months old., J Pediatr Gastroenterol Nutr, 2004, 197-9
  11. Alper A et al., Polyethylene glycol: a game-changer laxative for children. , J Pediatr Gastroenterol Nutr, 2013, Aug;57(2), 134-40
  12. Norgine BV., SPC Klean-Prep (RVG 15354) 05-09-2014, www.cbg-meb.nl
  13. Norgine B.V., Movicol Junior aromafrei 6,9 g Plv. z. Herst. e. Lsg. z. Einn. (1-26436), 04/2019
  14. Colombo C, et al, Guidelines for the diagnosis and management of distal intestinal obstruction syndrome in cystic fibrosis patients, Journal of Cystic Fibrosis, 2011, 10 Suppl 2, S24–S28
  15. 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
  16. Nederlandse Vereniging voor Kindergeneeskunde, Obstipatie bij kinderen van 0 tot 18 jaar. , www.nvk.nl, Last Modified 1-12-2015, accessed 26-8-2021
  17. 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
  18. 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
  19. 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., BMC Pediatr, 2012, 12, 178
  20. Nederlandse Vereniging voor Kindergeneeskunde, Obstipatie bij kinderen van 0 tot 18 jaar., www.nvk.nl, Last Modified 1-12-2015, accessed 26-8-2021
  21. Alper A et al., Polyethylene glycol: a game-changer laxative for children., J Pediatr Gastroenterol Nutr, 2013, Aug;57(2), 134-40

Changes

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Overdose