Macrogol compound npf oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations containing macrogol '3350' and electrolytes.
Drugs List
Therapeutic Indications
Uses
Faecal impaction
Treatment of chronic constipation
Dosage
Adults
Chronic constipation
1 to 3 macrogol compound NPF sugar free sachets daily in divided doses according to individual response.
OR
2 to 6 macrogol compound NPF half strength sugar free sachets daily in divided doses according to individual response.
A course of treatment does not normally exceed two weeks, although this can be repeated if required.
For extended use, the dose can be adjusted down to 1 or 2 macrogol compound NPF sugar free sachets or 2 to 4 macrogol compound NPF half strength sugar free sachets daily.
Faecal impaction
8 macrogol compound NPF sugar free sachets daily in divided doses, all of which should be consumed within a 6 hour period.
OR
16 macrogol compound NPF half strength sugar free sachets daily in divided doses, all of which should be consumed within a 6 hour period.
A course of treatment for faecal impaction does not normally exceed three days.
Children
Not all brands are licensed for use in children under 12 years.
Chronic Constipation
Children aged 12 to 18 years
(See Dosage; Adult).
Children aged 7 to 12 years
2 paediatric half strength sachets daily. The dose should be adjusted to produce regular soft stools. Maximum dose 4 sachets per day.
Children aged 2 to 7 years
1 paediatric half strength sachet daily. The dose should be adjusted to produce regular soft stools. Maximum dose 4 sachets per day.
Children aged 1 to 2 years (unlicensed)
1 paediatric half strength sachet daily. The dose should be adjusted to produce regular soft stools. Maximum dose 4 sachets per day.
Children aged 1 month to 1 year (unlicensed)
Half to one paediatric half strength sachet daily.
Faecal Impaction
Children aged 12 to 18 years
(See Dosage; Adult).
Children aged 5 to 12 years
4 paediatric half strength sachets on first day, then increased in steps of 2 sachets daily to a maximum of 12 sachets daily. A course of treatment for faecal impaction with paediatric half strength sachets is up to seven days.
Children aged 1 to 5 years (unlicensed)
2 paediatric half strength sachets on first day, then 4 sachets daily for two days, then 6 sachets daily for two days, then 8 sachets daily. Treat until impaction resolves then switch to maintenance laxative therapy.
Children aged 1 month to 1 year (unlicensed)
Half to one paediatric half strength sachet daily.
The daily number of sachets should be taken in divided doses, all consumed within a 12 hour period.
Additional Dosage Information
For patients with impaired cardiovascular function, when treating faecal impaction the dose should be divided so that no more than 2 of the macrogol compound NPF sugar free sachets or 4 of the macrogol compound NPF half strength sugar free sachets are taken in any one hour. Contraindicated for use in children with impaired cardiovascular function, as there are no data available on use in this patient population.
Contraindications
Neonates
Appendicitis
Crohn's disease
Gastrointestinal obstruction
Gastrointestinal perforation
Hereditary fructose intolerance
Impaired cardiovascular function in children under 12 years
Paralytic ileus
Renal impairment in children under 12 years
Toxic megacolon
Ulcerative colitis
Precautions and Warnings
Children under 2 years
Impaired consciousness
Predisposition to aspiration or regurgitation
Restricted sodium intake
Cardiac impairment
Reflux oesophagitis
Some formulations contain more than 1mmol (23mg) sodium per dose
Dysphagia: Mixing with starch thickeners may increase risk of aspiration
Not all available brands are licensed for use in children under 12 years
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Ensure patient has adequate fluid intake
No other medicines for 1 hour before/after use
Confirm faecal impaction by physical or radiological examination
Monitor periodically for signs of fluid or electrolyte imbalance
Discontinue if signs of fluid or electrolyte imbalance occur
Not licensed for all indications in all age groups
Avoid prolonged use
Extended use may be necessary in the care of patients with severe chronic or resistant constipation, secondary to multiple sclerosis or Parkinson's disease, or induced by regular constipating medication, in particular opioids and antimuscarinics.
Addition of polyethylene glycol to a liquid that has been thickened with a starch-based thickener can produce a mixture that is thin and watery.
Pregnancy and Lactation
Pregnancy
Macrogol is considered safe for use during pregnancy.
The manufacturer advises that macrogol may be used safely during pregnancy. Studies in animals have shown indirect reproductive toxicity. Clinically, no effects during pregnancy are anticipated, since systemic exposure to macrogol 3350 is negligible.
Lactation
Macrogol is considered safe for use during breastfeeding.
The manufacturer states macrogol may be used safely when breastfeeding. No effects on the breastfed infant are anticipated since the systemic exposure of the breastfeeding woman is negligible.
Side Effects
Abdominal distension
Abdominal pain
Allergic reaction
Anaphylactic reaction
Angioedema
Borborygmi
Diarrhoea/loose stools
Dyspepsia
Dyspnoea
Electrolyte disturbances
Erythema
Flatulence
Headache
Hyperkalaemia
Hypokalaemia
Nausea
Perianal inflammation
Perianal soreness
Peripheral oedema
Pruritus
Rash
Rhinitis
Urticaria
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: January 2020
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Summary of Product Characteristics: Compound Macrogol Oral powder Sugar Free. Galen Limited. Revised November 2018.
Summary of Product Characteristics: CosmoCol Half 6.9 g powder for oral solution. Stirling Anglian Pharmaceuticals Ltd. Revised January 2016.
Summary of Product Characteristics: CosmoCol Lemon and Lime powder for oral solution. Stirling Anglian Pharmaceuticals Ltd. Revised February 2016.
Summary of Product Characteristics: CosmoCol Orange powder for oral solution. Stirling Anglian Pharmaceuticals Ltd. Revised February 2016.
Summary of Product Characteristics: CosmoCol Orange Lemon and Lime powder for oral solution. Stirling Anglian Pharmaceuticals Ltd. Revised February 2016.
Summary of Product Characteristics: CosmoCol Paediatric 6.9 g powder for oral solution. Stirling Anglian Pharmaceuticals Ltd. Revised January 2016.
Summary of Product Characteristics: Laxido Orange, powder for oral solution. Galen Limited. Revised November 2018.
Summary of Product Characteristics: Laxido Paediatric Plain 6.9g powder for oral solution. Galen Limited. Revised October 2017.
Summary of Product Characteristics: Macilax 13.8g Powder for Oral Solution. Teva UK Ltd. Revised February 2014.
Summary of Product Characteristics: Macilax Paediatric 6.9g Powder for Oral Solution. Teva UK Ltd. Revised February 2014.
Summary of Product Characteristics: Molative 13.8g powder for oral solution. Generics [UK] Ltd t/a Mylan. Revised June 2016.
Summary of Product Characteristics: Molative Paediatric 6.9g powder for oral solution. Generics [UK] Ltd t/a Mylan. Revised January 2016.
Summary of Product Characteristics: Molaxole powder for oral solution. Mylan Products Ltd. Revised October 2018.
Summary of Product Characteristics: Movicol 13.8g sachet, powder for oral solution. Norgine Limited. Revised May 2013.
Summary of Product Characteristics: Movicol Plain 13.7g sachet, powder for oral solution. Norgine Limited. Revised April 2019.
Summary of Product Characteristics: Movicol Chocolate 13.9g sachet, powder for oral solution. Norgine Limited. Revised October 2019.
Summary of Product Characteristics: Movicol-Half. Norgine Limited. Revised July 2019.
Summary of Product Characteristics: Movicol Paediatric Plain 6.9g sachet, powder for oral solution. Norgine Limited. Revised April 2019.
Summary of Product Characteristics: Movicol Paediatric Chocolate 6.9g sachet, powder for oral solution. Norgine Limited. Revised October 2019.
Summary of Product Characteristics: CosmoCol Plain powder for oral solution. Stirling Anglian Pharmaceuticals Ltd. Revised March 2015.
Summary of Product Characteristics: Movicol Ready to Take oral solution in sachet. Norgine Limited. Revised April 2019.
MHRA Drug Safety Update April 2021
Available at: https://www.mhra.gov.uk
Last accessed: 13 May 2021
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 07 January 2020
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