Drugs List

Therapeutic Indications

Uses

The treatment of chronic constipation for adults, adolescents and the elderly.

Administration

For oral administration

Reconstitution

Macrogol should be diluted with 100ml of water.

After dilution keep covered and any unused solution should be discarded within 24 hours.

Once opened macrogol oral liquid should be used within 30 days.

Contraindications

Gastrointestinal perforation or obstruction due to structural or functional disorders of the gut wall

Paralytic ileus

Severe inflammatory conditions of the intestinal tract such as Crohn's disease and ulcerative colitis

Toxic megacolon

Faecal impaction

Precautions and Warnings

Pregnancy - see Pregnancy section
Breastfeeding - see Lactation section

Absorption of other medicinal products may be transiently reduced by macrogol compound due to the increase in gastrointestinal transit rate. Oral medication in solid dose form administered within one hour of taking large volumes of macrogol preparations may be flushed through the gastrointestinal tract and not absorbed.

Macrogol compound should be used with caution in patients with an impaired gag reflex, reflux oesophagitis and diabetes. Some preparations advise caution in cardiac impairment.

Monitor periodically for signs of fluid or electrolyte imbalance. The patient may develop symptoms that indicate a shift in fluids/electrolytes (e.g. oedema, shortness of breath, increasing fatigue, dehydration or cardiac failure). Should the patient develop any of these symptoms macrogol compound should be stopped, electrolytes measured and treated appropriately.

Prolonged use is not recommended. A course of macrogol compound oral solution for constipation does not normally exceed 2 weeks, although the course can be repeated if required. 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.

Use with caution in patients on a low sodium diet. Macrogol compound contains 8.125mmol of sodium per each diluted dose of 125ml.

Macrogol compound contains 45.6mg of benzyl alcohol per each diluted dose of 125ml.

Caution should be use as macrogol compound contains ethyl and methyl parahydroxybenzoates as they may cause a delayed allergic reaction.

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. Patients with dysphagia who swallow the thinner liquid are potentially at greater risk of aspiration.

Pregnancy and Lactation

Pregnancy

Manufacturer advises to use only if considered essential during pregnancy.

At the time of writing there is no published experience of use during pregnancy. However, Schaefer suggests that it seems acceptable to use macrogol compounds with molecular weight greater than 3000 during pregnancy because of their low intestinal resorption.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Manufacturer advises to use only if considered essential during breast-feeding.

It is unknown if macrogol compound is excreted in breast milk, a risk to the infant cannot be excluded.

At the time of writing there is no published experience concerning the use of macrogol during breast-feeding. However, Schaefer suggests that it seems acceptable to use macrogol compounds with molecular weight greater than 3000 during breast-feeding because of their low intestinal resorption.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Allergic reaction
Anaphylactic reaction
Angioedema
Rash
Erythema
Urticaria
Pruritus
Electrolyte disturbances
Hyperkalaemia
Headache
Diarrhoea/loose stools
Vomiting
Abdominal distension
Borborygmi
Flatulence
Peripheral oedema
Dyspnoea
Hypokalaemia
Abdominal pain
Nausea
Dyspepsia
Anal pain

Presentation

Macrogol compound oral liquid

Containing the following active ingredients in 25ml of macrogol compound oral solution:
Macrogol 3350 - 13.125g
Sodium chloride - 0.3507g
Sodium bicarbonate - 0.1785g
Potassium chloride - 0.0466g

Drugs List

Therapeutic Indications

Uses

The treatment of chronic constipation for adults, adolescents and the elderly.

Dosage

Adults

Elderly

Children

Administration

For oral administration

Reconstitution

Macrogol should be diluted with 100ml of water.

After dilution keep covered and any unused solution should be discarded within 24 hours.

Once opened macrogol oral liquid should be used within 30 days.

Contraindications

Gastrointestinal perforation or obstruction due to structural or functional disorders of the gut wall

Paralytic ileus

Severe inflammatory conditions of the intestinal tract such as Crohn's disease and ulcerative colitis

Toxic megacolon

Faecal impaction

Precautions and Warnings

Pregnancy - see Pregnancy section
Breastfeeding - see Lactation section

Absorption of other medicinal products may be transiently reduced by macrogol compound due to the increase in gastrointestinal transit rate. Oral medication in solid dose form administered within one hour of taking large volumes of macrogol preparations may be flushed through the gastrointestinal tract and not absorbed.

Macrogol compound should be used with caution in patients with an impaired gag reflex, reflux oesophagitis and diabetes. Some preparations advise caution in cardiac impairment.

Monitor periodically for signs of fluid or electrolyte imbalance. The patient may develop symptoms that indicate a shift in fluids/electrolytes (e.g. oedema, shortness of breath, increasing fatigue, dehydration or cardiac failure). Should the patient develop any of these symptoms macrogol compound should be stopped, electrolytes measured and treated appropriately.

Prolonged use is not recommended. A course of macrogol compound oral solution for constipation does not normally exceed 2 weeks, although the course can be repeated if required. 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.

Use with caution in patients on a low sodium diet. Macrogol compound contains 8.125mmol of sodium per each diluted dose of 125ml.

Macrogol compound contains 45.6mg of benzyl alcohol per each diluted dose of 125ml.

Caution should be use as macrogol compound contains ethyl and methyl parahydroxybenzoates as they may cause a delayed allergic reaction.

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. Patients with dysphagia who swallow the thinner liquid are potentially at greater risk of aspiration.

Pregnancy and Lactation

Pregnancy

Manufacturer advises to use only if considered essential during pregnancy.

At the time of writing there is no published experience of use during pregnancy. However, Schaefer suggests that it seems acceptable to use macrogol compounds with molecular weight greater than 3000 during pregnancy because of their low intestinal resorption.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Manufacturer advises to use only if considered essential during breast-feeding.

It is unknown if macrogol compound is excreted in breast milk, a risk to the infant cannot be excluded.

At the time of writing there is no published experience concerning the use of macrogol during breast-feeding. However, Schaefer suggests that it seems acceptable to use macrogol compounds with molecular weight greater than 3000 during breast-feeding because of their low intestinal resorption.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Effects on Ability to Drive and Operate Machinery

There is no effect on the ability to drive and use machines.

Side Effects

Allergic reaction
Anaphylactic reaction
Angioedema
Rash
Erythema
Urticaria
Pruritus
Electrolyte disturbances
Hyperkalaemia
Headache
Diarrhoea/loose stools
Vomiting
Abdominal distension
Borborygmi
Flatulence
Peripheral oedema
Dyspnoea
Hypokalaemia
Abdominal pain
Nausea
Dyspepsia
Anal pain

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 ).

Shelf Life and Storage

Do not refrigerate or freeze.

Further Information

Last Full Review Date: June 2011

Reference Sources

British National Formulary, 61st Edition (2011) Pharmaceutical Press, London.

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

MHRA Drug Safety Update April 2021
Available at: https://www.mhra.gov.uk
Last accessed: 13 May 2021

Summary of Product Characteristics: Movicol Liquid Orange Flavour. Norgine pharmaceuticals Ltd. Revised May 2011.