Drugs List

Therapeutic Indications

Uses

Treatment of chronic constipation

Administration

Each sachet should be dissolved in half a glass of water (approximately 100 ml) immediately before use.

Contraindications

Abdominal pain of unknown cause
Children under 17 years
Gastrointestinal obstruction
Gastrointestinal perforation
Severe inflammatory bowel disease
Toxic megacolon

Precautions and Warnings

Disorder of fluid balance
Predisposition to aspiration or regurgitation
Electrolyte imbalance

Dysphagia: Mixing with starch thickeners may increase risk of aspiration
Exclude an organic disorder before initiating treatment
Discontinue if signs of fluid or electrolyte imbalance occur
Only recommended for short term use

The treatment of constipation with medicinal products should only be considered alongside a healthy diet and lifestyle. This should include appropriate exercise, an increase in dietary fibre and liquids, and rehabilitation of the bowel reflex.

Treatment with macrogol 3350 should not normally exceed 2 weeks, although this may be repeated if necessary. If the patient is still experiencing symptoms, despite associated dietary measure, an underlying cause should be further investigated.

Consider electrolyte control in patients prone to fluid or electrolyte imbalances. If a patient develops symptoms indicating shifts of fluid/electrolytes, macrogol 3350 should be discontinued, electrolytes measured and any abnormality treated promptly.

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 3350 is considered safe for use in pregnancy.

No effects during pregnancy are expected as the systemic exposure of macrogol 3350 is limited. Animal studies show no signs of reproductive toxicity.

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 to 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

Macrogol 3350 is considered safe for use in breastfeeding.

Systemic exposure of macrogol 3350 is limited and thus adverse effects on the breast fed infant are not expected. Schaefer (2015) suggests that bulking agents and osmotic laxatives are the medications of choice for constipation whilst breastfeeding.

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

Abdominal distension
Abdominal pain
Abnormal liver function tests
Accelerated erythrocyte sedimentation
Acne
Anaemia
Anaphylactic shock
Creatine phosphokinase increased
Decrease in haematocrit
Dehydration
Diarrhoea
Dizziness
Dysgeusia
Electrolyte disturbances
Elevated amylase levels
Facial oedema
Faecal incontinence
Flatulence
Gastro-enteritis
Gastro-intestinal abscess
Gastrointestinal disorder
Hiccups
Hypersensitivity reactions
Hypertension
Hypoglycaemia
Hypothyroidism
Increase in serum glucose
Increased appetite
Migraine
Naso-sinus congestion
Nausea
Neuritis
Pain
Pelvic pain
Peripheral oedema
Pruritus
Quincke's oedema
Rash
Swelling(localised)
Tachycardia
Twitching
Urticaria
Vomiting

Presentation

Oral formulations of macrogol 3350

Drugs List

Therapeutic Indications

Uses

Treatment of chronic constipation

Dosage

Adults

Elderly

Administration

Each sachet should be dissolved in half a glass of water (approximately 100 ml) immediately before use.

Contraindications

Abdominal pain of unknown cause
Children under 17 years
Gastrointestinal obstruction
Gastrointestinal perforation
Severe inflammatory bowel disease
Toxic megacolon

Precautions and Warnings

Disorder of fluid balance
Predisposition to aspiration or regurgitation
Electrolyte imbalance

Dysphagia: Mixing with starch thickeners may increase risk of aspiration
Exclude an organic disorder before initiating treatment
Discontinue if signs of fluid or electrolyte imbalance occur
Only recommended for short term use

The treatment of constipation with medicinal products should only be considered alongside a healthy diet and lifestyle. This should include appropriate exercise, an increase in dietary fibre and liquids, and rehabilitation of the bowel reflex.

Treatment with macrogol 3350 should not normally exceed 2 weeks, although this may be repeated if necessary. If the patient is still experiencing symptoms, despite associated dietary measure, an underlying cause should be further investigated.

Consider electrolyte control in patients prone to fluid or electrolyte imbalances. If a patient develops symptoms indicating shifts of fluid/electrolytes, macrogol 3350 should be discontinued, electrolytes measured and any abnormality treated promptly.

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 3350 is considered safe for use in pregnancy.

No effects during pregnancy are expected as the systemic exposure of macrogol 3350 is limited. Animal studies show no signs of reproductive toxicity.

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 to 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

Macrogol 3350 is considered safe for use in breastfeeding.

Systemic exposure of macrogol 3350 is limited and thus adverse effects on the breast fed infant are not expected. Schaefer (2015) suggests that bulking agents and osmotic laxatives are the medications of choice for constipation whilst breastfeeding.

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

Abdominal distension
Abdominal pain
Abnormal liver function tests
Accelerated erythrocyte sedimentation
Acne
Anaemia
Anaphylactic shock
Creatine phosphokinase increased
Decrease in haematocrit
Dehydration
Diarrhoea
Dizziness
Dysgeusia
Electrolyte disturbances
Elevated amylase levels
Facial oedema
Faecal incontinence
Flatulence
Gastro-enteritis
Gastro-intestinal abscess
Gastrointestinal disorder
Hiccups
Hypersensitivity reactions
Hypertension
Hypoglycaemia
Hypothyroidism
Increase in serum glucose
Increased appetite
Migraine
Naso-sinus congestion
Nausea
Neuritis
Pain
Pelvic pain
Peripheral oedema
Pruritus
Quincke's oedema
Rash
Swelling(localised)
Tachycardia
Twitching
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: April 2017

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Summary of Product Characteristics: TRANSISOFT 8.5g powder for oral solution in sachet. HFA Healthcare Products Ltd. Revised July 2016.

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