Drugs List

Therapeutic Indications

Uses

Preparation for radiological, endoscopic and surgical procedures on colon

Unlicensed Uses

Distal intestinal obstruction in cystic fibrosis: treatment

Administration

For oral or nasogastric administration after reconstitution.

Via oral - Doses should be taken at the rate of 250ml every 10 to 15 minutes, and the entire volume should be consumed within 4 to 6 hours.

Via nasogastric tube - Administer at a rate of 20ml to 30ml per minute.

The rate of administration should be slowed or stopped temporarily if nausea, vomiting, abdominal pain or distension arise.

Contraindications

Children under 1 year
Delayed gastric emptying
Gastrointestinal obstruction
Gastrointestinal perforation
Gastrointestinal ulcer
New York Heart Association class III failure
New York Heart Association class IV failure
Paralytic ileus
Phenylketonuria
Toxic colitis
Toxic megacolon

Precautions and Warnings

Children aged 1 to 18 years
Debilitation
Impaired consciousness
Predisposition to aspiration or regurgitation
Restricted sodium intake
Acute renal failure
Breastfeeding
Cardiac arrhythmias
Electrolyte imbalance
Gag reflex impaired
New York Heart Association class I failure
New York Heart Association class II failure
Pregnancy
Reflux oesophagitis
Ulcerative colitis

Contains aspartame - caution in phenylketonuria
Observe closely unconscious/semiconscious patient during administration
Observe patients prone to aspiration/regurgitation during administration
Sodium content of formulation may be significant
Correct hypovolaemia prior to administration
Dysphagia: Mixing with starch thickeners may increase risk of aspiration
Avoid solid food for at least 2 hours prior to administration
Ensure patient has adequate fluid intake
No other medicines for 1 hour before/after use
Measure electrolytes before & after use where risk of electrolyte imbalance
Measure renal function where risk of fluid or electrolyte imbalance
Monitor pre & post-treatment electrolytes in patients with cardiac disorder
Monitor ECG prior to and during treatment in existing cardiac abnormalities
Monitor renal function in patients with cardiac impairment
Monitor renal function in patients with renal impairment
Not licensed for use in children under 18 years
May affect the gastro-intestinal absorption of other drugs
Advise patient of the vigorous nature of the purgation

Caution is advised when the bowel cleansing treatment is used in patients taking ACE inhibitors, angiotensin-II receptor antagonists and NSAIDs due to the risk of dehydration and hypovolaemia. Consider withholding these drugs on the day and for up to 72 hours after the procedure. Caution is also advised in patients already receiving diuretics which may be associated with hypokalaemia. Consider withholding diuretics on the day that the bowel cleansing preparation is given.

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

The manufacturer advises that the preparation should be used only if considered essential, as at the time of writing there is no experience of use during pregnancy.

The purpose and mechanisms of use should be taken into account if considering administration.

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

The manufacturer advises that the preparation should be used only if considered essential, as at the time of writing there is no experience of use during breastfeeding.

Due to macrogol low resorption, the use of macrogol would be acceptable during breastfeeding. The purpose and mechanisms of use should be taken into account if considering administration.

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
Anal pain
Anaphylactic reaction
Angioedema
Arrhythmias
Confusion
Convulsions
Dehydration
Disorientation
Dizziness
Dyspnoea
Electrolyte disturbances
Erythema
Flatulence
Headache
Hypertension
Hypokalaemia
Hyponatraemia
Increased blood pressure
Malaise
Nausea
Palpitations
Pruritus
Pyrexia
Rash
Rigors
Skin reactions
Thirst
Urticaria
Vomiting

Presentation

Powder for oral solution containing macrogol with sodium sulfate and electrolytes

Drugs List

Therapeutic Indications

Uses

Preparation for radiological, endoscopic and surgical procedures on colon

Unlicensed Uses

Distal intestinal obstruction in cystic fibrosis: treatment

Dosage

Adults

Elderly

Children

Administration

For oral or nasogastric administration after reconstitution.

Via oral - Doses should be taken at the rate of 250ml every 10 to 15 minutes, and the entire volume should be consumed within 4 to 6 hours.

Via nasogastric tube - Administer at a rate of 20ml to 30ml per minute.

The rate of administration should be slowed or stopped temporarily if nausea, vomiting, abdominal pain or distension arise.

Contraindications

Children under 1 year
Delayed gastric emptying
Gastrointestinal obstruction
Gastrointestinal perforation
Gastrointestinal ulcer
New York Heart Association class III failure
New York Heart Association class IV failure
Paralytic ileus
Phenylketonuria
Toxic colitis
Toxic megacolon

Precautions and Warnings

Children aged 1 to 18 years
Debilitation
Impaired consciousness
Predisposition to aspiration or regurgitation
Restricted sodium intake
Acute renal failure
Breastfeeding
Cardiac arrhythmias
Electrolyte imbalance
Gag reflex impaired
New York Heart Association class I failure
New York Heart Association class II failure
Pregnancy
Reflux oesophagitis
Ulcerative colitis

Contains aspartame - caution in phenylketonuria
Observe closely unconscious/semiconscious patient during administration
Observe patients prone to aspiration/regurgitation during administration
Sodium content of formulation may be significant
Correct hypovolaemia prior to administration
Dysphagia: Mixing with starch thickeners may increase risk of aspiration
Avoid solid food for at least 2 hours prior to administration
Ensure patient has adequate fluid intake
No other medicines for 1 hour before/after use
Measure electrolytes before & after use where risk of electrolyte imbalance
Measure renal function where risk of fluid or electrolyte imbalance
Monitor pre & post-treatment electrolytes in patients with cardiac disorder
Monitor ECG prior to and during treatment in existing cardiac abnormalities
Monitor renal function in patients with cardiac impairment
Monitor renal function in patients with renal impairment
Not licensed for use in children under 18 years
May affect the gastro-intestinal absorption of other drugs
Advise patient of the vigorous nature of the purgation

Caution is advised when the bowel cleansing treatment is used in patients taking ACE inhibitors, angiotensin-II receptor antagonists and NSAIDs due to the risk of dehydration and hypovolaemia. Consider withholding these drugs on the day and for up to 72 hours after the procedure. Caution is also advised in patients already receiving diuretics which may be associated with hypokalaemia. Consider withholding diuretics on the day that the bowel cleansing preparation is given.

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

The manufacturer advises that the preparation should be used only if considered essential, as at the time of writing there is no experience of use during pregnancy.

The purpose and mechanisms of use should be taken into account if considering administration.

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

The manufacturer advises that the preparation should be used only if considered essential, as at the time of writing there is no experience of use during breastfeeding.

Due to macrogol low resorption, the use of macrogol would be acceptable during breastfeeding. The purpose and mechanisms of use should be taken into account if considering administration.

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
Anal pain
Anaphylactic reaction
Angioedema
Arrhythmias
Confusion
Convulsions
Dehydration
Disorientation
Dizziness
Dyspnoea
Electrolyte disturbances
Erythema
Flatulence
Headache
Hypertension
Hypokalaemia
Hyponatraemia
Increased blood pressure
Malaise
Nausea
Palpitations
Pruritus
Pyrexia
Rash
Rigors
Skin reactions
Thirst
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: May 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: Klean Prep 69g, sachet powder for oral solution. Norgine Limited. Revised May 2020.

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: 9 June 2017.