Macrogol with sodium sulfate and electrolytes and ascorbic acid and sodium
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Powder for oral solution containing macrogol with electrolytes, ascorbic acid and sodium ascorbate.
Bowel evacuation - prior to investigative procedure
Bowel evacuation - prior to surgical procedure
One pair of sachets (A and B) should be dissolved together in one litre of water and drunk over a period of one to two hours. This procedure should then be repeated.
A course of treatment consists of two litres of reconstituted solution.
The course of treatment can be taken as follows:
Divided as one litre of reconstituted solution in the evening before and one litre of reconstituted solution in the early morning of the day of the clinical procedure
In the evening preceding the clinical procedure or in the morning of the clinical procedure.
Two separate non-identical 500ml doses to be taken followed by at least 500ml of additional clear fluid.
The course of treatment can be taken as follows:
Two-day split dosing schedule
The first dose should be taken the evening before the clinical procedure (approximately 18:00 hours) and the second dose in the early morning of the clinical procedure (approximately 06:00 hours).
Morning only dosing schedule
Both dose 1 and dose 2 to be taken on the morning of the day of the clinical procedure (Dose 1 at approximately 05:00 hours). The two doses should be separated by a minimum 1 hour interval.
Day before dosing schedule
Both dose 1 and dose 2 to be taken in the evening of the day before the clinical procedure (Dose 1 at approximately 18:00 hours). The two doses should be separated by a minimum 1 hour interval.
Additional Dosage Information
During the course of treatment it is recommended that additional clear liquid such as water, clear soup, fruit juice without pulp, soft drinks or tea/coffee without milk be taken. Any fluid coloured red or purple (e.g. blackcurrant juice) should be avoided.
All fluids should be stopped at least 2 hours before the clinical procedure when under general anaesthesia or 1 hour before the clinical procedure without general anaesthesia.
Children under 18 years
Delayed gastric emptying
Precautions and Warnings
Predisposition to aspiration or regurgitation
Restricted potassium intake
Restricted sodium intake
Risk factors for ischaemic colitis
Acute inflammatory bowel disease
Glucose-galactose malabsorption syndrome
New York Heart Association class III failure
New York Heart Association class IV failure
Renal impairment - creatinine clearance below 30 ml/minute
Contains aspartame - caution in phenylketonuria
Contains more than 1 mmol (23 mg) sodium per dose
Correct dehydration before commencing therapy
Observe closely unconscious/semiconscious patient during administration
Observe patients prone to aspiration/regurgitation during administration
Dysphagia: Mixing with starch thickeners may increase risk of aspiration
Some formulations contain glucose
Avoid solid food from the start of treatment until after clinical procedure
Ensure patient has adequate fluid intake
No other medicines for 1 hour before/after use
Measure renal function where risk of fluid or electrolyte imbalance
Monitor ECG & serum potassium in patients at risk of ventricular arrhythmia
Monitor periodically for signs of fluid or electrolyte imbalance
Perform ECG if arrhythmic symptoms develop
Abdominal pain may indicate bowel obstruction
Advise patient to report abdominal pain and rectal bleeding
May affect the gastro-intestinal absorption of other drugs
Advise patient of the vigorous nature of the purgation
The fluid content of the reconstituted solution does not replace regular fluid intake and adequate fluid intake must be maintained.
Baseline and post-treatment electrolyte, renal function and ECG should be considered in debilitated fragile patients, patients with poor health, those with clinically significant renal impairment, arrhythmia and those at risk of electrolyte imbalance.
If severe bloating, abdominal distension or abdominal pain occur, the treatment should be slowed or discontinued temporarily until the symptoms subside.
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.
Post marketing cases of ischaemic colitis, some serious have been reported in patients treated with macrogol for bowel preparation. Caution is advised in patients with known risk factors for ischaemic colitis or concomitant use of stimulant laxatives.
Pregnancy and Lactation
Use with caution in pregnancy.
There is no adequate data from the use of this medication during pregnancy. Animal studies have shown indirect harmful effects with respect to reproductive toxicity. Since systemic exposure to macrogol 3350 is negligible, no effects during pregnancy are expected.
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 ).
Use with caution in breastfeeding.
There is no adequate data from the use of this medication by breastfeeding women and it should only be used if considered essential by the physician.
Depending on the procedure which follows treatment, it may be possible to temporarily discontinue breastfeeding to allow the use of this product. Breastfeeding can be resumed following completion of the procedure.
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
Abnormal liver function tests
Decrease in blood bicarbonate
Elevation of liver enzymes (transient)
Increased blood pressure (transient)
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 ).
Last Full Review Date: May 2013
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MHRA Drug Safety Update April 2021
Available at: https://www.mhra.gov.uk
Last accessed: 13 May 2021
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.