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Macrogol 3350 oral powder 110g

Presentation

Oral formulations of high strength macrogol 3350 (110g)

Drugs List

  • macrogol 3350 powder for oral solution 110g
  • VISTAPREP 110g powder for oral solution
  • Therapeutic Indications

    Uses

    Bowel evacuation - prior to investigative procedure

    Dosage

    Adults

    Each sachet should be dissolved in 1litre of solution immediately before use.

    On examination day, 200ml to 300ml of solution should be drunk every 10 minutes until the rectal effluent is clear or a maximum of 4litres have been drunk, usually over 4 hours. Alternatively, the total amount can be taken on the evening before, or some taken on the evening before and the rest on the examination morning.

    Elderly

    Each sachet should be dissolved in 1litre of solution immediately before use.

    On examination day, 200ml to 300ml of solution should be drunk every 10 minutes until the rectal effluent is clear or a maximum of 4litres have been drunk, usually over 4 hours. Alternatively, the total amount can be taken on the evening before, or some taken on the evening before and the rest on the examination morning.

    Contraindications

    Children under 18 years
    Impaired consciousness
    Predisposition to aspiration or regurgitation
    Predisposition to gastrointestinal perforation
    Delayed gastric emptying
    Gag reflex impaired
    Gastrointestinal obstruction
    Gastrointestinal perforation
    Hepatic impairment
    New York Heart Association class III failure
    New York Heart Association class IV failure
    Paralytic ileus
    Renal impairment
    Severe dehydration
    Toxic megacolon
    Ulcerative colitis

    Precautions and Warnings

    Debilitation
    Elderly
    Restricted potassium intake
    Restricted sodium intake
    Cardiac conduction defects
    History of cardiac arrhythmias
    Inflammatory bowel disease
    New York Heart Association class I failure
    New York Heart Association class II failure
    Reflux oesophagitis

    Contains more than 1 mmol (23 mg) sodium per dose
    Observe patients prone to aspiration/regurgitation during 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
    Monitor periodically for signs of fluid or electrolyte imbalance

    There are 260mmol of sodium and 20mmol of potassium per 4litres of solution.

    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.

    At the time of writing there is limited experience concerning exposed pregnancies and their outcomes. No teratogenic effects were seen in animals trials.

    Schaefer suggests that as macrogol has a high molecular weight, it is not absorbed enterally and is well tolerated.

    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.

    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

    Anal irritation
    Anaphylactic shock
    Cardiac arrhythmias
    Decrease in plasma calcium
    Decreased serum sodium
    Dermatitis
    Disorientation
    Flatulence
    Insomnia
    Malaise
    Nausea
    Pulmonary oedema
    Reduced plasma potassium levels
    Rhinorrhoea
    Seizures
    Sensation of fullness
    Stomach pain
    Tachycardia
    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: June 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: VistaPrep 110g powder for oral solution. Tillotts Pharma UK Limited. Revised October 2016

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

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