Use of high dose loperamide to reduce stoma output

Some patients with a stoma resulting from an ileostomy, jejunostomy or a colostomy, can experience high-volume liquid stoma output. This can be problematic for a variety of reasons (e.g. leakage or metabolic disturbances may occur) (1).

High dose loperamide has been used as a method of reducing stoma output.

A review concluded (1):

• use of high doses of loperamide may be warranted in patients who require pharmacological intervention to reduce high volume stoma output
  
  
• depending on baseline volume of stoma output, a starting dose of 2mg - 10mg four times a day of loperamide may be prescribed and titrated according to individual response
  
  
• specialist centres in the UK typically use a maximum total daily dose of 64mg, although this may occasionally be exceeded in resistant cases, possibly up to a total of 96mg daily
  • The British Society of Gastroenterology guidelines for the management of patients with a short bowel suggest that 12mg to 24mg four times a day of loperamide may be required. This would equate to a maximum daily dose of 96mg. Some specialists advise that doses above 12mg four times a day (total of 48mg daily) are rarely required (4)
    
    
• there are published case reports from outside the UK where higher doses were used, up to a maximum dose of 400mg daily
  
  
• this information is however based on practical experience and does not conform to the maximum dose stipulated in the loperamide Summaries of Product Characteristics (SPCs) . The use of high dose loperamide (>16mg daily) would therefore be off-licence
  
  
• the US Food and Drug Administration (FDA) (2) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) (3) have issued safety alerts over the use of high doses with case reports of cardiac arrhythmias when loperamide has been abused or misused
  
  
• although not usually reported in patients taking high doses for reducing stoma output, caution is advised, particularly as patients may be at increased risk if they have electrolyte disturbances
  
  
• a statement following the MHRA safety alert (3) has been issued by the British Intestinal Failure Alliance advocating continuing use of high dose loperamide in high output stoma patients but to limit the total daily dose to below 80mg. The statement recommends ECG monitoring if doses exceed 16mg daily and serum loperamide levels if doses exceed 80mg daily

If no improvement seen despite high doses (4)

• some people may need an additional antimotility agent such as codeine.
• if stoma output continues to increase despite antimotility treatments, seek advice from a specialist, as there may be a possibility of a bowel obstruction (blockage)

When to take loperamide (4)

• individuals should aim to take loperamide 30 to 60 minutes before food, when bowel transit (the passage of food through the gut) is slower

QT prolongation

• an additional concern for individuals with high stoma output is that, due to their intestinal losses, they may have salt or electrolyte disturbances, such as low magnesium or low potassium in their blood
  • these electrolyte disturbances may further increase their risk of changes in heart rhythms, in particular a form called QT interval prolongation, which can be life threatening
• it is not clear how much of an increase in risk there is in this group of individuals, particularly as the amount of loperamide they absorb may be reduced due to their bowel surgery or short bowel

Monitoring (4)

• in response to the above MHRA safety alert, the British Intestinal Failure Alliance (BIFA) published a position statement on the use of high dose loperamide in patients with intestinal failure. They recommend continuing the use of high dose loperamide (more than 16mg daily) since there is a greater risk associated with an untreated high stoma or fistula output than the risk of loperamide causing cardiac arrhythmias, but suggest that the total daily dose should be less than 80mg
• however, they recommend to:
  • perform an electrocardiogram (ECG) to measure the QT interval of the heart in all patients starting or already taking high dose loperamide (more than 16mg in 24 hours)
  • document the QT interval in the patients record
  • repeat the ECG every 3 years if the patient remains on high dose loperamide
  • measure blood levels of loperamide in those taking more than 80mg in 24 hours or if there are serious cardiac concerns. However, at present there is limited availability of this test in the UK, even within specialist centres

Management of toxicity

• individuals who show signs of loperamide toxicity, should seek urgent medical attention. Healthcare professionals can contact the National Poisons Information Service (0344 892 0111) for advice on the management of suspected loperamide toxicity.

Given the information above - a primary care clinician should seek expert advice before using high dose loperamide as a method of reducing stoma output.

Reference:

1. UKMi Southampton Medicines Advice Service (October 25th 2018). Can high dose loperamide be used to reduce stoma output?
2. U.S. Food and Drug Administration, Drug Safety Communications - FDA warns about serious heart problems with high doses of the antidiarrheal medicine loperamide (Imodium), including from abuse and misuse, issued 07/06/2016. Available at https://www.fda.gov/downloads/Drugs/DrugSafety/UCM505108.pdf
3. Medicines and Healthcare products Regulatory Agency. Loperamide (Imodium): reports of serious cardiac adverse reactions with high doses of loperamide associated with abuse or misuse; 26 September 2017. Drug Safety Update 11(2): 2. Available at https://www.gov.uk/drug-safety-update/loperamide-imodium-reports-of-serious-cardiac-adverse-reactions-with-high-doses-of-loperamide-associated-with-abuse-or-misuse
4. NHS Specialist Pharmacy Service (SPS) (January 2022).High dose loperamide use in high stoma output or short bowel syndrome
5. NHS Specialist Pharmacy Service (SPS) (November 2024). Using loperamide in high output stoma or short bowel syndrome