Loperamide oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of loperamide.
Drugs List
Therapeutic Indications
Uses
Diarrhoea - acute
Diarrhoea - chronic
Unlicensed Uses
Faecal incontinence
Dosage
Adults
Doses may vary according to brand.
Acute diarrhoea
Initial dose: 4mg.
Maintenance dose: 2mg after each loose stool for up to five days. Usual dose 6mg to 8mg daily.
Maximum daily dose: 16mg.
Chronic diarrhoea
Initial dose: 4mg to 8mg daily to be taken in divided doses.
Maintenance dose: Adjust dosage according to response and give in two divided doses.
Maximum daily dose: 16mg.
Faecal incontinence (unlicensed)
Initial dose: 500 micrograms daily.
Maintenance dose: Adjust dosage according to response and give in divided doses.
Maximum daily dose: 16mg.
Children
Doses may vary according to brand.
Acute diarrhoea
Children aged 12 to 18 years
Initial dose: 4mg.
Maintenance dose: 2mg after each loose stool for up to five days. Usual dose 6mg to 8mg daily.
Maximum daily dose: 16mg.
Children aged 8 to 12 years
2mg four times daily for up to five days.
Children aged 4 to 8 years
1mg three or four times a day for up to three days.
Children under 4 years
Not recommended.
Chronic diarrhoea (unlicensed)
Children aged 12 to 18 years
2mg to 4mg two to four times a day.
Maximum daily dose: 16mg.
Children aged 1 to 12 years
100micrograms/kg to 200micrograms/kg (up to 2mg per dose) three to four times daily. Up to 1.25mg/kg daily in divided doses may be required
Maximum daily dose: 16mg.
Children aged 1 month to 1 year
100micrograms/kg to 200micrograms/kg twice daily, 30 minutes before feeds. Up to 2mg/kg daily in divided doses may be required.
Contraindications
Neonates under 1 month
Acute ulcerative colitis
Bacterial enterocolitis
Megacolon
Paralytic ileus
Pseudomembranous enterocolitis
Toxic megacolon
Precautions and Warnings
Children under 12 years
Breastfeeding
Brugada syndrome
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of drug misuse
Lactose intolerance
Phenylketonuria
Pregnancy
Some formulations contain aspartame - caution in phenylketonuria
Advise ability to drive/operate machinery may be affected by side effects
Not all available brands are licensed for all indications
Restore electrolyte & fluid balance in case of dehydration
Should not be used alone to treat acute dysentery
Some formulations contain hydroxybenzoate
Some formulations contain lactose
Some formulations contain Ponceau 4R (E124)-may cause allergic reactions
Some formulations contain propylene glycol
Some formulations may contain alcohol
Some products may contain soya or soya derivative
If diarrhoea persists reassess for possibility of underlying disorders
Discontinue if abdominal distension develops
Discontinue if constipation develops
Discontinue if paralytic ileus occurs
AIDS patients: Discontinue promptly at first signs of abdominal distention
Not licensed for all indications in all age groups
Avoid prolonged use
Advise IBS patients to consult Dr if symptoms continue for more than 2weeks
Advise patient to consult a doctor if symptoms persist for more than 24hrs
Advise patients with IBS to consult a doctor if pattern of symptoms changes
Patients should not exceed recommended dose
There have been isolated cases of toxic megacolon in AIDS patients with infectious colitis from both viral and bacterial pathogens treated with loperamide.
Higher than recommended doses of loperamide can cause serious cardiac events, including QT interval and QRS complex prolongation, Torsades de Pointes or other ventricular arrhythmias, syncope and cardiac arrest. Overdose can also unmask existing Brugada syndrome.
If a clinical improvement of irritable bowel syndrome is not observed within 48 hours, the administration of loperamide should be discontinued.
Pregnancy and Lactation
Pregnancy
Use loperamide with caution during pregnancy.
The Manufacturer advises that this medication should be avoided in pregnancy, especially during the first trimester.
Safety in human pregnancy has not been established, although studies in animals have not demonstrated any teratogenic and embryotoxic effects. Briggs (2015) concludes that the clinical data suggests that the human risk is also low.
Lactation
Use loperamide with caution during breastfeeding.
The manufacturer does not recommended the use of loperamide during breastfeeding.
The fraction of loperamide excreted in the human milk is extremely low and is unlikely to affect the infant. LactMed (2018) indicates that the use of loperamide during breastfeeding is unlikely to affect the infant. Schaefer (2015) also concludes that when dietary measures are really insufficient, loperamide may be taken temporarily during breast feeding, preferably after the first trimester.
Side Effects
Abdominal discomfort
Abdominal distension
Abdominal pain
Anaphylactic reaction
Anaphylactic shock
Anaphylactoid reaction
Angioedema
Bullous eruption
Constipation
Dizziness
Drowsiness
Dry mouth
Dyspepsia
Erythema multiforme
Flatulence
Glossodynia
Headache
Hypersensitivity reactions
Hypertonia
Ileus
Impaired co-ordination
Loss of consciousness (transient)
Miosis
Nausea
Pruritus
Rash
Somnolence
Stevens-Johnson syndrome
Stupor
Tiredness
Toxic epidermal necrolysis
Toxic megacolon
Urinary retention
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: November 2015
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3nd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Imodium 1mg/5ml oral solution. Janssen-Cilag. Revised March 2020.
Summary of Product Characteristics: Imodium Classic 2mg Capsules. McNeil Products Ltd. Revised January 2020.
Summary of Product Characteristics: Imodium IBS Relief 2mg capsules. McNeil Products Ltd. Revised January 2020.
Summary of Product Characteristics: Imodium Instant Melts. McNeil Products Ltd. Revised August 2020.
Summary of Product Characteristics: Imodium Instants. McNeil Products Ltd. Revised August 2020.
Summary of Product Characteristics: Imodium Original 2mg Capsules. McNeil Products Ltd. Revised January 2020.
Summary of Product Characteristics: Norimode 2mg Tablets. Tillomed Laboratories Ltd. Revised October 2020.
The Pharmaceutical Journal. June 2016, Vol 296, No 7890. FDA issues warning over loperamide heart risks.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 25 February 2021
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Loperamide. Last revised: 31 October 2018
Last accessed: 25 February 2021
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