Loperamide with simeticone oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of loperamide and simeticone.
Drugs List
Therapeutic Indications
Uses
Acute diarrhoea and associated symptoms
Dosage
Adults
Two tablets initially, followed by one after each loose stool, up to a maximum dose of 4 tablets per day for no more than two days.
Children
Children aged 12 to 18 years
One tablet initially, followed by one tablet after each loose stool, to a maximum of 4 tablets a day for no more than 2 days.
Contraindications
Children under 12 years
Acute ulcerative colitis
Bacterial enterocolitis
Dysentery
Pseudomembranous enterocolitis
Precautions and Warnings
Breastfeeding
Glucose-galactose malabsorption syndrome
Hepatic impairment
Pregnancy
Renal impairment
Advise patient dizziness may affect ability to drive or operate machinery
Advise patient drowsiness may affect ability to drive or operate machinery
Contains glucose
Monitor CNS toxicity in patients with hepatic impairment
Monitor periodically for signs of fluid or electrolyte imbalance
Discontinue if abdominal distension develops
Discontinue if constipation develops
Discontinue if no improvement is seen within 48 hours and consult doctor
Patients should not exceed recommended dose
Since treatment of diarrhoea with loperamide and simeticone is symptomatic, diarrhoea should be treated causally whenever such treatment is available.
Stop therapy in patients with AIDS at the earliest signs of abdominal distension. There is an increased risk of toxic megacolon in AIDS patients with infectious colitis from viral and bacterial pathogens treated with loperamide hydrochloride.
Higher than recommended doses of loperamide can cause serious cardiac events, including QT interval and QRS complex prolongation and Torsades de Pointes.
Pregnancy and Lactation
Pregnancy
Use loperamide and simeticone with caution during pregnancy.
The manufacturer advises caution if loperamide and simeticone is used during pregnancy, especially during the first trimester. At the time of writing, there is no published experience concerning exposed pregnancies and their outcomes. Reproduction studies in rats show no evidence of impaired fertility, teratogenicity or foetal adverse effects.
Lactation
Use loperamide and simeticone with caution during breastfeeding.
The manufacturer does not recommend the use of loperamide and simeticone during breastfeeding. Small amounts of loperamide may appear in human breast milk. Schaefer concludes that loperamide may be taken temporarily whilst breastfeeding where dietary measures are insufficient (Schaefer 2015) and Briggs concludes that loperamide is probably compatible (Briggs 2015).
Side Effects
Abdominal discomfort
Abdominal distension
Abdominal pain
Acute pancreatitis
Anaphylactic shock
Anaphylactoid reaction
Angioedema
Asthenia
Constipation
Dizziness
Dry mouth
Dysgeusia
Dyspepsia
Erythema multiforme
Fatigue
Flatulence
Headache
Hypersensitivity reactions
Hypertonia
Ileus
Impaired co-ordination
Impaired consciousness
Loss of consciousness (transient)
Miosis
Nausea
Paralytic ileus
Pruritus
Rash
Somnolence
Stevens-Johnson syndrome
Stupor
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 2022
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.
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 Dual Action Relief tablets (P). McNeil Products Ltd. Revised April 2022.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 10 November 2022
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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