Finished product reference
Loperamide Hydrochloride
Tablet · Oral · 2 mg
- List code
- 1848
WARNING: TORSADES DE POINTES AND SUDDEN DEATH Cases of Torsades de Pointes, cardiac arrest, and death have been reported with the use of a higher than recommended dosage of loperamide hydrochloride capsules (see WARNINGS and OVERDOSAGE ). Loperamide hydrochloride capsules are contraindicated in pediatric patients less than 2 years of age (see CONTRAINDICATIONS ).
Indications
INDICATIONS AND USAGE Loperamide hydrochloride capsules are indicated for the control and symptomatic relief of acute nonspecific diarrhea in patients 2 years of age and older and of chronic diarrhea in adults associated with inflammatory bowel disease. Loperamide hydrochloride capsules are also indicated for reducing the volume of discharge from ileostomies.
Dosage and administration (summary)
DOSAGE AND ADMINISTRATION Loperamide hydrochloride capsules USP are contraindicated in pediatric patients less than 2 years of age due to the risks of respiratory depression and serious cardiac adverse reactions (see CONTRAINDICATIONS ). Avoid loperamide hydrochloride capsules dosages higher than recommended in adult or pediatric patients 2 years of age and older due to the risk of serious cardiac adverse reactions (see WARNINGS , OVERDOSAGE ). (1 capsule = 2 mg) Patients should receive appropriate fluid and electrolyte replacement as needed.
Contraindications
CONTRAINDICATIONS Loperamide hydrochloride capsules are contraindicated in: pediatric patients less than 2 years of age due to the risks of respiratory depression and serious cardiac adverse reactions (see WARNINGS ). patients with a known hypersensitivity to loperamide hydrochloride or to any of the excipients. patients with abdominal pain in the absence of diarrhea. patients with acute dysentery, which is characterized by blood in stools and high fever. patients with acute ulcerative colitis.
Warnings and precautions
WARNINGS Cardiac Adverse Reactions, Including Torsades de Pointes and Sudden Death Cases of prolongation of the QT/QTc interval, Torsades de Pointes, other ventricular arrhythmias, cardiac arrest, some resulting in death, have been reported in adults with use of higher than recommended doses per day of loperamide hydrochloride capsules. Cases include patients who were abusing or misusing loperamide hydrochloride (see OVERDOSAGE and DRUG ABUSE AND DEPENDENCE ).
Pregnancy
Pregnancy Teratogenic Effects. Teratology studies have been performed in rats using oral loperamide hydrochloride doses of 2.5 mg/kg/day, 10 mg/kg/day, and 40 mg/kg/day, and in rabbits using oral doses of 5 mg/kg/day, 20 mg/kg/day, and 40 mg/kg/day.
Storage and supply
HOW SUPPLIED Loperamide hydrochloride capsules USP, 2 mg are available as brown opaque cap imprinted with ‘˄’ in black ink and brown opaque body imprinted ‘A30’ in black containing white to off white powder.
Source: Loperamide Hydrochloride (Loperamide Hydrochloride) — US FDA prescribing information, 2026-01-05, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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