Uses
Diarrhea
Control and symptomatic relief of acute nonspecific diarrhea and of chronic diarrhea associated with inflammatory bowel disease.
Effective in controlling chronic functional (idiopathic) diarrhea† and chronic diarrhea caused by bowel resection or organic lesions†.
Symptomatic treatment of mild or uncomplicated travelers’ diarrhea, including that occurring in adult travelers with HIV infection. Should not be used in travelers with severe diarrhea or with high fever or blood in the stools; these travelers may benefit from short-term treatment with an anti-infective (e.g., a fluoroquinolone).
Ineffective for prevention of travelers’ diarrhea; some antiperistaltic agents may increase incidence of travelers’ diarrhea.
Self-medication in children and adults for symptomatic control of diarrhea, including travelers’ diarrhea.
Self-medication (in fixed-combination with simethicone) in children and adults for symptomatic control of diarrhea accompanied by flatulence, bloating, pressure, cramps, and gas pain.
Ileostomy Discharge
Reduction of discharge volume from ileostomies.
Dosage and Administration
Administration
Oral Administration
In children 2–5 years of age, administer as oral solution using only the calibrated measuring cup provided by the manufacturer. Do not administer in children <2 years of age.
Administer appropriate fluid and electrolyte replacement as needed.
Discontinue if symptoms of acute diarrhea persist >48 hours or worsen.
Do not admix or dilute oral solution with other solvents.
Dosage
Available as loperamide hydrochloride; dosage expressed in terms of the salt.
Pediatric Patients
Acute Diarrhea
Oral
Children 2–12 years of age: Dosage is based on age and body weight. The following pediatric dosages are recommended for the first day of therapy:
Initial Dosage for Children 2–12 Years of Age
| Age (weight) |
Dosage (initial 24 hours) |
| 2–5 years (13–20 kg) |
1 mg 3 times daily |
| 6–8 years (20–30 kg) |
2 mg twice daily |
| 8–12 years (>30 kg) |
2 mg 3 times daily |
On the second and subsequent days of therapy, administer 0.1 mg/kg only after each unformed stool; do not exceed dosage appropriate for weight/age for the first day.
For self-medication (alone or combined with simethicone) of acute nonspecific diarrhea, determine dosage based on body weight if possible; otherwise use age. The following pediatric dosages are recommended:
Dosage for Self-Medication in Children 6–12 Years of Age
| Age (weight) |
Dosage |
| <6 years (≤21.4 kg) |
Do not use unless directed by a clinician |
| 6–8 years (21.8–26.8 kg) |
2 mg after first unformed stool, followed by 1 mg after each subsequent unformed stool (not to exceed 4 mg in 24 hours) |
| 9–11 years (27.3–43.2 kg) |
2 mg after first unformed stool, followed by 1 mg after each subsequent unformed stool (not to exceed 6 mg in 24 hours) |
| ≥12 years |
4 mg after first unformed stool, followed by 2 mg after each subsequent unformed stool (not to exceed 8 mg in 24 hours) |
Discontinue if there is no improvement after 48 hours of therapy.
Chronic Diarrhea
Oral
Although a dosage of 0.08–0.24 mg/kg daily in 2 or 3 divided doses† has been used in a limited number of children for management of chronic diarrhea, therapeutic dosage for this age group not established.
Adults
Acute Diarrhea
Oral
Initially, 4 mg, followed by 2 mg after each unformed stool, up to a maximum of 16 mg daily.
For self-medication, initial dosage (alone or combined with simethicone) is also 4 mg, followed by 2 mg after each subsequent unformed stool; however, do not exceed 8 mg in a 24-hour period unless directed by a clinician.
Chronic Diarrhea
Oral
Initially, 4 mg, followed by 2 mg after each unformed stool until symptoms are controlled and then reduce for maintenance as required. When optimal dosage established, may administer as single or divided doses.
In clinical trials, average maintenance dosage was 4–8 mg daily.
If improvement after treatment with a maximum daily dosage of 16 mg is not observed within 10 days, symptoms are unlikely to be controlled by further administration. May continue therapy if diarrhea cannot be adequately controlled with diet or specific treatment.
Prescribing Limits
Pediatric Patients
Acute Diarrhea
Oral
Children 2–5 years of age: Maximum 3 mg daily; not for self-medicationunless directed by a clinician.
Children 6–8 years of age: Maximum 4 mg daily. Self-medication should not exceed 2 days unless otherwise directed by a clinician.
Children 9–11 years of age: Maximum 6 mg daily. Self-medication should not exceed 2 days unless otherwise directed by a clinician.
Children ≥12 years of age: For self-medication, maximum 8 mg daily. Self-medication should not exceed 2 days unless otherwise directed by a clinician.
Adults
Acute Diarrhea
Oral
Maximum 16 mg daily.
For self-medication, maximum 8 mg in a 24-hour period unless otherwise directed by a clinician.
Chronic Diarrhea
Oral
16 mg daily in divided doses.
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