From the Guidelines
Loperamide should be taken at an initial dose of 4 mg followed by 2 mg every 4 hours or after every unformed stool, not exceeding 16 mg per day. This recommendation is based on the most recent and highest quality study available, which suggests that loperamide is effective in reducing stool weight, frequency of bowel movements, urgency, and fecal incontinence in acute and chronic diarrhea 1. The medication works quickly, usually within 1-3 hours, by slowing intestinal movement and reducing the frequency of bowel movements.
Key Considerations
- Loperamide can be used with or without food and should be stored at room temperature away from moisture.
- Side effects may include constipation, dizziness, and drowsiness.
- This medication should be avoided in cases of bloody diarrhea, severe colitis, bacterial enterocolitis, or in children under 2 years of age.
- Patients with liver disease may need dose adjustments due to the drug's metabolism in the liver.
- For acute diarrhea, treatment should generally not exceed 2 days without medical supervision, and if symptoms persist beyond 48 hours, medical attention should be sought as this could indicate a more serious condition.
Dosage and Administration
- Initial dose: 4 mg
- Subsequent doses: 2 mg every 4 hours or after every unformed stool
- Maximum daily dose: 16 mg
- The dosage may vary depending on the severity of the diarrhea and the patient's response to treatment, as outlined in the ESMO clinical practice guidelines 2, 3, 1.
Monitoring and Precautions
- Patients should be monitored for signs of paralytic ileus, especially when using high-dose loperamide.
- Medical attention should be sought if symptoms persist or worsen over time.
From the FDA Drug Label
DOSAGE AND ADMINISTRATION Loperamide hydrochloride capsules are contraindicated in pediatric patients less than 2 years of age... Acute Diarrhea Adults and Pediatric Patients 13 Years and Older: The recommended initial dose is 4 mg (two capsules) followed by 2 mg (one capsule) after each unformed stool. The maximum daily dose is 16 mg (eight capsules). Pediatric Patients 2 Years to 12 Years of Age: ...the following schedule for capsules or liquid will usually fulfill initial dosage requirements: Recommended First Day Dosage Schedule Two to five years (13 to 20 kg): 1 mg three times daily (3 mg total daily dosage) Six to eight years (20 to 30 kg): 2 mg twice daily (4 mg total daily dosage) Eight to twelve years (greater than 30kg): 2 mg three times daily (6 mg total daily dosage) Chronic Diarrhea Adults The recommended initial dose is 4 mg (two capsules) followed by 2 mg (one capsule) after each unformed stool until diarrhea is controlled, after which the dosage of loperamide hydrochloride capsules should be reduced to meet individual requirements When the optimal daily dosage has been established, this amount may then be administered as a single dose or in divided doses. The average daily maintenance dosage in clinical trials was 4 to 8 mg (two to four capsules per day). The maximum daily dosage is 16 mg (eight capsules per day)
The recommended dose and frequency of Loperamide are as follows:
- Acute Diarrhea:
+ Adults and Pediatric Patients 13 Years and Older: Initial dose of 4 mg, followed by 2 mg after each unformed stool. Maximum daily dose is 16 mg.
+ Pediatric Patients 2-12 Years:
- 2-5 years: 1 mg three times daily
- 6-8 years: 2 mg twice daily
- 8-12 years: 2 mg three times daily
- Chronic Diarrhea: + Adults: Initial dose of 4 mg, followed by 2 mg after each unformed stool until diarrhea is controlled, then reduce dosage to meet individual requirements. Average daily maintenance dosage is 4-8 mg. Maximum daily dosage is 16 mg. 4
From the Research
Recommended Dose and Frequency of Loperamide
The recommended dose and frequency of Loperamide vary depending on the study and the condition being treated.
- For the treatment of 5-fluorouracil-induced diarrhea in colorectal cancer patients, an initial dose of 4 mg followed by 4 mg every 8 hours (total dose 16 mg/24 hours) was used 5.
- In the treatment of chronic diarrhea, patients were instructed to increase the daily dose gradually until control was achieved or side effects became intolerable, with a median dose of 2.3 capsules (4.6 mg) of loperamide per day 6.
- For traveler's diarrhea, an initial dose of 4 mg, followed by 2 mg after passage of each unformed stool, up to 8 mg/day was used 7.
- In the treatment of acute diarrhea in adults, two tablets (1 mg or 2 mg) were taken initially and then one tablet after each watery, loose, or pasty stool to a maximum of eight tablets per day 8.
- For fluorouracil-induced diarrhea, loperamide 4 mg orally initially and then 2 mg every 6 hours for 3 days was used 9.
Comparison of Loperamide with Other Treatments
Loperamide has been compared with other treatments, such as codeine, diphenoxylate, and octreotide, in various studies.
- Loperamide was found to be more effective than diphenoxylate in the symptomatic treatment of chronic diarrhea 6.
- Octreotide was found to be more effective than loperamide in the treatment of fluorouracil-induced diarrhea 9.
- Loperamide plus oral rehydration therapy was found to be equivalent to loperamide alone in the treatment of traveler's diarrhea 7.