DOSAGE AND ADMINISTRATION
(1 capsule = 2 mg)
Patients should receive appropriate fluid and electrolyte replacement as needed.
ACUTE DIARRHEA
Adults: The recommended initial dose is 4 mg (two capsules) followed by 2 mg (one capsule) after each unformed stool. Daily dosage should not exceed 16 mg (eight capsules). Clinical improvement is usually observed within 48 hours. Children: IMODIUM® (loperamide hydrochloride) use is not recommended for children under 2 years of age. In children 2 to 5 years of age (20 kg or less), the non-prescription liquid formulation (IMODIUM A-D 1 mg/5 ml) should be used; for ages 6 to 12, either IMODIUM® Capsules of IMODIUM® A-D liquid may be used. For children 2 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: 1 mg t.i.d. (3 mg daily dose) (13 to 20 kg)
Six to eight years: 2 mg b.i.d. (4 mg daily dose) (20 to 30 kg)
Eight to twelve years: 2 mg t.i.d. (6 mg daily dose) (greater than 30 kg)
               RECOMMENDED SUBSEQUENT DAILY DOSAGE
Following the first treatment day, it is recommended that subsequent IMODIUM® doses (1 mg/10 kg body weight) be administered only after a loose stool. Total daily dosage should not exceed recommended dosages for the first day.
CHRONIC DIARRHEA
Children: Although IMODIUM® has been studied in a limited number of children with chronic diarrhea, the therapeutic dose for the treatment of chronic diarrhea in a pediatric population has not been established. 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 IMODIUM® 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). A dosage of 16 mg (eight capsules) was rarely exceeded. If clinical improvement is not observed after treatment with 16 mg per day for at least 10 days, symptoms are unlikely to be controlled by further administration. IMODIUM® administration may be continued if diarrhea cannot be adequately controlled with diet or specific treatment.
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