Mcneil Consumer Healthcare
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Mcneil Consumer Healthcare Drugs
(1 capsule = 2 mg)Patients should receive appropriate fluid and electrolyte replacement as needed.
Adults: The recommended initial dose is 4mg (two capsules) followed by 2 mg (one capsule) after each unformed stool. Daily dose should not exceed 16mg (eight capsules). Clinical improvement is usually observed within 48 hours.
Children: In children 2 to 5 years of age (20 kg or less), the non-prescription liquid formulation (IMODIUM® A-D 1 mg/7.5 mL) should be used; for ages 6 to 12, either IMODIUM® Capsules or 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. (3mg daily dose) (13 to 20 kg)Six to eight years: 2 mg b.i.d. (4mg daily dose) (20 to 30 kg)Eight to twelve years: 2mg t.i.d. (6mg 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.
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.
Children under 2 Years
The use of IMODIUM in children under 2 years is not recommended. There have been rare reports of paralytic ileus associated with abdominal distention. Most of these reports occurred in the setting of acute dysentery, overdose, and with very young children less than two years of age.
No formal pharmacokinetic studies were conducted in elderly subjects. However, there were no major differences reported in the drug disposition in elderly patients with diarrhea relative to young patients. No dosage adjustment is required in the elderly.
No pharmacokinetic data are available in patients with renal impairment. Since the metabolites and the unchanged drug are mainly excreted in the feces, no dosage adjustment is required for patients with renal impairment (see PRECAUTIONS section).
Although no pharmacokinetic data are available in patients with hepatic impairment, IMODIUM should be used with caution in such patients because of reduced first pass metabolism. (see Precautions).
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