Imodium
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Questions & Answers
Side Effects & Adverse Reactions
Fluid and electrolyte depletion often occur in patients who have diarrhea. In such cases, administration of appropriate fluid and electrolytes is very important. The use of IMODIUM® does not preclude the need for appropriate fluid and electrolyte therapy.
In general, IMODIUM should not be used when inhibition of peristalsis is to be avoided due to the possible risk of significant sequelae including ileus, megacolon and toxic megacolon. IMODIUM must be discontinued promptly when constipation, abdominal distention or ileus develop.
Treatment of diarrhea with IMODIUM is only symptomatic. Whenever an underlying etiology can be determined, specific treatment should be given when appropriate (or when indicated).
Patients with AIDS treated with IMODIUM for diarrhea should have therapy stopped at the earliest signs of abdominal distention. There have been isolated reports of toxic megacolon in AIDS patients with infectious colitis from both viral and bacterial pathogens treated with loperamide hydrochloride.
IMODIUM® should be used with special caution in young children because of the greater variability of response in this age group. Dehydration, particularly in younger children, may further influence the variability of response to IMODIUM®.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
IMODIUM® (loperamide hydrochloride) is indicated for the control and symptomatic relief of acute nonspecific diarrhea and of chronic diarrhea associated with inflammatory bowel disease. IMODIUM® is also indicated for reducing the volume of discharge from ileostomies.
History
There is currently no drug history available for this drug.
Other Information
IMODIUM® (loperamide hydrochloride), 4-(p-chlorophenyl)-4-hydroxy-N,N-dimethyl-a,a-diphenyl-1-piperidinebutyramide monohydrochloride, is a synthetic antidiarrheal for oral use.
IMODIUM® is available in 2mg capsules.
The inactive ingredients are: Lactose, cornstarch, talc, and magnesium stearate. IMODIUM® capsules contain FD&C Yellow No. 6.
Sources
Imodium Manufacturers
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Mcneil Consumer Healthcare
![Imodium (Loperamide Hydrochloride) Capsule [Mcneil Consumer Healthcare]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Imodium | Mcneil Consumer Healthcare
(1 capsule = 2 mg)
Acute Diarrhea
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
Chronic Diarrhea
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 YearsThe 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.
ElderlyNo 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.
Renal ImpairmentNo 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).
Hepatic ImpairmentAlthough 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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Mcneil Consumer Healthcare Div. Mcneil-ppc, Inc
Imodium | Mcneil Consumer Healthcare Div. Mcneil-ppc, Inc
drink plenty of clear fluids to help prevent dehydration caused by diarrhea take only on an empty stomach (1 hour before or 2 hours after a meal) find right dose on chart. If possible, use weight to dose; otherwise, use age. adults and children
12 years and over chew 2 tablets after the first loose stool;
chew 1 tablet after each subsequent loose stool;
but no more than 4 tablets in 24 hours children 9-11 years
(60-95 lbs) chew 1 tablet after the first loose stool;
chew ½ tablet after each subsequent loose stool;
but no more than 3 tablets in 24 hours children 6-8 years
(48-59 lbs) chew 1 tablet after the first loose stool;
chew ½ tablet after each subsequent loose stool;
but no more than 2 tablets in 24 hours children under 6 years
(up to 47 lbs) ask a doctor
![Imodium (Loperamide Hydrochloride) Tablet, Chewable [Mcneil Consumer Healthcare Div. Mcneil-ppc, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d011ae1a-680c-4476-a489-5407df13648f&name=imodium-01.jpg)
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