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Lomotil

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Lomotil

Indications
Dosage
How Supplied

INDICATIONS

Lomotil (diphenoxylate and atropine) is effective as adjunctive therapy in the management of diarrhea.

DOSAGE AND ADMINISTRATION

DO NOT EXCEED RECOMMENDED DOSAGE.

Adults: The recommended initial dosage is two Lomotil (diphenoxylate and atropine) tablets four times daily or 10 ml (two regular teaspoonfuls) of Lomotil (diphenoxylate and atropine) liquid four times daily (20 mg per day). Most patients will require this dosage until initial control has been achieved, after which the dosage may be reduced to meet individual requirements. Control may often be maintained with as little as 5 mg (two tablets or 10 ml of liquid) daily.

Clinical improvement of acute diarrhea is usually observed within 48 hours. If clinical improvement of chronic diarrhea after treatment with a maximum daily dose of 20 mg of diphenoxylate hydrochloride is not observed within 10 days, symptoms are unlikely to be controlled by further administration.

Children: Lomotil (diphenoxylate and atropine) is not recommended in children under 2 years of age and should be used with special caution in young children (see WARNINGS and PRECAUTIONS). The nutritional status and degree of dehydration must be considered. In children under 13 years of age, use Lomotil (diphenoxylate and atropine) liquid. Do not use Lomotil (diphenoxylate and atropine) tablets for this age group.

Only the plastic dropper should be used when measuring Lomotil (diphenoxylate and atropine) liquid for administration to children.

Dosage schedule for children: The recommended initial total daily dosage of Lomotil (diphenoxylate and atropine) liquid for children is 0.3 to 0.4 mg/kg, administered in four divided doses. The following table provides an approximate initial daily dosage recommendation for children.

Age (years) Approximate weight
(kg)             (lb)
Dosage in ml (four times daily)
2 11-14 24-31 1.5-3.0
3 12-16 26-35 2.0-3.0
4 14-20 31-44 2.0-4.0
5 16-23 35-51 2.5-4.5
6-8 17-32 38-71 2.5-5.0
9-12 23-55 51-121 3.5-5.0

These pediatric schedules are the best approximation of an average dose recommendation which may be adjusted downward according to the overall nutritional status and degree of dehydration encountered in the sick child. Reduction of dosage may be made as soon as initial control of symptoms has been achieved. Maintenance dosage may be as low as one-fourth of the initial daily dosage. If no response occurs within 48 hours, Lomotil (diphenoxylate and atropine) is unlikely to be effective.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

HOW SUPPLIED

Tablets - round, white, with SEARLE debossed on one side and 61 on the other side and containing 2.5 mg of diphenoxylate hydrochloride and 0.025 mg of atropine sulfate, supplied as:

NDC Number Size
0025-0061-31 bottle of 100
0025-0061-51 bottle of 500
0025-0061-52 bottle of 1,000
0025-0061-55 bottle of 2,500
0025-0061-34 carton of 100 unit dose

Liquid-containing 2.5 mg of diphenoxylate hydrochloride and 0.025 mg of atropine sulfate per 5 ml; bottles of 2 fl oz (NDC Number 0025-0066-02). Dispense only in original container.

A plastic dropper calibrated in increments of 1/2 ml (1/4 mg) with a capacity of 2 ml (1 mg) accompanies each 2-oz bottle of Lomotil (diphenoxylate and atropine) liquid. Only this plastic dropper should be used when measuring Lomotil (diphenoxylate and atropine) liquid for administration to children.

Rx only
Distributed by: G D Searle., Division of Pfizer Inc., NY, NY 10017
Revised: October 2005
FDA Rev date: 4/8/2006

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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