July 28, 2016
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Lomotil

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Lomotil




Indications
Dosage
How Supplied

INDICATIONS

Lomotil 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 tablets four times daily or 10 ml (two regular teaspoonfuls) of Lomotil 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 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 liquid. Do not use Lomotil tablets for this age group.

Only the plastic dropper should be used when measuring Lomotil liquid for administration to children.

Dosage Schedule for Children

The recommended initial total daily dosage of Lomotil 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 Dosage in ml (four times daily)
(kg) (lb)
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 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

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 liquid. Only this plastic dropper should be used when measuring Lomotil liquid for administration to children.

Distributed by : G.D. Searle LLC, Division of Pfizer Inc., NY, NY 10017. Revised: Oct 2014

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 2/1/2016

Indications
Dosage
How Supplied

Lomotil - User Reviews

Lomotil User Reviews

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