Lomotil (diphenoxylate HCl/atropine sulfate)

Dosage of diphenoxylate preparations is expressed in terms of diphenoxylate hydrochloride. In antidiarrheal efficacy, 2.5 mg of the drug is equivalent to about 5 mL of paregoric.

The initial adult dosage of diphenoxylate hydrochloride for treatment of diarrhea is 5 mg 4 times daily. The initial dosage of diphenoxylate hydrochloride in children 13-16 years of age is 5 mg 3 times daily. The initial dosage in children 2-12 years of age is 0.3-0.4 mg/kg daily, given in 4 divided doses. Approximate initial dosages for children 2-12 years of age based on patient weight are as follows (see Table):

Table. Initial Dosages for Pediatric Patients 2-12 Years of Age.

Age Approximate Weight Dosage of diphenoxylate hydrochloride in mg (mL of oral solution) 2 years 11-14 kg 0.75-1.5 mg (1.5-3 mL) 4 times daily 3 years 12-16 kg 1-1.5 mg (2-3 mL) 4 times daily 4 years 14-20 kg 1-2 mg (2-4 mL) 4 times daily 5 years 16-23 kg 1.25-2.25 mg (2.5-4.5 mL) 4 times daily 6-8 years 17-32 kg 1.25-2.5 mg (2.5-5 mL) 4 times daily 9-12 years 23-55 kg 1.75-2.5 mg (3.5-5 mL) 4 times daily

Pediatric dosage schedules are approximations of an average dosage recommendation and should be adjusted downward according to overall nutritional status and degree of dehydration. Use in children younger than 2 years of age is not recommended. (See Cautions: Pediatric Precautions.)

Recommended adult and pediatric dosages of diphenoxylate hydrochloride should not be exceeded. Dosage should be continued at initial levels until symptoms are controlled and then reduced for maintenance as required. Maintenance dosage may be as low as one-fourth (e.g., 5 mg daily in adults) the initial daily dosage. If no clinical improvement of acute diarrhea in adult or pediatric patients occurs within 48 hours, the drug is not likely to be effective. If no clinical improvement of chronic diarrhea occurs following treatment for 10 days with a maximum dosage of 20 mg daily in adults, symptoms are unlikely to be controlled by further administration of the drug.

Diphenoxylate hydrochloride is administered orally. Children 2-12 years of age should be given the drug as the oral solution rather than tablets, using only the calibrated measuring device provided by the manufacturer for measuring doses.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

No enhanced messaging available.

The effect of diphenoxylate hydrochloride on the human fetus is not known, and the drug should not be administered to pregnant women or to women of childbearing age who might become pregnant, unless the potential benefits to the patient outweigh the possible risk to the fetus.

Atropine and, possibly, diphenoxylic acid (an active metabolite of diphenoxylate hydrochloride) are distributed into milk. Caution is advised if fixed combinations of diphenoxylate and atropine are administered in nursing women.

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