Adult Dosing
Adjunctive therapy for diarrhea
- Initial dose: 2 tabs PO qid or 10 mL soln PO qid; until achieving initial control
- Max: 20 mg/day
- Reduce the dosage to meet individual requirements; Maintenance dose: 5 mg/day (10 mL/day of solution)
Notes- Improvement of acute diarrhea is usually observed within 48 hrs
- If no clinical improvement of chronic diarrhea is seen within 10 days of treatment with a max dose:20 mg/day of diphenoxylate hydrochloride, symptoms are unlikely to be controlled by further administration
Pediatric Dosing
Adjunctive therapy for diarrhea
- 0.3-0.4 mg/kg/day PO div qid
Notes:- In children <13 yrs of age, use only oral solution
- Not recommended in children <2 yrs of age and use with special caution in young children
- Consider nutritional status and degree of dehydration
- Improvement of acute diarrhea is usually observed within 48 hrs
- On no clinical improvement of chronic diarrhea within 10 days after treatment with a Max dose:20 mg/day of diphenoxylate hydrochloride symptoms are unlikely to be controlled by further administration
See Supplemental Patient Information
- Strictly adhere to dosage recommendations especially in children; not recommended for children < 2 yrs of age. Use with caution in children as signs of atropinism have occurred even with recommended doses, particularly in patients with Down’s syndrome. Severe respiratory depression and coma, possibly leading to permanent brain damage or death have occurred on overdosage
- Maintain appropriate fluid and electrolytes during therapy, when indicated. Withheld doses of atropine/diphenoxylate until appropriate corrective measures for severe dehydration and electrolyte imbalance are initiated. Retention of fluid in the intestine leading to further aggravation of dehydration and electrolyte imbalance have occurred on drug-induced inhibition of peristalsis
- Use with special caution in young children as this age group is more prone to delayed diphenoxylate toxicity
- Prolongation and/or worsening of diarrhea associated with organisms that penetrate the intestinal mucosa (toxigenic E. coli, Salmonella, Shigella), and pseudomembranous enterocolitis associated with broad-spectrum antibiotics have occurred. Avoid usage of antiperistaltic agents in these conditions
- Carefully monitor patients with acute ulcerative colitis and discontinue therapy on occurrence of abdominal distention or other untoward symptoms
- Concomitant use of this drug with monoamine oxidase (MAO) inhibitors may precipitate hypertensive crisis
- Closely monitor patients having concomitant use of barbiturates, tranquilizers, and alcohol with the therapy
Cautions: Use cautiously in
- Advanced hepatorenal disease
- Hepatic impairment
- Volume depletion
- Young children
Supplemental Patient Information
- Instruct the patient/caregivers not to exceed the recommended dosage and to keep the medication out of the reach of children and in a child-resistant container
- Inform the patient of the consequences of overdosage, including severe respiratory depression and coma, possibly leading to permanent brain damage or death
- Patient should be informed about not operating hazardous machinery or driving an automobile since the drug may induce drowsiness/dizziness
Pregnancy Category:C
Breastfeeding: Literature unavailable on the use of atropine during breastfeeding. Prolonged use of atropine might reduce milk production/letdown, but an ophthalmic dose is unlikely to interfere with breastfeeding. During prolonged use, observe for signs of decreased lactation such as insatiety, poor weight gain. Literature unavailable on the use of diphenoxylate during breastfeeding. Rare small doses of diphenoxylate may be acceptable while breastfeeding an older infant, prefer alternatives especially while nursing a newborn. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT). Atropine is compatible and considered safe with breastfeeding based upon data from AAP Policy Guidelines (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776 last accessed 28 December 2010). Manufacturer advises caution.
US Trade Name(s)
US Availability
atropine/diphenoxylate (generic)
- TABS: 0.025 mg/2.5 mg
- SOLN: [0.025 mg/5mL]/[2.5 mg/5mL]
Lomotil
Lonox
Canadian Trade Name(s)
Canadian Availability
Lomotil (atropine/diphenoxylate)
UK Trade Name(s)
- Co-phenotrope
- Dymotil
- Lomotil
UK Availability
Co-phenotrope, Dymotil, Lomotil (atropine/diphenoxylate)
Australian Trade Name(s)
Australian Availability
Lofenoxal, Lomotil (atropine/diphenoxylate)
Pricing data from www.DrugStore.com in U.S.A.
- Lomotil 2.5-0.025 MG TABS [Bottle] (PFIZER U.S.)
30 mg = $45.99
90 mg = $115.97 - Lomotil 2.5-0.025 MG/5ML LIQD [Bottle] (PFIZER U.S.)
60 5ml = $35.99
180 5ml = $89.97
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.