Classes
DEA Class; Rx
Common Brand Names; Lomotil
- Antidiarrheals
Description
Diphenoxylate Hydrochloride, Atropine Sulfate/Diphenoxylate, Atropine/Lomotil Oral Sol: 5mL, 2.5-0.025mg
Diphenoxylate Hydrochloride, Atropine Sulfate/Diphenoxylate, Atropine/Lomotil/Lonox/Vi-Atro Oral Tab: 2.5-0.025mg
Indications
For adjunctive therapy in the management of diarrhea including AIDS-associated diarrhea† with no identifiable infectious agent.
Contraindications
Hypersensitivity to diphenoxylate or atropine
Children aged <6 years owing to risks of respiratory and CNS depression (tablets only)
Obstructive jaundice
Diarrhea associated with pseudomembranous enterocolitis or infectious enterotoxin-producing bacteria
Adverse Effects
- Anticholinergic effects
- Blurred vision
- Sedation
- Nausea
- Vomiting
- Abdominal discomfort
- Dryness of skin or mouth
- Pancreatitis
- Toxic megacolon
Warnings
Cases of severe respiratory depression and coma, leading to permanent brain damage or death reported in children aged <6 years administered tablets (see Contraindications)
May cause CNS depression; may impair physical or mental abilities; patients should use caution when performing tasks requiring mental alertness, including operating heavy machinery or driving
Use should be accompanied by appropriate fluid and electrolyte therapy, when indicated; if severe dehydration or electrolyte imbalance present, drug should be withheld until appropriate corrective therapy initiated; drug-induced inhibition of peristalsis may result in fluid retention in intestine, which may further aggravate dehydration and electrolyte imbalance
Use with extreme caution in patients with advanced hepatorenal disease and in all patients with abnormal liver function; hepatic coma may be precipitated
Pregnancy and Lactation
There are no adequate and well-controlled studies in pregnant women; drug should be used during pregnancy only if anticipated benefit justifies potential risk to fetus
Exercise caution when drug is administered to nursing woman, since physicochemical characteristics of major metabolite, diphenoxylic acid, are such that it may be excreted in breast milk and since it is known that atropine is excreted in breast milk
Maximum Dosage
20 mg/day PO.
20 mg/day PO.
20 mg/day PO.
6 to 12 years: Not recommended.
1 to 5 years: Do not use.
Do not use.
