||Less than 1%
|Dizziness and light-headedness
|Tiredness, nervousness, insomnia, confusion
||Less than 1%
The most common adverse events for Motofen (≥2%) are nausea, vomiting, dry mouth, dizziness and light-headedness, drowsiness, and headache. Constipation was reported in <1% of patients, indicating that it produces an antidiarrheal effect without causing constipation often seen with other antidiarrheal agents.
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Important Safety Information
- INDICATIONS AND USAGE
Motofen® (difenoxin and atropine sulfate tablets) is indicated as adjunctive therapy in the
management of acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea.
Motofen® is contraindicated in patients with diarrhea associated with organisms that penetrate
the intestinal mucosa (toxigenic E. coli, Salmonella species, Shigella) and pseudomembranous
colitis associated with broad spectrum antibiotics.
Motofen® is also contraindicated in children under 2 years of age, in patients with known
hypersensitivity to difenoxin, atropine, or any of the inactive ingredients, and in patients who are
- WARNINGS AND PRECAUTIONS
Motofen® is not an innocuous drug and dosage recommendations should be strictly adhered to.
Accidental overdose may result in severe respiratory depression and coma, possibly leading to permanent
brain damage or death.
The use of Motofen® does not preclude the administration of appropriate fluid and electrolyte therapy.
Dehydration, particularly in children, may further influence the variability of response to Motofen®
and may predispose to delayed difenoxin intoxication. Drug-induced inhibition of peristalsis may result
in fluid retention in the colon, and this may further aggravate dehydration and electrolyte imbalance.
Use with caution in patients with ulcerative colitis or liver or kidney disease.
Motofen® may produce drowsiness or dizziness. Use caution when engaging in activities
requiring mental alertness, such as driving or operating dangerous machinery.
Safety and effectiveness in children below the age of 12 have not been established.
Keep out of reach of children.
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REFERENCES: 1. Data on file, Sebela Pharmaceuticals.
2. Motofen [package insert]. Roswell, GA: Sebela Pharmaceuticals; August 2018.
3. Lomotil Tablets [package insert]. New York, NY: Pfizer Inc.; 2018.
Lomotil is a registered trademark of Pfizer Inc.
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