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 jaundiced.
- WARNINGS AND PRECAUTIONS
Motofen® is not an innocuous drug and dosage recommendations should be strictly adhered to.
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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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.REFERENCES: 1. Mayo Clinic. Diarrhea causes. http://www.mayoclinic.org/diseases-conditions/diarrhea/basics/causes/con-20014025. Accessed July 8, 2016. 2. Rome Foundation. Appendix A. Rome III Diagnostic Criteria for Functional Gastrointestinal Disorders. http://www.romecriteria.org/assets/pdf/19_RomeIII_apA_885-898.pdf. Accessed July 8, 2016. 3. Motofen [package insert]. Roswell, GA: Sebela Pharmaceuticals; August 2018. 4. Data on file, Sebela Pharmaceuticals. 5. Lomotil Tablets [package insert]. New York, NY: Pfizer Inc.; 2018.
Lomotil is a registered trademark of Pfizer Inc.
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