How to Prescribe Motofen

Each Motofen tablet contains 1 mg difenoxin and 0.025 mg atropine sulfate. Motofen is a schedule IV controlled substance. It contains a subtherapeutic dose of atropine sulfate to discourage deliberate overdose.²

Motofen dosing in adults²:

Initial dose: 2 tablets
1 tablet after each loose stool or every 3 to 4 hours as needed
Do not exceed 8 tablets in any 24-hour period

Click below to review the full poster on Motofen data

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.
CONTRAINDICATIONS: 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. 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.

Please click here for full Prescribing Information

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.

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.
CONTRAINDICATIONS: 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. 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.

Lomotil is a registered trademark of Pfizer Inc.