NO METABOLISM FOR ACTIVE DRUG
Motofen contains the active metabolite, difenoxin, and does not need to be converted in the liver. Motofen is rapidly and extensively absorbed, reaching peak plasma levels in 40 to 60 minutes.2
PEAK PLASMA LEVELS
After a Motofen dose of 2 mg, the approximate peak plasma level of 160 ng/mL was reached.2 Lomotil reached an approximate peak plasma level of 163 ng/mL after a 10-mg dose.3 Approximately the same peak plasma level was obtained for both drugs; however, the Motofen dose was one-fifth that of Lomotil. Studies have shown that difenoxin is five times as potent as diphenoxylate with a similar side-effect profile.1
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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
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.
Keep out of reach of children.
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REFERENCES: 1. Data on file, Sebela Pharmaceuticals Inc.
2. Motofen [package insert]. Roswell, GA: Sebela Pharmaceuticals Inc.; March 2017.
3. Lomotil Tablets [package insert]. New York, NY: Pfizer Inc.; 2018.
Lomotil is a registered trademark of Pfizer Inc.
Motofen is a registered trademark of Sebela International Ltd.
© 2018 Sebela Pharmaceuticals Inc. All rights reserved. MOT-200-0618E