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
Motofen reaches peak plasma levels in half the time as Lomotil. References: 2,3. After a dose of Motofen, the approximate peak plasma level was reached in 40 to 60 minutes. Reference: 2. Lomotil reached an approximate peak plasma level in 120 minutes. Reference: 3. Approximately the same peak plasma level was obtained for both drugs.
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.
- 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.
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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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