Motofen
Loading...Motofen Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
MOTOFEN® IS NOT AN INNOCUOUS DRUG AND DOSAGE RECOMMENDATIONS SHOULD BE STRICTLY ADHERED TO. MOTOFEN® IS NOT RECOMMENDED FOR CHILDREN UNDER 2 YEARS OF AGE. OVERDOSAGE MAY RESULT IN SEVERE RESPIRATORY DEPRESSION AND COMA, POSSIBLY LEADING TO PERMANENT BRAIN DAMAGE OR DEATH (SEEOVERDOSAGE). THEREFORE, KEEP THIS MEDICATION OUT OF THE REACH OF CHILDREN.
FLUID AND ELECTROLYTE BALANCE– 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.
IF SEVERE DEHYDRATION OR ELECTROLYTE IMBALANCE IS MANIFESTED, MOTOFEN® SHOULD BE WITHHELD UNTIL APPROPRIATE CORRECTIVE THERAPY HAS BEEN INITIATED.
Ulcerative Colitis – In some patients with acute ulcerative colitis, agents which inhibit intestinal motility or delay intestinal transit time have been reported to induce toxic megacolon. Consequently, patients with acute ulcerative colitis should be carefully observed and MOTOFEN® therapy should be discontinued promptly if abdominal distention occurs or if other untoward symptoms develop.
Liver and Kidney Disease – MOTOFEN® (difenoxin hydrochloride with atropine sulfate) should be used with extreme caution in patients with advanced hepatorenal disease and in all patients with abnormal liver function tests since hepatic coma may be precipitated.
Atropine – A subtherapeutic dose of atropine has been added to difenoxin hydrochloride to discourage deliberate overdosage. Usage of MOTOFEN® in recommended doses is not likely to cause prominent anticholinergic side effects, but MOTOFEN® should be avoided in patients in whom anticholinergic drugs are contraindicated. The warnings and precautions for use of anticholinergic agents should be observed. In children, signs of atropinism may occur even with recommended doses of MOTOFEN®, particularly in patients with Down’s Syndrome.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
MOTOFEN® (difenoxin hydrochloride with atropine sulfate) is indicated as adjunctive therapy in the management of acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea.
History
There is currently no drug history available for this drug.
Other Information
Each five-sided dye free MOTOFEN® tablet contains:
Difenoxin (as the hydrochloride) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1.0 mg
Atropine Sulfate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .0.025 mg
Difenoxin hydrochloride, 1-(3-cyano-3,3-diphenylpropyl)-4-phenyl-4-piperidinecarboxylic acid monohydrochloride, is an orally administered antidiarrheal agent which is chemically related to the narcotic meperidine.
The structural formula is:
Difenoxin Hydrochloride
Atropine sulfate is present to discourage deliberate overdosage.
Atropine sulfate, an anticholinergic, is endo (±)-α-(hydroxymethyl) benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1] oct-3-yl ester sulfate (2:1) (salt) monohydrate and has the following structural formula:
Inactive ingredients: calcium stearate, cellulose, lactose, corn starch.
Sources
Motofen Manufacturers
-
Valeant Pharmaceuticals North America Llc
![Motofen (Difenoxin Hydrochloride) Tablet [Valeant Pharmaceuticals North America Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Motofen | Valeant Pharmaceuticals North America Llc
The recommended starting dose of MOTOFEN® tablets in adults is 2 tablets (2 mg), then 1 tablet (1 mg) after each loose stool or 1 tablet (1 mg) every 3 to 4 hours as needed, but the total dosage during any 24-hour treatment period should not exceed 8 tablets (8 mg). In the treatment of diarrhea, if clinical improvement is not observed in 48 hours, continued administration of this type of medication is not recommended. For acute diarrheas and acute exacerbations of functional diarrhea, treatment beyond 48 hours is usually not necessary.
Studies in children below the age of 12 have been inadequate to evaluate the safety and effectiveness of MOTOFEN® in this age group. MOTOFEN® is contraindicated in children under 2 years of age.
Login To Your Free Account