Difenoxin

Mechanism-of-action class: Receptor Interactions.

• MOTOFEN ® 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.contraindicated

The recommended starting dose of MOTOFEN ® tablets in adults is 2 tablets then 1 tablet after each loose stool or 1 tablet every 3 to 4 hours as needed, but the total dosage during any 24-hour treatment period should not exceed 8 tablets. 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.

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 (SEE OVERDOSAGE ). 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 ® 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.

In view of the small amount of atropine present (0.025 mg/tablet), such effects such as dryness of the skin and mucous membranes, flushing, hyperthermia, tachycardia and urinary retention are very unlikely to occur, except perhaps in children. Many of the adverse effects reported during clinical investigation of MOTOFEN ® are difficult to distinguish from symptoms associated with the diarrheal syndrome. However, the following events were reported at the stated frequencies: Gastrointestinal: Nausea, 1 in 15 patients; vomiting, 1 in 30 patients; dry mouth, 1 in 30 patients; epigastric distress, 1 in 100 patients; and constipation, 1 in 300 patients. Central Nervous System: Dizziness and light-headedness, 1 in 20 patients; drowsiness, 1 in 25 patients; and headache, 1 in 40 patients; tiredness, nervousness, insomnia and confusion ranged from 1 in 200 to 1 in 600 patients. Other less frequent reactions: Burning eyes and blurred vision occurred in a few cases. The following adverse reactions have been reported in patients receiving chemically-related drugs: numbness of extremities, euphoria, depression, sedation, anaphylaxis, angioneurotic edema, urticaria, swelling of the gums, pruritus, toxic megacolon, paralytic ileus, pancreatitis, and anorexia. THIS MEDICATION SHOULD BE KEPT IN A CHILD-RESISTANT CONTAINER AND OUT OF THE REACH OF CHILDREN SINCE AN OVERDOSAGE MAY RESULT IN SEVERE RESPIRATORY DEPRESSION AND COMA, POSSIBLY LEADING TO PERMANENT BRAIN DAMAGE OR DEATH.

Pregnancy/Teratogenic Effects Pregnancy Category C. Reproduction studies in rats and rabbits with doses at 31 and 61 times the human therapeutic dose respectively, on a mg/kg basis, demonstrated no evidence of teratogenesis due to MOTOFEN ® . Pregnant rats receiving oral doses of difenoxin hydrochloride/atropine 20 times the maximum human dose had an increase in delivery time as well as a significant increase in the percent of stillbirths. Neonatal survival in rats was also reduced with most deaths occurring within four days of delivery. There are no well controlled studies in pregnant women. MOTOFEN ® should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus.

Diagnosis and Treatment In the event of overdosage (initial signs may include dryness of the skin and mucous membranes, flushing, hyperthermia and tachycardia followed by lethargy or coma, hypotonic reflexes, nystagmus, pinpoint pupils and respiratory depression) gastric lavage, establishment of a patent airway and possibly mechanically assisted respiration are advised. The narcotic antagonist naloxone may be used in the treatment of respiratory depression caused by narcotic analgesics of pharmacologically related compounds such as MOTOFEN ® tablets. When naloxone is administered intravenously, the onset of action is generally apparent within two minutes. Naloxone may be administered subcutaneously or intramuscularly providing a slightly less rapid onset of action but a more prolonged effect. To counteract respiratory depression caused by MOTOFEN ® overdosage, the following dosage schedule for naloxone should be followed: Adult Dosage: The usual initial adult dose of naloxone is 0.4 mg (one mL) administered intravenously. If respiratory function does not adequately improve after the initial dose, the same IV dose may be repeated at two-to-three minute intervals.

• Jul 14, 1978NDANDA017744Legacy Pharma

1. 1Vomiting415%
2. 2Diarrhoea312%
3. 3Drug Ineffective312%
4. 4Nausea312%
5. 5Pain312%
6. 6Product Dose Omission Issue312%
7. 7Bone Disorder27.7%
8. 8Fall27.7%
9. 9Irritable Bowel Syndrome27.7%
10. 10Product Availability Issue27.7%
11. 11Abdominal Distension13.8%
12. 12Abdominal Pain13.8%
13. 13Abdominal Pain Upper13.8%
14. 14Arthrodesis13.8%
15. 15Asthenia13.8%

Frequently asked questions

How does Difenoxin work?

Mechanism-of-action class: Receptor Interactions.

What is Difenoxin used for?

According to FDA labeling, Difenoxin carries indications including: MOTOFEN ® is indicated as adjunctive therapy in the management of acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Difenoxin?

Difenoxin is classified as Antipropulsives, Antidiarrheal, Receptor Interactions, Decreased GI Motility, Stimulation Large Intestine Fluid/Electrolyte Absorption, Stimulation Small Intestine Fluid/Electrolyte Absorption.

What are the brand names for Difenoxin?

Difenoxin is marketed under brand names including Motofen.

What are the contraindications for Difenoxin?

Difenoxin labeling lists contraindications including: 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.. Always consult the full prescribing information and a clinician.