Adult Dosing

Diarrhea

• 2 tabs (2 mg) PO then 1 tab (1 mg) after each stool; alt: 1 tab q3-4 hrs as required
• Max dose: 8 tabs/day (8 mg)

Pediatric Dosing

Diarrhea

• 2 tabs (2 mg) PO then 1 tab (1 mg) after each stool; alt: 1 tab q3-4 hrs as required
• Max dose: 8 tabs/day (8 mg)

• If clinical improvement is not observed in 48 hrs, continued administration of this drug is not recommended
• Safety and effectiveness in pediatric patients <12 yrs of age have not been established

• Adjunctive therapy in the management of acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea

• Hypersensitivity to any of the ingredients of the product
• Diarrhea associated with organisms that penetrate the intestinal mucosa and pseudomembranous colitis
• Children <2 yrs of age
• Jaundice
• Glaucoma, angle-closure

• N/A

Renal Dose Adjustment

• Advanced hepatorenal disease: Use with extreme caution

Hepatic Dose Adjustment

• Hepatic impairment: Use with extreme caution
• Obstructive jaundice: Contraindicated

See Supplemental Patient Information

• Strictly adhere to dosage recommendations; not recommended for children <2 yrs of age. Use with caution in children as signs of atropinism have occurred even with recommended doses, particularly in patients with Down’s syndrome. Severe respiratory depression and coma, possibly leading to permanent brain damage or death have occurred on overdosage
• Maintain appropriate fluid and electrolytes during therapy, when indicated. Withheld doses of atropine/difenoxin until appropriate corrective measures for severe dehydration and electrolyte imbalance are initiated. Retention of fluid in the intestine leading to further aggravation of dehydration and electrolyte imbalance have occurred on drug-induced inhibition of peristalsis
• Use with special caution in young children as this age group is more prone to delayed difenoxylate toxicity
• Prolongation and/or worsening of diarrhea associated with organisms that penetrate the intestinal mucosa (toxigenic E. coli, Salmonella, Shigella), and pseudomembranous enterocolitis associated with broad-spectrum antibiotics have occurred. Avoid usage of antiperistaltic agents in these conditions
• Carefully monitor patients with acute ulcerative colitis and discontinue therapy on occurrence of abdominal distention or other untoward symptoms
• Concomitant use of this drug with monoamine oxidase (MAO) inhibitors may precipitate hypertensive crisis
• Closely monitor patients having concomitant use of barbiturates, tranquilizers, and alcohol with the therapy

Cautions: Use cautiously in

• Advanced hepatorenal disease
• Hepatic impairment
• Ulcerative colitis

Supplemental Patient Information

• Instruct the patient/caregivers not to exceed the recommended dosage and to keep the medication out of the reach of children and in a child-resistant container
• Inform the patient of the consequences of overdosage, including severe respiratory depression and coma, possibly leading to permanent brain damage or death
• Patient should be informed about not operating hazardous machinery or driving an automobile since the drug may induce drowsiness/dizziness

Pregnancy Category:C

Breastfeeding: Literature unavailable on the use of atropine during breastfeeding. Prolonged use of atropine might reduce milk production/letdown, but an ophthalmic dose is unlikely to interfere with breastfeeding. During prolong use; observe for signs of decreased lactation such as insatiety, poor weight gain. Literature unavailable on the use of difenoxin during breastfeeding. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 6 January 2011). Manufacturer advises to make a decision for discontinuing nursing or drug taking into account importance of drug to the mother.

• GI: Toxic megacolon, paralytic ileus, pancreatitis, vomiting, nausea, anorexia
• RESP: Respiratory depression
• DERM: Angioneurotic edema, urticaria, pruritus
• CNS: Numbness of extremities, euphoria, depression, nervousness, lethargy, confusion, sedation, drowsiness, dizziness, headache, abuse, lightheadedness
• MISC: Anaphylaxis, swelling of the gums

Atropine

• Antimuscarinic; inhibits the muscarinic actions of acetylcholine and other cholinergic stimuli at postganglionic cholinergic receptors and on smooth muscles, discourages deliberate overdosage of diphenoxylate
• Metabolized by liver; CYP450: Unknown
• Excreted in urine (13%-50% unchanged)
• Half-life: 3.0 +/- 0.9 hrs

Difenoxin

• Opiate receptor agonist, Antidiarrheal; stimulates mu receptors in GI, decreases the peristalsis and constricts the sphincters
• Rapidly and extensively absorbed
• Undergoes hydroxylation; CYP450: Unknown
• Excreted in urine, feces
• Half-life: 4.5 hrs

US Trade Name(s)

• Motofen

US Availability

Motofen (atropine/difenoxin)

• TABS: 0.025 mg/1 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

Gastrointestinal

Antidiarrheals

Drug Name: Motofen (atropine 0.025 MG / difenoxin 1 MG) Oral Tablet

Ingredient(s): Atropine mixture with difenoxin

Imprint: 0500;V

Color(s): White

Shape: Pentagon (5 sides)

Size (mm): 3.00

Score: 2

Inactive Ingredient(s): calcium stearate / powdered cellulose / lactose / starch, corn

Drug Label Author:
Valeant Pharmaceutical

DEA Schedule:
CIV