Diphenoxylate - Probably acts both locally and centrally to reduce intestinal motility.
Atropine - Has anticholinergic activity. However, in this preparation atropine is included in doses below the therapeutic level in an attempt to prevent abuse by deliberate overdosage.

Diarrhea (treatment adjunct) - Diphenoxylate and atropine combination is indicated in adults, as an adjunct to fluid and electrolyte therapy, in the symptomatic treatment of acute and chronic diarrhea.
Diphenoxylate and atropine combination is not recommended for treatment of diarrhea in children.

Risk - benefit should be considered when the following medical problems exist:
Alcoholism - drug abuse or dependence - cardiovascular instability - dehydration - diarrhea caused by infectious organisms - diarrhea caused by poisoning, until toxic material has been eliminated from gastrointestinal tract - down's syndrome - dysentery, acute, characterized by bloody stools and elevated temperature - gallbladder disease or gallstones - gastrointestinal tract obstruction - glaucoma, angle - closure - renal or hepatic function impairment - hiatal hernia associated with reflux esophagitis hypertension hyperthyroidism hypothyroidism - intestinal atony of the elderly or debilitated - myasthenia gravis - prostatic hypertrophy - uuethral stricture -Urinary retention - respiratory disease or impairment - sensitivity to atropine or diphenoxylate. Contraindications are: colitis, severe - diarrhea associated with pseudomembranous colitis resulting from treatment with broad - spectrum antibiotics.

Studies in animaIs with diphenoxylate and atropine have not shown any evidence of teratogenicity.
FDA Pregnancy Category C.

Problems in humans have not been documented. However, both diphenoxylate's metabolite, diphenoxylic acid, and atropine are distributed into breast milk.

Combinations containing any of the following medications, depending on the amount present, may also interact with this medication:
Addictive medications, other, especially CNS depressants with habituating potential - Alcohol - CNS depression producing medications - Anticholinergics or other medications with anticholinergic action - Monoamine oxidase (MAO) inhibitors, including furazolidone, procarbazine, and selegiline - Naltrexone - Opioid analgesics.

Those indicating need for medical attention:
Incidence less frequent or rare: paralytic ileus or toxic megacolon.
Clinical effects of overdose: Anticholinergic effects, severe - coma - respiratory depression - unusual excitement - nervousness - restlessness - irritability.

Usual adult and adolescent dose and children 12 years of age and older: Antidiarrheal - (antiperistaltic) - Initial: Oral, 5 mg of diphenoxylate hydrochloride and 0.05 mg of atropine sulfate 3 or 4 times a day.
Maintenance: Oral, 5 mg of diphenoxylate hydrochloride and 0.05 mg of atropine sulfate once a day, as needed. Usual adult prescribing limits: 20 mg per day.
Usual pediatric dose: Antidiarrheal (antiperistaltic) - Children up to 12 years of age: Use is not recommended.