INFORM THE PATIENT (PARENT OR GUARDIAN) NOT TO EXCEED THE RECOMMENDED DOSAGE AND TO KEEP DIPHEN-OXYLATE HCL AND ATROPINE SULFATE 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.
Diphenoxylate HCl and atropine sulfate may produce drowsiness or dizziness. The patient should be cautioned regarding activities requiring mental alertness, such as driving or operati ng dangerous machinery. Potentiation of the action of alcohol, barbiturates and tranquilizers with concomitant use of diphenoxylate HCl and atropine sulfate should be explained to the patient. The physician should also provide the patient with other information in this labeling, as appropriate.
Known drug interactions include barbiturates, tranquilizers, and alcohol. Diphenoxylate HCl and atropine sulfate may interact with MAO inhibitors
In studies with male rats, diphenoxylate hydrochloride was found to inhibit the hepatic microsomal enzyme system at a dose of 2 mg/kg/day.
Therefore, diphenoxylate has the potential to prolong the biological half-lives of drugs for which the rate of elimination is dependent on the microsomal drug metabolizing enzyme system.
Diphenoxylate HCl and atropine sulfate is contraindicated in patients with:
1. Known hypersensitivity to diphenoxylate or atropine.
2. Obstructive jaundice.
3. Diarrhea associated with pseudomembranous enterocolitis or enterotoxin-* producing bacteria.