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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 or pharmacologically related compounds such as MOTOFEN (difenoxin and atropine) ® 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 (difenoxin and atropine) overdosage, the following dosage schedule for naloxone should be followed:
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.
The usual adult dose of naloxone for children is 0.01 mg/kg of body weight administered intravenously and repeated at twoto-three minute intervals if necessary.
Since the duration of action of difenoxin hydrochloride is longer than that of naloxone, improvement of respiration following administration may be followed by recurrent respiratory depression. Consequently, continuous observation is necessary until the effect of difenoxin hydrochloride on respiration (which effect may persist for many hours) has passed. Supplemental intramuscular doses of naloxone may be utilized to produce a longer lasting effect. TREAT ALL POSSIBLE MOTOFEN (difenoxin and atropine) ® OVERDOSAGES AS SERIOUS AND MAINTAIN MEDICAL OBSERVATION FOR AT LEAST 48 HOURS, PREFERABLY UNDER CONTINUOUS HOSPITAL CARE.
Although signs of overdosage and respiratory depression may not be evident soon after ingestion of difenoxin hydrochloride, respiratory depression may occur from 12 to 30 hours later.
MOTOFEN (difenoxin and atropine) ® 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. Antiperistaltic agents should not be used in these conditions because they may prolong and/or worsen diarrhea.
MOTOFEN (difenoxin and atropine) ® is contraindicated in children under 2 years of age because of the decreased margin of safety of drugs in this class in younger age groups.
MOTOFEN (difenoxin and atropine) ® is contraindicated in patients with a known hypersensitivity to difenoxin, atropine, or any of the inactive ingredients, and in patients who are jaundiced.
Last reviewed on RxList: 5/12/2009
This monograph has been modified to include the generic and brand name in many instances.
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