LOMOTIL Tablet Ref.[50639] Active ingredients: Atropine Diphenoxylate

Adults

The usual initial dose of LOMOTIL (diphenoxylate hydrochloride with atropine sulfate) is 5 mg (2 tablets) 3 or 4 times daily (20 mg/24 hrs in divided doses is the maximum recommended dosage). An individual maintenance dose can be subsequently determined. Downward adjustment should be made as soon as initial control of symptoms is accomplished. The maintenance dose may be as low as ¼ of the dose required for initial control.

Children

NOT FOR USE IN CHILDREN UNDER FOUR YEARS OF AGE (SEE WARNINGS AND PRECAUTIONS).

The recommended initial dosage of LOMOTIL determined by the child’s weight, is as follows:

0.3 – 0.4 mg/kg daily in divided doses

For convenience, approximate dosage (in children of average weight) may be determined by the following table:

As with adult therapy, adjustment of dosage downward should be made as soon as initial control of symptoms is accomplished.

These pediatric schedules are the best approximation of an average dose recommendation which should be adjusted according to the overall nutritional status and degree of dehydration encountered in the child. The recommended doses must not be exceeded.

If you think you have taken too much LOMOTIL, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Diphenoxylate hydrocholoride with atropine sulfate should be kept in a child-resistant container and out of the reach of children since overdosage may lead to severe respiratory depression and coma, possibly leading to permanent brain damage or death (See WARNINGS).

Symptoms

Initial signs of overdosage with LOMOTIL (diphenoxylate hydrochloride with atropine sulfate) may include dryness of the skin and mucous membranes, mydriasis, restlessness, flushing, hyperthermia and tachycardia followed by lethargy or coma, hypotonic reflexes, nystagmus, pinpoint pupils, tachypnea, toxic encephalopathy, seizures, and severe respiratory depression. Cardiac arrest has occurred in children.

Treatment

Treat all possible LOMOTIL overdoses as serious and maintain medical observation for at least 48 hours.

Gastric lavage, establishment of a patent airway, and possibly, mechanically-assisted respiration are advised. Gastric lavage should be undertaken with due caution in an unconscious patient, preferably following insertion of a cuffed endotracheal tube. If the patient is not comatose, administration of a slurry of activated charcoal may be indicated.

Narcotic antagonists such as Naloxone hydrochloride may be used for the treatment of respiratory depression caused by narcotic drugs or pharmacologically-related compounds, such as LOMOTIL.

Naloxone hydrochloride Dosage in Adults

Naloxone hydrochloride may be administered to adults at a dose of 0.4 mg intravenously. Additional doses of 0.4 mg may be given at 2- or 3-minute intervals until adequate improvement in pulmonary ventilation is demonstrated. Subsequent injections of this drug must be governed by the degree of respiratory depression present and should be titrated accordingly. Since the duration of action of naloxone hydrochloride is short in comparison to that of diphenoxylate hydrochloride improvement of respiration after its administration may be followed by subsequent respiratory depression. It should be noted that although signs of overdosage and respiratory depression may not be evident with LOMOTIL after ingestion, respiratory depression may occur 12 to 30 hours later. Consequently, continuous observation is necessary until the effect of diphenoxylate hydrochloride on respiration, which may persist for many hours, has passed. The period of observation should extend over at least 48 hours, preferably under continuous hospital care.

Naloxone hydrochloride Dosage in Children

For known or suspected narcotic overdosage, the initial dosage of Naloxone hydrochloride in children is 0.005-0.01 mg/kg body weight when given intravenously, intramuscularly, or subcutaneously. This dose can be repeated as for adults above. If necessary, Naloxone hydrochloride can be diluted with Sterile Water for Injection.