Lomotil Drug Information

Lomotil is indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.

Management of Diarrhea in Patients 13 Years of Age and Older Lomotil is recommended as adjunctive therapy for the management of diarrhea in patients 13 years of age and older. Consider the nutritional status and degree of dehydration in patients prior to initiating therapy with Lomotil. The use of Lomotil should be accompanied by appropriate fluid and electrolyte therapy, when indicated.

If severe dehydration or electrolyte imbalance is present, do not administer Lomotil until appropriate corrective therapy has been indicated (see WARNINGS ). Initial and Maximum Recommended Dosage in Patients 13 Years of Age and Older The initial adult dosage is 2 Lomotil tablets four times daily (maximum total daily dose of 20 mg per day of diphenoxylate hydrochloride). Most patients will require this dosage until initial control of diarrhea has been achieved. Clinical improvement of acute diarrhea is usually observed within 48 hours. Dosage after Initial Control of Diarrhea After initial control has been achieved, the Lomotil dosage may be reduced to meet individual requirements.

Control may often be maintained with as little as two Lomotil tablets daily. Duration of Treatment If clinical improvement of chronic diarrhea after treatment with the maximum recommended daily dosage is not observed within 10 days, discontinue Lomotil as symptoms are unlikely to be controlled by further administration.

• The following serious adverse reactions are described elsewhere in labeling:
• Respiratory and/or CNS depression (see WARNINGS )
• Anticholinergic and opioid-toxicities, including atroponism (see WARNINGS and PRECAUTIONS )
• Dehydration and electrolyte imbalance (see WARNINGS )
• GI Complications in patients with infectious diarrhea (see WARNINGS )
• Toxic megacolon in patients with acute ulcerative colitis (see WARNINGS ) At therapeutic doses of Lomotil, the following other adverse reactions have been reported; they are listed in decreasing order of severity, but not of frequency: Nervous system: numbness of extremities, euphoria, depression, malaise/lethargy, confusion, sedation/drowsiness, dizziness, restlessness, headache, hallucination Allergic: anaphylaxis, angioneurotic edema, urticaria, swelling of the gums, pruritus Gastrointestinal system: megacolon, paralytic ileus, pancreatitis, vomiting, nausea, anorexia, abdominal discomfort The following adverse reactions related to atropine sulfate are listed in decreasing order of severity, but not of frequency: hyperthermia, tachycardia, urinary retention, flushing, dryness of the skin and mucous membranes.

Drug interactions: Alcohol Alcohol may increase the CNS depressant effects of Lomotil and may cause drowsiness (see WARNINGS ). Avoid concomitant use of Lomotil with alcohol. Other Drugs that Cause CNS Depression The concurrent use of Lomotil with other drugs that cause CNS depression (e.g., barbiturates, benzodiazepines, opioids, buspirone, antihistamines, muscle relaxants), may potentiate the effects of Lomotil (see WARNINGS ). Either Lomotil or the other interacting drug should be chosen, depending on the importance of the drug to the patient. If CNS-acting drugs cannot be avoided, monitor patients for CNS adverse reactions.

MAO Inhibitors Diphenoxylate may interact with monoamine oxidase inhibitors (MAOIs) and precipitate a hypertensive crisis. Avoid use of Lomotil in patients who take MAOIs and monitor for signs and symptoms of hypertensive crisis (headache, hyperthermia, hypertension).

Pregnancy Diphenoxylate hydrochloride has been shown to have an effect on fertility in rats when given in doses 50 times the human dose (see above discussion). Other findings in this study include a decrease in maternal weight gain of 30% at 20 mg/kg/day and of 10% at 4 mg/kg/day. At 10 times the human dose (4 mg/kg/day), average litter size was slightly reduced. Teratology studies were conducted in rats, rabbits, and mice with diphenoxylate hydrochloride at oral doses of 0.4 to 20 mg/kg/day.

Due to experimental design and small numbers of litters, embryotoxic, fetotoxic, or teratogenic effects cannot be adequately assessed. However, examination of the available fetuses did not reveal any indication of teratogenicity. There are no adequate and well-controlled studies in pregnant women.

Lomotil should be used during pregnancy only if the anticipated benefit justifies the potential risk to the fetus.

Pediatric use The safety and effectiveness of Lomotil have been established in pediatric patients 13 years of age and older as adjunctive therapy in the management of diarrhea. The safety and effectiveness of Lomotil have not been established in pediatric patients less than 13 years of age. Lomotil is contraindicated in pediatric patients less than 6 years of age due to the risks of severe respiratory depression and coma, possibly resulting in permanent brain damage or death (see CONTRAINDICATIONS ). Lomotil has caused atropinism, particularly in pediatric patients with Down's syndrome (see PRECAUTIONS ). In case of accidental ingestion of Lomotil by pediatric patients, see OVERDOSAGE for recommended treatment.

• Lomotil is contraindicated in:
• Pediatric patients less than 6 years of age due to the risks of respiratory and central nervous system (CNS) depression (see WARNINGS ).
• Patients with diarrhea associated with pseudomembranous enterocolitis ( Clostridium difficile ) or other enterotoxin-producing bacteria due to the risk of gastrointestinal (GI) complications, including sepsis (see WARNINGS ).
• Patients with known hypersensitivity to diphenoxylate or atropine.
• Patients with obstructive jaundice.

Diagnosis Overdosage can be life-threatening. Symptoms of overdosage may include opioid and/or anticholinergic effects including respiratory depression, coma, delirium, lethargy, dryness of the skin and mucous membranes, mydriasis or miosis, flushing, hyperthermia, tachycardia, hypotonia, tachypnea, toxic encephalopathy, seizures and incoherent speech. Respiratory depression has been reported up to 30 hours after ingestion and may recur despite an initial response to narcotic antagonists.

Treat all possible Lomotil overdosages as serious and maintain medical observation/hospitalization until patients become asymptomatic without naloxone use. Treatment A pure narcotic antagonist (e.g., naloxone) should be used in the treatment of respiratory depression caused by Lomotil. Refer to the prescribing information for naloxone.

Consider Lomotil toxicity even in settings of negative toxicology tests. Following initial improvement of respiratory function, repeated doses of naloxone hydrochloride may be required to counteract recurrent respiratory depression. If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.