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

LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE WITH ATROPINE SULFATE) IS NOT AN INNOCUOUS DRUG AND DOSAGE RECOMMENDATIONS SHOULD BE STRICTLY ADHERED TO, ESPECIALLY IN CHILDREN. LOMOTIL (DIPHENOXYLATE HYDROCHLORIDE WITH ATROPINE SULFATE) IS NOT RECOMMENDED FOR USE IN CHILDREN UNDER FOUR YEARS OF AGE. OVERDOSAGE MAY RESULT IN TACHYPNEA, SEIZURES, SEVERE RESPIRATORY DEPRESSION AND COMA, POSSIBLY LEADING TO PERMANENT BRAIN DAMAGE OR DEATH (SEE OVERDOSAGE). THEREFORE, KEEP THIS MEDICATION OUT OF THE REACH OF CHILDREN.

Use In Pregnancy and Lactation

The use of LOMOTIL in women of childbearing potential or during pregnancy and lactation requires that the expected benefits of the drug be weighed against any possible hazard to the mother and child. Caution should be exercised when LOMOTIL is administered to a nursing mother, since diphenoxylate hydrochloride and atropine sulfate are excreted in breast milk. If a nursing mother is taking LOMOTIL, the infant may exhibit some effects of the drug.

General

LOMOTIL (diphenoxylate hydrochloride with atropine sulfate) may produce drowsiness or dizziness. The effect of LOMOTIL on the ability to drive or use machines has not been systematically evaluated. Patients should refrain from driving or using machines until they know that LOMOTIL does not negatively affect these abilities as confusional state, lethargy, sedation, somnolence, and dizziness may occur.

Slowing of intestinal motility by an agent such as LOMOTIL does not preclude the need for appropriate fluid and electrolyte replacement. Dehydration may further influence the variability of response to LOMOTIL and may predispose to delayed diphenoxylate intoxication. Drug-induced inhibition of peristalsis may result in fluid retention in the colon which may further aggravate dehydration and electrolyte imbalance. If severe dehydration or electrolyte imbalance is present, withhold LOMOTIL until appropriate corrective therapy has been initiated.

Central Nervous System (CNS) depression, dizziness or drowsiness may be potentiated with the concomitant use of LOMOTIL with other CNS depressants such as barbiturates, benzodiazepines and other sedatives/hypnotics, anxiolytics, and tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, and alcohol. Therefore, the patient should be closely observed when any of these are used concomitantly.

Use in Children

In children, LOMOTIL should be used with special caution, since signs of atropinism may occur even with recommended doses, particularly in patients with Down’s syndrome. LOMOTIL should be used with special caution in young children because of their variable response. LOMOTIL is not recommended for children under 4 years of age (see WARNINGS).

Patients with Special Diseases and Conditions

LOMOTIL should be used with extreme caution in patients with cirrhosis and other hepatic disease and in all patients with abnormal liver function tests, since hepatic coma may be precipitated.

In some patients with acute ulcerative colitis, agents which inhibit intestinal motility or delay intestinal transit time have been reported to induce toxic megacolon. Consequently, patients with acute ulcerative colitis should be carefully observed and LOMOTIL therapy should be discontinued promptly if abdominal distension occurs or if other untoward symptoms develop.

Dependence Liability

Addiction to (dependency on) LOMOTIL is theoretically possible at high dosage. Therefore, the recommended dosage should not be exceeded. Because of the structural and pharmacological similarity of diphenoxylate to meperidine and similar drugs with a definite addiction potential, LOMOTIL should be administered with considerable caution to patients who are receiving addicting drugs, to individuals known to be addiction-prone, or to those whose histories suggest that they may increase the dosage on their own initiative. Because a subtherapeutic dose of atropine sulfate has been added to the diphenoxylate hydrochloride, to discourage deliberate overdosage, there should be strict observance of the contraindications and precautions relative to the use of atropine sulfate.

Drug Interactions

LOMOTIL may potentiate the action of barbiturates, tranquilizers and alcohol. Therefore, the patient should be closely observed when these medications are used concomitantly.

Since the chemical structure of diphenoxylate is similar to that of meperidine, the concurrent use of LOMOTIL with monoamine oxidase inhibitors may in theory precipitate a hypertensive crisis.

CNS depression, dizziness or drowsiness may be potentiated with the concomitant use of LOMOTIL with other CNS depressants.

The most frequently reported adverse effect is nausea. Other symptoms which have been reported at therapeutic doses are:

General Disorders: Malaise.

Nervous System: Drowsiness, coma, lethargy, sedation/drowsiness, restlessness, dizziness, insomnia, headache, blurring of vision, depression, euphoria, confusion, paraesthesia, hallucination, somnolence.

Respiratory: Respiratory depression.

GI: Vomiting, anorexia, nausea, abdominal bloating, abdominal discomfort, cramps, paralytic ileus, toxic megacolon, pancreatitis, gastrointestinal disorder.

Allergy: Anaphylaxis, pruritis, skin eruption, giant urticaria, angioedema.

Atropine sulfate effects such as dryness of the skin and mucous membranes, hyperthermia, tachycardia, urinary retention and flushing may also occur, especially in children.