Sun-Dianox Special Precautions

A subtherapeutic dose of atropine has been added to the diphenoxylate hydrochloride. Hence consideration should be given to the precautions relating to the use of atropine. In children, Sun-Dianox should be used with caution since signs of atropinism may occur even with recommended doses, particularly in patients with Down's syndrome. Sun-Dianox may produce drowsiness or dizziness. The patient should be cautioned regarding activities requiring mental alertness, such as driving or operating dangerous machinery. Potentiation of the action of alcohol, barbiturates, and tranquilizers with concomitant use of Sun-Dianox. Diphenoxylate HCl should be used with extreme caution in patients with advanced hepatorenal disease and in all patients with abnormal liver function since hepatic coma may be precipitated.
Appropriate fluid and electrolyte therapy should be given to protect against dehydration in all cases of diarrhoea. Oral rehydration therapy which is the use of appropriate fluids including oral rehydration salts remains the most effective treatment for dehydration due to diarrhoea. The intake of as much of these fluids as possible is therefore imperative. Drug-induced inhibition of peristalsis may result in fluid detention in the intestine, which may aggravate and mask dehydration and depletion of electrolytes, especially in young children. If severe dehydration of electrolyte imbalance is present, diphenoxylate should be withheld until appropriate corrective therapy has been initiated.
Dependence: Short-term administration of diphenoxylate with atropine in the recommended dosage carries a negligible risk of dependence, although prolonged use or use of high doses may produce dependence of the morphine type. Since addiction to diphenoxylate hydrochloride is possible at high doses, the recommended dosage should not be exceeded.
Use in children: The use of diphenoxylate is not recommended for children under 6 years of age. Sun-Dianox should be used with special caution in young children because this age group may be predisposed to delayed diphenoxylate toxicity and because of the greater variability of response in this age group.
Use in elderly: Consideration should be given to the present of other diseases and concomitant drug therapy.