LOW DOSE OF DICYCLOMINE ASSOCIATED WITH RESPIRATORY DISTRESS AND DEATH IN AN INFANT
Noorizan Abdul Aziz, Muhammad Bayu Teja, Yahaya Hassan,
Muhammad Roziha Rujhan, and Kamaruddin Jaalam

OBJECTIVE:To report a case of a low dose of oral dicyclomine associated with respiratory distress and death in an infant.

CASE SUMMARY: A 35-day-old Malay boy was given a total of 1.0 mL of Colimix syrup (per 5 mL containing dicyclomine HCl 5 mg and simethicone 50 mg) by a general practitioner for vomiting. About 24 hours later, the boy was referred to the hospital because of abdominal distension and difficulty in breathing. On admission to the intensive care unit, the patient was unconscious, hypotensive, tachycardic, apneic, and cyanotic. His condition continued to deteriorate despite acute treatment and resuscitation, and the patient died about 72 hours later.

DISCUSSION: Metabolic disorder and septic shock were not likely and not convincing diagnoses considering the laboratory data and other patient information. Furthermore, this patient's condition deteriorated within a short time and did not respond to antibiotics and other drug treatments. Dicyclomine is highly suspected because the respiratory distress began after he was given the drug. This drug is contraindicated in children younger than six months and has been reported to cause respiratory distress and death. Most of the cases reported occurred after the patient received one to two oral doses (5–10 mg) of dicyclomine. Unfortunately, in our patient, respiratory distress developed even with a very low dose (0.5–1 mg). The causal relationship of this incident was classified as "probable" based on the Naranjo method.

CONCLUSIONS: A low dose of oral dicyclomine was probably the cause of respiratory distress and death in this infant. Drugs that are contraindicated should not be administered, even at very small doses.

J Pharm Technol 1999;15:56-8.