From the FDA Drug Label
8.4 Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see Contraindications (4)] There are published cases reporting that the administration of dicyclomine hydrochloride to infants has been followed by serious respiratory symptoms (dyspnea, shortness of breath, breathlessness, respiratory collapse, apnea and asphyxia), seizures, syncope, pulse rate fluctuations, muscular hypotonia, and coma, and death, however; no causal relationship has been established.
Bentyl (dicyclomine) is not established as safe or effective in pediatric patients. It is contraindicated in infants less than 6 months of age due to the risk of serious adverse reactions 1.
From the Research
Bentyl (dicyclomine) is generally not recommended for routine use in pediatric patients, especially infants under 6 months of age, due to the risk of serious adverse effects. The use of Bentyl in pediatric patients is a concern due to its potential side effects, including respiratory depression, seizures, syncope, asphyxia, and even death, as reported in the literature 2, 3, 4, 5. For children 6 months to 2 years old, use should be extremely cautious and only when clearly necessary. In older children (over 2 years), dicyclomine may be used at reduced doses (typically 10 mg three to four times daily) for functional abdominal pain or irritable bowel syndrome when other interventions have failed, as suggested by studies 4, 5. The medication works as an anticholinergic agent that relaxes smooth muscle in the gastrointestinal tract, potentially relieving cramping and pain. However, side effects can include dry mouth, blurred vision, urinary retention, constipation, and central nervous system effects. Before considering Bentyl in pediatric patients, non-pharmacological approaches should be tried first, including dietary modifications, stress reduction techniques, and other safer medications, as recommended by recent studies 6. If prescribed, parents should be educated about potential side effects and instructed to seek immediate medical attention if concerning symptoms develop. Some key points to consider when prescribing Bentyl to pediatric patients include:
- The risk of serious adverse effects, particularly in infants under 6 months of age
- The need for cautious use in children 6 months to 2 years old
- The potential for reduced doses in older children (over 2 years) for functional abdominal pain or irritable bowel syndrome
- The importance of non-pharmacological approaches before considering Bentyl
- The need for parent education on potential side effects and when to seek medical attention.