What are the guidelines for using Dicyclomine Hydrochloride (anticholinergic antispasmodic) in infants?

Guidelines for Using Dicyclomine Hydrochloride in Infants

Absolute Contraindication in Infants Under 6 Months

Dicyclomine hydrochloride is absolutely contraindicated in infants less than 6 months of age due to serious and potentially fatal adverse effects. 1

• The FDA drug label explicitly states that dicyclomine is contraindicated in infants under 6 months, with published cases reporting serious respiratory symptoms including dyspnea, respiratory collapse, apnea, and asphyxia, as well as seizures, syncope, pulse rate fluctuations, muscular hypotonia, coma, and death 1
• Parents and caregivers must be specifically counseled not to administer dicyclomine to infants less than 6 months of age 1
• The American Academy of Pediatrics does not recommend dicyclomine below 6 months of age, citing cases of apnea, seizures, and coma in this age group 2

Use in Infants Over 6 Months of Age

For infants older than 6 months with intestinal colic, dicyclomine may be used at 0.1 mg/kg/dose three times daily, with a maximum of 10 mg/day, but only for short-term use. 2

• Multiple international guidelines (AIIMS/IAP Guidelines from India, Harriet Lane Handbook, BNF for Children 2024) consistently recommend 0.1 mg/kg/dose administered three times daily (every 8 hours) for infants over 6 months 2
• The maximum daily dose should not exceed 10 mg/day 2
• Use should be limited to short-term treatment of abdominal colic only; prolonged use should be avoided 2

Important Safety Considerations

Even in infants over 6 months, dicyclomine carries significant risks and should be used with extreme caution.

• Adverse effects reported in clinical studies include prolonged sleep (4%), wide-eyed state (4%), and drowsiness (13%) 3
• Two of five studies examining dicyclomine reported relevant adverse effects, making it a less favorable option compared to other interventions 3
• Current evidence shows that dicyclomine cannot be recommended as a first-line agent for infantile colic due to sparse evidence prone to bias and inconsistent benefits 3

Contraindication in Breastfeeding

Dicyclomine is absolutely contraindicated in women who are breastfeeding. 1

• The drug is excreted in human milk and poses serious risks to breastfed infants 1
• A decision must be made to either discontinue nursing or discontinue the drug 1
• Lactating women must be advised not to use dicyclomine while breastfeeding 1

Alternative Management Approaches

Proper counseling of parents about the benign, self-limiting nature of infantile colic is considered first-line management. 2

• Simethicone has no role in decreasing symptoms of colic and should not be used 2
• Dietary modifications (hypoallergenic formulas, maternal diet elimination in breastfeeding) show more promise than pharmacological treatment, with one study showing 95.4% improvement with dietary changes versus 53.3% with dicyclomine 4
• Herbal agents containing Foeniculum vulgare, Matricariae recutita, and Melissa officinalis showed reduction in crying time compared to placebo, though evidence quality is low 5

Critical Clinical Pitfall

The most dangerous error is administering dicyclomine to any infant under 6 months of age—this can result in respiratory arrest and death. 1 Always verify the infant's age before considering this medication, and even in eligible infants over 6 months, exhaust non-pharmacological and dietary interventions first given the significant adverse effect profile and limited evidence of benefit 2, 3.