Bentyl (Dicyclomine) is Contraindicated in Infants Under 6 Months of Age
Bentyl (dicyclomine) should NOT be used in pediatric patients under 6 months of age due to serious safety concerns, including reports of respiratory symptoms, seizures, syncope, asphyxia, pulse rate fluctuations, and muscular hypotonia. For older children, the evidence base is extremely limited and the drug lacks FDA approval for pediatric use.
Critical Safety Contraindication
- Dicyclomine is absolutely contraindicated in infants under 6 months of age due to documented serious adverse events including breathing difficulties, seizures, loss of consciousness, and death 1
- The FDA has issued warnings against use in this age group based on post-marketing surveillance data showing severe anticholinergic toxicity in young infants 1
Limited Evidence for Older Children
Infantile Colic Studies (Historical Context)
- One study used 5 mg/kg/day divided into doses for infants with colic, showing efficacy in 63% versus 25% with placebo, but this was conducted before safety concerns emerged 1
- Another study employed 3 mg/kg/day in formula-fed infants, with 53.3% showing improvement, though this dosing is no longer recommended given current safety data 2
Current Clinical Reality
There is no established safe or effective pediatric dosing regimen for dicyclomine in children of any age. The drug:
- Lacks FDA approval for pediatric patients
- Has insufficient safety data in children over 6 months
- Carries significant anticholinergic side effects that may be poorly tolerated in pediatric populations 3
Alternative Approaches
For conditions where dicyclomine might be considered (such as functional gastrointestinal disorders):
- Dietary modifications proved superior to dicyclomine in formula-fed infants with colic (95.4% vs 53.3% improvement), using hypoallergenic formulas 2
- Non-pharmacologic interventions should be prioritized in pediatric patients
- If antispasmodic therapy is absolutely necessary in older children, consultation with a pediatric gastroenterologist is essential to consider safer alternatives
Clinical Pitfall to Avoid
Do not extrapolate adult dosing to children - the historical pediatric studies used weight-based dosing (3-5 mg/kg/day), but even these regimens are not validated for safety in modern practice 4, 5. The serious adverse events reported in young infants underscore that children are not simply "small adults" and require drug-specific pediatric safety data that does not exist for dicyclomine 4.