Dicyclomine Injection is Contraindicated in Pediatric Patients
Dicyclomine (injection or any formulation) is NOT recommended for use in children younger than 6 months of age, and there is no established safe per kg dosing for injectable dicyclomine in the pediatric population. 1
Critical Safety Information
Contraindication in Infants
- Dicyclomine is specifically contraindicated in infants under 6 months of age due to serious safety concerns including respiratory complications and potential adverse effects. 1
- The drug has been associated with significant risks in young infants, making it unsuitable for this vulnerable population. 1
Lack of Established Pediatric Injectable Dosing
- No evidence-based per kg dosing guidelines exist for injectable dicyclomine in children of any age group. 1
- The available literature does not provide safe, validated dosing protocols for intramuscular or intravenous administration of dicyclomine in pediatric patients. 1
Clinical Implications
For Infantile Colic Management
- If dicyclomine is being considered for infantile colic (its historical indication), proper counseling of parents about the benign, self-limiting nature of the condition is considered first-line management. 1
- Simethicone has been shown to have no role in decreasing colic symptoms, and dicyclomine carries unacceptable risks in this age group. 1
Alternative Approaches
- For any condition requiring antispasmodic therapy in children, alternative medications with established pediatric safety profiles should be considered. 1
- Treatment decisions in pediatric patients should be made on a case-by-case basis with appropriate specialist consultation when antispasmodic therapy is deemed necessary. 1
Important Caveats
- Children are not simply "small adults" and dosing cannot be linearly scaled down from adult doses based solely on weight, as this approach fails to account for developmental differences in drug metabolism and elimination. 2, 3
- Neonates and infants have immature drug elimination pathways, making them particularly vulnerable to adverse effects from medications not specifically studied in their age group. 2
- The absence of pharmacokinetic and pharmacodynamic data for injectable dicyclomine in children represents a critical knowledge gap that precludes safe dosing recommendations. 3