Cyclopam Syrup is Contraindicated in Infants Under 6 Months
Dicyclomine (the active ingredient in Cyclopam syrup) should NOT be used in infants under 6 months of age due to serious safety concerns, including reported deaths from respiratory depression and apnea. For children ≥6 months, if dicyclomine is deemed necessary despite limited pediatric evidence, the typical dose is 5-10 mg orally 3-4 times daily, though this remains off-label with significant safety concerns.
Critical Safety Warning
- Fatal cases have been documented in infants receiving dicyclomine, with toxic blood levels reaching 0.505 micrograms/mL—nearly 10 times adult therapeutic concentrations—resulting in death attributed to dicyclomine overdose 1
- The medication poses particular risk in young infants due to immature hepatic metabolism and renal clearance, leading to drug accumulation 2
- Anticholinergic side effects (dry mouth, constipation, urinary retention, tachycardia, drowsiness) are common and can be severe in pediatric patients 3, 4
Dosing for Children ≥6 Months (Off-Label Use)
- For children 6 months to 2 years: 5 mg orally 3-4 times daily (maximum 20 mg/day) 3
- For children 2-12 years: 10 mg orally 3-4 times daily (maximum 40 mg/day) 3
- Doses should be administered 30 minutes before meals when possible to maximize efficacy 3
Important Clinical Considerations
- Dicyclomine lacks robust pediatric efficacy data for common indications like infantile colic or abdominal pain 3
- The drug's anticholinergic properties can mask serious underlying conditions requiring different management 4
- Children under 2 years are pharmacologically immature and cannot be dosed by simply scaling adult doses—they require weight-based calculations with careful monitoring 2
- Alternative therapies should be strongly considered before resorting to dicyclomine in any pediatric patient 3
Common Pitfalls to Avoid
- Never use dicyclomine in infants <6 months under any circumstances 1
- Do not exceed maximum daily doses, as cumulative toxicity can occur 3, 1
- Avoid combining with other anticholinergic medications due to additive effects 4
- Do not use for prolonged periods without reassessing the underlying condition 3
Formulation Considerations
- Cyclopam syrup typically contains dicyclomine 10 mg/5 mL 5
- For a 7 kg infant (approximately 2-6 months old), no dose should be administered due to the absolute contraindication in this age group 2, 1
- Liquid formulations are preferred over tablets in young children, but safety concerns override formulation advantages in infants 5