Is 8 drops of Decolic (dicyclomine) drop 10 mg/mL as needed for abdominal pain in a 7-month-old baby an appropriate or high dose?

Dicyclomine 8 Drops (10 mg/mL) in a 7-Month-Old is CONTRAINDICATED and Dangerous

Dicyclomine is absolutely contraindicated in infants less than 6 months of age, and should not be used in a 7-month-old infant due to serious safety concerns including respiratory collapse, apnea, seizures, and death. 1

Critical Safety Concerns

FDA Contraindication in Infants

• Dicyclomine is explicitly contraindicated in infants less than 6 months of age 1
• Published cases report serious adverse events following dicyclomine administration to infants, including:
  • Dyspnea, shortness of breath, and respiratory collapse 1
  • Apnea and asphyxia 1
  • Seizures and syncope 1
  • Pulse rate fluctuations 1
  • Muscular hypotonia and coma 1
  • Death 1

Dosing Analysis for This Case

• 8 drops at 10 mg/mL = 0.8 mL = 8 mg total dose
• For a typical 7-month-old weighing approximately 8 kg, this represents 1 mg/kg per dose
• This dose is concerning even if the drug were appropriate for this age group, as adult starting doses are typically 20 mg orally 4 times daily 1

Evidence Against Use in Infantile Colic

Efficacy Data

• A Cochrane systematic review found that dicyclomine cannot be recommended for infants with colic due to sparse evidence prone to bias and small sample sizes 2
• Only one small study (48 infants) showed benefit, but this was outweighed by safety concerns 2

Safety Profile in Studies

• Serious adverse effects were reported in dicyclomine studies: longer sleep (4%), wide-eyed state (4%), and drowsiness (13%) 2
• These adverse effects were unique to dicyclomine compared to other agents studied for colic 2

Alternative Management for Abdominal Pain in 7-Month-Old

Age-Appropriate Pain Management

• For procedural pain in infants: Oral sucrose (0.1-1 mL of 24% solution) 2 minutes before painful procedures is evidence-based 3
• For colic-related pain: Herbal agents showed moderate-quality evidence for increasing response (RR 2.05,95% CI 1.56 to 2.70) 2
• Acetaminophen may be considered for postoperative or significant pain, though data in neonates are limited 3

Non-Pharmacologic Approaches

• Infantile colic typically peaks at 6 weeks to 2-4 months and resolves by 4 months of age 4
• At 7 months, persistent abdominal pain warrants evaluation for other causes beyond typical colic 4
• Parental support and reassurance are critical, as crying is the most common trigger of abusive head trauma 4

Clinical Pitfalls to Avoid

• Never use dicyclomine in any infant under 6 months - this is an absolute contraindication 1
• Exercise extreme caution in infants 6-12 months - safety and effectiveness have not been established in pediatric patients 1
• Dicyclomine is contraindicated in breastfeeding mothers due to excretion in breast milk and risk to nursing infants 1
• Intravenous administration must be avoided due to thrombosis risk 5

Recommended Action

Discontinue dicyclomine immediately and evaluate the infant for:

• Respiratory status and oxygen saturation
• Alternative causes of abdominal pain at 7 months (constipation, gastroenteritis, intussusception, other surgical emergencies)
• Consider age-appropriate analgesics only if pain is confirmed and significant
• Provide parental education about normal infant crying patterns and safe soothing techniques 4