Dicyclomine-Simethicone Syrup Should NOT Be Given to Pediatric Patients
Dicyclomine is contraindicated in infants less than 6 months of age and is not recommended for children younger than 6 months due to serious safety concerns, including life-threatening respiratory symptoms, seizures, and death. 1
FDA Contraindication and Safety Profile
Absolute contraindication: The FDA drug label explicitly states that dicyclomine hydrochloride is contraindicated in infants less than 6 months of age. 1
Serious adverse events documented: Published cases report that administration of dicyclomine to infants has been followed by serious respiratory symptoms (dyspnea, shortness of breath, respiratory collapse, apnea, and asphyxia), seizures, syncope, pulse rate fluctuations, muscular hypotonia, coma, and death. 1
Lack of established safety and efficacy: Safety and effectiveness in pediatric patients have not been established for dicyclomine hydrochloride. 1
Evidence Against Use in Infantile Colic
No proven benefit: Dicyclomine is not recommended in children younger than six months, and proper counseling of parents about the benign nature of infantile colic is considered first-line management. 2
Simethicone ineffective: Simethicone (the other component of this combination) has no role in decreasing the symptoms of colic, making the combination product doubly inappropriate. 2
Conflicting and methodologically flawed evidence: A systematic review found that while some studies on dicyclomine hydrochloride showed favorable results for colic, side effects were noted along with significant issues in study methodology. 3
Age-Appropriate Alternatives for Gastrointestinal Symptoms
For Gastroenteritis in Children:
First-line therapy: Reduced-osmolarity oral rehydration solution (ORS) is the recommended first-line treatment for mild-to-moderate dehydration in infants with acute diarrhea. 4
Antiemetics only for older children: Ondansetron may be given only to children > 4 years of age to facilitate oral rehydration when vomiting is present; it is not recommended for children < 4 years. 4
Antimotility agents contraindicated: Antimotility drugs (which would include anticholinergic agents like dicyclomine) should not be given to children under 18 years of age with acute diarrhea due to risks of serious adverse events including ileus, abdominal distension, lethargy, and death (particularly in children under 3 years). 5
For Infantile Colic:
Parental counseling: Counseling of parents about the benign nature of the condition is considered first-line management. 2
Dietary modifications: There is some scientific evidence to support the use of casein hydrolysate formula in formula-fed infants or a low-allergen maternal diet in breastfed infants with infantile colic. 3
Common Pitfalls to Avoid
Do not prescribe based on historical practice: Dicyclomine may have been used in the past for pediatric gastrointestinal complaints, but current evidence and FDA labeling clearly contraindicate this practice in infants. 1, 2
Do not assume combination products are safer: The addition of simethicone does not mitigate the serious safety concerns with dicyclomine in young children, and simethicone itself lacks efficacy for colic. 2, 3
Do not use anticholinergic agents for pediatric diarrhea: The anticholinergic properties of dicyclomine make it particularly dangerous in the setting of acute gastroenteritis, where antimotility effects can lead to serious complications. 5