Promethazine Dosing in Pediatric Patients
Critical Age Restriction
Promethazine is contraindicated in children under 2 years of age due to risk of fatal respiratory depression. 1
Standard Pediatric Dosing by Indication
Allergy
- Children ≥2 years: 6.25 to 12.5 mg orally three times daily, or 12.5 mg at bedtime 1
- After initiation, adjust dosage to the smallest amount adequate to relieve symptoms 1
- Single 25 mg doses at bedtime or 6.25 to 12.5 mg three times daily will usually suffice 1
Motion Sickness
- Children ≥2 years: 12.5 to 25 mg orally twice daily 1
- Initial dose should be taken one-half to one hour before anticipated travel and repeated 8 to 12 hours later if necessary 1
Nausea and Vomiting
- Weight-based dosing: 0.5 mg per pound of body weight (approximately 1.1 mg/kg) 1
- Alternative fixed dosing: 12.5 to 25 mg every 4 to 6 hours as necessary 1
- Adjust dose to the age and weight of the patient and severity of the condition 1
- Important caveat: Antiemetics should not be used in vomiting of unknown etiology in children and adolescents 1
Sedation
- Nighttime sedation: 12.5 to 25 mg orally or by rectal suppository at bedtime 1
- Preoperative medication: 0.5 mg per pound of body weight (approximately 1.1 mg/kg) in combination with appropriately reduced doses of narcotic or barbiturate and atropine-like drug 1
- Postoperative sedation: 12.5 to 25 mg 1
Formulation Considerations
- Available as tablets (12.5,25,50 mg), syrup (6.25 mg/5 mL), and rectal suppositories 2
- Oral syrup is preferred over rectal suppositories when possible due to more consistent absorption 2
Critical Safety Warnings
Respiratory Depression Risk
- Promethazine can cause significant respiratory depression, particularly when combined with other sedatives 3, 4
- In one study, 4 of 95 patients (4.2%) developed respiratory depression, with one requiring naloxone and another experiencing respiratory arrest 4
- Patients with acute or underlying neurologic abnormalities are at significantly increased risk for complications 5
Other Serious Adverse Effects
- High sedation rate: 60-73%, substantially higher than second-generation antihistamines 2
- Can cause agitation, hallucinations, seizures, and dystonic reactions 3
- Possible association with apparent life-threatening events or sudden infant death syndrome 3
- Has substantial anticholinergic effects 2
Management of Dystonic Reactions
- If acute dystonic reactions occur, administer diphenhydramine 1-2 mg/kg or 25-50 mg parenterally 2
Common Pitfalls to Avoid
- Never use in children <2 years old - this is an absolute contraindication with black box warning 1
- Avoid in patients with head injuries or neurologic abnormalities - significantly increased complication risk 5
- Do not combine with other sedatives without extreme caution - additive respiratory depression risk 4
- Avoid using for vomiting of unknown etiology - may mask serious underlying conditions 1
- Monitor frequently when used parenterally - respiratory depression can occur within 30 minutes even at recommended doses 4