Promethazine Dosing for Children
Promethazine is contraindicated in children under 2 years of age, and for children 2 years and older, the dose is 0.5 mg per pound (approximately 1.1 mg/kg) of body weight, adjusted to age, weight, and severity of condition, not to exceed 25 mg per dose. 1
Critical Safety Warning
- Promethazine must never be used in children under 2 years of age due to the risk of fatal respiratory depression 1
- This is an FDA black box warning that supersedes all other considerations 1
Dosing by Indication
For Nausea and Vomiting
- Standard dose: 0.5 mg per pound of body weight (approximately 1.1 mg/kg), adjusted for age, weight, and severity 1
- Doses of 12.5-25 mg may be repeated every 4-6 hours as necessary 1
- Antiemetics should not be used in vomiting of unknown etiology in children and adolescents 1
For Allergies
- Initial dose: 12.5 mg taken three times daily or 6.25-12.5 mg three times daily 1
- Single 25 mg dose at bedtime may be used 1
- After initiation, adjust to the smallest amount adequate to relieve symptoms 1
For Motion Sickness
- Dose: 12.5-25 mg twice daily 1
- Initial dose should be taken 30-60 minutes before anticipated travel 1
- Repeat 8-12 hours later if necessary 1
For Sedation
- Bedtime sedation: 12.5-25 mg at bedtime 1
- Preoperative sedation: 0.5 mg per pound of body weight in combination with appropriately reduced doses of narcotic or barbiturate and atropine-like drug 1
- Postoperative sedation: 12.5-25 mg 1
Important Clinical Considerations
Adverse Effects Profile
- Promethazine has been associated with significant sedation, agitation, hallucinations, seizures, dystonic reactions, and possibly apparent life-threatening events 2
- These adverse reactions are most concerning in children under 2 years of age, who are most vulnerable 2
- If dystonic reactions occur, diphenhydramine (1-2 mg/kg or 25-50 mg parenterally) can be administered 3
Misuse Potential
- Promethazine has documented misuse and abuse potential, particularly in adolescents 4
- Misuse is often associated with concomitant opioid use and has been linked to drug-related fatalities 4
- Healthcare providers should be vigilant about potential misuse, especially since promethazine may be available over-the-counter in some formulations 4