Bromfed DM Dosing
For adults and children ≥12 years: administer 10 mL (2 teaspoonfuls) every 4 hours; for children 6 to <12 years: 5 mL every 4 hours; for children 2 to <6 years: 2.5 mL every 4 hours; do not exceed 6 doses in 24 hours 1.
Adult Dosing (≥12 years)
- Standard dose: 10 mL (2 teaspoonfuls) every 4 hours
- Maximum: 6 doses per 24 hours
- Each 10 mL dose provides:
- Brompheniramine 4 mg
- Dextromethorphan 20 mg
- Pseudoephedrine 60 mg
Pediatric Dosing
Children 6 to <12 years
- Dose: 5 mL (1 teaspoonful) every 4 hours
- Maximum: 6 doses per 24 hours
- Each dose provides: Brompheniramine 2 mg, Dextromethorphan 10 mg, Pseudoephedrine 30 mg
Children 2 to <6 years
- Dose: 2.5 mL (½ teaspoonful) every 4 hours
- Maximum: 6 doses per 24 hours
- Each dose provides: Brompheniramine 1 mg, Dextromethorphan 5 mg, Pseudoephedrine 15 mg
Infants 6 months to <2 years
- Dosage must be established by a physician 1
- No standardized dosing available for this age group
Clinical Context and Evidence
The FDA-approved dosing is based on age-based rather than weight-based calculations 1. While research suggests dextromethorphan may show dose-response effects at approximately 0.5 mg/kg 2, the approved formulation uses fixed age-based dosing that results in variable mg/kg dosing (0.35-0.94 mg/kg range in studied populations).
Important caveat: Evidence for antitussive efficacy in children is limited. A 2022 Cochrane review found that antihistamine-decongestant combinations showed some benefit in adults and older children, but there is no evidence of effectiveness in young children 3. The American Academy of Pediatrics does not support routine use of dextromethorphan for acute cough in children 2.
Safety Considerations
Serotonin syndrome risk: Bromfed DM can precipitate serotonin syndrome in patients taking SSRIs or other serotonergic medications due to the dextromethorphan component 4. Avoid concurrent use or use with extreme caution.
Sedation profile: Brompheniramine is a first-generation antihistamine that causes sedation. Non-sedating alternatives may be preferable for daytime use 5, 6.
Pseudoephedrine concerns: The decongestant component carries cardiovascular risks including hypertension and arrhythmias, particularly in patients with pre-existing cardiac conditions 6.
Adverse effects: Combination products show higher adverse effect rates compared to placebo, with drowsiness being most common from the antihistamine component 3.
Administration Guidelines
- Administer every 4 hours as needed for symptom control
- Do not exceed 6 doses in any 24-hour period
- The formulation contains 0.95% alcohol 1
- Can be taken with or without food