What is the recommended dosage of Bromfed (Brompheniramine and Pseudoephedrine) for pediatric patients?

Bromfed Should Generally Be Avoided in Children Under 6 Years of Age

Bromfed (brompheniramine and pseudoephedrine combination) should not be used in children below 6 years of age due to lack of established efficacy and significant safety concerns, including reported fatalities. 1

Critical Safety Concerns

Age-Related Restrictions

• Children under 6 years: The use of OTC cough and cold medications containing antihistamine-decongestant combinations should be avoided due to potential toxicity and lack of proven efficacy 1

• Fatal outcomes: Between 1969-2006, there were 9 fatalities associated with brompheniramine in children ≤6 years (with 41 deaths from antihistamines overall reported below age 2 years), often resulting from overdose errors, use of multiple products, medication errors, or accidental exposures 1

• Decongestant component risks: Pseudoephedrine (the decongestant in Bromfed) was associated with 46 fatalities in the same age group, with 43 occurring in children under 1 year 1

Lack of Efficacy Evidence

• Controlled trials have demonstrated that antihistamine-decongestant combination products are not effective for symptoms of upper respiratory tract infections in young children 1

• The efficacy of cold and cough medications for symptomatic treatment has not been established for children younger than 6 years 1

FDA-Approved Dosing (When Appropriate)

For children 6 years and older only, the FDA label provides the following dosing 2:

• Ages 6 to under 12 years: 5 mL (1 teaspoonful) every 4 hours
• Ages 12 years and over: 10 mL (2 teaspoonfuls) every 4 hours
• Ages 2 to under 6 years: 2.5 mL (½ teaspoonful) every 4 hours (though this contradicts guideline recommendations to avoid use in this age group)
• Infants 6 months to under 2 years: Dosage to be established by a physician only
• Maximum: Do not exceed 6 doses in 24 hours 2

Important Clinical Caveats

Anticholinergic Properties

• Brompheniramine possesses anticholinergic properties and should be avoided in patients with anticholinergic delirium or intoxication from drugs with anticholinergic effects 3

• The terminal elimination half-life is approximately 12.4 hours in children, indicating prolonged duration of action and potential for accumulation 3, 4

Safer Alternatives

• Second-generation antihistamines (cetirizine, desloratadine, fexofenadine, levocetirizine, loratadine) have been shown to be well tolerated with a very good safety profile in young children and should be preferred 1

• For allergic rhinitis specifically, intranasal corticosteroids are the most effective medication class and should be considered first-line therapy 1

Practical Algorithm for Decision-Making

1. Age < 6 years: Do not prescribe Bromfed; consider second-generation antihistamines or intranasal corticosteroids instead 1

2. Age 6-12 years with allergic rhinitis: Consider second-generation antihistamines or intranasal corticosteroids first; if Bromfed is deemed necessary, use 5 mL every 4 hours (maximum 6 doses/24 hours) 1, 2

3. Age ≥12 years: May use 10 mL every 4 hours if indicated, but safer alternatives should still be considered first 2

4. Any patient with anticholinergic sensitivity or concurrent anticholinergic medications: Avoid Bromfed entirely 3