Bromfed Pediatric Dosing
For Bromfed (brompheniramine/pseudoephedrine combination), use the FDA-approved age-based dosing: children 6 to under 12 years receive 5 mL (1 teaspoonful) every 4 hours, children 2 to under 6 years receive 2.5 mL (½ teaspoonful) every 4 hours, and infants 6 months to under 2 years require physician-established dosing, with a maximum of 6 doses in 24 hours. 1
Age-Based Dosing Regimen
The FDA-approved dosing for Bromfed oral solution follows a straightforward age-stratified approach 1:
- Ages 12 years and older: 10 mL (2 teaspoonfuls) every 4 hours 1
- Ages 6 to under 12 years: 5 mL (1 teaspoonful) every 4 hours 1
- Ages 2 to under 6 years: 2.5 mL (½ teaspoonful) every 4 hours 1
- Infants 6 months to under 2 years: Dosage must be established by a physician 1
Critical safety limit: Do not exceed 6 doses during a 24-hour period regardless of age 1
Pharmacokinetic Considerations in Children
The brompheniramine component demonstrates favorable pharmacokinetics in pediatric patients 2, 3:
- Onset of action: Significant H1-blockade begins at 0.5 hours after administration 2
- Peak effect: Maximum wheal inhibition occurs at approximately 12 hours, with maximum flare inhibition at 6 hours 2
- Duration: Single doses produce peripheral H1-blockade lasting up to 30 hours 2
- Half-life: Terminal elimination half-life is approximately 12.4 hours in children 2
Research indicates that age/weight-based dosing nomograms using a 4-fold dose range achieve similar maximum concentrations (Cmax) and area under the curve (AUC) across pediatric age groups 3. Following allometric scaling, no clinically significant age-related differences in clearance or volume of distribution exist 3.
Important Clinical Caveats
Sedation Risk
Sedation is the most commonly reported adverse effect and appears more prevalent in the 2- to 5-year-old age group 3. Close monitoring for excessive sedation is warranted, particularly in younger children.
Anticholinergic Effects
Brompheniramine possesses anticholinergic properties and should be avoided in patients presenting with anticholinergic delirium or intoxication from drugs with anticholinergic properties, as it may worsen the clinical condition 4, 5.
Dosing Frequency Considerations
Given the 12-hour half-life and prolonged duration of action demonstrated in pharmacokinetic studies 2, the FDA-approved every-4-hour dosing schedule may be more frequent than pharmacologically necessary. However, adhere to the FDA-approved regimen 1 unless specific clinical circumstances warrant physician modification.
Infants Under 2 Years
For infants 6 months to under 2 years, individualized physician dosing is mandatory 1. The lack of established dosing reflects both safety concerns and limited pharmacokinetic data in this vulnerable population.