What is the recommended dose of brompheniramine (Bromphed) for pediatric patients?

Brompheniramine Pediatric Dosing

The FDA-approved dosing for brompheniramine in children is age-based: 2.5 mL (½ teaspoonful) every 4 hours for ages 2 to under 6 years, 5 mL (1 teaspoonful) every 4 hours for ages 6 to under 12 years, and 10 mL (2 teaspoonfuls) every 4 hours for ages 12 years and older, with a maximum of 6 doses in 24 hours. 1

Age-Specific Dosing Recommendations

Infants (6 months to under 2 years)

• Dosage must be established by a physician 1
• No standardized dosing exists for this age group in the FDA labeling 1

Young Children (2 to under 6 years)

• 2.5 mL (½ teaspoonful) every 4 hours 1
• Do not exceed 6 doses in 24 hours 1

School-Age Children (6 to under 12 years)

• 5 mL (1 teaspoonful) every 4 hours 1
• Maximum of 6 doses per 24-hour period 1

Adolescents (12 years and older)

• 10 mL (2 teaspoonfuls) every 4 hours 1
• Adult dosing applies with the same 6-dose daily maximum 1

Pharmacokinetic Considerations in Children

The pharmacokinetic profile of brompheniramine in pediatric patients demonstrates age-related differences that support the FDA dosing recommendations:

• Peak plasma concentrations (Cmax) occur at approximately 3.2 hours after oral administration in children with a mean age of 9.5 years 2
• The terminal elimination half-life is approximately 12.4 hours in children 2
• Peripheral H1-blockade begins within 0.5 hours and persists for up to 30 hours after a single 4 mg dose 2
• Maximum wheal inhibition occurs at 12 hours (52% reduction) and maximum flare inhibition at 6 hours (72% reduction) 2

Recent pharmacokinetic studies using age/weight-based dosing (ranging from 1-4 mg) demonstrated that Cmax remains similar across age groups, though AUC is 15-30% higher in older children 3. Importantly, after allometric scaling, no age-related differences in clearance or volume of distribution exist 3.

Clinical Monitoring

Sedation is the most common adverse effect and appears more prevalent in children aged 2-5 years 3. Monitor younger children more closely for excessive drowsiness when initiating therapy 3.

The duration of action supports twice-daily dosing in clinical practice, though the FDA label maintains every-4-hour dosing with a 6-dose maximum 2.

Important Caveats

• Pediatric dosing should never be calculated as a simple fraction of adult doses without considering developmental pharmacokinetic differences 4
• The absence of standardized dosing for infants under 2 years necessitates physician oversight due to unique pharmacokinetic parameters in this population 1, 4
• Do not exceed 6 doses in any 24-hour period regardless of age group 1