Is Bromfed DM (Brompheniramine and Dextromethorphan) safe for 11 and 14 year old children?

Bromfed DM Safety for 11 and 14-Year-Old Children

Bromfed DM is not recommended for children under 6 years of age, but can be used in 11 and 14-year-old children with appropriate caution for potential side effects. 1

Safety and Dosing Considerations

• Bromfed DM contains brompheniramine (antihistamine), dextromethorphan (antitussive), and pseudoephedrine (decongestant), a combination that requires careful consideration in pediatric populations 1
• The FDA label specifically states that safety and effectiveness have not been established in pediatric patients below 6 months of age, implying that it can be used in older children including 11 and 14-year-olds 1
• Children in the 11-14 age range are generally considered appropriate candidates for Bromfed DM when used according to age-appropriate dosing guidelines 1

Efficacy in Children

• Dextromethorphan, a key component in Bromfed DM, has demonstrated efficacy in reducing cough frequency during daytime by 25.5% compared to placebo in children aged 6-11 years 2
• Studies show that dextromethorphan doses of approximately 0.5 mg/kg may provide a balance between symptomatic relief and avoiding adverse events in pediatric patients 3

Important Precautions

• Over-the-counter cough and cold medications containing dextromethorphan should be used with caution in children due to potential adverse effects 4
• The most common adverse events associated with dextromethorphan in children include:
  • Central nervous system effects (e.g., ataxia) 5
  • Autonomic symptoms (e.g., tachycardia) 5
  • Flushing and/or urticarial rash (occurring in approximately 18% of cases) 5

Contraindications and Drug Interactions

• Bromfed DM should not be used concurrently with:
  • MAO inhibitors due to risk of hyperpyrexia, hypotension, and potentially fatal reactions 1
  • CNS depressants, as antihistamines have additive effects with alcohol and other CNS depressants 1
• Caution is advised in patients with:
  • History of bronchial asthma
  • Narrow angle glaucoma
  • Gastrointestinal obstruction
  • Urinary bladder neck obstruction 1

Monitoring and Safety Guidance

• Parents should be warned about the medication's potential to cause drowsiness, affecting activities requiring mental alertness (e.g., school performance, sports) 1
• Most adverse events with dextromethorphan (a component of Bromfed DM) are associated with overdose rather than therapeutic dosing 5
• No deaths or pathologic dysrhythmias have been reported with dextromethorphan-only ingestions in children, suggesting relative safety when used appropriately 5

Practical Recommendations

• For 11 and 14-year-old children, follow age-appropriate dosing as specified on the product label 1
• Monitor for side effects including drowsiness, dizziness, or excitability 1
• Limit duration of use to the shortest period necessary to control symptoms 4
• Consider non-pharmacological approaches to managing cough before or alongside medication use 4

While Bromfed DM can be used in 11 and 14-year-old children, parents should be educated about proper dosing, potential side effects, and the importance of not exceeding recommended doses to ensure safe use of this medication.