Can levodropropizine and chlorpheniramine be given to individuals under 18 years of age?

Levodropropizine and Chlorpheniramine Use in Patients Under 18 Years

Direct Answer

Chlorpheniramine can be given to children 6 years and older, but not below age 6, while levodropropizine can be used in pediatric patients with appropriate dosing, though specific age restrictions vary by formulation and country. 1

Chlorpheniramine Age Restrictions

FDA-Approved Dosing by Age

• Children under 6 years: Do not use 1
• Children 6 to under 12 years: ½ tablet every 4-6 hours, maximum 3 tablets in 24 hours 1
• Children 12 years and over: 1 tablet every 4-6 hours, maximum 6 tablets in 24 hours 1

Safety Concerns in Young Children

• Between 1969-2006, antihistamines were associated with 69 fatalities in children under 6 years, with 41 deaths occurring in children under 2 years due to drug overdose and toxicity 2
• The FDA's advisory committees recommended in 2007 that OTC cough and cold medications should not be used in children below 6 years of age due to lack of efficacy and safety concerns 2
• Chlorpheniramine was specifically identified among the antihistamines associated with these pediatric fatalities 2

Critical Clinical Pitfall

• Combination products containing chlorpheniramine with opioids (such as hydrocodone/chlorpheniramine) carry additional risks. A review found 4 fatalities in patients aged 6 to <18 years using hydrocodone/chlorpheniramine, and the FDA concluded these products should no longer be indicated for patients under 18 years 3

Levodropropizine Age Considerations

Pediatric Use Evidence

• Levodropropizine has demonstrated efficacy and safety in pediatric populations in multiple studies 4, 5, 6
• A meta-analysis of 7 clinical studies including 1,178 patients showed levodropropizine was statistically significantly more effective than central antitussives (codeine, cloperastine, dextromethorphan) in reducing cough intensity, frequency, and nocturnal awakenings (p = 0.0015) 4
• Studies have evaluated levodropropizine in children as young as 4.5 years (mean age 4 years 6 months ± 3 years 5 months) with various respiratory conditions 6

Recommended Pediatric Dosing

• Standard pediatric dose: 2 mg/kg orally three times daily 5, 6
• Treatment duration typically ranges from 3-5 days depending on clinical evolution 5, 6

Safety Profile in Children

• Levodropropizine carries a lower risk of daytime somnolence compared to dropropizine (5.3% vs 10.3%) 5
• Gastrointestinal symptoms when present are generally mild 5
• The drug is classified as a peripheral antitussive, avoiding the central nervous system effects and abuse potential associated with opioid antitussives 4, 7

Important Contraindication Note

The FDA drug label for levodopa/carbidopa (often confused with levodropropizine due to similar naming) explicitly states: "Safety and effectiveness in pediatric patients have not been established. Use of the drug in patients below the age of 18 is not recommended." 8 However, this refers to levodopa (for Parkinson's disease), not levodropropizine (an antitussive), which are entirely different medications.

Clinical Decision Algorithm

For patients under 18 years with cough:

1. Age <6 years:

   • Chlorpheniramine: Contraindicated 1
   • Levodropropizine: Can be considered at 2 mg/kg three times daily based on published pediatric studies 5, 6

2. Age 6 to <12 years:

   • Chlorpheniramine: Approved at ½ tablet every 4-6 hours 1
   • Levodropropizine: Can be used at 2 mg/kg three times daily 5

3. Age 12 to <18 years:

   • Chlorpheniramine: Approved at adult dosing 1
   • Levodropropizine: Can be used at standard pediatric dosing 4

Avoid all combination products containing opioids (hydrocodone, codeine) with chlorpheniramine in patients under 18 years due to unfavorable benefit-risk profile and FDA recommendations 3