Tussionex Dosing Guidelines
Critical Contraindication
Tussionex (hydrocodone/chlorpheniramine) is contraindicated in all patients under 18 years of age and should not be prescribed for cough in this population. 1
Evidence Supporting Age Restriction
The FDA determined in 2017 that hydrocodone-containing cough medications should no longer be indicated for treatment of cough in patients under 18 years, based on an unfavorable benefit-risk profile. 1
A comprehensive pharmacovigilance review identified 4 fatalities in patients aged 6 to <18 years taking hydrocodone/chlorpheniramine, with 9 of 10 total pediatric deaths attributed to overdose. 1
No robust clinical trial evidence exists demonstrating efficacy of hydrocodone/chlorpheniramine for cough relief in patients under 18 years of age. 1
The risks of respiratory depression, overdose, and death outweigh any potential benefits in the pediatric population. 1
Dosing for Patients ≥18 Years
For adults and patients 18 years and older, Tussionex is dosed as 5 mL (containing 10 mg hydrocodone and 8 mg chlorpheniramine) orally every 12 hours, with a maximum daily volume of 10 mL (20 mg hydrocodone/16 mg chlorpheniramine). 2
The extended-release formulation allows twice-daily dosing, typically administered every 12 hours. 2
The maximum daily dose should not exceed 10 mL to avoid opioid toxicity and excessive anticholinergic effects from chlorpheniramine. 3
Alternative Treatments for Pediatric Cough
For children requiring cough symptom management, non-opioid alternatives should be used:
Children Under 4 Years
Over-the-counter cough and cold medications should not be used due to potential harm and lack of benefit. 4
Vapor rub, buckwheat honey (for children ≥1 year), and supportive care are appropriate options. 4
Children 4-17 Years
Dextromethorphan-based antitussives may be considered, though evidence of efficacy is limited. 5
Honey (for children ≥1 year) has demonstrated modest benefit for cough symptoms. 4
First-generation antihistamines like chlorpheniramine alone (without opioids) may provide symptomatic relief, particularly for nighttime cough, at age-appropriate doses. 3, 6
Common Pitfalls to Avoid
Never prescribe Tussionex or any hydrocodone-containing cough medication to patients under 18 years, regardless of cough severity. 1
Do not exceed the maximum daily dose of 10 mL in adults, as this increases risk of opioid-related respiratory depression and anticholinergic toxicity. 3
Avoid combining Tussionex with other CNS depressants (alcohol, benzodiazepines, other opioids) due to additive sedation and respiratory depression risk. 3
Do not use in elderly patients without dose adjustment consideration, as chlorpheniramine causes increased anticholinergic side effects (urinary retention, confusion, falls) in this population. 3
Recognize that first-generation antihistamines like chlorpheniramine cause significant sedation and cognitive impairment that persists beyond bedtime dosing due to prolonged half-life. 3
Monitoring and Safety Considerations
Counsel patients on signs of opioid toxicity: excessive sedation, respiratory depression, confusion, and constipation. 1
Warn about anticholinergic effects: dry mouth, urinary retention, constipation, and potential for narrow-angle glaucoma exacerbation. 3
Advise against driving or operating machinery due to combined sedative effects of both hydrocodone and chlorpheniramine. 3
Screen for concurrent medications that may interact, including other CNS depressants and anticholinergic agents. 3