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1.2. Pediatrics

In January 2018 the U.S. Food and Drug Administration changed the labeling to indicate that opioid cough and cold medicines containing codeine or hydrocodone are no longer indicated for patients less than 18 years of age.11 For analgesia, safety and efficacy of the hydrocodone/acetaminophen combination have not been established in children younger than 2 years of age, while the hydrocodone/ibuprofen combination is not indicated for use in children younger than 16 years of age due to lack of safety and efficacy data2,5,6. The hydrocodone single-entity product, Hysingla ER and generic hydrocodone extended release capsules are not FDA-approved in the pediatric population (less 18 years of age) as safety and efficacy in this age group have not been established2,8,9.

Analgesic hydrocodone dosages should be determined based on pain severity and patient response/ tolerance. Reduced hydrocodone dosages are indicated in very young patients2,5. Like adult patients, the maximum daily dosage for the acetaminophen/ hydrocodone combination is restricted by the maximum acetaminophen dose (as determined by age and weight – see Table 3) to limit the risk of hepatic damage and severe hypersensitivity reactions associated with acetaminophen use2,5.

Recommended pediatric hydrocodone dosages as combination therapy are summarized in Table 3. Dosages exceeding these recommendations will be reviewed.

Table 3. Recommended Pediatric Hydrocodone Dosages: Combination Therapy2,5,6
Drug/Indication    Usual Dosage RegimenMaximum Recommended Dose
Analgesic hydrocodone bitartrate/acetaminophen (APAP) (Lortab®, Norco®, generics)
  • 2-3 years of age (12 to 15 kg): 
    • 1.875 mg every 4-6 hours as needed
  • 4-6 years of age (16 to 22 kg):  
    • 2.5 mg every 4-6 hours as needed
  • 7-9 years of age (23 to 31 kg):
    • 3.75 mg every 4-6 hours as needed
  • 10-13 years of age (32 to 45 kg):      
    • 5 mg every 4-6 hours as needed
  • Greater than or equal to 14 years of age (greater than or equal to 46 kg): 
    • 7.5 mg every 4-6 hours as needed
  • 750 mg daily (APAP+)*
  • 1 g daily (APAP)*
  • 1.5 g daily (APAP)*
  • 2 g daily (APAP)*
  • 3 g daily (APAP)*
Analgesic hydrocodone bitartrate/ibuprofen (Vicoprofen®, Ibudone®, Reprexain®, generics)16 years and older: 2.5-10 mg/200 mg every 4-6 hours as needed5 tablets daily**

Legend:

  • +APAP = acetaminophen
  • *dosage limit based on maximum acetaminophen daily dose
  • **short-term use (less than 10 days) recommended