Prior to 2018, Hydrocodone was not FDA-approved for use as an antitussive in pediatric patients younger than 6 years of age as safety and efficacy have not been established. 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 data.2-5 The hydrocodone single-entity products, Zohydro® ER and Hysingla® ER are not FDA-approved in the pediatric population (less than 18 years of age) as safety and efficacy in this age group have not been established ^.2,3,8,9.

Analgesic hydrocodone dosages should be determined based on pain severity and patient response/ tolerance. In individuals with severe pain or those who have become tolerant to the analgesic effects of hydrocodone, it may be necessary to exceed the usual dosage. Reduced hydrocodone dosages are indicated in very young patients. 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 use ^2-10.

Recommended pediatric hydrocodone dosages as combination therapy are summarized in Table 3^2-5 . Dosages exceeding these recommendations will be reviewed.