The only once-a-day hydrocodone with FDA-approved abuse-deterrent properties (ADP)1
Hysingla ER has FDA-approved labeling that describes abuse-deterrent properties based on the results from Category 1 and 3 studies
Formulated with properties intended to:
Make the tablet more difficult to misuse and abuse
Maintain some extended-release characteristics if physically compromised
The in vitro data demonstrate that Hysingla ER has physical and chemical properties that are expected to deter intranasal and intravenous abuse
The data from the clinical abuse potential studies, along with support from the in vitro data, also indicate that Hysingla ER has physicochemical properties that are expected to reduce intranasal abuse and oral abuse when chewed
Abuse-deterrent properties do not prevent or reduce the risk of addiction2
Abuse of Hysingla ER by the intravenous, intranasal, and oral routes is still possible
All patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use
With parenteral abuse, the inactive ingredients in Hysingla ER can result in local tissue necrosis, infection, pulmonary granulomas, increased risk of endocarditis and valvular heart injury, embolism, and death. Parenteral drug abuse is commonly associated with transmission of infectious diseases, such as hepatitis and HIV
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