Considerations for prescribing Hysingla ER

Hysingla ER should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain


Hysingla® ER (hydrocodone bitartrate) is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Limitations of Use

  • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Hysingla ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
  • Hysingla ER is not indicated as an as-needed (prn) analgesic.

Opioids should be prescribed only if expected benefits outweigh risks—and in combination with non-pharmacologic and non-opioid therapy, as appropriate1

When starting opioid therapy for chronic pain, consider an immediate-release (IR) opioid first before prescribing an extended-release (ER) opioid.

PRIOR to initiating therapy with opioids, and periodically during therapy1
  • Work with your patient to set realistic treatment goals, including a plan to discontinue opioid treatment if benefits do not outweigh risks
  • Educate your patient about the realistic benefits and known risks of opioid therapy
  • Discuss patient and clinician responsibilities for managing opioid treatment
  • Evaluate risk factors for opioid-related harms—such as history of overdose, substance use disorder, high opioid dosages, or concurrent benzodiazepine use—and incorporate risk mitigation strategies
  • Review state PDMP data to see if your patient is receiving opioid dosages or dangerous combinations that pose high risk for overdose
  • Consider drug testing* to assess for prescribed opioid medications, other controlled prescription drugs, and illicit drugs
  • Plan to evaluate benefits and harms with your patient within 1 to 4 weeks of starting therapy or dose escalation, and continually thereafter (every 3 months or more frequently)
  • Avoid prescribing opioid pain medications and benzodiazepines concurrently whenever possible
During Hysingla ER therapy, use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals

*Not every urine drug test reliably detects synthetic or semisynthetic opioids, such as hydrocodone, especially those designed for in-office use, and many laboratories will report urine drug concentrations below a specified "cut-off" as "negative." Therefore, ensure that the assay's sensitivity and specificity are appropriate, and consider the urine drug test's limitations when interpreting results.2-4

PDMP = prescription drug monitoring program.

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