INDICATIONS AND USAGE
EXALGO (hydromorphone HCI) Extended-Release Tablets (CII) is indicated for the management of pain in opioid-tolerant patients severe enough to require daily, around-the clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Patients considered opioid tolerant are those who are taking for one week or longer at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day or an equianalgesic dose of another opioid.
Because of the risks of addiction, abuse, misuse, overdose, and death with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve EXALGO 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. EXALGO is not indicated as an as-needed (prn) analgesic.