Intended for U.S. healthcare professionals only.
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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 receiving, 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, and misuse 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.
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Addiction, Abuse, and Misuse
EXALGO exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing EXALGO, and monitor all patients regularly for the development of these behaviors and conditions.
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of EXALGO. Monitor for respiratory depression, especially during initiation of EXALGO or following a dose increase. Instruct patients to swallow EXALGO tablets whole; crushing, chewing, or dissolving EXALGO tablets can cause rapid release and absorption of a potentially fatal dose of hydromorphone.
Accidental ingestion of even one dose of EXALGO, especially by children, can result in a fatal overdose of hydromorphone.
Neonatal Opioid Withdrawal Syndrome
Prolonged use of EXALGO during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
EXALGO is contraindicated in:
The most common adverse reactions (>10%) are constipation, nausea, vomiting, somnolence, headache, and dizziness. The most common treatment-related serious adverse reactions from controlled and uncontrolled chronic pain studies were drug withdrawal syndrome, overdose, confusional state, and constipation. The overall incidence of adverse reactions was higher in patients greater than 65 years of age and in female patients.
This is not a complete list of potential adverse events associated with EXALGO. Please see Full Prescribing Information for a complete list.
|Description||Dark yellow tablet|
|Generic Name||Hydromorphone HCl extended-release tablets, CII|
|Dosage Strength||12 mg|
|Identification Code||dark yellow, round tablet printed with “EXH 12” on one side|
|NDC #||Package Size||Case Quantity|
For additional information on EXALGO® (hydromorphone HCl) extended-release tablets, CII 12 mg, call Customer Service at 1.800.325.8888 or Medical Information at 1.800.778.7898.
Revised September 2018