WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; and NEONATAL WITHDRAWAL SYNDROME
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 or 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 in 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.