HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS.
TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN tablets, for oral use, CIV
Initial U.S. Approval – 2001
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE­-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; HEPATOTOXICITY; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
Tramadol hydrochloride and acetaminophen exposes users to the risks of addiction, abuse and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing tramadol hydrochloride and acetaminophen, and monitor regularly for these behaviors or conditions. (5.1)
Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially during initiation or following a dose increase. (5.2)
Accidental ingestion of tramadol hydrochloride and acetaminophen, especially by children, can result in a fatal overdose of tramadol. (5.2)
Prolonged use of tramadol hydrochloride and acetaminophen, during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. (5.3)
The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol are complex. Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol hydrochloride and acetaminophen requires careful consideration of the effects on the parent drug, tramadol, and the active metabolite, M1. (5.4, 7)
Tramadol hydrochloride and acetaminophen tablets contain acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen containing product. (5.5)
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. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. (5.6, 7)
RECENT MAJOR CHANGES
Boxed Warning