Ultracet Warnings

Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the risks of overdose and death with immediate release opioid formulations, ULTRACET (tramadol hydrochloride and paracetamol tablets) should only be used in patients for whom alternative treatment options (e.g., non-opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide appropriate management of pain (see Dosage & Administration).
Addiction, Abuse, and Misuse: ULTRACET poses risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Each patient's risk should be assessed prior to prescribing ULTRACET, and all patients should be monitored regularly for the development of these behaviours or conditions (see Precautions). ULTRACET should be stored securely to avoid theft or misuse.
Life-threatening Respiratory Depression - OVERDOSE: Serious, life-threatening, or fatal respiratory depression may occur with use of ULTRACET. Infants exposed in-utero or through breast milk are at risk of life-threatening respiratory depression upon delivery or when nursed. Patients should be monitored for respiratory depression, especially during initiation of ULTRACET or following a dose increase.
ULTRACET must be swallowed whole. Cutting, breaking, crushing, chewing or dissolving ULTRACET can lead to dangerous adverse events including death (see Precautions). Further, instruct patients of the hazards related to taking opioids including fatal overdose.
Accidental Exposure: Accidental ingestion of even one dose of ULTRACET, especially by children, can result in a fatal overdose of tramadol and paracetamol (see Disposal under Cautions for Usage, for instructions on proper disposal).
Neonatal Opioid Withdrawal Syndrome: Prolonged maternal use of ULTRACET during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening (see Precautions).
Interaction with Alcohol: The co-ingestion of alcohol with ULTRACET should be avoided as it may result in dangerous additive effects, causing serious injury or death (see Precautions and Interactions).
Hepatotoxicity: ULTRACET contains paracetamol. Paracetamol 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 paracetamol at doses that exceed the maximum daily limits, and often involve more than one paracetamol-containing product.
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 (see Neurologic under Precautions; Interactions).
Reserve concomitant prescribing of ULTRACET and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and sedation.