Abuse and dependence

SEGLENTIS contains tramadol, a Schedule IV controlled substance with high potential for abuse similar to other opioids, and it can be abused and is subject to misuse, addiction, and criminal diversion. The use of opioid analgesics carries the risk of addiction or abuse even under appropriate medical circumstances. Prescription drug abuse is the intentional use of medication for its physiological or psychological effect. Patients treated with opioids require careful monitoring for signs of addiction and abuse.1

Physical dependence differs from abuse and addiction. Dependence is a physiological state in which the body becomes accustomed to regular exposure of opioids, and an abrupt discontinuation results in withdrawal symptoms.1

Signs of drug-seeking behavior, such as making calls or visits toward the end of office hours, repeated loss of prescriptions, reluctance to provide medical records or information, or doctor shopping, should be closely monitored. All patients should receive thorough assessment, proper prescribing and dispensing of their treatment, guidance on appropriate storing practices, and periodic re-evaluation of therapy to help limit the abuse of SEGLENTIS.1

Because opioids like SEGLENTIS can lead to physical dependence or addiction, withdrawal syndrome may occur if the treatment is abruptly discontinued.1

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  1. SEGLENTIS [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; October 2021.