Rybix ODT (Oral)

Addiction, Abuse, and Misuse:TraMADol hydrochloride 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 traMADol hydrochloride, and monitor all patients regularly for the development of these behaviors or conditions .Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to: complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacists, and consider other tools to improve patient, household, and community safety .Life-Threatening Respiratory Depression:Serious, life-threatening, or fatal respiratory depression may occur with use of traMADol hydrochloride. Monitor for respiratory depression, especially during initiation of traMADol hydrochloride or following a dose increase . Instruct patients to swallow traMADol hydrochloride extended release formulations intact, and not to cut, break, chew, crush, or dissolve the tablets to avoid exposure to a potentially fatal dose of traMADol .Accidental Ingestion:Accidental ingestion of even one dose of traMADol hydrochloride, especially by children, can result in a fatal overdose of traMADol .Ultra-Rapid Metabolism of TraMADol and Other Risk Factors for Life-Threatening Respiratory Depression in Children:Life-threatening respiratory depression and death have occurred in children who received traMADol. Most of the reported cases occurred following tonsillectomy and/or adenoidectomy, and many of the children had evidence of being an ultra-rapid metabolizer of traMADol due to a CYP2D6 polymorphism. TraMADol hydrochloride tablets are contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of traMADol hydrochloride tablets in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of traMADol .Neonatal Opioid Withdrawal Syndrome:Prolonged use of traMADol hydrochloride 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 .Interaction..