Robidone (Oral)

Prior to prescribing hydrocodone, assess each patient's risk for opioid addiction, abuse, and misuse, and regularly monitor all patients for opioid addiction behaviors or conditions. 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 Risk Evaluation and Mitigation Strategy (REMS) for these products. Monitor for respiratory depression, which can be serious, life-threatening, or fatal, especially during initiation or following a dose increase. Instruct patients to swallow extended release forms whole to avoid potentially fatal overdose. Accidental ingestion of hydrocodone can result in a fatal overdose, especially in children. If prolonged opioid use is necessary during pregnancy, advise patient of potential risk of life-threatening neonatal opioid withdrawal syndrome and ensure appropriate treatment will be available. Use with CYP3A4 inhibitors or inducers may change hydrocodone plasma levels resulting in prolonged adverse effects or potentially fatal respiratory depression; monitoring is recommended. Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options, limit dosage and duration to the minimum required, and monitor for respiratory depression and sedation. Alcoholic beverages or medications containing alcohol should be avoided due to the potential for increased hydrocodone plasma levels and a potentially fatal overdose .

Addiction, Abuse, and MisuseHydrocodone extended-release (ER) 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 Hydrocodone ER, and