CYP450 3A4 INTERACTION: The concomitant use with all CYP450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations which could cause potentially fatal respiratory depression.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. NEONATAL OPIOID WITHDRAWAL SYNDROME: Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated treatment requires management according to protocols developed by neonatology experts. ACCIDENTAL INGESTION of even one dose, especially by children, can result in a fatal overdose of hydrocodone.Monitor for respiratory depression, especially during initiation of therapy or following a dose increase. LIFE-THREATENING RESPIRATORY DEPRESSION: Serious, life-threatening, or fatal respiratory depression may occur with use.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 pharmacist, and consider other tools to improve patient, household, and community safety. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. RISK EVALUATION AND MITIGATION STRATEGY (REMS): To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, a REMS is required for these products. Assess each patient's risk prior to prescribing this drug and monitor all patients regularly for the development of these behaviors or conditions.
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