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Zohydro® ER (hydrocodone bitartrate) is an extended-release opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.LIMITATIONS OF USE
- Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Zohydro ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
- Zohydro ER is not indicated as an as-needed (prn) analgesic.
WARNING: ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTION WITH ALCOHOL; and CYTOCHROME P450 3A4 INTERACTIONAddiction, Abuse, and Misuse
Zohydro 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 Zohydro ER and monitor all patients regularly for the development of these behaviors or conditions.Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of Zohydro ER. Monitor for respiratory depression, especially during initiation of Zohydro ER or following a dose increase. Instruct patients to swallow Zohydro ER capsules whole; crushing, chewing, or dissolving Zohydro ER capsules can cause rapid release and absorption of a potentially fatal dose of hydrocodone.Accidental Ingestion
Accidental ingestion of even one dose of Zohydro ER, especially by children, can result in a fatal overdose of hydrocodone.Neonatal Opioid Withdrawal Syndrome
Prolonged use of Zohydro ER 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 with Alcohol
Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking Zohydro ER. The co-ingestion of alcohol with Zohydro ER may result in increased plasma levels and a potentially fatal overdose of hydrocodone.Cytochrome P450 3A4 Interaction
The concomitant use of Zohydro ER with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Monitor patients receiving Zohydro ER and any CYP3A4 inhibitor or inducer.
Zohydro ER is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma, known or suspected paralytic ileus, or hypersensitivity to hydrocodone bitartrate.WARNINGS AND PRECAUTIONS
See Boxed WARNINGS
- Interactions with CNS Depressants: Concomitant use may cause profound sedation, respiratory depression, and death. If coadministration is required, consider dose reduction of one or both drugs.
- Elderly, Cachectic, Debilitated Patients, and Those with Chronic Pulmonary Disease: Monitor closely because of increased risk for life-threatening respiratory depression.
- Hypotensive Effects: Monitor during dose initiation and titration.
- Patients with Head Injury or Increased Intracranial Pressure: Monitor for sedation and respiratory depression. Avoid use of Zohydro ER in patients with impaired consciousness or coma susceptible to intracranial effects of CO2 retention.
- Concomitant use of CYP3A4 inhibitors may increase opioid effects.
- Potential serious adverse events caused by opioids include addiction, abuse, and misuse; life-threatening respiratory depression; neonatal opioid withdrawal syndrome; interactions with other CNS depressants; hypotensive effects; gastrointestinal conditions; and seizures.
- Adverse reactions in ≥2% of patients in placebo-controlled trials include constipation, nausea, somnolence, fatigue, headache, dizziness, dry mouth, vomiting, pruritus, abdominal pain, peripheral edema, upper respiratory tract infection, muscle spasms, urinary tract infection, back pain, and tremor.
- With intravenous abuse, the inactive ingredients in Zohydro ER can result in death, local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart injury. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.
- Mixed Agonists/Antagonists and Partial Agonist Analgesics: Avoid use with Zohydro ER because they may reduce analgesic effect of Zohydro ER or precipitate withdrawal symptoms.
- The use of MAO inhibitors or tricyclic antidepressants with Zohydro ER may increase the effect of either the antidepressant or Zohydro ER.
You are encouraged to report negative side effects of prescription drugs to the FDA.Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.