Now approved for chronic pain -- The first and only extended-release hydrocodone -- Now you can help your chronic pain patients find their zone of control.
and learn more about proper use of your pain medication.
Zohydro™ ER is an extended-release, opioid agonist, oral formulation of hydrocodone bitartrate 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 for use as an as-needed analgesic.
IMPORTANT SAFETY INFORMATION
WARNING: ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION;
ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME and INTERACTION WITH ALCOHOL
Addiction, 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 consumption of even one dose of Zohydro ER, especially by children, can result in a fatal overdose of hydrocodone.
Neonatal Opioid Withdrawal Syndrome
For patients who require opioid therapy while pregnant, be aware that infants may require treatment for neonatal opioid withdrawal syndrome. Prolonged maternal use of Zohydro ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening and requires management according to protocols developed by neonatology experts.
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.
Zohydro ER is contraindicated in patients with: significant respiratory depression; acute or severe bronchial asthma or hypercarbia; known or suspected paralytic ileus; and hypersensitivity to hydrocodone bitartrate or any other ingredients in Zohydro ER.
WARNINGS AND PRECAUTIONS
- Addiction, Abuse, and Misuse: Zohydro ER is an opioid agonist and a Schedule II controlled substance with a high potential for abuse similar to fentanyl, methadone, morphine, oxycodone, and oxymorphone. As modified-release products such as Zohydro ER deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of hydrocodone present.
- Life-Threatening Respiratory Depression: Serious, life-threatening respiratory depression has been reported with the use of modified-release opioids, even when used as recommended, and may lead to respiratory arrest and death if not immediately treated. The risk of respiratory depression is greatest during initiation of therapy or following a dose increase. Proper dosing and titration are essential.
- 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.
- Chronic Pulmonary Disease: Monitor patients with significant chronic obstructive pulmonary disease for respiratory depression as even the usual therapeutic doses of Zohydro ER may decrease respiratory drive to the point of apnea.
- 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.
- Hypotensive Effect: Zohydro ER may cause severe hypotension. There is an added risk to individuals whose ability to maintain blood pressure has been compromised. Avoid the use of Zohydro ER in patients with circulatory shock.
- Prolonged Gastric Obstruction: May occur in patients with gastrointestinal obstruction. Monitor patients with biliary tract disease, including acute pancreatitis.
- Cytochrome P450 CYP3A4 Inhibitors and Inducers: Concomitant use of CYP3A4 inhibitors may increase or prolong opioid effects. CYP3A4 inducers may decrease hydrocodone plasma concentrations.
- Impaired Mental/Physical Abilities: Caution must be used with potentially hazardous activities.
- Interaction with Mixed Agonist/Antagonist Opioid Analgesics: Avoid the use of mixed agonist/antagonist analgesics with full opioid agonist analgesics, including Zohydro ER.
- Potential serious adverse events caused by opioids include respiratory depression, potential for misuse and abuse, and CNS depressant effects.
- 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.
- The CYP3A4 isoenzyme plays a major role in the metabolism of Zohydro ER. Drugs that inhibit CYP3A4 activity may cause decreased clearance of hydrocodone which could lead to an increase in hydrocodone plasma concentrations.
- CNS Depressants: Increased risk of respiratory depression, hypotension, profound sedation, coma or death. When combined therapy with CNS depressant is contemplated, the dose of one or both agents should be reduced.
- Mixed Agonists/Antagonists: May precipitate withdrawal or decrease analgesic effect if given concurrently with Zohydro ER.
- 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.
Please read Full Prescribing Information for the full boxed warning, complete safety information, and medication guide.
Zohydro™ ER is a trademark of Zogenix, Inc.
Manufactured by Alkermes Gainesville LLC for Zogenix, Inc. (San Diego, CA) under license from Alkermes Pharma Ireland Limited (APIL), Ireland, using APIL's SODAS® technology. SODAS® is a registered trademark of Alkermes Pharma Ireland Limited. U.S. Patent Nos.: US 6,228,398 and US 6,902,742.
Other trademarks, registered or otherwise, are the property of their respective owners.