HOW TO FIND ZOHYDRO® ER IN A LOCAL PHARMACY
Call toll free 1-844-676-96631-844-676-9663
Monday - Friday, 8 am - 9 pm EST
A friendly Pharmacy Locator Specialist will determine which local pharmacies have Zohydro® ER (hydrocodone bitartrate) Extended-Release Capsules, CII,
in stock and call you back
What you should know before your pharmacy visit
- Zohydro ER is a controlled substance. Like many medications of this type, it may take up to 2 or 3 days for your pharmacy to receive Zohydro ER after it is ordered. Your health care provider may continue your current medication until Zohydro ER is received
You may feel isolated or frustrated because of your severe chronic pain. But did you know there are thousands of people who are dealing with the same challenges that you are? Reading stories from others in similar situations, and getting educated about what to expect as you manage your condition, may help you live successfully with chronic pain.
Visit the following websites for chronic pain support and educational resources:
- American Chronic Pain Association (ACPA): Supports and educates people living with chronic pain, as well as their families, so that they may live more fulfilling lives in spite of their pain.
- LOCKMED: Offers a variety of safes and storage containers to protect your medications.
- Lock Your Meds®: Helps you understand how important it is to take responsibility for keeping your medication safe.
- PainACTION.com: Designed especially for people living with pain, with helpful tools and resources.
- PainPathways Magazine: Provides information and inspiration to people living with pain.
Practical Pain Management: A trusted source for information for patients about chronic pain conditions and pain management treatments.
Project Lazarus: A secular, non-profit organization that provides technical assistance to empower communities and individuals to prevent drug overdoses and meet the needs of those living with chronic pain.
Safer Lock™: Sells locking bottles and caps, designed to keep your medication safe.
- US Pain Foundation (USPF): Provides support and advocacy with the goal of helping to educate, empower, and inspire people living with pain.
Lock Your Meds® is a registered trademark of National Family Partnership.
Safer Lock™ is a trademark of Cap-N-Lock LLC.
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.
IMPORTANT SAFETY INFORMATION
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION;
ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTION WITH ALCOHOL; and
CYTOCHROME P450 3A4 INTERACTION
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 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.
Please read full Prescribing Information for the full boxed warning, complete safety information, and medication guide.
Available by prescription only.
ZOHYDRO® ER with BeadTekTM is manufactured for Pernix Ireland Pain Limited and distributed by Pernix Therapeutics, LLC., Morristown, NJ 07960. US Patent Nos.: US 6,228,398 and US 6,902,742.
ZOHYDRO® ER is a registered trademark of Pernix Ireland Pain Limited. BeadTekTM is a trademark used by Pernix Ireland Pain Limited under license.