Important Things to Remember
In rare instances a person may experience a serious reaction, especially if Zohydro® ER (hydrocodone bitartrate) Extended-Release Capsules, CII, is not taken exactly as directed. Call your health care provider immediately or get emergency medical help if you:
- Take too much Zohydro ER (overdose)
- Have trouble breathing (Zohydro ER can cause breathing problems that can lead to death, even if you take your dose as prescribed)
- Feel extremely drowsy and your breathing has slowed
- Have very little chest movement with each breath
- Feel faint or dizzy
- Have swelling of face, tongue, or throat
- Have any other unusual symptoms
OTHER IMPORTANT FACTS:
- Zohydro® ER is a strong, long-acting (extended-release) prescription pain medicine that contains an opioid (narcotic). Taking Zohydro ER can cause opioid addiction, abuse, misuse, overdose and death, even if you take your dose correctly as prescribed. Because of this, Zohydro ER is used only to manage pain that is severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.
- Zohydro® ER should not be used to treat pain that is not around-the-clock.
- You should not drink alcohol or take over-the-counter products that contain alcohol (such as cough medicine) when taking Zohydro® ER. Alcohol can increase your risk of life-threatening respiratory depression. That means your breathing can become so slow it stops.
- You must always swallow Zohydro® ER capsules whole and must not cut, break, chew, crush, dissolve, snort, or inject Zohydro® ER. Taking cut, broken, chewed, crushed, or dissolved Zohydro ER capsules or their contents can cause your body to absorb too much hydrocodone, which can lead to death. 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.
- Your prescribed dose of Zohydro® ER should be taken once every 12 hours, at the same time every day. Do not change your dose. Take Zohydro ER exactly as prescribed by your health care provider. Do not take more than your prescribed dose in 12 hours. If you miss a dose, wait to take your next dose at your usual time and skip the missed dose. If you still have periods of pain, call your health care provider. Do not take extra doses of Zohydro® ER.
- Do not drive or operate dangerous machinery while taking Zohydro® ER until you are familiar with how it affects you. Zohydro ER can make you sleepy, dizzy, or lightheaded.
- Never give anyone else your Zohydro® ER. They could die from taking it. Store Zohydro ER away from children and in a safe place to prevent stealing or abuse. Selling or giving away Zohydro ER is against the law.
- Do not take Zohydro® ER if you have: severe asthma, trouble breathing, or other lung problems; or a bowel blockage or narrowing of the stomach or intestines.
TELL YOUR HEALTH CARE PROVIDER IF YOU ARE:
- Pregnant or planning to become pregnant. Prolonged use of Zohydro ER during pregnancy can cause
withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
- Breastfeeding. Not recommended; may harm your baby.
- Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Zohydro ER with certain other medicines can cause serious side effects that could lead to death.
BEFORE TAKING ZOHYDRO® ER, TELL YOUR HEALTH CARE PROVIDER IF YOU HAVE A HISTORY OF:
- Head injury, seizures
- Liver, kidney, thyroid problems
- Problems urinating
- Pancreas or gallbladder problems
- Abuse of street or prescription drugs, alcohol addiction, or mental health problems
THE POSSIBLE SIDE EFFECTS OF ZOHYDRO® ER ARE:
- Dry mouth
- Abdominal pain
Call your health care provider if you have any of these symptoms and they are severe.
These are not all the possible side effects of Zohydro ER. For a complete list, ask your health care provider or read Section 6 of the full Prescribing Information.
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.