EXTEND EXPECTATIONS:
What to Expect From Zohydro® ER

  1. It may take a few days for Zohydro® ER to reach your pharmacy.

  • Zohydro® ER (hydrocodone bitartrate) Extended-Release Capsules, CII, 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 doctor may continue your current medication until Zohydro ER is received
  • Before you start taking Zohydro ER, you will need to stop taking any other around-the-clock opioids you may be taking
  • You can call 1-844-676-9663, Monday through Friday, 8 am to 9 pm EST, to find a nearby pharmacy that carries Zohydro ER. This service will call you back with a pharmacy that will fill your prescription
  1. It can take a few days to feel pain control once you start Zohydro® ER.

  • If you do not feel an effect right away, it does not necessarily mean that the medication isn't working. It may take a few days for your body to adjust
  • Take your prescribed dose every 12 hours, at the same time every day. Do not take more than your prescribed dose in 12 hours. If you miss a dose, take your next dose at your usual time
  • Your doctor may prescribe a short-acting pain medicine to take if you experience breakthrough pain or while you are adjusting to Zohydro ER
  • Stop taking any other around-the-clock opioid drugs when you start taking Zohydro ER
  1. What if I experience side effects?

  • Sometimes side effects can go away once your body adjusts. But other times, your healthcare provider may need to change your dose. That is why it is important to tell your healthcare provider about any and all side effects you experience
  • Possible side effects of Zohydro ER are constipation, nausea, sleepiness, tiredness, headache, dizziness, dry mouth, vomiting, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe
  • Never stop taking Zohydro ER without talking to your healthcare provider first. It can lead to withdrawal

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.

Side Effects

Everyone's body processes medication in a slightly different way, so it is important to talk to your doctor if you experience side effects. The most common side effects of Zohydro ER are:
  • Constipation
  • Nausea
  • Drowsiness/sleepiness
  • Tiredness
  • Headache
  • Dizziness
  • Dry mouth
  • Vomiting
  • Abdominal pain

Like other opioid medications, Zohydro ER carries a risk of more severe side effects, though they happen very rarely. Tell your family or caregiver to watch for the following side effects and get emergency medical help if:

  • You have trouble breathing
  • You feel extremely drowsy and your breathing slows down
  • You have very little chest movement with each breath
  • You feel faint, dizzy, or lightheaded
  • You have swelling of face, tongue, or throat
  • You have any other unusual symptoms

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.

Will side effects go away?

Sometimes side effects can go away once your body adjusts to the new medication. But other times, your health care provider may need to change your dose. That is why it is important to tell him or her about any and all side effects you experience. He or she can decide how best to move forward with treatment.

Should I stop taking Zohydro® ER because of side effects?

No, you should not stop taking Zohydro ER without talking to your health care provider first, as you may need to gradually reduce the amount of medication you are taking to avoid any other complications, including withdrawal symptoms.

Know the Difference: Drug Abuse, Physical Dependence, Tolerance, and Addiction

You may be anxious about taking opioid medications because you are nervous about becoming addicted or because you worry that others may think you abuse drugs. This fear may keep you from taking the medication the way you are supposed to, which may result in it being less effective than it should be. It is important to know that there is a difference between abuse, dependence, tolerance, and addiction.

  • Abuse is when someone uses a medication for a reason other than why it is prescribed
  • Physical dependence is when the body may start to rely on a medication after someone has used it for a period of time. They can have "withdrawal" symptoms if they quickly reduce the amount they are taking, or if they stop taking the medication altogether. Withdrawal can be dangerous if not managed properly
  • Tolerance describes when the body gets used to a medication over time. This is normal, but it means that the medication may not work as well after a while, and someone may be a candidate for a different medication or a way to treat their pain
  • Addiction is when someone feels an overwhelming urge to use a medication and cannot control how often or how much of it they use, even if it has a bad effect on their life or health


INDICATION

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

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
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.

CONTRAINDICATIONS

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

ADVERSE REACTIONS

DRUG INTERACTIONS

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.

IMPORTANT SAFETY INFORMATION AND INDICATION

INDICATION

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.

CONTRAINDICATIONS

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 may increase opioid effects.

ADVERSE REACTIONS

  • 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.

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
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.

DRUG INTERACTIONS

  • 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.