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39 million people in the United States have chronic pain1

Patients with chronic pain may need more than short-term solutions

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Zohydro® ER (hydrocodone bitartrate) Extended-Release Capsules, CII, with BeadTek™ is the
hydrocodone you know in an ER formulation that delivers true 12-hour pain control, from start to finish.2

Immediate-Release (IR) Hydrocodone in Combination With Acetaminophen is the Most Prescribed Opioid Formulation for Pain*

More than 100 million
prescriptions annually*

39 million people
in the United States have chronic pain1

*IMS Health, National Prescription Audit, January 2015.

FOR SOME PATIENTS WITH CHRONIC PAIN, IR OPIOID THERAPY HAS LIMITATIONS

  • Peaks and troughs in plasma levels lead to inconsistent efficacy3
  • Concerns about “clock-watching” between doses4
  • Dosing 4 to 6 times a day may not fit work and sleep schedules5
  • Some dosing regimens may exceed the recommended daily intake limit of acetaminophen (3000 mg to 4000 mg per day depending on patient health)6
  • Excessive pill burden for patients and health care professionals6

do you have patients with pain severe enough to need around-the-clock pain control?

Zohydro® ER is not indicated for acute pain, nor as an as-needed (prn) analgesic. Zohydro® ER does not provide immediate pain control.

TO START YOUR PATIENTS ON ZOHYDRO® ER WITH BEADTEK™

START FAST, FINISH STRONG

The flexibility of 6 dosage strengths7

ZOHYDRO® ER (hydrocodone bitartrate) Extended-Release Capsules, CII, with beadtek™ provides the flexibility to7:

  • Reduce pill burden for patients taking IR hydrocodone around the clock
  • Prescribe therapeutic doses without concern for acetaminophen dose ceilings
  • Provide low doses for patients who are new to ER opioid therapy
  • Titrate to a dose that provides adequate pain management and minimizes adverse events, preferably at increments of 10 mg every 12 hours every 3 to 7 days
capsules capsules

Capsules are not shown at actual size.

1:1 conversion ratio when transitioning from IR hydrocodone7

EXAMPLE OF A CONVERSION FACTOR to Zohydro® ER with BeadTek™ (not equianalgesic doses)7

Example of a Conversion Factor Example of a Conversion Factor

Vicodin®, Vicodin ES®, and Vicodin HP® are registered trademarks of AbbVie Inc.

This table cannot be used to convert from Zohydro® ER with BeadTek™ to IR hydrocodone.

For breakthrough pain, patients may require a dose increase of Zohydro® ER with BeadTek™ or a rescue medication with an appropriate dose of an IR analgesic.7

Discontinue all other around-the-clock opioid drugs when Zohydro® ER with BeadTek™ therapy is initiated. Instruct patients to never take a dose of Zohydro® ER with BeadTek™ beyond what is prescribed. Zohydro® ER with BeadTek™ is NOT indicated as an as-needed (prn) analgesic.7

Titration7

Zohydro® ER with beadtek™ is taken once every 12 hours

explain starting twice-daily explain starting twice-daily

Titrate Zohydro ER with BeadTek™ to a dose that provides adequate pain management and minimizes adverse events, preferably by increments of 10 mg every 12 hours every 3 to 7 days

Monitor closely to maintain pain control, assess adverse events, and identify any signs of addiction, abuse, or misuse

Maintenance7

Periodically reassess the continued need for opioid analgesics.

After starting Zohydro ER with BeadTek™, patients may require an explanation that it may take a few days for the body to adjust and experience pain control.

Monitor patients and ask if they are still experiencing uncontrolled pain, or have unacceptable side effects.

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Periodically reassess the continued need for opioid analgesics

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After starting Zohydro ER with BeadTek™, you should explain to patients that it may take a few days for the body to adjust and experience pain control

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Monitor patients and ask if they are still experiencing uncontrolled pain, or have unacceptable side effects

Patients STILL EXPERIENCING UNCONTROLLED PAIN MAY REQUIRE:

  • A dose increase of Zohydro® ER with BeadTek™

If the level of pain increases after dose stabilization, attempt to identify the source of increased pain while adjusting the Zohydro ER with BeadTek™ dose

OR

  • A rescue medication with an appropriate dose of an IR analgesic

Zohydro® ER with BeadTek™ is NOT indicated as an as-needed (prn) analgesic

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

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.

Rx Only.
DEA order form required.

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.