You Have Questions…We Have Answers
Once you have a prescription for Zohydro® ER (hydrocodone bitartrate) Extended-Release Capsules, CII, simply call
to find a nearby pharmacy that carries the medication. Pharmacy Locator Specialists are available Monday through Friday, 8 am - 9 pm EST.
You will receive a callback providing pharmacy information.
What you should know before your pharmacy visit
Zohydro ER is a controlled substance. Like many medications of this type, it may take 24-48 hours for your pharmacy to receive Zohydro ER after it is ordered. Your health care provider may continue your current treatment until you receive Zohydro ER.
Your health care provider has diagnosed you with chronic pain that is severe enough to require daily, around-the-clock, long-term pain management, and for which other treatments have not worked adequately. You may need a medication that does not include acetaminophen (also known as Tylenol®), which can be harmful to your liver if taken in large amounts. If you have had side effects from other pain medications, your health care provider may also recommend that you try Zohydro® ER (hydrocodone bitartrate) Extended-Release Capsules, CII, instead.
You should not notice any change in the efficacy or tolerability of the medication from the original formulation. The capsule colors and doses are the same; the capsule sizes are different between the formulations.
Zohydro ER with BeadTek has been reformulated with an additional inactive ingredient. If it is injected, it can cause serious adverse events, including death.
Are the dosing instructions different for Zohydro ER with BeadTekTM?
The dosing instructions of Zoydro ER have not changed. When taken as directed, Zohydro ER with BeadTek provides true 12-hour pain control.
Does Zohydro® ER with BeadTekTM cost more?
There is no increase in cost due to reformulation and Zohydro ER with BeadTek is covered by most insurance plans. You may be eligible for copay assistance. Click here to learn more.
Hydrocodone bitartrate is the active ingredient in Zohydro® ER and has been proven effective and generally well tolerated when taken properly and exactly as prescribed. Hydrocodone bitartrate is found in other medications like Vicodin, but unlike Vicodin, Zohydro ER is designed to work for 12 hours instead of 4-6 hours. Also, Zohydro ER, unlike Vicodin, does not include acetaminophen (also known as Tylenol®), which can be bad for your liver if you take too much of it over too long a period of time.
The only active ingredient in Zohydro® ER is hydrocodone bitartrate. Zohydro ER is the only 12-hour version of this pain medication available today without acetaminophen. Other long-acting opioids have different dosing schedules, different doses, or different ingredients, such as oxycodone or hydromorphone.
This is important because different medications can cause negative reactions when taken together and/or can potentially decrease the effectiveness of your medications or supplements.
Everyone's body processes medication in a slightly different way, so it is important to talk to your health care provider if you experience side effects. Never stop taking Zohydro ER without talking to your health care provider first, as this can lead to additional unpleasant symptoms and withdrawal. The most commonly reported side effects of Zohydro ER are:
- Dry mouth
- Abdominal pain
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. Get emergency medical help if you have: trouble breathing; shortness of breath; fast heartbeat; chest pain; swelling of your face, tongue, or throat; extreme drowsiness; or you are feeling faint.
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.
Any unused medication should be immediately disposed of by following your state's guidelines or regulations. This may include flushing unused medication down the toilet.
Many law enforcement agencies (such as police stations) have secure and anonymous places where you can drop off unused medications.
It's also important to scratch or peel off any personal information before you throw away your empty medicine bottles.
Lortab® is a registered trademark of UCB S.A., Belgium.
Tylenol® is a registered trademark of McNEIL-PPC, Inc.
Vicodin® is a registered trademark of AbbVie Inc.
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.