Generic Name: hydrocodone bitartrate extended-release capsules
Date of Approval: October 25, 2013
Company: Zogenix, Inc.
Treatment for: Chronic Pain
FDA Approves Zohydro ER
The U.S. Food and Drug Administration has approved Zohydro ER (hydrocodone bitartrate extended-release capsules) for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate.
Zohydro ER, a Schedule II controlled substance under the Controlled Substances Act, is the first FDA-approved single-entity (not combined with an analgesic such as acetaminophen) and extended-release hydrocodone product.
Zohydro ER is in the class of extended-release/long-acting (ER/LA) opioid analgesics. Due to the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with ER/LA opioid formulations, Zohydro ER should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. It is not approved for as-needed pain relief.
Zohydro ER Medication Guide
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.
- Not for use to treat pain that is not around-the-clock.
- Get emergency help right away if you take too much Zohydro ER (overdose). This medicine can cause breathing problems that can lead to death, even if you take your dose as prescribed.
- Never give anyone else your Zohydro ER. They could die from taking it. Store this medicine away from children and in a safe place to prevent stealing or abuse.
- Selling or giving away Zohydro ER is against the law.
Who should not take Zohydro ER?
Do not take Zohydro ER if you have:
- severe asthma, trouble breathing, or other lung problems.
- a bowel blockage or have narrowing of the stomach or intestines.
Before taking Zohydro ER, tell your healthcare 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.
Tell your healthcare provider if you are:
- pregnant or planning to become pregnant. Zohydro ER may harm your unborn baby. Long-term (chronic) use during pregnancy can cause life-threatening withdrawal symptoms in your newborn baby.
- breastfeeding. Zohydro ER passes into breast milk and 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.
How do I take Zohydro ER?
When taking Zohydro ER:
- Do not change your dose. Take exactly as prescribed by your healthcare provider.
- 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 the next day.
- Swallow capsules whole. Do not cut, break, chew, crush, or dissolve Zohydro ER because this may cause you to overdose and die. Call your healthcare provider if the dose you are taking does not control your pain.
- Do not stop taking this medicine without talking to your healthcare provider.
- After you stop taking Zohydro ER, flush any unused capsules down the toilet.
While taking Zohydro ER Do Not:
- Drive or operate heavy machinery, until you know how Zohydro ER affects you. This medicine can make you sleepy, dizzy, or lightheaded.
- Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with Zohydro ER may cause you to overdose and die.
Zohydro ER side effects
The possible side effects of Zohydro ER are:
- constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.
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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)