Zohydro ER (hydrocodone) is an opioid pain medication. An opioid is sometimes called a narcotic.
Zohydro ER is an extended-release form of hydrocodone that is used for around-the-clock treatment of severe pain. Extended-release hydrocodone is not for use on an as-needed basis for pain.
Zohydro ER may also be used for purposes not listed in this medication guide.
Important information
Zohydro ER can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Do not crush, break, or open an extended-release capsule. Swallow the capsule whole to avoid exposure to a potentially fatal dose. Hydrocodone may be habit-forming, even at regular doses. Never share Zohydro ER with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.
MISUSE OF NARCOTIC MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.
You should not use Zohydro ER if you have severe asthma or breathing problems, or a blockage in your stomach or intestines.
Tell your doctor if you are pregnant. Hydrocodone may cause life-threatening withdrawal symptoms in a newborn.
Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with hydrocodone.
Before taking this medicine
You should not use Zohydro ER if you are allergic to hydrocodone, or if you have:
Zohydro ER may be habit forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away Zohydro ER is against the law.
To make sure Zohydro ER is safe for you, tell your doctor if you have:
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any type of breathing problem or lung disease;
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a history of head injury, brain tumor, or seizures;
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a history of drug abuse, alcohol addiction, or mental illness;
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urination problems;
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liver or kidney disease;
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a heart rhythm disorder called long QT syndrome;
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a blockage in your stomach or intestines; or
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problems with your gallbladder, pancreas, or thyroid.
It is not known whether Zohydro ER will harm an unborn baby. If you use hydrocodone while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.
Hydrocodone can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using Zohydro ER.
How should I take Zohydro ER?
Take Zohydro ER exactly as prescribed by your doctor. Hydrocodone may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away Zohydro ER is against the law.
Follow all directions on your prescription label. Hydrocodone can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never use Zohydro ER in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.
Your dose needs may be different if you have recently used a similar opioid (narcotic) pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.
Do not crush, break, or open an extended-release capsule. Swallow it whole to avoid exposure to a potentially fatal dose.
Do not stop using Zohydro ER suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using this medicine.
Never crush or break a Zohydro ER capsule to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death with the misuse of hydrocodone and similar prescription drugs.
Store at room temperature, away from heat, moisture, and light. Keep the medication in a place where others cannot get to it.
Keep track of the amount of medicine used from each new bottle. Hydrocodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
Do not keep leftover Zohydro ER capsules. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush any unused capsules down the toilet. Disposal of medicines by flushing is recommended to reduce the danger of accidental overdose causing death. This advice applies to a very small number of medicines only. The FDA, working with the manufacturer, has determined this method to be the most appropriate route of disposal and presents the least risk to human safety.
Zohydro ER Dosing Information
Usual Adult Dose for Pain:
Zohydro ER should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
Initial dose: 10 mg orally every 12 hours
Titration: The dose should be increased in increments of 10 mg orally every 12 hours every 3 to 7 days as needed to achieve adequate analgesia. Zohydro ER should be titrated to a dose that provides adequate analgesia and minimizes adverse reactions. Patients should be monitored routinely to assess the maintenance of pain control and incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse. Patients who experience breakthrough pain may require a dose increase, or may need a rescue medication with an appropriate dose of an immediate-release analgesic.
-If unacceptable adverse reactions are observed, the dose may be reduced. The dose should be adjusted to obtain an appropriate balance between management of pain and adverse reactions.
Maximum dose: A single dose of Zohydro ER greater than 40 or 50 mg, or a total daily dose greater than 80 mg are only for patients in whom tolerance to an opioid of comparable potency is established.
Approved indication: 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
What happens if I miss a dose?
Since Zohydro ER is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A hydrocodone overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.
What should I avoid while taking Zohydro ER?
Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with hydrocodone. Check your food and medicine labels to be sure these products do not contain alcohol.
This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how hydrocodone will affect you. Dizziness or severe drowsiness can cause falls or other accidents.
Zohydro ER side effects
Get emergency medical help if you have any signs of an allergic reaction to Zohydro ER: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using Zohydro ER and call your doctor at once if you have:
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weak or shallow breathing;
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pain or burning when you urinate;
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confusion, tremors, severe drowsiness; or
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a light-headed feeling, like you might pass out.
Hydrocodone is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.
Common Zohydro ER side effects may include:
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constipation, stomach pain, nausea, vomiting;
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dry mouth;
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itching;
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swelling in your hands or feet;
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muscle pain, back pain,
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cold symptoms such as stuffy nose, sneezing, sore throat;
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mild drowsiness, tired feeling; or
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headache, dizziness.
This is not a complete list of side effects and others may occur. 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)
What other drugs will affect Zohydro ER?
Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking Zohydro ER with a sleeping pill, muscle relaxer, other pain medicine, or medicine for anxiety, depression, or seizures.
Other drugs may interact with hydrocodone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
