Zohydro ER

Zohydro ER is a prescription medication used to treat severe pain that requires around-the-clock treatment and is not relieved by other medications. Zohydro ER belongs to a group of drugs called narcotic analgesics. These work by changing the way that the brain and nervous system respond to pain.

This medication comes as an extended release (long-acting) capsule and is usually taken 2 times a day. Do not chew, crush, or dissolve Zohydro ER. Swallow the capsules whole.

Common side effects of Zohydro ER include constipation, nausea, and tiredness. Zohydro ER can also can drowsiness and dizziness. Do not drive or operate heavy machinery until you know how Zohydro ER affects you.

Zohydro ER is part of the drug class:

• Opium alkaloids and derivatives

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Zohydro ER, there are no specific foods that you must exclude from your diet when receiving this medication.

Do not drink alcohol or take products containing alcohol while taking Zohydro ER.

Take Zohydro ER exactly as prescribed.

Zohydro ER 50 mg capsules, a single dose of Zohydro ER greater than 40 mg, or a total daily dose greater than 80 mg are only for use if you have been recieving opiate medications to the point where you become tolerant and require higher doses.

Zohydro ER comes in extended release capsule form and is taken twice daily. This formulation is difficult to crush, break or dissolve to reduce abuse.

Do not chew, divide, dissolve, or break Zohydro ER capsules. Swallow the capsules whole.

If you miss a dose, take your next dose at your usual time. Do not take two doses of Zohydro ER at the same time.

In the U.S.

• Hysingla ER
• Vantrela ER
• Zohydro ER

In Canada

• Hycodan
• Robidone

Available Dosage Forms:

• Tablet, Extended Release
• Capsule, Extended Release
• Liquid
• Syrup
• Tablet

Therapeutic Class: Analgesic

Chemical Class: Hydrocodone

Hydrocodone is used to treat severe pain. It belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

When hydrocodone is used for a long time, it may become habit-forming, causing mental or physical dependence. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly.

This medicine is available only with your doctor's prescription.

This section provides information on the proper use of a number of products that contain hydrocodone. It may not be specific to Zohydro ER. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Swallow the extended-release capsule or tablet whole with water. Do not crush, break, chew, or dissolve it. Do not pre-soak, lick, or wet the tablet before placing it in the mouth, or take one tablet at a time with enough water to ensure complete swallowing immediately after placing in the mouth.

Take this medicine at the same time each day.

Hydrocodone should only be used by patients who have already been taking narcotic pain medicines, also called opioids. These patients are called opioid-tolerant. If you are uncertain whether or not you are opioid-tolerant, check with your doctor before using this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For severe pain:
  • For oral dosage form (extended-release capsules):
    • Patients who are not taking narcotic medicines:
      • Adults—At first, 10 milligrams (mg) every 12 hours. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.
    • Patients switching from other narcotic medicines:
      • Adults—The capsule is given every 12 hours. Your doctor will determine your dose and adjust the dose as needed.
      • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (extended-release tablets):
    • Patients who are not taking narcotic medicines:
      • Adults—
        • Hysingla: At first, 20 milligrams (mg) every 24 hours. Your doctor may adjust your dose as needed.
        • Vantrela™: At first, 15 mg every 12 hours. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.
    • Patients switching from other narcotic medicines:
      • Adults—
        • Hysingla: The tablet is given every 24 hours. Your doctor will determine your dose and adjust the dose as needed.
        • Vantrela™: The tablet is given every 12 hours. Your doctor will determine your dose and adjust the dose as needed.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Hydrocodone can cause serious unwanted effects or fatal overdose if taken by children, pets, or adults who are not used to strong narcotic pain medicines. Make sure you store the medicine in a safe and secure place to prevent others from getting it.

Do not throw unused medicine in the trash. Ask your pharmacist about the best way to dispose of medicine you do not use.

It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Do not use this medicine if you have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

This medicine will add to the effects of alcohol and other CNS depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your doctor before taking any of these medicines while you are using this medicine.

This medicine may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert. Stand or sit up slowly if you are dizzy.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Signs of an overdose include dark urine, difficult or troubled breathing, irregular, fast or slow, or shallow breathing, nausea or vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or yellow eyes or skin.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

Do not suddenly stop or change your dose without first checking with your doctor.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.

Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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.

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 if the mother has taken this medicine during pregnancy.

Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

You should not use Zohydro ER if you are allergic to hydrocodone, or if you have:

• severe asthma or breathing problems; or

• a blockage in your stomach or intestines.

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.

Some medicines can interact with hydrocodone and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

To make sure Zohydro ER is safe for you, tell your doctor if you have ever had:

• any type of breathing problem or lung disease;

• a head injury, brain tumor, or seizures;

• drug or alcohol addiction, or mental illness;

• urination problems;

• liver or kidney disease;

• a heart rhythm disorder called long QT syndrome;

• problems with your gallbladder, pancreas, or thyroid; or

• if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

If you use Zohydro ER while you are pregnant, your baby could become dependent on hydrocodone. 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.

Do not breast-feed while you are using Zohydro ER. Hydrocodone can pass into breast milk and cause drowsiness, breathing problems, or death in a nursing baby.

Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• other narcotic medications - opioid pain medicine or prescription cough medicine;

• drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, sedative, tranquilizer, or antipsychotic medicine; or

• drugs that affect serotonin levels in your body - medicine for depression, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may interact with hydrocodone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.