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 a prescription medication used to relieve severe pain in patients who require daily, around-the-clock, long-term treatment with opioid analgesics.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended starting dose of Zohydro ER (hydrocodone) for the treatment of severe pain is 10 mg every 12 hours and may be increased as you become tolerant.

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 Zohydro ER.

Accidental Ingestion
Accidental ingestion of even one dose of Zohydro ER, especially by children, can result in a fatal overdose of Zohydro ER.

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 Zohydro ER.

The concomitant use of Zohydro ER with all cytochrome P450 3A4 inhibitors may result in an increase in Zohydro ER 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 Zohydro ER plasma concentration. Monitor patients receiving Zohydro ER and any CYP3A4 inhibitor or inducer.

Serious side effects have been reported with Zohydro ER including the following:

• Respiratory problems. You have a higher risk of death and coma from respiratory problems if you take  Zohydro ER with other medicines that cause respiratory problems, such as benzodiazepines including diazepam (Valium), alprazolam (Xanax), clonazepam (Klonopin), lorazepam (Ativan), and zolpidem (Ambien).
• Sleepiness, dizziness, and problems with coordination
• Decreased blood pressure. You may feel dizzy if you get up too fast from sitting or lying down.
• Dependency or abuse
• Liver problems. Tell your doctor right away if you have any of the following signs or symptoms of liver problems:
  • Yellowing of the skin or eyes
  • Dark urine
  • Light colored stools
  • Decreased appetite
  • Stomach pain
• Allergic reaction. Tell your doctor right away if you have any of the following signs or symptoms of an allergic reaction:
  • Rash
  • Hives
  • Swelling of the face
  • Wheezing
  • Decreased blood pressure
  • Loss of consciousness
• Opioid withdrawal. Symptoms of opioid withdrawal may include:
  • Shaking
  • Excessive sweating
  • Feeling hot or cold more than normal
  • Runny nose
  • Watery eyes
  • Goose bumps
  • Diarrhea
  • Vomiting
  • Muscle aches
• Zohydro ER can cause dizziness and drowsiness. Do not drive or operate heavy machinery until you know how Zohydro ER affects you.

Do not take Zohydro ER if you:

• are allergic to Zohydro ER or to any of its ingredients
• are taking any other products containing Zohydro ER or other narcotic medications, such as morphine or codeine

Serious side effects have been reported with Zohydro ER. See the "Zohydro ER Precautions” section.

Common side effects of Zohydro ER include the following:

• Nausea
• Vomiting
• Constipation
• Drowsiness
• Dizziness
• Lightheadedness
• Headache
• Fuzzy thinking
• Anxiety
• Abnormally happy or abnormally sad mood
• Dry throat
• Difficulty urinating
• Rash
• Itching
• Narrowing of the pupils
• Upper respiratory tract infection

This is not a complete list of Zohydro ER side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Antidepressants
• Antihistamines
• Antipsychotics (medications for mental illness)
• Ipratropium (Atrovent)
• Medications for irritable bowel disease, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems
• Monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate)
• Sedatives
• Sleeping pills
• Tranquilizers

This is not a complete list of Zohydro ER drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Zohydro ER falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Lactation studies have not been conducted with Zohydro ER, and no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. Because of the potential for serious adverse reactions, including excess sedation, breastfeeding is not recommended during treatment with Zohydro ER.

Hydrocodone has the potential for addiction, abuse, and misuse. Use this medication only as prescribed.

Seek immediate medical attention if you have difficulty breathing.

Do not abruptly discontinue using hydrocodone. Discuss a tapering regimen with your health care provider before you stop taking hydrocodone.