Zohydro ER

Generic name: Hydrocodone (oral)
Drug class: Opioids (narcotic analgesics)

Usage of Zohydro ER

Zohydro ER is an opioid pain medication.

Zohydro ER is an extended-release capsule used for around-the-clock treatment of severe pain.

Zohydro ER capsule are not for use on an as-needed basis for pain.

Zohydro ER side effects

Get emergency medical help if you have signs of an allergic reaction to Zohydro ER: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Stop using Zohydro ER and call your doctor at once if you have:

noisy breathing, sighing, shallow breathing, breathing that stops during sleep;

a slow heart rate or weak pulse;

pain or burning when you urinate;

confusion, tremors, severe drowsiness;

a light-headed feeling, like you might pass out;

low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or

high levels of serotonin in the body - agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.

Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common Zohydro ER side effects may include:

constipation, nausea, vomiting;

dizziness, drowsiness, feeling tired;

headache; or

cold symptoms such as stuffy nose, sneezing, sore throat.

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.

Before taking Zohydro ER

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.

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

breathing problems, sleep apnea;

a head injury, brain tumor, or seizures;

drug or alcohol addiction, or mental illness;

urination problems;

liver or kidney disease;

problems with your gallbladder, pancreas, or thyroid; or

a heart rhythm disorder called long QT syndrome.

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 opioids may need medical treatment for several weeks.

Ask a doctor before using Zohydro ER if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Relate drugs

How to use Zohydro ER

Usual Adult Dose for Chronic Pain:

The following dosing recommendations can only be considered suggested approaches to what is actually a series of clinical decisions over time; each patient should be managed individually. As First Opioid Analgesic and For Patients who are NOT Opioid Tolerant: Extended-Release Zohydro ER Capsules: Initial dose: 10 mg orally every 12 hours Comments: -Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression; monitor patients closely for respiratory depression, especially during the first 24 to 72 hours. -An opioid tolerant patient is one who has been receiving for 1-week or longer at least: oral morphine 60 mg/day, fentanyl transdermal patch 25 mcg per hour, oral oxycodone 30 mg/day, oral hydromorphone 8 mg/day, oral oxymorphone 25 mg/day, or an equianalgesic dose of another opioid.

Warnings

Hydrocodone can slow or stop your breathing. Never use Zohydro ER in larger amounts, or for longer than prescribed. Do not crush, break, or open an extended-release pill. Swallow it 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 OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep Zohydro ERin a place where others cannot get to it.

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 Zohydro ER with alcohol, or with other drugs that cause drowsiness or slow your breathing.

What other drugs will affect Zohydro ER

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

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

cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");

medicines for motion sickness, irritable bowel syndrome, or overactive bladder;

other opioids - opioid pain medicine or prescription cough medicine;

a sedative like Valium - diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;

drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or

drugs that affect serotonin levels in your body - a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or 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 here.

Disclaimer

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