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Hydrocodone is an opioid pain medication.
Zohydro ER and Hysingla ER are extended-release forms of hydrocodone that are used for around-the-clock treatment of severe pain.
Extended-release hydrocodone is not for use on an as-needed basis for pain.
Hydrocodone 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 pill. Swallow it whole to avoid exposure to a potentially fatal dose.
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. Keep the medication in a place where others cannot get to it.
MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in 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 opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.
You should not use hydrocodone if you are allergic to it, or if you have:
severe asthma or breathing problems; or
a blockage in your stomach or intestines.
To make sure hydrocodone 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 opioid medicine 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 opioids may need medical treatment for several weeks.
Do not breastfeed while taking this medicine. Hydrocodone can pass into breast milk and cause drowsiness, breathing problems, or death in a nursing baby.
Hydrocodone may be habit-forming, even at regular doses. Follow the directions on your prescription label and read all medication guides. Never use hydrocodone in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of this medicine.
Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away opioid medicine is against the law.
Your dose needs may be different if you have recently used a similar opioid 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 pill. Swallow it whole to avoid exposure to a potentially fatal dose. Never crush or break a hydrocodone pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This can cause death.
Do not stop using this medicine suddenly after long-term use, or you could have serious withdrawal symptoms. Ask your doctor how to safely stop using hydrocodone.
Store at room temperature, away from heat, moisture, and light. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.
Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.
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 Capsules (Zohydro(R) ER): Initial dose: 10 mg orally every 12 hours
Extended-Release Tablets (Hysingla(R) ER): Initial dose: 20 mg orally every 24 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.
Since hydrocodone is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.
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 heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, very slow breathing, or coma.
Do not drink alcohol. Dangerous side effects or death could occur.
Avoid driving or hazardous activity until you know how hydrocodone will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.
Get emergency medical help if you have signs of an allergic reaction to hydrocodone: 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 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 hydrocodone 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; or
low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.
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.
Serious side effects may be more likely in older adults and those who are malnourished or debilitated.
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 hydrocodone 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.
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 narcotic medications - 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.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use hydrocodone only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Hydrocodone Bitartrate Er (www.drugs.com/hydrocodone.html).
Applies to hydrocodone: oral capsule extended release, oral tablet extended release
Oral route (Capsule, Extended Release)
Prior to prescribing hydrocodone, assess each patient's risk for opioid addiction, abuse, and misuse, and regularly monitor all patients for opioid addiction behaviors or conditions. To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products. Monitor for respiratory depression, which can be serious, life-threatening, or fatal, especially during initiation or following a dose increase. Instruct patients to swallow extended release forms whole to avoid potentially fatal overdose. Accidental ingestion of hydrocodone can result in a fatal overdose, especially in children. If prolonged opioid use is necessary during pregnancy, advise patient of potential risk of life-threatening neonatal opioid withdrawal syndrome and ensure appropriate treatment will be available. Use with CYP3A4 inhibitors or inducers may change hydrocodone plasma levels resulting in prolonged adverse effects or potentially fatal respiratory depression; monitoring is recommended. Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options, limit dosage and duration to the minimum required, and monitor for respiratory depression and sedation. Alcoholic beverages or medications containing alcohol should be avoided due to the potential for increased hydrocodone plasma levels and a potentially fatal overdose.
Oral route (Tablet, Extended Release)
Addiction, Abuse, and MisuseHydrocodone extended-release (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 Hydrocodone ER, and monitor all patients regularly for the development of these behaviors or conditions.Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to: complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacists, and consider other tools to improve patient, household, and community safety.Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of Hydrocodone ER. Monitor for respiratory depression, especially during initiation of Hydrocodone ER or following a dose increase. Instruct patients to swallow hydrocodone bitartrate ER tablets whole; crushing, chewing, or dissolving hydrocodone bitartrate tablets can cause rapid release and absorption of a potentially fatal dose of hydrocodone bitartrate.Accidental IngestionAccidental ingestion of even one dose of Hydrocodone ER, especially by children, can result in a fatal overdose of Hydrocodone ER.Neonatal Opioid Withdrawal SyndromeProlonged use of Hydrocodone 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.Cytochrome P450 3A4 InteractionThe concomitant use of Hydrocodone ER with all cytochrome P450 3A4 inhibitors may result in an increase in Hydrocodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in Hydrocodone plasma concentration. Monitor patients receiving Hydrocodone ER and any CYP3A4 inhibitor or inducer.Risks from Concomitant Use with Benzodiazepines or Other CNS DepressantsReserve concomitant prescribing of Hydrocodone ER and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
Along with its needed effects, hydrocodone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking hydrocodone:
Less common
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking hydrocodone:
Symptoms of overdose
Some side effects of hydrocodone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
For Healthcare Professionals
Applies to hydrocodone: compounding powder, oral capsule extended release, oral tablet extended release
GeneralThe most commonly reported side effects included constipation, nausea, vomiting, fatigue, upper respiratory tract infection, dizziness, headache, and somnolence.
RespiratoryCommon (1% to 10%): Upper respiratory tract infection, cough, bronchitis, nasopharyngitis, sinusitis, nasal congestion
Uncommon (0.1% to 1%): Dyspnea
CardiovascularCommon (1 to 10%): Hot flush, hypertension, chest pain, peripheral edema
Rare (less than 0.1%): Hypotension, orthostatic hypotension, palpitations, presyncope, syncope
Frequency not reported: QTC interval prolongation
QT interval prolongation has been observed in healthy subjects following daily dosing with hydrocodone extended-release tablets. The difference in QT interval at steady state was found to be 6 milliseconds, 7 milliseconds, and 10 milliseconds at doses of 80 mg, 120 mg and 160 mg, daily, respectively.
GastrointestinalVery common (10% or more): Constipation (up to 11%), nausea (up to 10%)
Common (1% to 10%): Dry mouth, vomiting, abdominal pain or discomfort, gastroesophageal reflux disease, diarrhea, dyspepsia
Rare (less than 0.1%): Dysphagia, esophageal obstruction, retching, chocking
Very rare (less than 0.01%): Difficulty swallowing tablet
In clinical trials with extended release tablets, 11 or 2476 subjects reported difficulty swallowing the tablets. These reports included esophageal obstruction, dysphagia, and choking. One case required medical intervention to remove the tablet.
Nervous systemCommon (1% to 10%): Somnolence, fatigue, headache, tremor, dizziness, lethargy, migraine, paresthesia, sedation
Uncommon (0.1% to 1%): Abnormal thinking
OtherCommon (1% to 10%): Pain, pyrexia, fatigue, tinnitus, chills
Uncommon (0.1% to 1%): Asthenia, neonatal abstinence syndrome, drug withdrawal
PsychiatricCommon (1 to 10%): Anxiety, depression, insomnia
Uncommon (0.1% to 1%): Agitation, altered mood, irritability, libido decreased
MetabolicCommon (1% to 10%): Dehydration, hypokalemia, increased blood cholesterol, decreased appetite
Uncommon (0.1% to 1%): Thirst
HepaticCommon (1 to 10%): Increased gamma-glutamyltransferase
MusculoskeletalCommon (1% to 10%): Back pain, muscle spasms , contusion, fall, foot fracture, joint injury or sprain, muscle strain, arthralgia, musculoskeletal pain, myalgia, neck pain, osteoarthritis, pain in extremity
Uncommon (0.1% to 1%): Muscle twitching
HypersensitivityUncommon (0.1% to 1%): Drug hypersensitivity
EndocrineUncommon (0.1% to 1%): Hypogonadism
DermatologicCommon (1% to 10%): Pruritus, skin laceration, hyperhidrosis, night sweats, rash
GenitourinaryCommon (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Urinary retention
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Hydrocodone Bitartrate Er (www.drugs.com/hydrocodone.html).
December 16, 2020
March 1, 2021
February 15, 2021
March 1, 2021
February 1, 2021
January 31, 2021
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