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hydrocodone

Pronunciation

Generic Name: hydrocodone (oral) (HYE droe KOE done)
Brand Name: Hysingla ER, Zohydro ER

What is hydrocodone?

Hydrocodone is an opioid pain medication. An opioid is sometimes called a narcotic.

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 may also be used for purposes not listed in this medication guide.

What is the most important information I should know about hydrocodone?

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.

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MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

You should not use this medicine 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.

What should I discuss with my healthcare provider before taking hydrocodone?

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

  • severe asthma or breathing problems; or

  • a bowel obstruction called paralytic ileus.

To make sure hydrocodone is safe for you, tell your doctor if you have:

  • any type of breathing problem or lung disease;

  • a history of head injury, brain tumor, or seizures;

  • a history of drug abuse, alcohol addiction, or mental illness;

  • urination problems;

  • liver or kidney disease;

  • a heart rhythm disorder called long QT syndrome;

  • a blockage in your stomach or intestines; or

  • problems with your gallbladder, pancreas, or thyroid.

It is not known whether this medicine 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 hydrocodone.

How should I take hydrocodone?

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 hydrocodone in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

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 MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away hydrocodone is against the law.

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 pill. Swallow it whole to avoid exposure to a potentially fatal dose.

Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using hydrocodone.

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 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 hydrocodone pills. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush any unused pills down the toilet.

What happens if I miss a dose?

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 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 hydrocodone?

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.

Hydrocodone side effects

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

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

  • weak or shallow breathing;

  • pain or burning when you urinate;

  • confusion, tremors, severe drowsiness; or

  • 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 side effects may include:

  • constipation, stomach pain, nausea, vomiting;

  • dry mouth;

  • itching;

  • swelling in your hands or feet;

  • muscle pain, back pain,

  • cold symptoms such as stuffy nose, sneezing, sore throat;

  • mild drowsiness, tired feeling; or

  • 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)

Hydrocodone dosing information

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.

TITRATION AND MAINTENANCE:
Individually titrate to a dose that provides adequate analgesia and minimizes adverse reactions.
--Dose adjustments to hydrocodone extended-release capsules should be made in 10 mg increments every 12 hours, every 3 to 7 days.
--Dose adjustments to hydrocodone extended-release tablets should be made in 10 to 20 mg increments every 24 hours, every 3 to 5 days.
--If unacceptable side effects occur, the dose may be reduced.
Breakthrough Pain: If the level of pain increases after dose stabilization, attempt to identify the source before increasing dose; rescue medication with appropriate immediate-release analgesia may be helpful

DOSE CONVERSIONS: Dose conversions should be done carefully and with close monitoring due to large patient variability in regards to opioid analgesic response. Discontinue all other around the clock opioid drugs when initiating therapy with extended-release hydrocodone.

Hydrocodone Extended-Release (ER) CAPSULES:
-The 50 mg capsules, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are reserved for opioid tolerant individuals.
CONVERSION FROM OTHER ORAL OPIOIDS:
-Published potency tables can be used to estimate a patient's 24-hour oral hydrocodone requirement; however, due to substantial inter-patient variability, it is best to underestimate a patient's 24-hour requirement and provide rescue medication as the dose is titrated.
-Alternatively, the following conversion factors (CF) may be used to convert selected oral opioids to the hydrocodone extended-release capsule: Hydrocodone, CF=1; Oxycodone, CF=1; Methadone, CF= 1, Oxymorphone, CF=2; Hydromorphone, CF=2.67; Morphine, CF=0.67; Codeine, CF=0.1.
-These CFs cannot be used to convert from hydrocodone extended-release to the selected oral opioid as doing so will result in overestimation of the oral opioid dose and may result in fatal respiratory depression.
-Example: Sum the total daily dose of prior oral opioid; multiply that sum by the CF to obtain 24-hour oral hydrocodone requirement; divide 24-hour requirement by 2 (round down, if necessary ) and give 1 dose orally every 12 hours.
CONVERSION FROM TRANSDERMAL FENTANYL: Remove the transdermal fentanyl patch and 18 hours later initiate hydrocodone extended-release capsules at 10 mg every 12 hours for each 25 mcg/hr fentanyl transdermal patch; monitor closely as there is limited documented experience with this conversion.

Hydrocodone Extended-Release (ER) TABLETS:
-Daily dose greater than or equal to 80 mg are reserved for use in opioid tolerant individuals.
-CONVERSION FROM ORAL HYDROCODONE FORMULATIONS: Administer patient's total daily oral hydrocodone dose as extended-release tablet orally once a day.
-CONVERSION FROM OTHER ORAL OPIOIDS:
-Published potency tables can be used to estimate a patient's 24-hour oral hydrocodone requirement; however, due to substantial inter-patient variability, it is best to underestimate a patient's 24-hour requirement and provide rescue medication as the dose is titrated.
-To obtain the initial hydrocodone extended-release tablet dose, use the following conversion factors (CF) to convert selected oral opioids and then reduce that dose by 25%. Tramadol, CF=0.1; Oxycodone, CF=1; Methadone, CF= 1.5, Oxymorphone, CF=2; Hydromorphone, CF=4; Morphine, CF=0.5; Codeine, CF=0.15.
-These CFs cannot be used to convert from hydrocodone extended-release to the selected oral opioid as doing so will result in overestimation of the oral opioid dose and may result in fatal respiratory depression.
-Example: Sum the total daily dose of prior oral opioid; multiply that sum by the CF to obtain 24-hour oral hydrocodone requirement; reduce that hydrocodone requirement by 25% to account for interpatient variability, round down, if necessary; administer calculated dose orally once a day.
CONVERSION FROM TRANSDERMAL FENTANYL: Remove the transdermal fentanyl patch and 18 hours later initiate hydrocodone extended-release tablets at 20 mg every 24 hours for each 25 mcg/hr fentanyl transdermal patch; monitor closely as there is limited documented experience with this conversion.
CONVERSION FROM TRANSDERMAL BUPRENORPHINE: Patients receiving transdermal buprenorphine 20 mcg/hr or less should initiate extended-release hydrocodone tablets at 20 mg every 24 hours; monitor closely as there is limited documented experience with this conversion.

Comments:
-When converting from methadone, close monitoring is of particular importance due to methadone's long half-life.

Use: 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 other drugs will affect hydrocodone?

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 hydrocodone 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.

Where can I get more information?

  • Your pharmacist can provide more information about hydrocodone.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.05. Revision Date: 2015-06-08, 10:40:28 AM.

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