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    Oxymorphone HCL ER

    COMMON BRAND NAME(S): Opana ER

    GENERIC NAME(S): oxymorphone

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    WARNINGS:

    Oxymorphone has a risk for abuse and addiction, which can lead to overdose and death. Oxymorphone may also cause severe, possibly fatal, breathing problems. To lower your risk, your doctor should have you take the smallest dose of oxymorphone that works, and take it for the shortest possible time. See also How to Use section for more information about addiction.

    The risk for severe breathing problems is higher when you start this medication and after a dose increase, or if you take the wrong dose/strength. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death. Be sure you know how to take oxymorphone and what other drugs you should avoid taking with it. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.

    This medication must be swallowed whole. Do not break, chew, dissolve, or crush the medication. This may cause a rapid release of the medication that may be fatal. Also, do not drink alcohol or take any products that contain alcohol while taking this medication. This may cause an increase of the medication in your body that may be fatal.

    Keep this medicine in a safe place to prevent theft, misuse, or abuse. If someone accidentally swallows this drug, get medical help right away.

    Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Babies born to mothers who use this drug for a long time may develop severe (possibly fatal) withdrawal symptoms. Tell the doctor right away if you notice any symptoms in your newborn baby such as crying that doesn't stop, slow/shallow breathing, irritability, shaking, vomiting, diarrhea, poor feeding, or difficulty gaining weight.Who should not take Oxymorphone HCL ER?

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    Uses

    Oxymorphone extended-release is used to help relieve severe ongoing pain. It belongs to a class of drugs known as long-acting opioid (narcotic) analgesics. It works in the brain to change how your body feels and responds to pain.

    Do not use the extended-release form of oxymorphone to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.

    How to use Oxymorphone HCL ER

    See also Warning section.

    Read the Medication Guide provided by your pharmacist before you start taking oxymorphone extended-release and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

    Take this medication on a regular schedule as directed by your doctor, not as needed for sudden (breakthrough) pain.

    Take this medication by mouth without food (at least 1 hour before or 2 hours after eating) as directed by your doctor, usually every 12 hours. Swallow the tablets whole. Do not break, chew, dissolve, or crush them. Do not pre-soak, lick, or wet the tablets before putting them in your mouth. Take one tablet at a time with enough water to completely swallow the tablet. If you have nausea, ask your doctor or pharmacist about ways to decrease nausea (such as lying down for 1 to 2 hours with as little head movement as possible).

    The dosage is based on your medical condition and response to treatment. Do not increase your dose or use this drug more often or for longer than prescribed because your risk of side effects may increase. Properly stop the medication when so directed.

    Before you start using this medication, ask your doctor or pharmacist if you should stop or change how you use your other opioid medication(s). Other pain relievers (such as acetaminophen, ibuprofen) may also be prescribed. Ask your doctor or pharmacist about using oxymorphone safely with other drugs.

    This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, watering eyes, runny nose, nausea, sweating, muscle aches) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.

    When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

    Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

    Tell your doctor if your pain persists or worsens.

    Side Effects

    See also Warning section.

    Nausea, vomiting, headache, constipation, dry mouth, mild itching, lightheadedness, dizziness, or drowsiness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

    To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

    To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

    Sometimes a soft mass that looks like the tablet may appear in your stool. This effect is harmless because your body has already absorbed the medication.

    Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

    Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as agitation, confusion, hallucinations), stomach/abdominal pain, vision changes, slow/fast heartbeat, difficulty urinating, difficulty swallowing this medication (such as choking, gagging), signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss).

    Get medical help right away if you have any very serious side effects, including: slow/shallow breathing, fainting, seizure, severe drowsiness/difficulty waking up.

    A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

    This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

    In the US -

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

    In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

    Precautions

    Before taking oxymorphone, tell your doctor or pharmacist if you are allergic to it; or to other opioid pain medications (such as codeine, morphine, oxycodone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

    Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), gallbladder disease, kidney disease, liver disease, mental/mood disorders (such as confusion, depression, thoughts of suicide), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), stomach/intestinal problems (such as blockage, surgery, constipation, diarrhea due to infection, paralytic ileus), cancer of the esophagus or colon, difficulty swallowing, disease of the pancreas (pancreatitis), difficulty urinating (such as due to enlarged prostate).

    This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

    Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

    Older adults may be more sensitive to the side effects of the drug, especially confusion, dizziness, drowsiness, slow/shallow breathing.

    During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. (See also Warning section.)

    It is unknown if this drug passes into breast milk. However, similar drugs pass into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor right away if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.

    Interactions

    See also Warning section.

    Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

    Some products that may interact with this drug include: products that contain alcohol (such as cough-and-cold syrups), certain pain medications (mixed opioid agonist-antagonists such as pentazocine, nalbuphine, butorphanol), opioid antagonists (such as naltrexone, naloxone).

    The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

    Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

    This medication may interfere with certain laboratory tests (including amylase and lipase levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

    Overdose

    If someone has overdosed and has serious symptoms such as passing out or trouble breathing, give them naloxone if available, then call 911. If the person is awake and has no symptoms, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow/shallow breathing, slow heartbeat, coma.

    Notes

    Do not share this medication with others. It is against the law.

    This medication has been prescribed for your current condition only. Do not use it later for another condition unless your doctor directs you to do so. A different medication may be necessary in that case.

    Ask your doctor or pharmacist if you should have naloxone available to treat opioid overdose. Teach your family or household members about the signs of an opioid overdose and how to treat it.

    Missed Dose

    If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip themissed dose and resume your usual dosing schedule. Do not double the dose to catch up.

    Storage

    Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. See also Warning section.

    Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. In the US, the FDA recommends flushing this medication down the toilet or pouring into a drain. Consult your pharmacist or local waste disposal company.Information last revised January 2017. Copyright(c) 2017 First Databank, Inc.

    Images

    oxymorphone ER 40 mg tablet,extended release,12 hr
    oxymorphone ER 40 mg tablet,extended release,12 hr
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    oxymorphone ER 7.5 mg tablet,extended release,12 hr
    oxymorphone ER 7.5 mg tablet,extended release,12 hr
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    oxymorphone ER 15 mg tablet,extended release,12 hr
    oxymorphone ER 15 mg tablet,extended release,12 hr
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    oxymorphone ER 30 mg tablet,extended release,12 hr
    oxymorphone ER 30 mg tablet,extended release,12 hr
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    oxymorphone ER 5 mg tablet,extended release,12 hr
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    oxymorphone ER 10 mg tablet,extended release,12 hr
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    G72
    oxymorphone ER 20 mg tablet,extended release,12 hr
    oxymorphone ER 20 mg tablet,extended release,12 hr
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    G73
    oxymorphone ER 7.5 mg tablet,extended release,12 hr
    oxymorphone ER 7.5 mg tablet,extended release,12 hr
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    logo, 261
    oxymorphone ER 15 mg tablet,extended release,12 hr
    oxymorphone ER 15 mg tablet,extended release,12 hr
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    logo, 262
    oxymorphone ER 40 mg tablet,extended release,12 hr
    oxymorphone ER 40 mg tablet,extended release,12 hr

    Identification

    color
    orange
    shape
    round
    imprint
    G74
    This medicine is a orange, round, film-coated, tablet imprinted with "G74".
    oxymorphone ER 7.5 mg tablet,extended release,12 hr
    oxymorphone ER 7.5 mg tablet,extended release,12 hr

    Identification

    color
    gray
    shape
    round
    imprint
    G75
    This medicine is a gray, round, film-coated, tablet imprinted with "G75".
    oxymorphone ER 15 mg tablet,extended release,12 hr
    oxymorphone ER 15 mg tablet,extended release,12 hr

    Identification

    color
    white
    shape
    round
    imprint
    G76
    This medicine is a white, round, film-coated, tablet imprinted with "G76".
    oxymorphone ER 30 mg tablet,extended release,12 hr
    oxymorphone ER 30 mg tablet,extended release,12 hr

    Identification

    color
    brown
    shape
    round
    imprint
    G77
    This medicine is a brown, round, film-coated, tablet imprinted with "G77".
    oxymorphone ER 5 mg tablet,extended release,12 hr
    oxymorphone ER 5 mg tablet,extended release,12 hr

    Identification

    color
    purple
    shape
    round
    imprint
    G71
    This medicine is a purple, round, film-coated, tablet imprinted with "G71".
    oxymorphone ER 10 mg tablet,extended release,12 hr
    oxymorphone ER 10 mg tablet,extended release,12 hr

    Identification

    color
    orange
    shape
    round
    imprint
    G72
    This medicine is a orange, round, film-coated, tablet imprinted with "G72".
    oxymorphone ER 20 mg tablet,extended release,12 hr
    oxymorphone ER 20 mg tablet,extended release,12 hr

    Identification

    color
    green
    shape
    round
    imprint
    G73
    This medicine is a green, round, film-coated, tablet imprinted with "G73".
    oxymorphone ER 7.5 mg tablet,extended release,12 hr
    oxymorphone ER 7.5 mg tablet,extended release,12 hr

    Identification

    color
    gray
    shape
    round
    imprint
    logo, 261
    This medicine is a gray, round, tablet imprinted with "logo" and "261".
    oxymorphone ER 15 mg tablet,extended release,12 hr
    oxymorphone ER 15 mg tablet,extended release,12 hr

    Identification

    color
    white
    shape
    round
    imprint
    logo, 262
    This medicine is a white, round, tablet imprinted with "logo" and "262".

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    Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

    CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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