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    Opana Ampul

    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 use the smallest dose of oxymorphone that works, and use 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 use the wrong dose/strength. Using 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 use 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.

    Keep this medicine in a safe place to prevent theft, misuse, or abuse. If someone accidentally uses 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, use 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 Opana Ampul?
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    Uses

    This medication is used to relieve moderate to severe pain. Oxymorphone is an opioid (narcotic) pain reliever. It acts on certain centers in the brain to give you pain relief.

    How to use Opana Ampul

    This medication is given by injection into a vein, into a muscle, or under the skin. Use exactly as directed by your doctor. Learn the proper way to give injections. If you have any questions about the use of this medication, consult your doctor or pharmacist.

    Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. If this medication is given into a muscle or under the skin, it is important to change the location of the injection site with each dose to avoid problem areas under the skin.

    Use needles and syringes only once. Learn how to store and discard needles and medical supplies safely. Consult your pharmacist for more details.

    The dosage is based on your medical condition and response to treatment. Pain medications work best if they are used when the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well. Do not increase your dose, use the medication more frequently, or use it for a longer time than prescribed. Properly stop the medication when so directed.

    If nausea occurs, consult your doctor or pharmacist for ways to decrease it (such as lying down for 1 to 2 hours with as little head movement as possible).

    If you have ongoing pain (such as due to cancer), your doctor may direct you to also take long-acting opioid medications. In that case, this medication might be used for sudden (breakthrough) pain only as needed. 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 mental/mood changes, fast breathing, yawning, sweating, watering eyes, goosebumps, muscle twitching ) 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.

    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). Use this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

    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.

    Tell your doctor if your pain persists or worsens.

    Side Effects

    See also Warning section.

    Nausea, vomiting, constipation, lightheadedness, dizziness, or drowsiness may occur. Pain, redness, or swelling at the injection site may also 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 lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

    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: fast/slow/irregular heartbeat, severe stomach/abdominal pain, mental/mood changes (such as agitation, hallucinations, confusion), difficulty urinating, 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: severe drowsiness/difficulty waking up, slow/shallow/irregular breathing, fainting, seizures.

    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 using oxymorphone injection, tell your doctor or pharmacist if you are allergic to it; or to other opioid pain medications (such as 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 (e.g., head injury, tumor, seizures), breathing problems (e.g., asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (e.g., confusion, depression, thoughts of suicide), disease of the pancreas (pancreatitis), gallbladder disease, personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), stomach/intestinal problems (e.g., blockage, constipation, diarrhea due to infection, paralytic ileus), difficulty urinating (e.g., 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 the use of alcohol and certain other medications that cause drowsiness (see also Drug Interactions section).

    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 dizziness, drowsiness, slow/shallow breathing and confusion.

    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.)

    This medication may pass into breast milk. Discuss the risks and benefits with 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: certain pain medications (mixed opioid agonist-antagonists such as pentazocine, nalbuphine, butorphanol), opioid antagonists (e.g., naltrexone).

    The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is used with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are using 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/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, cold/clammy skin, bluish skin/lips/nails, seizures, 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 told to do so by your doctor. 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 are prescribed this medication on a regular schedule and miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed 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. Keep all medications away from children and pets.

    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. Consult your pharmacist or local waste disposal company.Information last revised January 2017. Copyright(c) 2017 First Databank, Inc.

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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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