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    OXYCODONE HCL-IBUPROFEN

    COMMON BRAND NAME(S): Combunox

    GENERIC NAME(S): Ibuprofen-Oxycodone

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    WARNINGS:

    Oxycodone has a risk for abuse and addiction, which can lead to overdose and death. Oxycodone may also cause severe, possibly fatal, breathing problems. To lower your risk, your doctor should have you take the smallest dose of oxycodone 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. Also, other medications can affect the removal of oxycodone from your body, which may affect how oxycodone works. Be sure you know how to take ibuprofen/oxycodone 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 swallows this drug, get medical help right away.

    The other ingredient in this medication, ibuprofen, may rarely cause serious (rarely fatal) bleeding from the stomach or intestines. Also, nonsteroidal anti-inflammatory drugs (including ibuprofen) may rarely increase the risk for a heart attack or stroke. This effect can happen at any time while taking this drug but is more likely if you take it for a long time. The risk may be greater if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes). Do not take this drug right before or after heart bypass surgery (CABG). Talk to your doctor or pharmacist about the benefits and risks of treatment, as well as other possible medication choices.

    If you notice any of the following rare but very serious side effects, stop taking this medication and get medical help right away: black stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds, chest pain, weakness on one side of the body, sudden vision changes, or slurred speech.

    Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits (such as miscarriage, trouble getting pregnant). 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 is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery. If this medication must be used, 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 OXYCODONE HCL-IBUPROFEN?
    See More

    Uses

    This medication is used for the short-term treatment of moderate to severe pain. It contains 2 pain relievers: oxycodone and ibuprofen. Oxycodone is an opioid (narcotic) pain reliever that acts on certain parts of the brain to relieve pain. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that works by blocking a certain natural substance in your body to reduce pain and swelling.

    How to use OXYCODONE HCL-IBUPROFEN

    Read the Medication Guide provided by your pharmacist before you start using this product and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.

    Take this medication by mouth with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 10 minutes after taking this drug. If stomach upset occurs while taking this medication, take it with food, milk, or an antacid.

    Dosage and duration are based on your medical condition and response to therapy. Take this medication exactly as directed by your doctor. To minimize the risk of side effects (such as stomach bleeding), the manufacturer recommends using no more than 4 tablets per day for the shortest possible time (usually no more than 7 days). If you are instructed to take this medication for more than 7 days, discuss the risks and benefits with your doctor. Also follow your doctor's or pharmacist's instructions for the safe use of other pain relievers (such as acetaminophen). Consult your doctor or pharmacist if you have any questions regarding your treatment.

    If you are taking this medication as needed, remember to take it as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.

    If this medication has been taken regularly for a long time or in high doses, withdrawal symptoms (such as runny nose, irritability, trouble sleeping, sweating, stomach cramps, diarrhea) may occur if you suddenly stop taking 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 taken for a long time, it may not work as well. Your doctor may need to increase your dose or change your medication. 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, constipation, dizziness, drowsiness, upset stomach, or weakness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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

    To prevent constipation, maintain 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).

    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: dizziness upon standing, swelling of the hands or feet, sudden or unexplained weight gain, fast/pounding heartbeat, persistent/severe headache, mental/mood changes, difficult/painful swallowing, signs of kidney problems (such as change in the amount of urine), easy bruising/bleeding, signs of infection (such as fever, persistent sore throat), severe stomach/abdominal pain, ringing in the ears, unexplained stiff neck, 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/irregular/shallow breathing, fainting, seizures, severe drowsiness/difficulty waking up.

    This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: yellowing eyes/skin, dark urine, persistent nausea/vomiting.

    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 this medication, tell your doctor or pharmacist if you are allergic to oxycodone or ibuprofen; or to other opioid pain relievers (such as codeine, hydrocodone, oxymorphone); or to aspirin or other NSAIDs (such as naproxen, celecoxib); 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: intestinal/bowel disorders (such as paralytic ileus, infectious diarrhea, colitis, blockage), recent heart bypass surgery (CABG), liver disease, bleeding/blood-clotting disorders (such as hemophilia, vitamin K deficiency, low platelet count), stomach/intestine/esophagus problems (such as bleeding, ulcers, recurring heartburn), diabetes, gout, lung diseases (such as asthma, chronic obstructive pulmonary disease-COPD), breathing problems (such as slow/shallow breathing, sleep apnea), growths in the nose (nasal polyps), a certain spinal problem (kyphoscoliosis), certain heart problems (such as low blood pressure, irregular heartbeat), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), brain disorders (such as seizures, head injury, tumor, increased intracranial pressure), underactive thyroid (hypothyroidism), difficulty urinating (for example, due to enlarged prostate or narrowed urethra), disease of the pancreas (such as pancreatitis), mental/mood disorders (such as toxic psychosis), gallbladder disease, adrenal gland problem (such as Addison's disease), certain enzyme deficiencies (pyruvate kinase or G6PD deficiency).

    Kidney problems can sometimes occur with the use of NSAID medications, including ibuprofen. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have a change in the amount of urine.

    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 that you are using this medication.

    This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.

    This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

    Older adults may be more sensitive to the side effects of this drug, especially slow/shallow breathing, drowsiness, dizziness, confusion, stomach bleeding, and kidney problems.

    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 passes into breast milk and may have undesirable effects on a nursing infant. 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 of the products that may interact with this drug include: aliskiren, ACE inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as losartan, valsartan), certain cancer drugs (mercaptopurine, methotrexate, pemetrexed), cidofovir, cimetidine, corticosteroids (such as prednisone), desmopressin, lithium, mifepristone, certain pain medications (mixed opioid agonist-antagonists such as pentazocine, nalbuphine, butorphanol), naltrexone.

    This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.

    Other medications can affect the removal of oxycodone from your body, which may affect how oxycodone works. Examples include azole antifungals (such as ketoconazole), macrolide antibiotics (such as erythromycin), HIV medications (such as ritonavir), rifamycins (such as rifabutin, rifampin), certain drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

    Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (including aspirin, NSAIDs such as celecoxib, ketorolac, or naproxen). These drugs are similar to ibuprofen and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Daily use of ibuprofen may decrease aspirin's ability to prevent heart attack/stroke. Talk to your doctor about using a different medication (such as acetaminophen) to treat pain/fever. If you must take ibuprofen, talk to your doctor about possibly taking immediate-release aspirin (not enteric-coated/EC) while taking ibuprofen. Take ibuprofen at least 8 hours before or at least 30 minutes after your aspirin dose. Do not increase your daily dose of aspirin or change the way you take aspirin/other medications without your doctor's approval.

    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, marijuana, 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: slowed or shallow breathing, slow heartbeat, excessive drowsiness, persistent dizziness/fainting, cold/clammy skin, limp/weak muscles, seizures, coma.

    Notes

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

    Laboratory and/or medical tests (such as complete blood count, kidney and liver function tests) may be performed to monitor your progress or check for side effects. Consult your doctor for more details.

    This medication has been prescribed for your current condition only. Do not take 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 take this medication regularly and you miss a dose, take 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. Do not store in the bathroom. 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 July 2017. Copyright(c) 2017 First Databank, Inc.

    Images

    ibuprofen-oxycodone 400 mg-5 mg tablet
    ibuprofen-oxycodone 400 mg-5 mg tablet
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    ibuprofen-oxycodone 400 mg-5 mg tablet
    ibuprofen-oxycodone 400 mg-5 mg tablet
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    ibuprofen-oxycodone 400 mg-5 mg tablet
    ibuprofen-oxycodone 400 mg-5 mg tablet

    Identification

    color
    yellow
    shape
    oblong
    imprint
    logo and 29
    This medicine is a yellow, oblong, scored, film-coated, tablet imprinted with "logo and 29".
    ibuprofen-oxycodone 400 mg-5 mg tablet
    ibuprofen-oxycodone 400 mg-5 mg tablet

    Identification

    color
    white
    shape
    oblong
    imprint
    b 778
    This medicine is a white, oblong, scored, film-coated, tablet imprinted with "b 778".

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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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