One ingredient in this medication, ibuprofen, may infrequently cause serious (rarely fatal) bleeding from the stomach or intestines. Also, related drugs rarely have caused blood clots to form, resulting in heart attacks and strokes. Ibuprofen might also rarely cause similar problems. 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), or with longer use. 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 seek immediate medical attention: 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.Who should not take ibuprofen-oxycodone?
This medication is used for the short-term treatment of moderate to severe pain. It contains 2 pain relievers: oxycodone and ibuprofen. Oxycodone is a narcotic pain reliever (opiate-type) 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.
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 non-narcotic 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 immediately.
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.
Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.
Tell your doctor if your pain persists or worsens.
See also Warning section.
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, unusual tiredness, change in 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.
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.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking this medication, tell your doctor or pharmacist if you are allergic to oxycodone or ibuprofen; or to other narcotic 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 regular use/abuse of drugs/alcohol/other substances, 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 any unusual 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. Avoid prolonged sun exposure, tanning booths or sunlamps. Use a sunscreen and wear protective clothing when outdoors.
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.
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 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, taking the smallest effective dose for the shortest possible time may lessen the risks. Tell the doctor right away if you notice symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea.
This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
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), cyclosporine, desmopressin, lithium, mifepristone, certain medications for pain (opiate partial agonists such as butorphanol, nalbuphine, pentazocine), 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 also affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, anti-seizure drugs (such as phenobarbital), medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, other narcotic pain relievers (such as codeine, oxymorphone), and psychiatric medicines (such as thioridazine, risperidone, amitriptyline, trazodone). Your medications or doses of your medications may need to be changed.
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.
If overdose is suspected, contact a poison control center or emergency room immediately. 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, or loss of consciousness.
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.
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.
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 April 2014. Copyright(c) 2014 First Databank, Inc.
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