Oxycodone/aspirin has a risk for abuse and addiction, which can lead to overdose and death. Oxycodone/aspirin may also cause severe, possibly fatal, breathing problems. To lower your risk, your doctor should have you take the smallest dose of oxycodone/aspirin 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/aspirin from your body, which may affect how oxycodone/aspirin works. Be sure you know how to take oxycodone/aspirin 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.Who should not take OXYCODONE HCL-ASPIRIN?
This medication is used to relieve moderate to moderately severe pain. It contains 2 pain relievers: oxycodone and aspirin. Oxycodone is an opioid (narcotic) pain reliever that acts on certain parts of the brain to relieve pain. Aspirin is known as a salicylate and a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking a certain natural substance in your body to reduce pain and swelling, therefore making you more comfortable and more able to function normally.
Take this medication by mouth as directed by your doctor. Take it with a full glass (8 ounces or 240 milliliters) of water. Do not lie down for at least 10 minutes after taking a dose. To help prevent stomach upset, take it with food or milk. 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). Follow your doctor's instructions exactly. Your doctor may instruct you to take this medication only as needed for shorter periods of pain (such as after surgery) or on a regular schedule for ongoing pain (such as cancer pain).
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.
The dosage is based on your medical condition, use of other pain medications, and response to treatment. Do not increase your dose without consulting your doctor or pharmacist. Do not take more than 4 grams (4000 milligrams) of aspirin in 24 hours. Use the smallest effective dose.
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 with this medication. Ask your doctor or pharmacist about using oxycodone safely with other drugs.
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.
See also Warning section.
Nausea, vomiting, upset stomach, constipation, dizziness, drowsiness, headache, increased sweating, dry mouth, lightheadedness, or weakness may occur. Some of these side effects may decrease after you have been using this medication for a while. 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: slow/fast/irregular heartbeat, mental/mood changes (such as depression, hallucinations, confusion), difficult/painful urination, ringing in the ears, decreased hearing, vision changes, easy bruising/bleeding, stomach/abdominal pain, black stools, vomit that looks like coffee grounds, yellowing eyes/skin, dark urine, persistent nausea, signs of kidney problems (such as change in the amount of urine), signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss).
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.
Before taking oxycodone with aspirin, tell your doctor or pharmacist if you are allergic to it; or to other opioids (such as codeine, hydrocodone, oxymorphone), salicylates (such as salsalate), or nonsteroidal anti-inflammatory drugs (such as ibuprofen, 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), kidney disease, liver disease, bleeding/blood-clotting disorders (such as hemophilia, vitamin K deficiency, low platelet count), stomach problems (such as ulcers, heartburn, stomach pain), 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).
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.
Before having surgery, tell your doctor or dentist that you are taking this medication.
Older adults may be more sensitive to the side effects of this drug, especially stomach/intestinal bleeding and ulcers, drowsiness, dizziness, slow/shallow breathing, confusion, difficulty urinating, and constipation.
This product contains aspirin. Children and teenagers less than 18 years old should not take aspirin if they have chickenpox, flu, or any undiagnosed illness, or if they have recently received a vaccine. In these cases, taking aspirin increases the risk of Reye's syndrome, a rare but serious illness.
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. This medication is not recommended for use during pregnancy. It may harm an unborn baby and interfere with normal labor/delivery. Consult your doctor for more details.
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: acetazolamide, certain cancer drugs (mercaptopurine, methotrexate), cimetidine, corticosteroids (such as prednisone), mifepristone, naltrexone, certain medications for pain (opioid partial agonists such as butorphanol, nalbuphine, pentazocine).
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.
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 all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (NSAIDs such as ibuprofen, naproxen, aspirin) that may increase your risk for side effects if taken together with this medication. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.
This medication may interfere with certain laboratory tests (blood amylase and lipase levels, urine sugar tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
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: ringing in the ears, fever, slow/shallow breathing, severe drowsiness, slow heartbeat, severe dizziness, pinpoint pupils, cold/clammy skin, limp/weak muscles, coma.
If you are using this medication regularly or at high doses, laboratory and/or medical tests (such as kidney and liver function tests, blood count, aspirin level) 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 use 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. See packaging for the exact temperature range. If you have any questions about storage, ask your pharmacist. Do not store in the bathroom. Keep all medicines 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. 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.
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