Therapeutic ClassificationsOpioid/NSAID Combination
Oxycodone hydrochloride/ibuprofen has the potential for addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing, and monitor for development of these behaviors or conditions. Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Accidental ingestion of oxycodone hydrochloride/ibuprofen, especially in children, can result in fatal overdose of oxycodone hydrochloride and ibuprofen. Prolonged use of oxycodone hydrochloride/ibuprofen during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Concomitant use of cytochrome P450 3A4 inhibitors or discontinuation of concomitantly used cytochrome P450 3A4 inducers may affect the plasma levels of oxycodone and lead to increased adverse reactions and fatal respiratory depression. Monitor patients carefully when oxycodone hydrochloride/ibuprofen and cytochrome P450 3A4 inhibitors and inducers are concurrently used. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options. Limit dosages and durations to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation. NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Oxycodone hydrochloride/ibuprofen is contraindicated for use in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also increase the risk of serious gastrointestinal (GI) adverse events (eg, bleeding, ulceration, and perforation of the stomach or intestines) especially in the elderly and patients with a prior history of ulcer disease and/or GI bleeding, which can be fatal .
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Ibuprofen is a nonsteroidal antiinflammatory drug (NSAID) that is used to relieve inflammation, swelling, and pain. Oxycodone is a narcotic analgesic that acts in the central nervous system to relieve pain. If oxycodone is used for a long time, it may become habit-forming (causing mental or physical dependence). Physical dependence may lead to withdrawal side effects when you stop taking the medicine. Since ibuprofen and oxycodone combination is only used for short-term (7 days or less) relief of pain, physical dependence probably will not occur.
This medicine is available only with your doctor's prescription.
For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Taking too much of this medicine may increase the chance of unwanted effects.
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For pain:
- Adults and children 14 years of age and older—1 tablet every 4 to 6 hours as needed. However, the dose is usually not more than 4 tablets per day, and should not be taken for longer than 7 days, unless directed by your doctor.
- Children and children younger than 14 years of age—Use and dose must be determined by your doctor.
- For pain:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Use & StorageTOP
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of ibuprofen and oxycodone combination in children younger than 14 years of age. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oxycodone and ibuprofen combination in the elderly. However, elderly patients who may be more sensitive than younger adults to the effects of ibuprofen and oxycodone combination, are more likely to have kidney, lung, or stomach problems, which may require caution in patients receiving oxycodone and ibuprofen combination.
|1st Trimester||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
|2nd Trimester||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
|3rd Trimester||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amtolmetin Guacil
- Bismuth Subsalicylate
- Chloral Hydrate
- Choline Magnesium Trisalicylate
- Choline Salicylate
- Dabigatran Etexilate
- Eslicarbazepine Acetate
- Ethacrynic Acid
- Flufenamic Acid
- Magnesium Salicylate
- Mefenamic Acid
- Methylene Blue
- Morphine Sulfate Liposome
- Niflumic Acid
- Nimesulide Beta Cyclodextrin
- Nitrous Oxide
- Opium Alkaloids
- Pentosan Polysulfate Sodium
- Phenyl Salicylate
- Protein C
- Salicylic Acid
- Sodium Oxybate
- Sodium Salicylate
- Tenofovir Disoproxil Fumarate
- Tiaprofenic Acid
- Tolfenamic Acid
- Tolonium Chloride
- Trolamine Salicylate
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Azilsartan Medoxomil
- Candesartan Cilexetil
- Olmesartan Medoxomil
- Perindopril Erbumine
- St John's Wort
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Other Medical ProblemsTOP
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Addison's disease (adrenal gland problem) or
- Alcohol abuse, history of or
- Brain tumor or
- Breathing or lung problems (eg, asthma, COPD, cor pulmonale, hypercapnia, hypoxia) or
- Depression, history of or
- Drug abuse or dependence, especially narcotic abuse or dependence, or history of or
- Enlarged prostate (BPH, prostatic hypertrophy) or
- Head injury or
- Hypothyroidism (underactive thyroid) or
- Kidney disease, severe or
- Kyphoscoliosis (curvature of spine that can cause breathing problems) or
- Liver disease, severe or
- Problems with urination or
- Psychosis (mental illness) or
- Systemic lupus erythematosus (SLE) or
- Weakened physical condition—Use with caution. May increase risk for more serious side effects.
- Anemia or
- Bleeding problems or
- Dehydration or
- Edema (fluid retention) or
- Heart attack, recent or
- Heart disease (eg, congestive heart failure) or
- Hypertension (high blood pressure) or
- Hypotension (low blood pressure) or
- Kidney disease or
- Liver disease or
- Pancreatitis (inflammation of the pancreas) or
- Seizures, history of or
- Stomach ulcers or bleeding, history of or
- Stroke, history of—Use with caution. May make these conditions worse.
It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.
Your doctor will want to check your blood pressure at the beginning of treatment and monitor it throughout treatment with this medicine. If high blood pressure occurs or worsens while taking this medicine, it may lead to serious heart problems.
Do not use more of this medicine or take it more often than your doctor tells you to. This can be life-threatening. Symptoms of an overdose include extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, and cold, clammy skin. Call your doctor right away if you notice these symptoms.
Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.
This medicine may increase your risk of having a heart attack or stroke. This is more likely to occur in people who already have heart disease. People who use this medicine for a long time might also have a higher risk. Some signs of serious heart problems are chest pain, tightness in the chest, fast or irregular heartbeat, or unusual flushing or warmth of the skin. Check with your doctor right away if you notice any of these warning signs.
Ibuprofen and oxycodone combination will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for hay fever, allergies, or colds, sedatives, tranquilizers, sleeping medicine, or other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Do not drink alcoholic beverages, and check with your medical doctor or dentist before taking any of the medicines listed above, while you are using this medicine.
This medicine may cause bleeding in your stomach or intestines. This is more likely to occur if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain other medicines (such as steroids or a blood thinner). These problems can occur at any time with or without warning, and can be fatal. You should contact your doctor immediately if any of the following symptoms occur including black, tarry stools, bloody stools, vomiting of blood or material that looks like coffee grounds, severe or continuing stomach pain, cramping, or burning, trouble breathing, severe or continuing nausea, heartburn and/or indigestion.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions (Stevens-Johnson syndrome). These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.
This medicine may cause some people to become drowsy, dizzy, lightheaded, or to feel a false sense of well-being. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and clearheaded. If these reactions are especially bothersome, check with your doctor.
Dizziness, lightheadedness, or fainting may occur, especially when getting up suddenly from a lying or sitting position. Getting up slowly may lessen this problem.
Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.
Ibuprofen and oxycodone combination may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.
Call your doctor right away if you have confusion, drowsiness, fever, a general feeling of illness, a headache, loss of appetite, nausea, a stiff neck or back, or vomiting. These could be symptoms of a serious condition called aseptic meningitis.
Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.
Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.