Oxycodone and ibuprofen (Oral route)
eye-bue-PROE-fen, ox-i-KOE-done hye-droe-KLOR-ide
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. Ibuprofen/oxycodone hydrochloride is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .
Propionic Acid (class)
Uses of This Medicine:
Ibuprofen and oxycodone combination is used to relieve acute, moderate to severe pain.
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used in this combination 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.
Before Using This Medicine:
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 below 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.
- Abiraterone Acetate
- Beta Glucan
- Chloral Hydrate
- Dabigatran Etexilate
- Eslicarbazepine Acetate
- Methylene Blue
- Morphine Sulfate Liposome
- Nitrous Oxide
- Pentosan Polysulfate Sodium
- Protein C
- Sodium Oxybate
- Tolonium Chloride
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
- Enalapril Maleate
- Ethacrynic Acid
- Olmesartan Medoxomil
- 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.
Other medical problems—
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 disease or
- Depression 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
- Lung disease, severe or
- Problems with urination or
- Psychosis (mental illness) or
- Seizure disorders or
- Systemic lupus erythematosus (SLE) or
- Weakened physical condition—Use with caution. May increase risk for more serious side effects.
- Anemia or
- Breathing problems (e.g., asthma, hypercapnia, hypoxia) or
- Bleeding problems or
- Dehydration or
- Edema (fluid retention) or
- Heart attack, history of or
- Heart disease (e.g., congestive heart failure) or
- Hypertension (high blood pressure) or
- Hypotension (low blood pressure) or
- Kidney disease or
- Liver disease or
- Lung disease (e.g., chronic obstructive pulmonary disease [COPD], cor pulmonale) or
- Pancreatitis (inflammation of the pancreas) or
- Shock or
- Stomach ulcers or bleeding, history of or
- Stroke, history of—Use with caution. May make these conditions worse.
- Aspirin-sensitive asthma or
- Aspirin sensitivity, history of or
- Bronchial asthma, acute or severe, or other chronic lung disease or
- Hypercarbia (large amount of carbon dioxide in the blood) or
- Paralytic ileus (bowel blockage) or
- Respiratory depression (troubled breathing)—Should not be used in patients with these conditions.
- Drug abuse or dependence, or history of—Dependence may be more likely to develop.
- Heart surgery (e.g., coronary artery bypass graft [CABG])—Should not be used to relieve pain right before or after the surgery.
Proper Use of This Medicine:
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 teenagers 14 years of age and older—One 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 teenagers 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.
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.
Precautions While Using This Medicine:
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.
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. Stop taking this medicine and 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.
Liver problems may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you have more than one of these symptoms: abdominal pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.
This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.
Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; a severe skin rash or acne; sores or ulcers on the skin; or fever or chills while you are using this medicine.
Using this medicine during late pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away. Do not use this medicine during the later part of a pregnancy unless your doctor tells you to.
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 meningitis.
If you have heart disease or congestive heart failure (CHF), tell your doctor if you have unexplained weight gain or edema (fluid retention or body swelling) with this medicine.
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.
Side Effects of This Medicine:
- Less common
- Feeling faint, dizzy, or lightheaded
- feeling of warmth or heat
- flushing or redness of the skin, especially on the face and neck
- Abdominal or stomach pain
- blurred vision
- changes in skin color
- chest pain
- decrease in frequency of urination
- decreased urine
- difficulty with breathing
- difficulty in passing urine (dribbling)
- dizziness, faintness, or lightheadedness when getting up from a lying position
- dry mouth
- excessive muscle tone
- fast heartbeat
- fast, pounding, or irregular heartbeat or pulse
- increased need to urinate
- increased thirst
- loss of appetite
- mood changes
- muscle pain or cramps
- muscle stiffness
- muscle tension or tightness
- nausea or vomiting
- numbness or tingling in the hands, feet, or lips
- pain, tenderness, or swelling of the foot or leg
- painful urination
- pale skin
- passing urine more often
- severe constipation
- severe vomiting
- shortness of breath
- troubled breathing with exertion
- unusual bleeding or bruising
- unusual tiredness or weakness
- Symptoms of overdose
- Change in consciousness
- chest pain or discomfort
- cold and clammy skin
- constricted pupils
- continuing ringing or buzzing or other unexplained noise in the ears
- decreased awareness or responsiveness
- difficult or troubled breathing
- difficulty with sleeping
- drowsiness to profound coma
- hearing loss
- irregular, fast or slow, or shallow breathing
- loss of bladder control
- loss of consciousness
- muscle spasm or jerking of all extremities
- pale or blue lips, fingernails, or skin
- severe sleepiness
- skeletal muscle flaccidity
- sleepiness or unusual drowsiness
- sudden fainting
- sudden loss of consciousness
- Less common
- Acid or sour stomach
- bloated full feeling
- difficulty having a bowel movement (stool)
- excess air or gas in the stomach or intestines
- lack or loss of strength
- passing gas
- stomach discomfort, upset, or pain
- Back pain
- body aches or pain
- bruising, large, flat, blue or purplish patches in the skin
- changes in vision
- cough or hoarseness
- difficult urination
- difficulty with moving
- dryness or soreness of the throat
- enlarged abdomen or stomach
- false or unusual sense of well-being
- impaired vision
- increase in body movements
- lower back or side pain
- pain, swelling, or redness in the joints
- runny nose
- taste perversion
- tender, swollen glands in the neck
- trouble with sleeping
- trouble with swallowing
- unable to sleep
- voice changes
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Get emergency help immediately if any of the following symptoms of overdose occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 11/4/2014