Description
Ibuprofen and oxycodone combination is used to relieve acute, moderate to severe pain.
Ibuprofen is a nonsteroidal antiinflammatory drug (NSAID) that is used to relieve inflammation, swelling, and pain. Oxycodone is an opioid 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 symptoms 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.
This product is available in the following dosage forms:
- Tablet
Before Using
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:
Allergies
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.
Pediatric
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.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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.
- Isocarboxazid
- Ketorolac
- Levoketoconazole
- Mavorixafor
- Naltrexone
- Phenelzine
- Safinamide
- Samidorphan
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.
- Abciximab
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Aceclofenac
- Acemetacin
- Acenocoumarol
- Acepromazine
- Aclidinium
- Alfentanil
- Almotriptan
- Alosetron
- Alprazolam
- Amantadine
- Amifampridine
- Amiloride
- Amineptine
- Amiodarone
- Amitriptyline
- Amitriptylinoxide
- Amobarbital
- Amoxapine
- Amphetamine
- Amprenavir
- Amtolmetin Guacil
- Anagrelide
- Anileridine
- Apalutamide
- Apixaban
- Aprepitant
- Ardeparin
- Argatroban
- Aripiprazole
- Aripiprazole Lauroxil
- Armodafinil
- Asciminib
- Asenapine
- Aspirin
- Atazanavir
- Atropine
- Avacopan
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.
- Acebutolol
- Amikacin
- Atenolol
- Azilsartan
- Azilsartan Medoxomil
- Benazepril
- Betaxolol
- Bisoprolol
- Candesartan
- Captopril
- Carteolol
- Carvedilol
- Celiprolol
- Desflurane
- Enalapril
- Enalaprilat
- Eprosartan
- Esmolol
- Fosinopril
- Irbesartan
- Labetalol
- Levobunolol
- Lisinopril
- Losartan
- Metipranolol
- Metoprolol
- Moexipril
- Nadolol
- Nebivolol
- Olmesartan
- Oxprenolol
- Penbutolol
- Perindopril
- Pindolol
- Propranolol
- Quinapril
- Ramipril
- Sotalol
- Spirapril
- Telmisartan
Other Interactions
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.
- Ethanol
- Grapefruit Juice
- 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 use disorder, history of or
- Brain tumor or
- Breathing or lung problems (eg, asthma, COPD, cor pulmonale, hypercapnia, hypoxia) or
- Depression, history of or
- Drug use disorder or dependence, especially opioid use disorder 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.
- Aspirin-sensitive asthma or
- Aspirin sensitivity, history of or
- Heart surgery (eg, coronary artery bypass graft [CABG]) or
- Lung or breathing problems (eg, asthma, respiratory depression), severe or
- Stomach or bowel blockage (eg, paralytic ileus)—Should not be used in patients with these conditions.
Proper Use
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.
Close follow-up with healthcare providers and creation of a pain management plan is an effective way to manage chronic pain. This plan may include limiting opioid medicines to the lowest effective dose for a limited period of time. The plan may also include non-medicine treatments such as relaxation techniques, massage therapy, or transcutaneous electrical stimulation (TENS).
Dosing
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. Your doctor may recommend a lower dose if you have a history of kidney disease or high risk for bleeding.
- Children and children younger than 14 years of age—Use and dose must be determined by your doctor.
- For pain:
Missed Dose
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.
Storage
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.
Drop off any unused opioid medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused opioid medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm
Precautions
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. Your doctor may prescribe naloxone to treat an overdose. Naloxone is a medicine that temporarily reverses the effects of an overdose. If you have been prescribed naloxone, make sure household members know how to use this on you in the event of an overdose or suspected overdose. Emergency medical attention is still needed after naloxone is used because the reversal effects are only temporary. 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 be present in breast milk and passed to your baby. Talk to your doctor if you plan to breastfeed or have questions about how this medicine may affect your baby.
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 opioids, 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.
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.
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.
Side Effects
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:
Less common
- Feeling faint, dizzy, or lightheaded
- feeling of warmth or heat
- flushing or redness of the skin, especially on the face and neck
- headache
- sweating
Rare
- Abdominal or stomach pain
- blurred vision
- changes in skin color
- chest pain
- confusion
- convulsions
- decrease in frequency of urination
- decreased urine
- difficulty in passing urine (dribbling)
- difficulty with breathing
- dizziness
- dizziness, faintness, or lightheadedness when getting up from a lying position
- dry mouth
- excessive muscle tone
- fainting
- 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
- troubled breathing with exertion
- unusual bleeding or bruising
- unusual tiredness or weakness
Get emergency help immediately if any of the following symptoms of overdose occur:
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
- disorientation
- drowsiness to profound coma
- fainting
- hearing loss
- irregular, fast or slow, or shallow breathing
- lethargy
- loss of bladder control
- loss of consciousness
- muscle spasm or jerking of all extremities
- pale or blue lips, fingernails, or skin
- seeing, hearing, or feeling things that are not there
- severe sleepiness
- skeletal muscle flaccidity
- sleepiness or unusual drowsiness
- sudden fainting
- sudden loss of consciousness
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:
Less common
- Acid or sour stomach
- belching
- bloated or full feeling
- diarrhea
- difficulty having a bowel movement (stool)
- excess air or gas in the stomach or intestines
- fever
- heartburn
- indigestion
- lack or loss of strength
- passing gas
- stomach discomfort, upset, or pain
Rare
- Back pain
- body aches or pain
- bruising, large, flat, blue or purplish patches in the skin
- changes in vision
- chills
- congestion
- cough or hoarseness
- delusions
- dementia
- difficult urination
- difficulty with moving
- dryness or soreness of the throat
- enlarged abdomen or stomach
- false or unusual sense of well-being
- fear
- hoarseness
- impaired vision
- increase in body movements
- lower back or side pain
- nervousness
- pain, swelling, or redness in the joints
- rash
- runny nose
- swelling
- taste perversion
- tender, swollen glands in the neck
- trouble with sleeping
- trouble with swallowing
- voice changes
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.
DRG-20062031
