Oxycodone and Ibuprofen (Oral Route)

Drug Information provided by: Micromedex

ARTICLE SECTIONS

US Brand Names

Combunox

Description

Ibuprofen and oxycodone combination is used to relieve pain.

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used in this combination to relieve inflammation, swelling, and pain.

The 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.

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 under 14 years of age. Safety and efficacy have not been established in children below the age of 14 years.

Geriatric

Respiratory problems, kidney problems, or gastrointestinal (GI) tract problems may be more likely to occur in elderly patients, who may be more sensitive than younger adults to the effects of ibuprofen and oxycodone combination. Special care should be taken when treating these patients.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	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.

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

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.

Ketorolac
Naltrexone

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. Discuss with your healthcare professional the use of your medicine with 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 (rare hormonal disease causing fatigue, low blood pressure) or
Anemia or
Alcohol abuse, or history of, or
Bleeding problems or
Dehydration or
Drug dependence, especially narcotic abuse, or history of or
Enlarged prostate or
High blood pressure or
Kidney disease or
Kyphoscoliosis (curvature of spine that can cause breathing problems) or
Liver disease or
Seizure disorders or
Tobacco use or
Toxic psychosis (hallucinations, paranoia) or
Tremors or
Underactive thyroid—The chance of side effects may be increased.

Brain disease or head injury or
Enlarged prostate or problems with urination—The side effects of ibuprofen and oxycodone combination may be dangerous with these conditions.

Bronchial asthma, acute or severe, or other chronic lung disease or
Hypercarbia (large amount of carbon dioxide in the blood) or
Paralytic ileus (blockage in the intestines) or
Respiratory depression (troubled breathing)—Ibuprofen and oxycodone combination should NOT be taken by patients with these conditions.

Coronary artery bypass graft (CABG) surgery (routes blood around blocked or hardened arteries in the heart)—Ibuprofen and oxycodone combination should NOT be used to relieve pain during this operation.

Gallstone problems or
Pancreatitis (inflammation of the pancreas)—May make these conditions worse.

Heart disease or
Heart failure or
Risk factors for heart disease—May increase the risk of serious heart problems, heart attacks, or strokes which could be fatal.

Lupus (disease affecting immune system)—May cause severe unwanted effects in patients taking ibuprofen.

Postoperative period (after a major surgery)—Oxycodone may cause problems if taken right after surgery.

Stomach or intestinal bleeding or ulcers—This medicine should be prescribed with extreme caution in these patients.

Proper Use

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 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 ordered by your health care professional. Taking too much of this medicine may increase the chance of unwanted effects and the chances of abuse.

For oral dosage form (tablets):
- For pain
  - Adults and teenagers (14 years of age and older)—1 tablet (400 milligrams (mg) ibuprofen and 5 mg oxycodone). You should not use more than 4 tablets per day, and this medicine should not be used for longer than 7 days, unless directed by your doctor.
  - Children—Use and dose must be determined by your doctor.

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

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.

Ibuprofen and oxycodone combination will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicines for hay fever, other allergies, or colds; sedatives, tranquilizers, sleeping medicine, or other prescription pain medication. 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.

You should tell your doctor if you are taking corticosteroids or anticoagulants (medicines that prevent blood clots). These medicines could increase your chances of stomach or intestinal bleeding when taken with ibuprofen.

Ibuprofen is an NSAID (nonsteroidal antiinflammatory drug) and NSAIDs can cause serious gastrointestinal (GI) problems including inflammation, bleeding ulcers or tearing of the stomach, small intestine or large intestine. 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.

Your chances of having GI bleeding could be greater if you are on this medicine for a long period of time, if you smoke or use alcohol, if you are older, or if you are in poor health.

This medicine may cause some people to become drowsy, dizzy, light-headed, 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, light-headedness, 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.

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 light-headed
Feeling of warmth or heat
Flushing or redness of skin, especially on face and neck
Headache
Sweating

Rare

Abdominal pain
Blurred vision
Changes in skin color
Chest pain
Confusion
Convulsions
Decrease in frequency of urination
Decreased urine
Difficulty in breathing
Difficulty in passing urine (dribbling)
Dizziness
Dizziness, faintness, or light-headedness when getting up from a lying position
Dry mouth
Excessive muscle tone
Fainting
Fast heartbeat
Fast, pounding, or irregular heartbeat or pulse
Increased need to urinate
Increased thirst
Irregular heartbeat
Loss of appetite
Mood changes
Muscle pain or cramps
Muscle stiffness
Muscle tension or tightness
Nausea or vomiting
Numbness or tingling in hands, feet, or lips
Pain, tenderness, swelling of 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
Weakness

Symptoms of Overdose

Get emergency help immediately if any of the following symptoms of overdose occur:

Blurred vision
Change in consciousness
Chest pain or discomfort
Cold and clammy skin
Confusion
Constricted pupils
Continuing ringing or buzzing or other unexplained noise in ears
Convulsions
Decreased awareness or responsiveness
Difficult or troubled breathing
Difficulty sleeping
Disorientation
Dizziness
Dizziness, faintness, or light-headedness when getting up from a lying position
Drowsiness to profound coma
Fainting
Fast or irregular heartbeat
Fast, pounding, or irregular heartbeat or pulse
Hallucination
Headache
Hearing loss
Irregular, fast or slow, or shallow breathing
Lethargy
Light-headedness, dizziness, or fainting
Loss of bladder control
Loss of consciousness
Mood or other mental changes
Muscle spasm or jerking of all extremities
Nausea
Pale or blue lips, fingernails, or skin
Severe sleepiness
Shortness of breath
Skeletal muscle flaccidity
Sleepiness or unusual drowsiness
Slow or irregular heartbeat
Stomach pain
Sudden fainting
Sudden loss of consciousness
Sweating
Trouble breathing
Unusual tiredness or weakness
Vomiting

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:

More common