IBUPROFEN AND OXYCODONE (Systemic)?

Some commonly used brand names are:

In the U.S.?

• Combunox

? Not commercially available in Canada.

Category

• Analgesic

Description

Ibuprofenand oxycodone (eye-byoo-PROE-fen and ox-i-KOE-done) combination is used to relieve pain.

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

The oxycodone is a narcotic analgesic that acts in the central nervoussystem to relieve pain. If oxycodone is used for a long time, it may becomehabit-forming (causing mental or physical dependence). Physical dependencemay lead to withdrawal side effects when you stop taking the medicine. Sinceibuprofen and oxycodone combination is only used for short-term (7 days orless) relief of pain, physical dependence probably will not occur.

This medicine is available only with your doctor's prescription, in thefollowing dosage forms:

Oral
• Tablets (U.S.)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For ibuprofen and oxycodonecombination, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to aspirin, oxycodone or other narcotic analgesics, oribuprofen or other nonsteroidal anti-inflammatory drugs (NSAIDs). Also tellyour doctor and pharmacist if you are allergic to any other substances, suchas foods, preservatives, or dyes.

Pregnancy?Studies on birth defects with ibuprofen and oxycodonecombination have not been done in pregnant women. However, there is a chancethat the ibuprofen in this combination may cause unwanted effects on the heartor blood flow of the fetus or newborn baby if they are taken during the lastfew months of pregnancy. Also, too much use during pregnancy of a narcoticanalgesic like the oxycodone in the combination may cause the baby to becomedependent on the medicine. This may lead to withdrawal side effects afterbirth. Oxycodone may also cause breathing problems in the newborn. Beforetaking this medicine, make sure your doctor knows if you are pregnant or ifyou may become pregnant.

Breast-feeding?Oxycodone passes into the breast milk and hasbeen shown to cause unwanted effects such as withdrawal symptoms and breathingproblems, in the breast-fed baby. It may be necessary for you to take anothermedicine or to stop breast-feeding during treatment. Be sure you have discussedthe risks and benefits of the medicine with your doctor.

Children?Studies on this medicine have been done only inadult and teenage patients, and there is no specific information comparinguse of ibuprofen and oxycodone combination in children with its use in otherage groups.

Older adults?Respiratory problems may be especially likely tooccur in elderly patients, who may be more sensitive than younger adults tothe effects of ibuprofen and oxycodone combination.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingibuprofen and oxycodone combination, it is especially important that yourdoctor and pharmacist know if you are taking any of the following:

• Alcohol or
• Central nervous system (CNS) depressants (medicine that causes drowsiness)?Seriousunwanted effects may be increased.

• Angiotensin-converting enzyme (ACE) inhibitors (Benazepril [e.g.,Lotensin], captopril [e.g., Capoten], enalapril [e.g., Vasotec], fosinopril[e.g., Monopril], lisinopril [e.g., Prinivil, Zestril], quinapril [e.g., Accupril],ramipril [e.g., Altace]?May decrease the effects of these medicines

• Diuretics (water pills)?May decrease the effects of the waterpills; the chance of kidney problems also may be increased.

• Lithium (e.g., Lithane) or
• Methotrexate (e.g., Mexate)?Higher blood levels of these medicinesand an increased chance of side effects may occur

• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g.,Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline[e.g., Eldepryl], tranylcypromine [e.g., Parnate])?May increase unwantedeffects; use of these medicines and ibuprofen and oxycodone combination shouldbe separated by at least 14 days.

• Warfarin (e.g., Coumadin)?The chance of bleeding may be increased

Other medical problems?The presence of other medicalproblems may affect the use of ibuprofen and oxycodone combination. Make sureyou tell your doctor if you have any other medical problems, especially:

• Addison's disease (rare hormonal disease causing fatigue, low bloodpressure) 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
• Heart disease or
• High blood pressure or
• Kidney disease or
• Khyphoscoliosis (curvature of spine that can cause breathing problems)or
• Liver disease or
• Seizure disorders or
• Stomach problems or
• Stomach ulcer or
• Tobacco use or
• Toxic psychosis (hallucinations, paranoia) or
• Tremors or
• Underactive thyroid?The chance of side effects may be increased

• Asthma or other chronic lung disease or
• Brain disease or head injury or
• Enlarged prostate or problems with urination?Side effects ofibuprofen and oxycodone combination may be dangerous with these conditions

• Gallstone problems or
• Pancreatitis (inflammation of the pancreas)?May make theseconditions worse

• Lupus (disease affecting immune system)?May cause severe unwantedeffects in patients taking ibuprofen.

• Postoperative (after a major surgery)?Oxycodone may cause problemsif taken right after surgery.

Proper Use of This Medicine

Dosing?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 fora longer time than ordered by your health care professional. Takingtoo much of this medicine may increase the chance of unwanted effects andthe chances of abuse.

The dose of ibuprofen and oxycodone 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 ibuprofen andoxycodone combination. If your dose is different, do notchange it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine.Also, the number of doses you take each day, the timeallowed between doses, and the length of time you take the medicine dependon the medical problem for which you are taking ibuprofen and oxycodone combination

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

Missed dose?If you miss a dose of this medicine, take itas soon as possible. However, if it is almost time for your next dose, skipthe missed dose and go back to your regular dosing schedule. Do not doubledoses.

Storage?To store this medicine:

• Keep out of the reach of children. Overdose of ibuprofen and oxycodonecombination is very dangerous in young children.
• Store away from heat
• Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask yourhealth care professional how you should dispose of any medicine you do notuse. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Ibuprofenand oxycodone combination will add to the effects of alcohol and other centralnervous system (CNS) depressants (medicines that slow down the nervous system,possibly causing drowsiness). Some examples of CNS depressants are antihistaminesor medicine 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 dentistbefore taking any of the medicines listed above, while you are using thismedicine.

This medicine may cause some people to become drowsy, dizzy, or lightheaded,or to feel a false sense of well-being. Make sure youknow how you react to this medicine before you drive, use machines, or doanything else that could be dangerous if you are dizzy or are not alert andclearheaded. If these reactions are especially bothersome, check withyour doctor.

Dizziness, lightheadedness, or fainting may occur,especially when getting up suddenly from a lying or sitting position. Gettingup slowly may lessen this problem.

Before having any kind of surgery (including dental surgery) or emergencytreatment, tell the medical doctor or dentist in charge that you are takingthis medicine.

Ibuprofen and oxycodone combination may cause dryness of the mouth. Fortemporary 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 than2 weeks, check with your dentist. Continuing dryness of the mouth may increasethe chance of dental disease, including tooth decay, gum disease, and fungusinfections.

Side Effects of This Medicine

Along with its needed effects, a medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.

Also, because of the way these medicines act on the body, there is a chancethat they might cause other unwanted effects that may not occur until monthsor years after the medicine is used. These may include certain types of cancer,such as leukemia or bladder cancer. Discuss these possible effects with yourdoctor.

Check with your doctorimmediately if any of the following side effects occur:

Less common

Feeling faint, dizzy, or lightheadedness; feeling of warmth or heat; flushing or redness ofskin, 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 lightheadednesswhen 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 painor 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; painfulurination; pale skin; passingurine more often; severe constipation; severe vomiting; shortness of breath; troubled breathing with exertion; unusual bleeding or bruising; unusualtiredness or weakness; weakness

Symptoms of Overdose

Get emergency help immediately if any of the followingsymptoms of overdose occur

Blurred vision; change in consciousness; chest pain or discomfort; cold and clammy skin; confusion; constricted pupils; continuing ringing or buzzingor other unexplained noise in ears; convulsions; decreased awareness or responsiveness; difficult or troubled breathing; difficulty sleeping; disorientation; dizziness; dizziness, faintness, or lightheadedness when gettingup from a lying position; drowsiness to profoundcoma; fainting; fast orirregular heartbeat; fast, pounding, or irregularheartbeat or pulse; hallucination; headache; hearing loss; irregular, fast or slow, or shallow breathing; lethargy; lightheadedness, 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 irregularheartbeat; stomach pain; sudden fainting; sudden loss of consciousness; sweating; trouble breathing; unusual tiredness or weakness; vomiting

Other side effects may occur that usually do not need medical attention.These side effects may go away during treatment as your body adjusts to themedicine. However, check with your doctor if any of the following side effectscontinue or are bothersome.

More common

Headache; sleepiness or unusual drowsiness

Less common

Acid or sour stomach; belching; bloated full feeling; diarrhea; difficulty having a bowel movement (stool); excess air or gas in 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 in moving; dryness or soreness of throat; enlargedabdomen; 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 joints; rash; runny nose; sleeplessness; stomach pain; swelling; taste perversion; tender, swollen glands in neck; trouble in swallowing; trouble sleeping; unableto sleep; voice changes

Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.