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|Combunox

IBUPROFEN AND OXYCODONE (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Combunox

† Not commercially available in Canada.

Category

• Analgesic

Description

Ibuprofen and 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 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, in the following 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 will do. This is a decision you and your doctor will make. For ibuprofen and oxycodone combination, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to aspirin, oxycodone or other narcotic analgesics, or ibuprofen or other nonsteroidal anti-inflammatory drugs (NSAIDs). Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies on birth defects with ibuprofen and oxycodone combination have not been done in pregnant women. However, there is a chance that the ibuprofen in this combination may cause unwanted effects on the heart or blood flow of the fetus or newborn baby if they are taken during the last few months of pregnancy. Also, too much use during pregnancy of a narcotic analgesic like the oxycodone in the combination may cause the baby to become dependent on the medicine. This may lead to withdrawal side effects after birth. Oxycodone may also cause breathing problems in the newborn. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Oxycodone passes into the breast milk and has been shown to cause unwanted effects such as withdrawal symptoms and breathing problems, in the breast-fed baby. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—Studies on this medicine have been done only in adult and teenage patients, and there is no specific information comparing use of ibuprofen and oxycodone combination in children with its use in other age groups.

Older adults—Respiratory problems may be especially likely to occur in elderly patients, who may be more sensitive than younger adults to the effects of ibuprofen and oxycodone combination.

Other medicines—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 ibuprofen and oxycodone combination, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Alcohol or
• Central nervous system (CNS) depressants (medicine that causes drowsiness)—Serious unwanted 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 water pills; the chance of kidney problems also may be increased.

• Lithium (e.g., Lithane) or
• Methotrexate (e.g., Mexate)—Higher blood levels of these medicines and 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 unwanted effects; use of these medicines and ibuprofen and oxycodone combination should be separated by at least 14 days.

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

Other medical problems—The presence of other medical problems may affect the use of ibuprofen and oxycodone combination. 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
• 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 of ibuprofen and oxycodone combination may be dangerous with these conditions

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

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

• Postoperative (after a major surgery)—Oxycodone may cause problems if 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 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.

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 and oxycodone combination. If your dose is different, do not change 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 time allowed between doses, and the length of time you take the medicine depend on 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 (400 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—To store this medicine:

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

Precautions While Using This Medicine

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 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 dentist before taking any of the medicines listed above, while you are using this medicine .

This medicine may cause some people to become drowsy, dizzy, or 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.

Side Effects of This Medicine

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.

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

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

Developed: 04/14/2005

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