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Generic Name: ibuprofen/oxycodone (EYE-bue-PROE-fen/OX-i-KOE-done)
Brand Name: Combunox

Combunox contains a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, heart attack, stroke). The risk may be greater if you already have heart problems or if you take Combunox for a long time. Do not use Combunox right before or after bypass heart surgery.

Combunox may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.

Combunox is used for:

Treating sudden, moderate to severe pain over a short period of time (no more than 7 days).

Combunox is a narcotic and NSAID combination. The NSAID reduces certain substances in the body that cause pain and inflammation. The narcotic works in the brain to decrease pain.

Do NOT use Combunox if:

  • you are allergic to any ingredient in Combunox or any other codeine- or morphine-related medicine (eg, codeine)
  • you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, hoarseness, dizziness) to aspirin or an NSAID (eg, ibuprofen, naproxen, celecoxib)
  • you have had asthma, a skin rash, or growths in the nose (nasal polyps) after taking aspirin or other NSAIDs
  • you have difficult or irregular breathing, active or severe asthma, high levels of carbon dioxide in the blood, severe bowel problems (eg, lack of muscle movement, diarrhea due to poisoning or antibiotic use), or severe kidney disease
  • you are taking sodium oxybate (GHB) or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days
  • you are having or have recently had heart bypass surgery
  • you are in the last 3 months of pregnancy

Contact your doctor or health care provider right away if any of these apply to you.

Before using Combunox:

Some medical conditions may interact with Combunox. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of high blood pressure, blood disorders, bleeding or clotting problems, heart problems (eg, heart failure, cor pulmonale), swelling or fluid buildup, a recent heart attack, or if you are at risk of any of these diseases
  • if you have poor health, dehydration or low fluid volume, low blood sodium levels, mouth inflammation, liver or kidney problems, pancreas or gallbladder problems, thyroid problems, an enlarged prostate, or trouble urinating
  • if you have stomach problems (eg, heartburn, stomach pain or upset) that keep coming back or bowel problems (eg, bleeding, perforation, ulcers)
  • if you have a history of Addison disease, asthma, lung or breathing problems (eg, chronic obstructive pulmonary disease [COPD]), growths or tumors in the brain, increased pressure in the brain, a recent head injury, severe curvature of the spine, severe drowsiness, coma, recent surgery, lupus, seizures, mental or mood problems, or suicidal thoughts or behavior
  • if you have a history of tobacco or cigarette use, drug or alcohol abuse or dependence, or withdrawal

Some MEDICINES MAY INTERACT with Combunox. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Antihistamines (eg, diphenhydramine), barbiturate anesthetics (eg, thiopental), barbiturates (eg, phenobarbital), cimetidine, narcotic pain medicine (eg, codeine), phenothiazines (eg, chlorpromazine), sodium oxybate (GHB), or tranquilizers because the risk of severe drowsiness or severe breathing problems may be increased
  • Anticoagulants (eg, warfarin), clopidogrel, corticosteroids (eg, prednisone), heparin, quinolone antibiotics (eg, ciprofloxacin), or salicylates (eg, aspirin) because the risk of bleeding or seizures may be increased
  • Anticholinergics (eg, benztropine), cyclosporine, MAOIs (eg, phenelzine), probenecid, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or tricyclic antidepressants (eg, amitriptyline) because they may increase this risk of Combunox's side effects
  • Agonist/antagonist analgesics (eg, pentazocine), naltrexone or rifampin, because they may decrease Combunox's effectiveness
  • Lithium, methotrexate, or neuromuscular blockers (eg, pancuronium) because the risk of their side effects may be increased by Combunox
  • Angiotensin-converting enzyme (ACE) inhibitors (eg, captopril), loop diuretics (eg, furosemide), or thiazide diuretics (eg, hydrochlorothiazide) because their effectiveness may be decreased by Combunox

This may not be a complete list of all interactions that may occur. Ask your health care provider if Combunox may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Combunox:

Use Combunox as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Combunox comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Combunox refilled.
  • Take Combunox by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.
  • Take Combunox with a full glass of water (8 oz/240 mL) as directed by your doctor.
  • Do not take more than 4 tablets in 24 hours unless directed otherwise by a doctor.
  • If you miss a dose of Combunox and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Combunox.

Important safety information:

  • Combunox may cause drowsiness, dizziness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Combunox. Using Combunox alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
  • Combunox may cause dizziness, lightheadedness, or fainting. Alcohol, hot weather, exercise, or fever can increase these effects. To prevent them, sit or stand up slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness.
  • Avoid drinking alcohol or taking other medicines that cause drowsiness (eg, sedatives, tranquilizers) while taking Combunox. Combunox will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
  • Do NOT take more than the recommended dose or take Combunox for longer than prescribed without checking with your doctor.
  • Serious stomach ulcers or bleeding can occur with Combunox. Taking Combunox in high doses, taking it for long periods of time, or drinking alcohol increases the risk of these side effects. Taking Combunox with food will NOT reduce the risk of these effects. If you have severe stomach or back pain, black tar-like stools, vomit that looks like blood or coffee grounds, or unusual weight gain or swelling, contact your doctor or emergency room immediately.
  • Tell your doctor or dentist that you take Combunox before you receive any medical or dental care, emergency care, or surgery.
  • Combunox contains ibuprofen. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains ibuprofen, an NSAID, or an aspirin-like medicine. If it does or if you are uncertain, contact your doctor or pharmacist.
  • Do not take aspirin while you are using Combunox unless your doctor tells you to.
  • Lab tests, including liver and kidney function tests or blood counts, may be performed while you use Combunox. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Combunox with caution in the ELDERLY; they may be more sensitive to its effects, especially breathing problems or stomach bleeding.
  • Use Combunox with extreme caution in CHILDREN younger than 14 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Combunox while you are pregnant. Avoid using Combunox during the last 3 months of pregnancy and during labor and delivery because it may cause harm to the fetus. Combunox is found in breast milk. Do not breast-feed while taking Combunox.

When used for long periods of time or at high doses, Combunox may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Combunox stops working well. Do not take more than prescribed.

When used for long periods of time or at high doses, some people develop a need to continue taking Combunox. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Combunox, you may experience WITHDRAWAL symptoms, including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Combunox:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anxiety; constipation; diarrhea; dizziness; drowsiness; headache; indigestion; infection; nausea; nervousness; sleeplessness; stomach pain; swelling; tiredness; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; blurred vision or other eye problems; chest pain; dark urine; fainting; fast or irregular heartbeat; fever; flu-like symptoms; increased or decreased urination; irregular or difficult breathing; mental or mood changes; red, swollen, blistered, or peeling skin; severe or persistent dizziness; severe or persistent nausea or stomach pain; shortness of breath; slurred speech; stiff neck; swelling of the arms or legs; unusual tiredness or weakness; unusual weight gain; vomit that looks like coffee grounds; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( ), or emergency room immediately. Symptoms may include blurred vision; cold, clammy skin; confusion; severe dizziness, drowsiness, or coma; severe muscle weakness; slow, shallow, or difficult breathing.

Proper storage of Combunox:

Store Combunox at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Combunox out of the reach of children and away from pets.

General information:

  • If you have any questions about Combunox, please talk with your doctor, pharmacist, or other health care provider.
  • Combunox is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Combunox or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Combunox. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Combunox. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Combunox.

Issue Date: June 3, 2015