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Generic Name: Ibuprofen/Oxycodone (eye-BYOO-pro-fen/ox-ee-KOE-done)
Brand Name: Combunox
Ibuprofen/Oxycodone contains a nonsteroidal anti-inflammatory drug (NSAID). NSAIDs have been associated with serious, possibly fatal, heart and blood vessel risks such as heart attack and stroke. This risk increases with long-term use of NSAIDs or if you have heart problems. NSAIDs should not be used right before or after bypass heart surgery. Additionally, NSAIDs can cause serious, possibly fatal stomach ulcers and bleeding, which can occur without warning signs. The following factors increase the risk of serious stomach problems in patients being treated with NSAIDs: history of stomach bleeding or ulcer disease, long-term use of NSAIDs, smoking, use of alcohol, poor health, older age, use of certain medicines such as anticoagulants (eg, warfarin) or corticosteroids
(eg, prednisone) while taking an NSAID. To reduce your risk
of serious side effects, take Ibuprofen/Oxycodone exactly as instructed, at the lowest dose possible, and for the shortest time needed.
Ibuprofen/Oxycodone is used for:
Treating moderate to severe pain over a short period of time (no more than 7 days).
Ibuprofen/Oxycodone is a narcotic and NSAID combination. The NSAID reduces the formation of prostaglandins that cause pain and inflammation. The narcotic works on the narcotic receptors in the brain to decrease pain.
Do NOT use Ibuprofen/Oxycodone if:
- you are allergic to any ingredient in Ibuprofen/Oxycodone 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 or nasal growths after taking aspirin
- 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
(MAO) inhibitor (eg, phenelzine) within the past 14 days
- you are having or have recently had heart bypass surgery
Contact your doctor or health care provider right away if any of these apply to you.
Before using Ibuprofen/Oxycodone :
Some medical conditions may interact with Ibuprofen/Oxycodone . 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 blood or
bleeding problems, dehydration, stomach or bowel problems (eg, ulcers, bleeding, blockage, perforation), mouth inflammation, liver or kidney problems, pancreas or gallbladder problems, heart problems
(eg, heart failure, cor pulmonale), a recent heart attack, circulation problems
(eg, circulatory shock), thyroid problems, an enlarged prostate, or trouble urinating
- if you have stomach problems (eg, heartburn, stomach pain or upset)
that keep coming back
- If you have a history of Addison disease, asthma, lung or breathing problems (eg, chronic obstructive pulmonary disease [COPD]), growths in the brain, increased pressure in the brain, a recent head injury, severe curvature of the spine, severe drowsiness, coma, recent surgery, lupus, high blood pressure, seizures, mental or mood problems, or suicidal thoughts or behavior
- If you have a history of tobacco use, drug or alcohol abuse or dependence, or withdrawal
- if you
have been severely ill or weakened
Some MEDICINES MAY INTERACT with Ibuprofen/Oxycodone . Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticholinergics (eg, benztropine), cyclosporine, MAO inhibitors (eg, phenelzine), probenecid, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or tricyclic antidepressants (eg, amitriptyline) because side effects of Ibuprofen/Oxycodone may be increased
- 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 excessive drowsiness or severe breathing problems may be increased
- Agonist/antagonist analgesics (eg, pentazocine) or naltrexone because the effectiveness of Ibuprofen/Oxycodone may be decreased
- Lithium, methotrexate, or neuromuscular blockers (eg, pancuronium) because side effects may be increased by Ibuprofen/Oxycodone
- Anticoagulants (eg, warfarin), corticosteroids (eg, prednisone), heparin, quinolone antibiotics (eg, ciprofloxacin), or salicylates (eg, aspirin) because the risk of bleeding or seizures may be increased
- Angiotensin-converting enzyme (ACE) inhibitors (eg, captopril), loop diuretics (eg, furosemide), or thiazide diuretics (eg, hydrochlorothiazide)
because the effectiveness may be decreased by Ibuprofen/Oxycodone
This may not be a complete list of all interactions that may occur. Ask your health care provider if Ibuprofen/Oxycodone 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 Ibuprofen/Oxycodone :
Use Ibuprofen/Oxycodone as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Ibuprofen/Oxycodone may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Do not take more than 4 tablets in 24 hours unless directed otherwise by a doctor.
- If you miss a dose of Ibuprofen/Oxycodone 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 Ibuprofen/Oxycodone .
Important safety information:
- Ibuprofen/Oxycodone 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 Ibuprofen/Oxycodone .
Using Ibuprofen/Oxycodone alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
- Ibuprofen/Oxycodone 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 Ibuprofen/Oxycodone . Ibuprofen/Oxycodone will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
- Do not exceed the recommended dose or take Ibuprofen/Oxycodone for longer than prescribed without checking with your doctor.
- Serious stomach ulcers or bleeding can occur with Ibuprofen/Oxycodone . Taking Ibuprofen/Oxycodone in high doses, taking it
for long periods of time, or drinking alcohol increases the risk of these side effects. Taking Ibuprofen/Oxycodone 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.
- Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Ibuprofen/Oxycodone .
- Ibuprofen/Oxycodone 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.
- Lab tests, including liver and kidney function tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
- Use Ibuprofen/Oxycodone with caution in the ELDERLY because they may be more sensitive to its effects, especially breathing problems or stomach bleeding.
- Use Ibuprofen/Oxycodone with extreme caution in CHILDREN younger than 14 years of age. Safety and effectiveness in this age group have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Ibuprofen/Oxycodone , discuss with your doctor the benefits and risks of using Ibuprofen/Oxycodone during pregnancy. Avoid using Ibuprofen/Oxycodone during the last 3 months of pregnancy and during labor and delivery because it may cause harm to the fetus. Ibuprofen/Oxycodone is excreted in breast milk. Do not breast-feed while taking Ibuprofen/Oxycodone .
When used for long periods of time or at high doses, Ibuprofen/Oxycodone 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 Ibuprofen/Oxycodone 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 Ibuprofen/Oxycodone . This is known as DEPENDENCE or addiction.
If you suddenly stop taking Ibuprofen/Oxycodone , 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 Ibuprofen/Oxycodone :
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:
Seek medical attention right away if any of these SEVERE side effects occur:
Anxiety; constipation; diarrhea; dizziness; drowsiness; headache; indigestion;
infection; nausea; nervousness; sleeplessness; stomach pain; swelling; tiredness;
upset stomach; vomiting;
Severe allergic reactions (rash; hives; 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; 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 stomach pain; 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 or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include blurred vision; cold and clammy skin; confusion; severe dizziness, drowsiness, or coma; severe muscle weakness; slow, shallow, or difficult breathing.
Proper storage of Ibuprofen/Oxycodone :
Store Ibuprofen/Oxycodone 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 Ibuprofen/Oxycodone out of the reach of children and away from pets.
- If you have any questions about Ibuprofen/Oxycodone , please talk with your doctor, pharmacist, or other health care provider.
- Ibuprofen/Oxycodone 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.
This information is a summary only. It does not contain all information about Ibuprofen/Oxycodone . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.
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