Combunox contains a combination of oxycodone and ibuprofen. Oxycodone is an opioid pain medicine, sometimes called a narcotic. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). This medicine works by reducing substances in the body that cause pain, fever, and inflammation.

Combunox is used short-term to relieve severe pain.

Combunox is not for treating arthritis pain.

Taking Combunox during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Oxycodone can slow or stop your breathing, and may be habit-forming. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Keep the medication in a place where others cannot get to it.

Fatal side effects can occur if you use Combunox with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Before taking this medicine

You should not use Combunox if you are allergic to oxycodone or ibuprofen, or if you have:

• severe asthma or breathing problems; or

• a blockage in your stomach or intestines.

Ibuprofen can increase your risk of fatal heart attack or stroke. Do not use Combunox just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal.

To make sure Combunox is safe for you, tell your doctor if you have ever had

• high blood pressure, heart problems, or a heart attack;

• a stomach ulcer or stomach bleeding;

• breathing problems, sleep apnea;

• liver or kidney disease;

• a head injury, brain tumor, or seizures;

• problems with your pancreas, thyroid, or gallbladder;

• urination problems; or

• alcoholism, drug addiction, mental illness.

Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. These medicines may interact with hydrocodone and cause a serious condition called serotonin syndrome.

If you are pregnant, you should not take Combunox unless your doctor tells you to. Taking an NSAID during the last 20 weeks of pregnancy can cause serious problems in the unborn baby and possible complications with your pregnancy. If you take opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks.

Ask a doctor before using Combunox if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Take Combunox exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides. Never use Combunox in larger amounts, or for longer than prescribed. Use the lowest dose that is effective in treating your condition. Tell your doctor if you feel an increased urge to take more of this medicine.

Never share Combunox with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Store Combunox at room temperature away from moisture and heat.

Do not keep leftover opioid medication. Just one dose can cause death in someone using Combunox accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

Usual Adult Dose of Combunox for Pain:

Initial dose: 1 tablet (oxycodone 5 mg/ibuprofen 400 mg) orally every 6 hours as needed for pain
Maximum dose: 4 tablets in 24 hours
Duration of therapy: Not to exceed 7 days

Comments:
-Because of the risks of addiction, abuse and misuse, the lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
-Monitor patients closely for respiratory depression within the first 24 to 72 hours of initiating therapy and following any increase in dose.

Use: For the short term management of acute to moderate pain severe enough to require an opioid analgesic for which alternative treatments are inadequate.

Usual Pediatric Dose of Combunox for Pain:

14 or older:
Initial dose: 1 tablet (oxycodone 5 mg/ibuprofen 400 mg) orally every 6 hours as needed for pain
Maximum dose: 4 tablets in 24 hours
Duration of therapy: Not to exceed 7 days

Comments:
-Because of the risks of addiction, abuse and misuse, the lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
-Monitor patients closely for respiratory depression within the first 24 to 72 hours of initiating therapy and following any increase in dose.

Use: For the short term management of acute to moderate pain severe enough to require an opioid analgesic for which alternative treatments are inadequate.

You should not use Combunox if you are allergic to oxycodone or ibuprofen, or if you have:

• severe asthma or breathing problems; or

• a blockage in your stomach or intestines.

Ibuprofen can increase your risk of fatal heart attack or stroke. Do not use Combunox just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal.

To make sure Combunox is safe for you, tell your doctor if you have ever had

• high blood pressure, heart problems, or a heart attack;

• a stomach ulcer or stomach bleeding;

• breathing problems, sleep apnea;

• liver or kidney disease;

• a head injury, brain tumor, or seizures;

• problems with your pancreas, thyroid, or gallbladder;

• urination problems; or

• alcoholism, drug addiction, mental illness.

Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. These medicines may interact with hydrocodone and cause a serious condition called serotonin syndrome.

If you are pregnant, you should not take Combunox unless your doctor tells you to. Taking an NSAID during the last 20 weeks of pregnancy can cause serious problems in the unborn baby and possible complications with your pregnancy. If you take opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks.

Ask a doctor before using Combunox if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Since Combunox is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An opioid overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include black or bloody stools, coughing up blood, severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don't wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

Avoid driving or hazardous activity until you know how Combunox will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Do not drink alcohol. Dangerous side effects or death could occur.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to ibuprofen (such as aspirin, ketoprofen, or naproxen).

Get emergency medical help if you have signs of an allergic reaction to Combunox (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg, swelling, feeling short of breath.

The oxycodone in Combunox can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;

• swelling or rapid weight gain;

• a skin rash, no matter how mild;

• pale skin, feeling light-headed;

• signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• kidney problems - little or no urination, swelling in your feet or ankles, feeling tired or short of breath;

• liver problems - loss of appetite, diarrhea, upper stomach pain, tiredness, flu-like symptoms, dark urine, jaundice (yellowing of the skin or eyes); or

• high levels of serotonin in the body - agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are malnourished or debilitated.

Common Combunox side effects may include:

• dizziness, drowsiness;

• blurred vision; or

• nausea, vomiting, upset stomach, constipation, diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");

• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;

• other narcotic medications - opioid pain medicine or prescription cough medicine;

• a sedative like Valium - <diazepam, alprazolam, lorazepam, Xanax, Klonopin, Ativan, and others;

• drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or

• drugs that affect serotonin levels in your body - a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may interact with ibuprofen and oxycodone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.