Combunox

DRUG DESCRIPTION

Each combination Combunox™ (oxycodone hcl and ibuprofen) tablet contains:

Oxycodone HCl, USP 5 mg
Ibuprofen, USP 400 mg

Combunox (oxycodone hcl and ibuprofen) is supplied in a fixed combination tablet form for oral administration and combines the opioid analgesic agent, oxycodone HCl, with the nonsteroidal anti-inflammatory (NSAID) agent, ibuprofen.

Oxycodone HCl is a centrally acting semisynthetic opioid analgesic. Its chemical name is 4,5?-Epoxy-14-hydroxy-3-methoxy-methylmorphinan-6-one hydrochloride. Its chemical formula is C18H21NO4 HCl and molecular weight is 351.83. Its structural formula is:

Oxycodone HCl  Structural Formula Illustration

Ibuprofen is a nonsteroidal anti-inflammatory drug with analgesic and antipyretic properties. Its chemical name is (±)-2-(p-isobutylphenyl) propionic acid. Its chemical formula is C13H18O2 and molecular weight is 206.29. Its structural formula is:

Inactive ingredients in Combunox (oxycodone hcl and ibuprofen) tablets include: sodium starch glycolate, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, calcium stearate, carboxymethylcellulose, povidone, Opadry® II White, Y-22 7719 coloring agent. Opadry® II White, Y-22 7719 coloring agent consists of titanium dioxide, polydextrose, hypromellose, triacetin and polyethylene glycol 8000.

What are the possible side effects of ibuprofen and oxycodone (Combunox)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
  • black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee ground;
  • swelling or rapid weight gain;
  • shallow breathing, slow...

Read All Potential Side Effects and See Pictures of Combunox »

What are the precautions when taking oxycodone hcl and ibuprofen (Combunox)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to oxycodone or ibuprofen; or to other narcotic pain relievers (such as codeine, hydrocodone); or to aspirin or other NSAIDs (such as naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: intestinal/bowel disorders (such as paralytic ileus, infectious diarrhea, colitis, blockage), recent heart bypass surgery (CABG), kidney disease, liver disease, bleeding/blood-clotting disorders (such as hemophilia, vitamin K deficiency, low platelet count),...

Read All Potential Precautions of Combunox »


Combunox Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, constipation, dizziness, drowsiness, upset stomach, or weakness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: slow/irregular/shallow breathing, dizziness upon standing, fainting, swelling of the hands or feet, sudden or unexplained weight gain, fast/pounding heartbeat, persistent/severe headache, mental/mood changes, difficult/painful swallowing.

Tell your doctor immediately if any of these rare but very serious side effects occur: change in amount of urine, easy bruising/bleeding, signs of infection (such as fever, persistent sore throat), severe stomach/abdominal pain, ringing in the ears, unexplained stiff neck, seizures.

This drug may rarely cause serious (possibly fatal) liver disease. If you notice any of the following highly unlikely but very serious side effects, stop taking this medication and consult your doctor or pharmacist immediately: yellowing eyes/skin, dark urine, unusual/extreme tiredness, persistent nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to oxycodone or ibuprofen; or to other narcotic pain relievers (such as codeine, hydrocodone); or to aspirin or other NSAIDs (such as naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: intestinal/bowel disorders (such as paralytic ileus, infectious diarrhea, colitis, blockage), recent heart bypass surgery (CABG), kidney disease, liver disease, bleeding/blood-clotting disorders (such as hemophilia, vitamin K deficiency, low platelet count), stomach/intestine/esophagus problems (such as bleeding, ulcers, recurring heartburn), diabetes, gout, lung diseases (such as asthma, chronic obstructive pulmonary disease-COPD), breathing problems (such as slow/shallow breathing, sleep apnea), growths in the nose (nasal polyps), a certain spinal problem (kyphoscoliosis), certain heart problems (such as low blood pressure, irregular heartbeat), personal or family history of regular use/abuse of drugs/alcohol/other substances, brain disorders (such as seizures, head injury, tumor, increased intracranial pressure), underactive thyroid (hypothyroidism), difficulty urinating (for example, due to enlarged prostate or narrowed urethra), disease of the pancreas (such as pancreatitis), mental/mood disorders (such as toxic psychosis), gallbladder disease, adrenal gland problem (such as Addison's disease), certain enzyme deficiencies (pyruvate kinase or G6PD deficiency).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication.

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths or sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Older adults may be more sensitive to the side effects of this drug, especially slow/shallow breathing, drowsiness, stomach bleeding, and kidney effects.

During the first 6 months of pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is not recommended for use during the last 3 months of pregnancy because of the potential for harm to an unborn baby and delay of normal labor/delivery. Use of this medication near or at the time of delivery may have undesirable side effects (such as slow/shallow breathing) on the newborn. Consult your doctor for more details. Infants born to mothers who have used oxycodone for a long time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. Tell your doctor immediately if you notice any of these symptoms in your newborn.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.


Combunox Patient Information Including Side Effects

Brand Names: Combunox

Generic Name: ibuprofen and oxycodone (Pronunciation: eye byoo PROE fen and ox i KOE done)

  • What is ibuprofen and oxycodone (Combunox)?
  • What are the possible side effects of ibuprofen and oxycodone (Combunox)?
  • What is the most important information I should know about ibuprofen and oxycodone (Combunox)?
  • What should I discuss with my healthcare provider before taking ibuprofen and oxycodone (Combunox)?
  • How should I take ibuprofen and oxycodone (Combunox)?
  • What happens if I miss a dose (Combunox)?
  • What happens if I overdose (Combunox)?
  • What should I avoid while taking ibuprofen and oxycodone (Combunox)?
  • What other drugs will affect ibuprofen and oxycodone (Combunox)?
  • Where can I get more information?

What is ibuprofen and oxycodone (Combunox)?

Oxycodone is in a group of drugs called narcotic pain relievers.

Ibuprofen is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Ibuprofen works by reducing hormones that cause inflammation and pain in the body.

The combination of ibuprofen and oxycodone is used short-term to relieve moderate to severe pain.

Ibuprofen and oxycodone may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of ibuprofen and oxycodone (Combunox)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
  • black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee ground;
  • swelling or rapid weight gain;
  • shallow breathing, slow heartbeat;
  • confusion, feeling light-headed, fainting;
  • easy bruising or bleeding;
  • nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • severe blistering, peeling, and red skin rash; or
  • fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).

Less serious side effects include:

  • headache, dizziness, drowsiness;
  • mild nausea, vomiting, upset stomach, bloating, gas, constipation, diarrhea;
  • blurred vision; or
  • dry mouth.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ibuprofen and oxycodone (Combunox)?

Ibuprofen can increase your risk of heart attack or stroke. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG). Seek emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

Ibuprofen can also increase your risk of serious effects on the stomach or intestines. These conditions can be fatal and can occur without warning at any time while you are taking ibuprofen. Call your doctor at once if you have black, bloody, or tarry stools, or if you cough up blood or vomit that looks like coffee grounds.

Oxycodone may be habit-forming and should be used only by the person this medicine was prescribed for. Keep the medication in a secure place where others cannot get to it.

Avoid drinking alcohol while taking ibuprofen and oxycodone. Alcohol may increase your risk of stomach bleeding while taking ibuprofen.

Tell your doctor if the medicine seems to stop working as well in relieving your pain.

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