Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID). Tramadol is an opioid pain medicine.

Celecoxib and tramadol is a combination medicine used in adults for the management of pain when other medicines cannot be used or have not worked.

Celecoxib and tramadol may also be used for purposes not listed in this medication guide.

MISUSE OF celecoxib and tramadol CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep this medicine where others cannot get to it.

Celecoxib and tramadol can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Celecoxib and tramadol may also cause stomach or intestinal bleeding, which can be fatal. This can occur without warning, especially in older adults.

Follow all directions on your prescription label and read all medication guides. Use the lowest dose that is effective in treating your condition. Do not take more than your prescribed dose.

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

Call your doctor if the dose you are taking does not control your pain.

You may have withdrawal symptoms if you stop using celecoxib and tramadol suddenly. Ask your doctor before stopping the medicine.

Do not keep leftover medicine. Just one dose can cause death in someone using it accidentally or improperly. Ask your pharmacist about a drug take-back program. You may also mix the leftover medicine with cat litter or coffee grounds in a sealed plastic bag and throw the bag in the trash.

Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Usual Adult Dose for Pain:

2 tablets orally every 12 hours as needed for pain

Comments:
-Patients should be monitored closely for respiratory depression, especially within the first 24 to 72 hours of starting therapy.

Use: For the management of acute pain that is severe enough to require an opioid analgesic and for which alternative therapies are inadequate

Celecoxib and tramadol can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Celecoxib and tramadol may also cause stomach or intestinal bleeding, which can be fatal. This can occur without warning, especially in older adults.

You should not use celecoxib and tramadol if you are allergic to it, or if you have:

• an allergy to sulfa drugs or opioids;

• severe asthma, trouble breathing, or other breathing problems;

• a bowel blockage or narrowing of the stomach or intestines; or

• a history of asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Do not give celecoxib and tramadol to people:

• younger than 12 years or younger than 18 years after surgery to remove the tonsils and/or adenoids.

Avoid giving celecoxib and tramadol to people 12 to 18 years who have sleep apnea, obesity, or other breathing problems.

Do not use celecoxib and tramadol if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine.

Tell your doctor if you have ever had:

• head injury or seizures;

• thyroid problems;

• problems urinating;

• pancreas or gallbladder problems;

• a stomach ulcer, bleeding in your stomach or intestines;

• heart disease, high blood pressure;

• asthma;

• drug or alcohol addiction, opioid overdose, or mental health problems; or

• liver or kidney disease.

You should not take celecoxib and tramadol unless your doctor tells you to. If you use celecoxib and tramadol during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks.

Taking this medicine during the last 20 weeks of pregnancy may harm an unborn baby. Tell your doctor if you become pregnant or think that you may be pregnant.

Do not breastfeed while using celecoxib and tramadol.

Skip the missed dose and take your next dose at the regular time. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include 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.

Avoid taking aspirin or other NSAIDs unless your doctor tells you to.

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

Avoid driving or hazardous activity until you know how celecoxib and tramadol will affect you.

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

Stop using celecoxib and tramadol and seek medical treatment 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.

Stop using celecoxib and tramadol and seek medical treatment right away if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Celecoxib and tramadol 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.

Celecoxib and tramadol may cause serious side effects. Call your doctor at once if you have:

• severe headache, blurred vision, pounding in your neck or ears, or severe constipation;

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

• decreased adrenal gland hormones--nausea, vomiting, stomach pain, loss of appetite, feeling tired or light-headed, muscle or joint pain, skin discoloration, craving salty foods;

• 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; or

• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Celecoxib and tramadol may cause serious side effects. Stop using celecoxib and tramadol and call your doctor at once if you have:

• low blood sodium--headache, confusion, problems with thinking or memory, weakness, feeling unsteady;

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

• liver problems--nausea, stomach pain (upper right side), itching, tiredness, dark urine, jaundice (yellowing of the skin or eyes); or

• heart problems--swelling, rapid weight gain, feeling short of breath.

Common side effects may include nausea, vomiting, dizziness, headache, and drowsiness.

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.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Ask your doctor before using celecoxib and tramadol if you take an antidepressant, benzodiazepines, NSAIDs, other opioids, or medicine to treat or prevent blood clots.

Many drugs can affect celecoxib and tramadol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.