This medicine is a nonsteroidal anti-inflammatory drug (NSAID) used for the short-term (up to 5 days) treatment of moderately severe pain (usually after surgery), alone or in combination with other medicines.
Follow the directions for using this medicine provided by your doctor. This medicine has a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. This medicine is usually administered as an injection at your doctor's office, hospital, or clinic. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. THIS MEDICINE WILL NOT be given for more than 5 days. THIS MEDICINE IS NOT for the treatment of mild to moderate or chronic pain (eg, headache). If this medicine contains particles, is cloudy or discolored, or if the vial is cracked or damaged in any way, do not use it. STORE THIS MEDICINE at room temperature, between 68 and 77 degrees F (20 and 25 degrees C) in a tightly closed container, away from heat, moisture, and light. Do not store in the bathroom. KEEP THIS MEDICINE, as well as syringes and needles, out of the reach of children and away from pets. IF YOU MISS A DOSE OF THIS MEDICINE and you are using it regularly, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
WARNING: This medicine is only intended for short-term (up to 5 days) treatment of moderately severe pain. It should not be used to treat minor or long-term pain. Do not use more of this medicine than prescribed. Do not use this medicine to treat children. This medicine is 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 this medicine for a long time. Do not use this medicine right before or after bypass heart surgery. This medicine 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. Do not take this medicine if you are allergic to it or to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, celecoxib), you are taking aspirin or another NSAID (eg, ibuprofen, celecoxib), you are breast-feeding or are in labor, you have recently had or will be having bypass heart surgery (CABG), you have a stomach ulcer or a history of ulcers or severe stomach problems (eg, bleeding, perforation), you have severe kidney problems or are at risk of kidney failure (eg, low blood volume, dehydrated), you have bleeding in the brain (eg, stroke, aneurysm) or bleeding problems (eg, platelet disorder, hemophilia), or if you are at risk for bleeding. Do not use this medicine to prevent pain before any major surgery. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking aspirin, NSAIDs, pentoxifylline, or probenecid. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking anticoagulants (eg, warfarin); clopidogrel; corticosteroids (eg, prednisone); heparin or other blood thinners (eg, dalteparin); selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine); cyclosporine; lithium; methotrexate; metformin; quinolones (eg, ciprofloxacin); angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril); or diuretics (eg, furosemide, hydrochlorothiazide). DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor if you drink alcohol, smoke, or if you have a history of alcohol abuse; kidney or liver problems; diabetes; stomach or bowel problems (eg, bleeding, perforation, ulcers); swelling or fluid buildup; asthma; growths in the nose (nasal polyps); or mouth inflammation. Inform your doctor of any other medical conditions including high blood pressure, blood disorder (eg, porphyria), bleeding or clotting problems, heart problems (eg, heart failure), blood vessel disease, or if you are at risk for any of these diseases; poor health; dehydration or low fluid volume; low blood sodium levels; allergies; pregnancy; or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have recently had or will be having bypass heart surgery, if you will be having major surgery, or if you have active ulcer or bleeding of the stomach or bowel; a history of stomach or bowel problems (eg, bleeding, ulcer, inflammation); severe kidney problems, or if you are at risk for kidney failure (eg, low blood volume, dehydrated); you have bleeding in the brain (eg, stroke, aneurysm) or bleeding problems (eg, platelet disorder, hemophilia), or if you are at risk for bleeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you are in the last 3 months of pregnancy, breast-feeding; or in labor. Use of this medicine in children under age 16 is not recommended. Discuss with your doctor the risks and benefits of giving this medicine to your child.
SIDE EFFECTS that may occur during treatment include constipation; diarrhea; dizziness; drowsiness; gas; headache; indigestion; mild stomach pain or upset; nausea; pain at the injection site; stomach fullness; sweating; or vomiting. CONTACT YOUR DOCTOR IMMEDIATELY if you experience bloody or black, tarry stools; bloody or cloudy urine; change in the amount of urine produced or trouble urinating; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; mental or mood changes; mouth sores; numbness of an arm or leg; one-sided weakness; persistent flu-like symptoms; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting or diarrhea; shortness of breath; sudden or unexplained weight gain; swelling of arms, hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; or yellowing of the skin or eyes. AN ALLERGIC REACTION TO THIS MEDICINE is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue, or unusual hoarseness. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include decreased urination; loss of consciousness; seizures; severe dizziness or drowsiness; severe nausea or stomach pain; slow or troubled breathing; tremor; unusual bleeding or bruising; vomit that looks like coffee grounds.
DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when it is full. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.