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Pharmacologic class: Nonsteroidal anti-inflammatory drug (NSAID)
Therapeutic class: Analgesic, antipyretic, anti-inflammatory
Pregnancy risk category B (third trimester: D)
FDA Box Warning
• Drug may increase risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke. Risk may increase with duration of use, and may be greater in patients who have cardiovascular disease or risk factors for it.
• Drug is contraindicated for perioperative pain in setting of coronary artery bypass graft surgery.
• Drug increases risk of serious GI adverse events, including bleeding, ulcers, and stomach or intestinal perforation, which can be fatal. These events can occur at any time during therapy and without warning. Elderly patients are at greater risk.
Unknown. Thought to inhibit cyclooxygenase, an enzyme needed for prostaglandin synthesis.
Capsules (liquigels): 200 mg
Injection: 400 mg/4-ml, 800 mg/8-ml vials
Oral suspension: 100 mg/5 ml
Pediatric drops: 50 mg/1.25 ml
Tablets: 100 mg, 200 mg, 400 mg, 600 mg, 800 mg
Tablets (chewable): 50 mg, 100 mg
Indications and dosages
➣ Rheumatoid arthritis; osteoarthritis
Adults: 1.2 to 3.2 g/day P.O. in three to four divided doses
➣ Mild to moderate pain
Adults: 400 mg P.O. q 4 to 6 hours p.r.n. or 400 to 800 mg I.V. over 30 minutes q 6 hours, as necessary
➣ Moderate to severe pain as adjunct to opioid analgesics
Adults: 400 to 800 mg I.V. over 30 minutes q 6 hours, as necessary
➣ Fever reduction
Adults: 400 mg I.V. over 30 minutes, followed by 400 mg P.O. q 4 to 6 hours or 100 to 200 mg P.O. q 4 hours as necessary
➣ Primary dysmenorrhea
Adults: 400 mg P.O. q 4 hours p.r.n.
➣ Juvenile arthritis
Children: 30 to 40 mg/kg/day P.O. in three or four divided doses. Daily dosages above 50 mg/kg aren't recommended.
➣ Fever reduction; pain relief
Children ages 6 to 12: 5 mg/kg P.O. if temperature is below 102.5 °F (39.2 °C) or 10 mg/kg if temperature is above 102.5 °F. Maximum daily dosage is 40 mg/kg.
• Migraine and tension headaches
• Hypersensitivity to drug or other NSAIDs
• Perioperative use in coronary artery bypass graft surgery
Use cautiously in:
• severe cardiovascular, renal, or hepatic disease; GI disease; asthma; chronic alcohol use
• elderly patients
• pregnant (avoid use after 30 weeks' gestation) or breastfeeding patients
• children younger than age 17 (safety and efficacy not established).
• Ideally, give oral form 1 hour before or 2 hours after meal. If GI upset occurs, give with meals.
• Be aware that patients must be well hydrated before I.V. form is administered.
• Dilute injection form before administering.
CNS: headache, dizziness, drowsiness, nervousness, aseptic meningitis
CV: hypertension, arrhythmias
EENT: amblyopia, blurred vision, tinnitus
GI: nausea, vomiting, constipation, dyspepsia, abdominal discomfort, GI bleeding
GU: cystitis, hematuria, azotemia, renal failure
Hematologic: anemia, prolonged bleeding time, aplastic anemia, neutropenia, pancytopenia, thrombocytopenia, leukopenia, agranulocytosis
Metabolic: hyperglycemia, hypoglycemia
Skin: rash, pruritus, urticaria, Stevens-Johnson syndrome
Other: edema, allergic reactions including anaphylaxis
Drug-drug. Antihypertensives, diuretics: decreased efficacy of these drugs
Aspirin and other NSAIDs, corticosteroids: additive adverse GI effects
Cefamandole, cefoperazone, cefotetan, drugs affecting platelet function (including abciximab, clopidogrel, eptifibatide, ticlopidine, tirofiban), plicamycin, thrombolytics, valproic acid, warfarin: increased risk of bleeding
Cyclosporine: increased risk of nephrotoxicity
Digoxin: slightly increased digoxin blood level
Lithium: increased lithium blood level, greater risk of lithium toxicity
Methotrexate: increased risk of methotrexate toxicity
Probenecid: increased risk of ibuprofen toxicity
Drug-diagnostic tests. Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, blood urea nitrogen, creatinine, lactate dehydrogenase, potassium: increased values
Bleeding time: prolonged
Creatinine clearance, glucose, hematocrit, hemoglobin, platelets, white blood cells: decreased values
Drug-herbs. Anise, arnica, chamomile, clove, dong quai, fenugreek, feverfew, garlic, ginger, ginkgo, ginseng, licorice: increased risk of bleeding
White willow: additive adverse GI effects
Drug-behaviors. Alcohol use: additive adverse GI effects
Sun exposure: phototoxicity
• Monitor for desired effect.
• Watch for GI upset, adverse CNS effects (such as headache and drowsiness), and hypersensitivity reaction.
• Stay alert for GI bleeding and ulcers, especially in long-term therapy.
• In long-term therapy, assess renal and hepatic function regularly.
• Monitor blood pressure closely during treatment.
• Tell patient to take oral drug with full glass of water, with food, or after meals to minimize GI upset.
• To help prevent esophageal irritation, instruct patient to avoid lying down for 30 to 60 minutes after taking dose.
☞ Instruct patient to immediately report irregular heartbeats, black tarry stools, vision changes, unusual tiredness, yellowing of skin or eyes, change in urination pattern, difficulty breathing, finger or ankle swelling, weight gain, itching, rash, fever, or sore throat.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration, alertness, and balance.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, herbs, and behaviors mentioned above.