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Pharmacologic class: Nonsteroidal cyclooxygenase-2 (COX-2) inhibitor, nonsteroidal anti-inflammatory drug (NSAID)
Therapeutic class: Antirheumatic
Pregnancy risk category C
FDA Box Warning
• Drug may increase risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke (which can be fatal). 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.
Exhibits anti-inflammatory, analgesic, and antipyretic action due to inhibition of COX-2 enzyme
Capsules: 50 mg, 100 mg, 200 mg, 400 mg
Indications and dosages
➣ Ankylosing spondylitis, osteoarthritis
Adults: 200 mg/day P.O. as a single dose or 100 mg P.O. b.i.d.
➣ Rheumatoid arthritis
Adults: 100 to 200 mg P.O. b.i.d.
➣ Adjunctive treatment in familial adenomatous polyposis to decrease the number of adenomatous colorectal polyps
Adults: 400 mg P.O. b.i.d.
➣ Acute pain or primary dysmenorrhea
Adults: 400 mg P.O. once, plus one additional 200 mg-dose as needed on first day; then 200 mg b.i.d. as needed
➣ Juvenile rheumatoid arthritis
Children age 2 and older weighing 10 to 25 kg (22 to 55 lb): 50 mg P.O. b.i.d.
Children age 2 and older weighing 25 kg or more: 100 mg P.O. b.i.d.
• Hepatic impairment
• Patients weighing less than 50 kg (110 lb)
• Hypersensitivity to drug, sulfonamides, or other NSAIDs
• Advanced renal disease
• Severe hepatic impairment
• Sensitivity precipitated by aspirin
• Third trimester of pregnancy
Use cautiously in:
• renal insufficiency, hypertension
• history of asthma, urticaria, renal disease, hepatic dysfunction, heart failure
• patients on long-term NSAID therapy
• elderly patients
• pregnant patients in first or second trimester
• children younger than age 18 (safety not established).
• When administering doses higher than 200/mg daily, give with food or milk to improve drug absorption.
CNS: dizziness, drowsiness, headache, insomnia, fatigue, stroke
CV: angina, tachycardia, peripheral edema, myocardial infarction
EENT: ophthalmic effects, tinnitus, epistaxis, pharyngitis, rhinitis, sinusitis
GI: nausea, diarrhea, constipation, abdominal pain, dyspepsia, flatulence, dry mouth, GI bleeding
GU: menorrhagia, renal failure
Hematologic: eosinophilia, ecchymosis, neutropenia, leukopenia, pancytopenia, thrombocytopenia, agranulocytosis, granulocytopenia, aplastic anemia, bone marrow depression
Metabolic: hyperchloremia, hypophosphatemia
Musculoskeletal: back pain, leg cramps
Respiratory: upper respiratory tract infection
Drug-drug. Angiotensin-converting enzyme inhibitors, furosemide, thiazides: reduced celecoxib efficacy
Antacids containing aluminum and magnesium: decreased celecoxib blood level
Aspirin (regular doses): increased risk of GI bleeding and GI ulcers
Fluconazole, lithium: increased blood levels of these drugs
Warfarin: increased risk of bleeding
Drug-diagnostic tests. Alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen: increased levels
Hematocrit, hemoglobin: decreased values
Drug-herbs. Dong quai, feverfew, garlic, ginger, horse chestnut, red clover: increased risk of bleeding
White willow: increased risk of GI ulcers
Drug-behaviors. Long-term alcohol use, smoking: GI irritation and bleeding
• Monitor CBC, electrolyte levels, creatinine clearance, occult fecal blood test, and liver function test results every 6 to 12 months.
Advise patient to immediately report bloody stools, vomiting of blood, or signs or symptoms of liver damage (nausea, fatigue, lethargy, pruritus, yellowing of eyes or skin, tenderness in upper right abdomen, or flulike symptoms).
• Instruct patient to take drug with food or milk.
• Tell patient to avoid aspirin and other NSAIDs (such as ibuprofen and naproxen) during therapy.
• 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.