REMS
Contraindicated in:
Coronary artery bypass graft surgery;
Recent MI
;Use Cautiously in:
Cardiovascular disease or risk factors for cardiovascular disease (may ↑ risk of serious cardiovascular thrombotic events, MI, and stroke, especially with prolonged use or use of higher doses)
;History of long duration of NSAID use, smoking, alcohol use, advanced liver disease, coagulopathy, or poor general health (↑ risk of GI bleeding);
↑risk of GI bleeding and renal impairment in older adults
.Exercise Extreme Caution in:
History of peptic ulcer disease or GI bleeding
.CV: edema, HF, hypertension, MI, THROMBOSIS
Derm: ACUTE GENERALIZED EXANTHEMATOUS PUSTULOSIS (AGEP), DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), EXFOLIATIVE DERMATITIS, GENERALIZED BULLOUS FIXED DRUG ERUPTION, rash, STEVENS-JOHNSON SYNDROME (SJS), TOXIC EPIDERMAL NECROLYSIS (TEN)
F and E: hyperkalemia
GI: abdominal pain, diarrhea, dyspepsia, flatulence, GI BLEEDING, GI PERFORATION, GI ULCERATION, nausea
GU: renal impairment
Hemat: anemia
Neuro: dizziness, headache, insomnia, STROKE
Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND SERIOUS SKIN REACTIONS)
Drug-drug:
↑risk of GI bleeding with anticoagulants, aspirin, clopidogrel, ticagrelor, prasugrel, corticosteroids, fibrinolytics, SNRIs, or SSRIs
.Osteoarthritis
Hepatic Impairment
Rheumatoid Arthritis
Hepatic Impairment
Ankylosing Spondylitis
Hepatic Impairment
Juvenile Rheumatoid Arthritis
Hepatic Impairment
Acute Pain or Primary Dysmenorrhea
Hepatic Impairment
Acute Treatment of Migraine
Hepatic Impairment
Absorption: Bioavailability unknown.
Distribution: Extensively distributed to tissues.
Protein Binding: 97%.
Half-Life: 11 hr.
Advise patient to notify health care provider promptly if signs or symptoms of GI toxicity (abdominal pain, black stools), skin rash, unexplained weight gain, or edema occur.
Inform patient of ↑ risk of MI and stroke. Use lowest effective dose for shortest time. Advise patient to notify health care provider immediately if signs and symptoms (shortness of breath or trouble breathing, chest pain, weakness in one part or side of body, slurred speech, swelling of the face or throat) occur.
NDC Code