BOXED WARNING NSAID: serious CV thrombotic events (MI, stroke); contraindicated in CABG setting; serious GI bleeding, ulceration, perforation (elderly at greater risk).
FDA dosing
Population
Start
Target
Max
Rheumatoid arthritis / osteoarthritis (signs and symptoms)
Adults
200 mg QD
200 mg QD
200 mg/day
Renal Mild impairment: max 150 mg/day; severe (GFR <25 mL/min/1.73 m2) or ESRD: max 100 mg/day; advanced renal disease not recommended
Hepatic Impaired liver function with serum albumin <3.5 g/dL: max initial 100 mg/day
Not recommended for acute pain (extended-release). Reduce initial dose if >75 yr; smaller starting doses in small, debilitated, or elderly patients.
Instructions
May take with antacids, food, or milk to reduce GI effects
Use lowest effective dose for shortest duration
Available strengths
ER cap 200 mg
cap 25, 50, 75 mg
Contraindications
Asthma, urticaria, or allergic-type reactions after aspirin or other NSAIDs
Coronary artery bypass graft (CABG) surgery setting
Cautions
Cardiovascular thrombotic events (incl. post-MI)
Hypertension
Heart failure and edema
GI ulceration, bleeding, perforation
Renal effects; advanced renal disease not recommended
Anaphylactoid reactions
Serious skin reactions (SJS/TEN, fixed drug eruption)
DRESS
Fetal toxicity (ductus closure, oligohydramnios)
Adverse reactions
Dyspepsia (11%)
Nausea
Abdominal pain
Diarrhea
Constipation
Flatulence
Headache
CNS inhibition or excitation (somnolence, insomnia, nervousness)
Impaired renal function (edema, increased BUN)
Pregnancy Avoid at ~30 weeks gestation and later (premature ductus closure); limit dose/duration at ~20–30 weeks (oligohydramnios/neonatal renal impairment).
Lactation Unknown whether excreted in human milk; not recommended in nursing mothers.