BOXED WARNING NSAID class: increased risk of serious cardiovascular thrombotic events (MI, stroke; may increase with duration) and serious GI bleeding, ulceration, and perforation (can occur without warning; elderly at greater risk); contraindicated in CABG surgery setting
FDA dosing
Population
Start
Target
Max
Mild to moderate pain
adults
50 mg q4–6h
50–100 mg q4–6h (100 mg if needed for optimal relief)
400 mg/day
Excessive menstrual blood loss & primary dysmenorrhea
200 mg/day in 3–4 divided doses (initiate at lower dosage)
200–400 mg/day in 3–4 divided doses, individualized
400 mg/day
Renal Undefined
Hepatic Undefined
Instructions
Use lowest effective dose for shortest duration consistent with treatment goals
May take with meals or milk if GI complaints occur
RA/OA: 2–3 wk may be needed for optimum benefit; a lower dose may suffice long-term
Terminate therapy if any severe adverse reaction occurs
Contraindications
Asthma, urticaria, or allergic-type reactions after aspirin or other NSAIDs (severe, rarely fatal anaphylactic-like reactions reported)
Setting of coronary artery bypass graft (CABG) surgery
Cautions
Serious CV thrombotic events (MI, stroke) — risk may occur early and increase with duration of use
Serious GI bleeding, ulceration, perforation — any time, without warning symptoms; elderly at greater risk
Fetal toxicity: avoid at ≥30 wk gestation; limit use at 20–30 wk (see pregnancy)
Adverse reactions
Diarrhea (10–33%, dose-related; ~4% discontinued)
Nausea/vomiting (11%)
Other GI disorders (10%)
Abdominal pain, pyrosis, flatulence (3–9%)
Rash, headache, dizziness (3–9%)
Edema, urticaria, pruritus, tinnitus
<1%: GI bleeding/perforation, peptic ulcer, renal failure, blood dyscrasias (neutropenia, agranulocytosis, hemolytic anemia), SJS/TEN/erythema multiforme, hepatic test alterations
Pregnancy Avoid at ≥30 wk gestation (premature closure of fetal ductus arteriosus); limit dose/duration at 20–30 wk (oligohydramnios/fetal renal dysfunction); consider ultrasound monitoring if use >48 h at ≥20 wk
Lactation Undefined
⚠ BOXED WARNINGS
Cardiovascular thrombotic events
Gastrointestinal bleeding, ulceration and perforation