Dosing & Uses
Dosage Forms & Strengths
- 400mg (Rx)
- 600mg (Rx)
- 800mg (Rx)
OTC: 200-400 mg PO q4-6hr; not to exceed 1.2 g unless directed by physician
Prescription: 400-800 mg PO/IV q6hr
400-800 mg PO q6-8hr; not to exceed 3.2 g/day
300 mg, 400 mg, 600 mg, or 800 mg PO q6-8hr; not to exceed 3.2 g/day
Monitor for gastrointestinal (GI) risks
300 mg, 400 mg, 600 mg, or 800 mg PO q6-8hr; not to exceed 3200 mg/day
Monitor for GI risks
Significantly impaired renal function: Monitor closely; consider reduced dosage if warranted
Severe hepatic impairment: Avoid use
Dosage Forms & Strengths
- 400mg (Rx)
- 600mg (Rx)
- 800mg (Rx)
4-10 mg/kg/dose PO q6-8hr; not to exceed 40 mg/kg/day
Patent Ductus Arteriosus
See ibuprofen IV drug monograph
Cystic Fibrosis (Off-label)
<4 years: Safety and efficacy not established
≥4 years: PO administration q12hr, adjusted to maintain serum levels of 50-100 mcg/mL; may slow disease progression in younger patients with mild lung disease
Serious - Use Alternative
Significant - Monitor Closely
Epigastric pain (3-9%)
Fluid retention (1-3%)
Acute renal failure (sometimes with acute tubular necrosis or hyperkalemia, polyuria, azotemia, cystitis, hematuria, decreased creatinine clearance, elevations in blood urea nitrogen (BUN) or creatinine without other manifestations of renal failure)
Erythematous macular rashes
Hemolytic anemia (with or without positive direct antiglobulin test results)
Thrombocytopenia (with or without purpura)
Toxic epidermal necrolysis (Lyell syndrome) and photosensitivity reactions
Black Box Warnings
- Nonsteroidal anti-inflammatory drugs (NSAIDs) may increase risk of serious cardiovascular thrombotic events, myocardial infarction (MI), and stroke, which can be fatal
- Risk may increase with duration of use
- Patients with existing cardiovascular disease or risk factors for such disease may be at greater risk
- NSAIDs are contraindicated for perioperative pain in setting of coronary artery bypass graft (CABG) surgery
- NSAIDs increase risk of serious GI adverse events, including bleeding, ulceration, and gastric or intestinal perforation, which can be fatal
- GI adverse events may occur at any time during use and without warning symptoms
- Elderly patients are at greater risk for serious GI events
- Aspirin allergy
- Perioperative pain in setting of coronary artery bypass graft (CABG) surgery
- Preterm infants with untreated proven or suspected infection; bleeding with active intracranial hemorrhage or GI bleed; thtombocytopenia, coagulation defects, proven or necrotizing enterocolitis, significant renal impairment, congenital heart disease where patency or the PDA is necessary for pulmonary or systemic blood flow
Use caution in asthma (bronchial), cardiac disease, congestive heart failure (CHF), hepatic or renal impairment, hypertension. bleeding disorder, duodenal/gastric/peptic ulcer, stomatitis, systemic lupus erythematosus (SLE), ulcerative colitis, upper GI disease, late pregnancy (may cause premature closure of ductus arteriosus)
Long-term administration of NSAIDs may result in renal papillary necrosis and other renal injury; patients at greatest risk include elderly individuals; those with impaired renal function, hypovolemia, heart failure, liver dysfunction, or salt depletion; and those taking diuretics, angiotensin-converting enzyme (ACE) inhibitors, or angiotensin receptor blockers
Junior Advil (100 mg): Doses higher than recommended may cause stomach bleeding
May cause serious adverse reactions, including exfoliative dermatitis, toxic epidermal necrolysis, Steven's Johnson syndrome reported
Children's and Junior Advil (50 mg, 100 mg): May cause severe and persistent sore throat
Fever, rash, abdominal pain, nausea, liver dysfunction, and meningitis have occurred in patients with collagen-vascular disease, especially SLE
Blurred vision, scotomate, and changes in color vision reported; discontinue therapy if symptoms occur
Platelet aggregation and adhesion may be decreased; monitor patients with coagulation disorders receiving the therapy
Risk of hyperkalemia may increase in patients with diabetes, the elderly, renal disease, or with concomitant use of agents that can induce hyperkalemia including ACE inhibitors; monitor potassium closely
May cause drowsiness and dizziness; may impair physical or mental abilities to operate heavy machinery or driving
Pregnancy & Lactation
Pregnancy category: C; D at ≥30 weeks' gestation; may cause premature closure of ductus arteriosus
Quebec Pregnancy Registry identified 4705 women who had spontaneous abortions by 20 weeks' gestation; each case was matched to 10 control subjects (n=47,050) who had not had spontaneous abortions; exposure to nonaspirin NSAIDs during pregnancy was documented in approximately 7.5% of cases of spontaneous abortions and in approximately 2.6% of controls
Lactation: Drug excreted into breast milk; use not recommended (American Academy of Pediatrics committee states that drug is compatible with nursing)
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Inhibits synthesis of prostaglandins in body tissues by inhibiting at least 2 cyclo-oxygenase (COX) isoenzymes, COX-1 and COX-2
May inhibit chemotaxis, alter lymphocyte activity, decrease proinflammatory cytokine activity, and inhibit neutrophil aggregation; these effects may contribute to anti-inflammatory activity
Rapidly absorbed (85%)
Onset: 30-60 min
Duration: 4-6 hr
Peak plasma time (adults)
- Conventional tablet: 120 min
- Chewable tablet: 62 min
- Oral suspension: 47 min
Peak plasma time (febrile children)
- Chewable tablet: 86 min
- Oral suspension: 58 min
Peak plasma concentration
- Conventional tablet: 20 mcg/mL
- Chewable tablet: 15 mcg/mL
- Oral suspension: 19 mcg/mL
Protein bound: 90-99%; concentrations >20 mcg/mL
Vd: 0.12 L/kg (adults); 0.164 L/kg (children)
Rapidly metabolized in liver (primarily by CYP2C9; CYP2C19 substrate) via oxidation to inactive metabolites
- Metabolite A: (+)-2-[4'-(2-hydroxy-2-methylpropyl) phenyl] propionic acid
- Metabolite B: (+)-2-[4'-(2-carboxypropyl) phenyl] propionic acid
Half-life: 2-4 hr (adults); 1.6 hr (children 3 mon to 1 year; 35-51 hr (day 3), 20-33 hr (day 5)
Excretion: Urine (50-60%; <10% unchanged); remainder in feces within 24 hr
Take with food or 8-12 oz of water to avoid GI effects
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|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
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|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
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