Classes
DEA Class; OTC, Rx
Common Brand Names; Advil, Motrin, PediaCare Children’s Pain Reliever/Fever Reducer IB, PediaCare Infant’s Pain Reliever/Fever Reducer IB
NSAIDs, Patent Ductus Arteriosus Agents
Description
Oral and intravenous non-steroidal anti-inflammatory drug (NSAID)
Used for the treatment of mild to severe pain, osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis/juvenile idiopathic arthritis, dysmenorrhea, and fever
Associated with serious adverse gastrointestinal and cardiovascular events; use lowest effective dose for shortest possible duration
Indications
For the treatment of rheumatoid arthritis (RA) and juvenile rheumatoid arthritis (JRA)/juvenile idiopathic arthritis (JIA).
For the treatment of osteoarthritis, dysmenorrhea.
For the treatment of mild pain to moderate pain, including minor aches and pains associated with arthralgia, dental pain, headache, musculoskeletal pain (including backache), and/or the common cold.
Contraindications
Hypersensitivity to drug, other NSAIDs, aspirin, or excipients
Perioperative pain in setting of coronary artery bypass graft (CABG) surgery
Adverse Effects
1-10%
Dizziness (3-9%)
Epigastric pain (3-9%)
Heartburn (3-9%)
Constipation (1-3%)
Nausea (3-9%)
Rash (3-9%)
Tinnitus (3-9%)
Edema (1-3%)
Fluid retention (1-3%)
Headache (1-3%)
Vomiting (1-3%)
<1%
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)
Agranulocytosis
Aplastic anemia
Erythema multiforme
Erythematous macular rashes
Exfoliative dermatitis
Warnings
If pregnant or breastfeeding, ask a health professional before use; it is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor; it may cause problems in the unborn child or complications during delivery
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
Pregnancy and Lactation
Pregnancy
There are no adequate and well-controlled studies in pregnant women; data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive
Lactation: No lactation studies have been conducted; however, limited published literature reports that, following oral administration, ibuprofen is present in human milk at relative infant doses of 0.06-0.6% of the maternal weight-adjusted daily dose; no information is available on effects of ibuprofen on milk production or on a breastfed infant
Maximum Dosage
3,200 mg/day PO/IV for Rx-only products; 1,200 mg/day PO for non-prescription use.
3,200 mg/day PO/IV for Rx-only products; 1,200 mg/day PO for non-prescription use.
17 years: 3,200 mg/day PO/IV for Rx-only products; 1,200 mg/day PO for non-prescription use.
13 to 16 years: 50 mg/kg/day PO (Max: 3,200 mg/day) and 2,400 mg/day IV for Rx-only products; 1,200 mg/day PO for non-prescription use.
12 years: 50 mg/kg/day PO (Max: 3,200 mg/day) and 2,400 mg/day IV for Rx-only products; 40 mg/kg/day PO (Max: 1,200 mg/day) for non-prescription use.
1 to 11 years: 50 mg/kg/day PO (Max: 3,200 mg/day) and 40 mg/kg/day IV (Max: 2,400 mg/day) for Rx-only products; 40 mg/kg/day PO (Max: 1,200 mg/day) for non-prescription use.
6 to 11 months: 40 mg/kg/day PO/IV.
1 to 5 months: Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Tablet
100mg
200mg
400mg (Rx)
600mg (Rx)
800mg (Rx)
Capsule
200mg
Tablet, chewable
50mg
100mg
Oral suspension
100mg/5mL
40mg/mL