ibuprofen

General

**BEERS Drug**

ibuprofen

Pronunciation:
eye-byoo- proe -fen


ibuprofen

Trade Name(s)

  • Advil
  • Advil Infants
  • Advil Junior Strength
  • Advil Migraine
  • Children's Advil
  • Children's Europrofen  Canadian Tradename
  • Children's Motrin
  • Motrin  Canadian Tradename
  • Motrin IB
  • Motrin Infants Drops
  • Motrin Junior Strength
  • PediaCare IB Ibuprofen

ibuprofen (injection)

Trade Name(s)

  • Caldolor
  • NeoProfen (ibuprofen lysine)

Ther. Class.
antipyretics
antirheumatics
nonopioid analgesics

Pharm. Class.
temporary class nonsteroidal anti-inflammatory drugs (NSAIDs)

Indications

  • PO  IV 

    Treatment of:

    • Mild to moderate pain,
    • Fever.
  • PO 

    Treatment of:

    • Inflammatory disorders including rheumatoid arthritis (including juvenile) and osteoarthritis,
    • Dysmenorrhea.
  • IV 

    Moderate to severe pain with opioid analgesics.

    Closure of a clinically significant PDA in neonates weighing 500–1500 g and ≤32 wk gestational age (ibuprofen lysine only)

Action

Inhibits prostaglandin synthesis.

Therapeutic Effect(s):

  • Decreased pain and inflammation.
  • Reduction of fever.

Pharmacokinetics

Absorption: Oral formulation is well absorbed (80%) from the GI tract; IV administration results in complete bioavailability.

Distribution: Does not enter breast milk in significant amounts.

Protein Binding: 99%.

Metabolism and Excretion: Mostly metabolized by the liver; small amounts (1%) excreted unchanged by the kidneys.

Half-life: Neonates: 26–43 hr; Children: 1–2 hr; Adults: 2–4 hr.

TIME/ACTION PROFILE

ROUTE ONSET PEAK DURATION
PO (antipyretic) 0.5–2.5 hr 2–4 hr 6–8 hr
PO (analgesic) 30 min 1–2 hr 4–6 hr
PO (anti-inflammatory) ≤7 days 1–2 wk unknown
IV (analgesic) unknown unknown 6 hr
IV (antipyretic) within 2 hr 10–12 hr† 4–6 hr
†With repeated dosing.

Contraindication/Precautions

Contraindicated in:

  • Hypersensitivity (cross-sensitivity may exist with other NSAIDs, including aspirin);
  • Active GI bleeding or ulcer disease;
  • Chewable tablets contain aspartame and should not be used in patients with phenylketonuria;
  • Coronary artery bypass graft (CABG) surgery;
  • History of recent MI;
  • Severe HF;
  • OB:   Avoid use after 30 wk gestation;
  • Pedi:   Ibuprofen lysine: Preterm neonates with untreated infection, congenital heart disease where patency of PDA is necessary for pulmonary or systemic blood flow, bleeding, thrombocytopenia, coagulation defects, necrotizing enterocolitis, significant renal dysfunction.

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); avoid use in patients with recent MI or HF;
  • Renal or hepatic disease, dehydration, or patients on nephrotoxic drugs (may ↑ risk of renal toxicity);
  • Aspirin triad patients (asthma, nasal polyps, and aspirin intolerance); can cause fatal anaphylactoid reactions;
  • Chronic alcohol use/abuse;
  • Coagulation disorders;
  • OB:   Use at or after 20 wk gestation may cause fetal or neonatal renal impairment; if treatment is necessary between 20 wk and 30 wk gestation, limit use to the lowest effective dose and shortest duration possible
  • Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
  • Pedi:   Safety and effectiveness not established for children <6 mo (oral and IV Caldolor); hyperbilirubinemia in neonates (may displace bilirubin from albumin-binding sites); safety and effectiveness of ibuprofen lysine only established in premature infants;
  • Geri:   ↑ risk of adverse in older adults secondary to age-related ↓ in renal and hepatic function, concurrent illnesses, and medications.0

Exercise Extreme Caution in:

History of GI bleeding or GI ulcer disease.

Adverse Reactions/Side Effects

CNS: headache , dizziness, drowsiness, intraventricular hemorrhage (ibuprofen lysine), psychic disturbances

CV: HF , MYOCARDIAL INFARCTION , STROKE , arrhythmias, edema, hypertension

Derm: DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS) , EXFOLIATIVE DERMATITIS , STEVENS-JOHNSON SYNDROME , TOXIC EPIDERMAL NECROLYSIS , rash, injection site reaction

EENT: amblyopia, blurred vision, tinnitus

F and E: hyperkalemia

GI: GI BLEEDING , HEPATITIS , constipation , dyspepsia , nausea , necrotizing enterocolitis (ibuprofen lysine), vomiting , abdominal discomfort

GU: cystitis, hematuria, renal failure

Hemat: anemia, blood dyscrasias, prolonged bleeding time

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

Drug-Natural Products:

↑ bleeding risk with  arnica ,  chamomile ,  feverfew ,  garlic ,  ginger ,  ginkgo ,  Panax ginseng  , and others.

Route/Dosage

Analgesia/Anti-Inflammatory/Antipyretic

PO  (Adults) : Anti-inflammatory–  400–800 mg 3–4 times daily (not to exceed 3200 mg/day).  Analgesic/antidysmenorrheal/antipyretic–  200–400 mg every 4–6 hr (not to exceed 1200 mg/day).

PO  (Children  6 mo–12 yr) : Anti-inflammatory–  30–50 mg/kg/day in 3–4 divided doses (maximum dose: 2.4 g/day).  Antipyretic–  5 mg/kg for temperature <102.5°F (39.17°C) or 10 mg/kg for higher temperatures (not to exceed 40 mg/kg/day); may be repeated every 4–6 hr.

PO  (Infants and Children) : Analgesic–  4–10 mg/kg/dose every 6–8 hr.

IV  (Adults) : Analgesic–  400–800 mg every 6 hr as needed (not to exceed 3200 mg/day);  Antipyretic–  400 mg initially, then 400 mg every 4–6 hr or 100–200 mg every 4 hr as needed (not to exceed 3200 mg/day).

IV  (Children 12–17 yr) : Analgesic and antipyretic–  400 mg every 4–6 hr as needed (not to exceed 2400 mg/day).

IV  (Children 6 mo–12 yr) : Analgesic and antipyretic–  10 mg/kg (not to exceed 400 mg) every 4–6 hr as needed (not to exceed 40 mg/kg/day or 2400 mg/day, whichever is less).

Pediatric OTC Dosing

PO  (Children  11 yr/72–95 lb) : 300 mg every 6–8 hr.

PO  (Children  9–10 yr/60–71 lb) : 250 mg every 6–8 hr.

PO  (Children  6–8 yr/48–59 lb) : 200 mg every 6–8 hr.

PO  (Children  4–5 yr/36–47 lb) : 150 mg every 6–8 hr.

PO  (Children  2–3 yr/24–35 lb) : 100 mg every 6–8 hr.

PO  (Children 12–23 mo/18–23 lb) : 75 mg every 6–8 hr.

PO  (Infants 6–11 mo/12–17 lb) : 50 mg every 6–8 hr.

PDA Closure

IV  (Neonates Gestational age ≤32 wk, 500–1500 g) : 10 mg/kg followed by two doses of 5 mg/kg at 24 and 48 hr after initial dose.

Availability (generic available)

Tablets: 200 mg OTC , 400 mg, 600 mg, 800 mg

Capsules (liquigels): 200 mg OTC

Chewable tablets (fruit, grape, orange, and citrus flavor ): 100 mg OTC

Oral solution (berry flavor): 50 mg/1.25 mL OTC

Oral suspension (fruit, berry, grape flavor): 100 mg/5 mL OTC

Solution for injection: 10 mg/mL (NeoProfen), 100 mg/mL (Caldolor)

In Combination with: decongestants OTC  , hydrocodone, famotidine (Duexis). See combination drugs .

Assessment

  • Patients who have asthma, aspirin-induced allergy, and nasal polyps are at increased risk for developing hypersensitivity reactions. Assess for rhinitis, asthma, and urticaria.
  • Assess for signs and symptoms of GI bleeding (tarry stools, light-headedness, hypotension), renal dysfunction (elevated BUN and serum creatinine levels, decreased urine output), and hepatic impairment (elevated liver enzymes, jaundice). Geri:   Higher risk for poor outcomes or death from GI bleeding. Age-related renal impairment increases risk of hepatic and renal toxicity.
  • Assess patient for skin rash frequently during therapy. Discontinue ibuprofen at first sign of rash; may be life-threatening. Stevens-Johnson syndrome or toxic epidermal necrolysis may develop. Treat symptomatically; may recur once treatment is stopped.
  • Monitor for signs and symptoms of DRESS (fever, rash, lymphadenopathy, facial swelling, eosinophilia) periodically during therapy. If symptoms occur discontinue ibuprofen.
  • Pain: Assess pain (note type, location, and intensity) prior to and 1–2 hr following administration.
  • Arthritis: Assess pain and range of motion prior to and 1–2 hr following administration.
  • Fever: Monitor temperature; note signs associated with fever (diaphoresis, tachycardia, malaise).
  • PDA Closure: Monitor preterm neonates for signs of bleeding, infection and decreased urine output. Monitor IV site for signs of extravasation. If ductus arteriosus closes or size significantly decreases, 2nd and 3rd doses are unnecessary.

Lab Test Considerations:

BUN, serum creatinine, CBC, and liver function tests should be evaluated periodically in patients receiving prolonged therapy.

  • Serum potassium, BUN, serum creatinine, alkaline phosphatase, LDH, AST, and ALT may show ↑ levels. Blood glucose, hemoglobin, and hematocrit concentrations, leukocyte and platelet counts, and CCr may be ↓.
  • May cause prolonged bleeding time; may persist for <1 day following discontinuation.
  •  PDA Closure: If urinary output <0.6 mL/kg/hr at time of 2nd or 3rd dose, hold dose until renal function has returned to normal.

Implementation

  • Do not confuse Motrin (ibuprofen) with Neurontin (gabapentin).
  • Administration of higher than recommended doses does not provide increased pain relief but may increase incidence of side effects.

    • Patient should be well hydrated before administration to prevent renal adverse reactions. Do not give to neonates with urine output <0.6 mL/kg/hr
    • Use lowest effective dose for shortest period of time, especially in the elderly, to minimize risk of cardiovascular thrombotic events.
    • Coadministration with opioid analgesics may have additive analgesic effects and may permit lower opioid doses.
  • PO  For rapid initial effect, administer 30 min before or 2 hr after meals. May be administered with food, milk, or antacids to decrease GI irritation. Tablets may be crushed and mixed with fluids or food; 800-mg tablet can be dissolved in water.
  • Dysmenorrhea: Administer as soon as possible after the onset of menses. Prophylactic treatment has not been shown to be effective.
  • Rate:  Infuse over at least 30 min for adults and at least 10 min for children for  Caldolor   or over 15 min for  NeoProfen .

Ibuprofen

  • Y-Site Compatibility:
    • metoprolol
  • Y-Site Incompatibility:
    • esmolol
    • labetalol

Ibuprofen Lysine

  • Y-Site Compatibility:
    • ceftazidime
    • epinephrine
    • furosemide
    • MORE...
      • heparin
      • hydrocortisone
      • insulin, regular
      • phenobarbital
      • potassium chloride
      • sodium bicarbonate
  • Y-Site Incompatibility:
    • amikacin
    • amino acids
    • caffeine citrate
    • MORE...
      • dobutamine
      • dopamine
      • isoproterenol
      • midazolam
      • multi-electrolyte concentrate
      • vancomycin
      • vecuronium

IV Administration

Intermittent Infusion:   Diluent:   0.9% NaCl, D5W, or LR. Concentration: Ibuprofen injection:   Dilute the 800 mg dose in at least 200 mL and the 100 mg, 200 mg, and 400 mg doses in at least 100 mL for a concentration of 4 mg/mL or less.  Ibuprofen lysine:   Dilute in appropriate volume of D5W or 0.9% NaCl and infuse over 15 min. Do not administer solutions that are discolored or contain particulate matter. Stable for up to 24 hr at room temperature. Discard remaining solution; does not contain preservatives.

Patient/Family Teaching

  • Advise patients to take ibuprofen with a full glass of water and to remain in an upright position for 15–30 min after administration.
  • Instruct patient to take medication as directed. Take missed doses as soon as remembered but not if almost time for next dose. Do not double doses. Pedi:   Teach parents and caregivers to calculate and measure doses accurately and to use measuring device supplied with product.
  • May cause drowsiness or dizziness. Advise patient to avoid driving or other activities requiring alertness until response to medication is known.
  • Caution patient to avoid the concurrent use of alcohol, aspirin including low dose aspirin, acetaminophen, and other OTC or herbal products without consulting health care professional.
  • Advise patient to inform health care professional of medication regimen prior to treatment or surgery.
  • Instruct patients not to take OTC ibuprofen preparations for more than 10 days for pain or more than 3 days for fever, and to consult health care professional if symptoms persist or worsen. Many OTC products contain ibuprofen; avoid duplication.
  • Caution patient that use of ibuprofen with 3 or more glasses of alcohol per day may increase the risk of GI bleeding.
  • Advise patient to consult health care professional if rash, itching, visual disturbances, tinnitus, weight gain, edema, epigastric pain, dyspepsia, black stools, hematemesis, persistent headache, or influenza-like syndrome (chills, fever, muscle aches, pain), or cardiovascular events (chest pain, shortness of breath, weakness, slurring of speech) occurs.
  • Pedi:   Advise parents or caregivers not to administer ibuprofen to children who may be dehydrated (can occur with vomiting, diarrhea, or poor fluid intake); dehydration increases risk of renal dysfunction.
  • Rep:   May cause fetal harm. Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected and to avoid ibuprofen starting at 20 wk gestation due to risk of oligohydramnios and 30 wk gestation because of risk of premature closing of the fetal ductus arteriosus. If NSAIDs are necessary between 20 and 30 wk gestation, limit use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if NSAID therapy extends beyond 48 hr. Discontinue ibuprofen if oligohydramnios occurs and follow up with infant. Advise women to avoid ibuprofen in the 3rd trimester of pregnancy (after 29 wks), may cause premature closure of the fetal ductus arteriosus. Use during labor or delivery may delay birth and increase risk of stillbirth. Advise patient to notify health care professional if breastfeeding. May cause temporary infertility in women.

Evaluation/Desired Outcomes

  • Decrease in severity of pain.
  • Improved joint mobility. Partial arthritic relief is usually seen within 7 days, but maximum effectiveness may require 1–2 wk of continuous therapy. Patients who do not respond to one NSAID may respond to another.
  • Reduction in fever.
  • Closure of PDA.
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