IBUPROFEN 
Pronounciation
- (EYE-bue-PROE-fen)
Trade Name(s)
- Caldolor
Baseline assessment and studies indicated; see Monitor. See Maternal/Child.
Use the lowest effective dose for the shortest duration of time based on individual needs and response. Re-evaluate after the initial dose. Adjust dose and frequency as indicated. Total daily dose should not exceed 3,200 mg. Adequate hydration and correction of hypovolemia required before administration to reduce the risk of adverse renal reactions.
400 to 800 mg every 6 hours as necessary.
400 mg followed by 400 mg every 4 to 6 hours or 100 to 200 mg every 4 hours as necessary.
a Maximum daily dose is 40 mg/kg or 2,400 mg, whichever is less. | ||||||||||||||||
See comments under Usual Dose and Maternal/Child.
To minimize the potential risk for an adverse cardiovascular (CV) event, use the lowest effective dose for the shortest duration possible.
■ Lower-end initial and reduced doses may be indicated in the elderly and/or debilitated. Consider potential for decreased organ function and concomitant disease or drug therapy.
Available as an 800 mg/200 mL (4 mg/mL) single-dose, ready-to-use flexible bag or as an 800 mg/8 mL single-dose vial (100 mg/mL). Vial must be diluted to a final concentration of 4 mg/mL or less for both adult and weight-based pediatric dosing using NS, D5W, or LR. Infusion without dilution can cause hemolysis. The 800 mg/200 mL ready-to-use bag is intended for 800-mg doses only.
Specific information not available; consult pharmacist.
Store vials at CRT. Diluted solutions stable for up to 24 hours at 20° to 25° C (68° to 77° F) and with ambient room lighting.
A single dose as an infusion over no less than 30 minutes.
A single dose as an infusion over no less than 10 minutes.
A nonsteroidal anti-inflammatory drug (NSAID) that has anti-inflammatory, analgesic, and antipyretic activity. Mechanism of action is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). It inhibits synthesis of prostaglandins, which are potent mediators of inflammation. Highly protein bound; the mean half-life of a 400-mg dose is 2.2 hours, and the mean half-life of an 800-mg dose is 2.44 hours. Metabolized in the liver via oxidation and excreted in the urine.
Management of mild to moderate pain.
■ Management of moderate to severe pain as an adjunct to opioid analgesics.
■ Reduction of fever.
Known hypersensitivity (anaphylactoid reactions, serious skin reactions) to ibuprofen or any component of the product.
■ Known history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
■ In the setting of coronary artery bypass graft (CABG) surgery.
■ See Maternal/Child.
For IV infusion only.
■ NSAIDs increase the risk for serious cardiovascular (CV) thrombotic events, including MI and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. The increase in CV thrombotic risk has been observed most consistently at higher doses.
■ There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID therapy. However, concurrent use does increase the risk of serious GI toxicity.
■ An increased incidence of MI and stroke was seen in patients who received an NSAID as an analgesic after CABG surgery; see Contraindications.
■ Avoid the use of ibuprofen in patients with a recent MI or in patients with severe heart failure unless the benefits are expected to outweigh the risks. Studies have shown these patients to be at increased risk for reinfarction, CV-related death, and all-cause mortality.
■ NSAIDs increase the risk for serious GI adverse events, including ulceration, bleeding, and/or perforation of the stomach or intestines. Can occur at any time, with or without warning symptoms, and can be fatal. Use extreme caution in patients with a prior history of peptic ulcer disease or GI bleeding. Risk is also increased in elderly or debilitated patients, in patients with advanced liver disease, and with concomitant use of aspirin, oral corticosteroids, anticoagulants, alcohol, selective serotonin reuptake inhibitors (SSRIs), or smoking or with longer durations of therapy.
■ May cause elevations of liver function tests (e.g., ALT, AST). Rare cases of serious, sometimes fatal, hepatic injury (fulminant hepatitis, liver necrosis, hepatic failure) have occurred.
■ May cause fluid retention and edema; use caution in patients with CHF or edema; see Drug/Lab Interactions.
■ May precipitate new-onset hypertension or worsen pre-existing hypertension; see Drug/Lab Interactions.
■ In addition to the usual caution in patients with reduced hepatic or renal function, NSAIDs may cause a dose-dependent reduction in renal prostaglandin formation and, secondarily, in renal blood flow, which can precipitate renal failure. Patients with impaired renal function, heart failure, liver dysfunction, dehydration, or hypovolemia; elderly patients; and patients receiving ACE inhibitors, angiotensin receptor blockers (ARBs), or diuretics are at greatest risk.
■ Avoid ibuprofen use in patients with advanced renal disease unless the benefits are expected to outweigh the risk.
■ Increases in serum potassium, including hyperkalemia, have been reported.
■ Anaphylactic reactions have occurred in patients with and without known hypersensitivity to ibuprofen and in patients with aspirin-sensitive asthma. Cross-reactivity between aspirin and other NSAIDs has been reported in aspirin-sensitive patients; see Contraindications. Use caution in patients with pre-existing asthma (without known aspirin sensitivity), and monitor for changes in S/S of asthma.
■ May cause serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) without warning; some have been fatal.
■ Anti-inflammatory and antipyretic effects may reduce the utility of these diagnostic signs in detecting infections.
■ May cause anemia. Anemia may be due to occult or gross GI blood loss, fluid retention, or an incompletely described effect on erythropoiesis.
■ NSAIDs inhibit platelet aggregation and may increase the risk of bleeding. Risk may be increased with comorbid conditions such as coagulation disorders or with concomitant use of several medications; see Drug/Lab Interactions.
■ Aseptic meningitis and ophthalmologic effects (e.g., blurred or diminished vision, changes in color vision) have been reported with oral ibuprofen.
■ See Maternal/Child.
Correct hypovolemia before administration and maintain adequate hydration.
■ Obtain baseline blood pressure and monitor frequently during therapy.
■ Consider baseline CBC, electrolytes, liver function tests, and SCr or CrCl. Repeat as needed if S/S of toxicity/adverse events develop.
■ Monitor patients with or without a previous history of CV disease for S/S of CV events (e.g., chest pain, dyspnea, edema, hypertension, limb or facial paralysis).
■ Monitor for edema or signs of worsening heart failure.
■ Observe for S/S of GI ulceration or bleeding and/or liver dysfunction.
■ Monitor renal function, especially in patients with impaired renal function.
■ Monitor for S/S of hypersensitivity or serious skin reactions (e.g., anaphylaxis, pruritus, rash, urticaria, or wheezing).
■ Monitor patients who may be adversely affected by alterations in platelet function (e.g., patients with coagulation disorders or patients receiving anticoagulants) for signs of bleeding.
Review FDA-approved medication guide.
■ Side effects have resulted in extended hospitalization and could be fatal.
■ Promptly report any S/S of CV thrombotic events (e.g., chest pain, shortness of breath, slurred speech, weakness), GI adverse events (e.g., dyspepsia, epigastric pain, hematemesis, melena), hepatotoxicity (e.g., diarrhea, fatigue, flu-like symptoms, jaundice, lethargy, nausea, pruritus, right upper quadrant tenderness), heart failure (e.g., edema, shortness of breath, weight gain), serious skin reaction, and/or a hypersensitivity reaction (e.g., difficulty breathing, swelling of the face or throat) or any type or rash.
■ Avoid use of concomitant NSAIDs. Over-the-counter medications for the treatment of fever, cold, and insomnia may contain NSAIDs. Consult pharmacist before use.
■ Discuss use of low-dose aspirin for cardiac prophylaxis with health care provider before initiating concomitant therapy; may increase risk of GI toxicity.
■ May be associated with a reversible delay in ovulation.
■ See Maternal/Child.
Avoid use starting at 30 weeks’ gestation (third trimester); premature closure of the ductus arteriosus in the fetus may occur. Use before 30 weeks’ gestation only if the potential benefit justifies the potential risk to the fetus.
■ Effects during labor and delivery unknown.
■ Use with caution during breast-feeding.
■ Safety and effectiveness for use in pediatric patients under 6 months of age not established.
Increased risk for serious NSAID-associated GI, cardiovascular, and/or renal adverse events.
■ Dosing should be cautious; see Dose Adjustments.
Concurrent use with other NSAIDs, aspirin, or other salicylates is not recommended; may increase the risk of toxicity and serious GI events.
■ Ibuprofen may interfere with the platelet effect in patients taking low-dose aspirin for cardioprotection, increasing the risk of CV events. In these patients, consider use of an alternate analgesic that does not interfere with the antiplatelet effect of aspirin.
■ Increased risk of bleeding with concomitant use of anticoagulants, antiplatelet agents, SSRIs, and serotonin-norepinephrine reuptake inhibitors (SNRIs). Monitor patients closely if concomitant use indicated.
■ NSAIDs may decrease the effectiveness of ACE inhibitors, ARBs, and beta-blockers; monitor BP.
■ Coadministration with an ACE inhibitor or ARB may result in deterioration of renal function in at-risk patients; monitor renal function.
■ Ibuprofen can reduce the natriuretic effects of loop diuretics (e.g., furosemide) and thiazide diuretics (e.g., hydrochlorothiazide); observe for signs of worsening renal function and ensure diuretic/therapeutic effectiveness.
■ May increase digoxin serum concentration and prolong half-life of digoxin; monitor digoxin levels with concomitant use.
■ Concurrent use of lithium with NSAIDs may decrease lithium clearance, increasing plasma levels of lithium; observe for signs of lithium toxicity.
■ Concurrent use of NSAIDs with methotrexate may enhance methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction); monitor for signs of methotrexate toxicity.
■ Concomitant use with cyclosporine may increase cyclosporine’s nephrotoxicity; monitor renal function.
■ Concomitant use with pemetrexed may increase the risk of pemetrexed-associated myelosuppression and renal and GI toxicity; avoid concomitant use for 2 to 5 days before pemetrexed administration and for 2 days following administration in patients with mild to moderate renal impairment (CrCl 45 to 79 mL/min). See pemetrexed monograph.
The most common side effects are dizziness, flatulence, headache, hemorrhage, and nausea and vomiting. Other side effects include abdominal discomfort, anemia, bacteremia, bacterial pneumonia, cough, diarrhea, dyspepsia, eosinophilia, hyperkalemia, hypernatremia, hypertension, hypoalbuminemia, hypokalemia, hypoproteinemia, hypotension, increased blood urea, increased lactic dehydrogenase (LDH), neutropenia, peripheral edema, thrombocytosis, urinary retention, and wound hemorrhage. See Precautions for potential major side effects.
The most common side effects are anemia, headache, infusion site pain, nausea, and vomiting.
Acute renal failure, coma, drowsiness, epigastric pain, GI bleeding, hypertension, lethargy, nausea, respiratory depression, and vomiting.
Keep the physician informed of significant side effects. With increasing severity or onset of symptoms of any major side effect (e.g., CHF; edema; hypersensitivity reactions; GI bleeding, ulceration, or perforation; hepatic or renal effects; hypertension; skin reactions; thrombotic events), discontinue the drug and notify the physician. A patent airway, artificial ventilation, oxygen therapy, and other symptomatic treatment must be instituted promptly if indicated. Treat anaphylaxis with epinephrine, diphenhydramine, and corticosteroids as indicated. No known antidote. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.