Possible increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI, stroke). Risk may increase with duration of use. Individuals with cardiovascular disease or risk factors for cardiovascular disease may be at increased risk. (See Cardiovascular Effects under Cautions.)
Contraindicated for the treatment of pain in the setting of CABG surgery.
GI Risk
Increased risk of serious (sometimes fatal) GI events (e.g., bleeding, ulceration, perforation of the stomach or intestine). Serious GI events can occur at any time and may not be preceded by warning signs and symptoms. Geriatric individuals are at greater risk for serious GI events. (See GI Effects under Cautions.)
When used for inflammatory diseases, pain, dysmenorrhea, or fever, consider potential benefits and risks of ibuprofen therapy as well as alternative therapies before initiating therapy with the drug. Use lowest effective dosage and shortest duration of therapy consistent with the patient's treatment goals.
Inflammatory Diseases
Symptomatic treatment of osteoarthritis and rheumatoid arthritis.
Management of juvenile rheumatoid arthritis in children.
Pericarditis
Reduction of pain, fever, and inflammation of pericarditis†; however, other drugs (i.e., aspirin) generally are preferred.
Pain
Relief of mild to moderate pain in children and adults.
NSAIAs considered first-line agents for mild to moderate migraine attacks or for severe attacks that have responded in the past to NSAIAs or nonopiate analgesics.
Self-medication in children and adults for the temporary relief of minor aches and pain associated with the common cold, influenza, or sore throat; headache (including migraine); toothache; muscular aches; backache; minor pain of arthritis.
Dysmenorrhea
Symptomatic management of primary dysmenorrhea.
Self-medication for the temporary relief of minor aches and pain associated with menstrual cramps.
Fever
Reduction of fever in children and adults.
Self-medication for reduction of fever in children and adults.
Patent Ductus Arteriosus (PDA)
Treatment of PDA in premature neonates (designated an orphan drug by FDA for this use). Used to promote closure of a clinically important PDA in premature neonates weighing 500–1500 g who are ≤32 weeks' gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support) is ineffective. Limited follow-up data available; reserve for neonates with clinically important PDA.
Dosage and Administration
General
For inflammatory diseases, pain, dysmenorrhea, or fever, consider potential benefits and risks of ibuprofen therapy as well as alternative therapies before initiating therapy with the drug.
Administration
Administer orally (for inflammatory diseases, pain, dysmenorrhea, or fever) or by IV infusion (for PDA).
Oral Administration
If GI disturbances occur, administer with meals or milk.
Pediatric Administration
Ibuprofen oral drops generally used in infants 6–23 months of age. Use the calibrated dosing device provided by the manufacturer for measurement of the dose.
Pediatric oral suspension commonly used in children ≥2 years of age; 50-mg chewable tablets also may be used in this age group. Use the calibrated dosage cup provided by the manufacturer for measurement of the dose of the suspension.
The 100-mg chewable or film-coated tablets may be used in children ≥6 years of age.
IV Administration
Administer by IV infusion using IV port nearest to the IV insertion site.
Do not infuse simultaneously through same line as parenteral nutrition solutions. If same line must be used, interrupt infusion of the nutrition solution for 15 minutes before and after administration of ibuprofen; maintain line patency by infusing dextrose injection or sodium chloride injection.
Avoid extravasation (irritating to extravascular tissues).
Dilution
Dilute ibuprofen lysine injection with an appropriate volume of dextrose injection or sodium chloride injection.
Administer within 30 minutes of preparation; discard any unused solution.
Rate of Administration
Administer dose over 15 minutes.
Dosage
Dosage of ibuprofen lysine expressed in terms of ibuprofen.
To minimize the potential risk of adverse cardiovascular and/or GI events, use lowest effective dosage and shortest duration of therapy consistent with the patient's treatment goals. Adjust dosage based on individual requirements and response; attempt to titrate to the lowest effective dosage.
Pediatric Patients
Dosage in children should be guided by body weight.
Inflammatory Diseases
Juvenile Rheumatoid Arthritis
Oral
30–40 mg/kg daily divided into 3 or 4 doses. 20 mg/kg daily in divided doses may be adequate for children with mild disease.
Pain
Oral
For mild to moderate pain in children 6 months to 12 years of age, 10 mg/kg every 6–8 hours. (See Pediatric Use under Cautions.)
Age- or Weight-Based Dosage for Self-medication of Minor Aches and Pain in Children 6 Months to 11 Years of Age
Age
Weight
Dose
6–11 months
12–17 pounds (approximately 5–8 kg)
50 mg
12–23 months
18–23 pounds (approximately 8–10 kg)
75 mg
2–3 years
24–35 pounds (approximately 11–16 kg)
100 mg
4–5 years
36–47 pounds (approximately 16–21 kg)
150 mg
6–8 years
48–59 pounds (approximately 22–27 kg)
200 mg
9–10 years
60–71 pounds (approximately 27–32 kg)
250 mg
11 years
72–95 pounds (approximately 33–43 kg)
300 mg
Dose may be administered every 6–8 hours.
For self-medication of minor aches and pain in children ≥12 years of age, 200 mg every 4–6 hours; may increase dosage to 400 mg every 4–6 hours if needed.
Fever
Oral
For children 6 months to 12 years of age: 5 mg/kg for temperatures <39°C; 10 mg/kg for temperatures >39°C. (See Pediatric Use under Cautions.)
Age- or Weight-Based Dosage for Self-medication of Fever in Children 6 Months to 11 Years of Age
Age
Weight
Dose
6–11 months
12–17 pounds (approximately 5–8 kg)
50 mg
12–23 months
18–23 pounds (approximately 8–10 kg)
75 mg
2–3 years
24–35 pounds (approximately 11–16 kg)
100 mg
4–5 years
36–47 pounds (approximately 16–21 kg)
150 mg
6–8 years
48–59 pounds (approximately 22–27 kg)
200 mg
9–10 years
60–71 pounds (approximately 27–32 kg)
250 mg
11 years
72–95 pounds (approximately 33–43 kg)
300 mg
Dose may be administered every 6–8 hours.
For self-medication of fever in children ≥12 years of age, 200 mg every 4–6 hours; may increase dosage to 400 mg every 4–6 hours if needed.
PDA
IV
Each course of therapy consists of 3 doses administered at 24-hour intervals.
Base dosage on neonate’s birth weight.
First dose is 10 mg/kg; second and third doses are 5 mg/kg each.
If anuria or oliguria (urine output <0.6 mL/kg per hour) is present at the time of a second or third dose, withhold the dose until laboratory determinations indicate that renal function has returned to normal.
If ductus arteriosus closes or is substantially constricted after completion of the first course, no further doses are necessary.
If ductus arteriosus fails to close or reopens, a second course of ibuprofen, alternative pharmacologic therapy, or surgery may be needed.
Adults
Inflammatory Diseases
Osteoarthritis or Rheumatoid Arthritis
Oral
1.2–3.2 g daily, given as 300 mg 4 times daily, or 400, 600, or 800 mg 3 or 4 times daily.
Pain
Oral
For mild to moderate pain, 400 mg every 4–6 hours as needed.
For self-medication of minor aches and pain, 200 mg every 4–6 hours; may increase dosage to 400 mg every 4–6 hours if needed.
For self-medication of migraine pain, 400 mg once in a 24-hour period.
Dysmenorrhea
Oral
400 mg every 4 hours as necessary; initiate at earliest onset of pain.
For self-medication, 200 mg every 4–6 hours; may increase to 400 mg every 4–6 hours if necessary.
Fever
Oral
For self-medication, 200 mg every 4–6 hours; may increase to 400 mg every 4–6 hours if needed.
Prescribing Limits
Pediatric Patients
Inflammatory Diseases
Juvenile Rheumatoid Arthritis
Oral
Maximum 50 mg/kg daily.
Pain
Oral
For mild to moderate pain in children 6 months to 12 years of age, maximum 40 mg/kg daily.
For self-medication of minor aches and pain in children 6 months to 11 years of age, do not exceed recommended dosage; do not administer recommended dose more than 4 times daily. (See Pediatric Use under Cautions.) Self-medication should not exceed 3 days unless otherwise directed by a clinician.
For self-medication of minor aches and pain in children ≥12 years of age, maximum 1.2 g daily. Self-medication should not exceed 10 days unless otherwise directed by a clinician.
Fever
Oral
Maximum 40 mg/kg daily in children 6 months to 12 years of age.
For self-medication in children 6 months to 11 years of age, do not exceed recommended dosage; do not administer recommended dose more than 4 times daily. (See Pediatric Use under Cautions.) Self-medication should not exceed 3 days unless otherwise directed by a clinician.
For self-medication in children ≥12 years of age, maximum 1.2 g daily. Self-medication should not exceed 3 days unless otherwise directed by a clinician.
Adults
Inflammatory Diseases
Osteoarthritis or Rheumatoid Arthritis
Oral
Maximum 3.2 g daily.
Pain
Oral
For mild to moderate pain, maximum 3.2 g daily.
For self-medication of minor aches and pain, maximum 1.2 g daily. Self-medication should not exceed 10 days unless otherwise directed by a clinician.
For self-medication of migraine pain, maximum 400 mg in a 24-hour period unless otherwise directed by a clinician.
Dysmenorrhea
Oral
Maximum 3.2 g daily.
For self-medication, maximum 1.2 g daily.
Fever
Oral
For self-medication, maximum 1.2 g daily. Self-medication should not exceed 3 days unless otherwise directed by a clinician.
Special Populations
Renal Impairment
Consider dosage reduction in patients with substantial renal impairment.
Selective COX-2 inhibitors have been associated with increased risk of cardiovascular events (e.g., MI, stroke) in certain situations. Several prototypical NSAIAs also have been associated with increased risk of cardiovascular events. Current evidence suggests that use of ibuprofen might be associated with increased cardiovascular risk.
Use NSAIAs with caution and careful monitoring (e.g., monitor for development of cardiovascular events), and at the lowest effective dosage for the shortest duration necessary.
Short-term use to relieve acute pain, especially at low dosages, does not appear to be associated with increased risk of serious cardiovascular events (except immediately following CABG surgery).
No consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious adverse cardiovascular events associated with NSAIAs. (See Specific Drugs under Interactions.)
Hypertension and worsening of preexisting hypertension reported; either event may contribute to the increased incidence of cardiovascular events. Use with caution in patients with hypertension; monitor BP. Impaired response to certain diuretics may occur. (See Specific Drugs under Interactions.)
Fluid retention and edema reported. Caution in patients with fluid retention or heart failure.
GI Effects
Serious GI toxicity (e.g., bleeding, ulceration, perforation) can occur with or without warning symptoms; increased risk in those with a history of GI bleeding or ulceration, geriatric patients, smokers, those with alcohol dependence, and those in poor general health.
For patients at high risk for complications from NSAIA-induced GI ulceration (e.g., bleeding, perforation), consider concomitant use of misoprostol; alternatively, consider concomitant use of a proton-pump inhibitor (e.g., omeprazole) or use of an NSAIA that is a selective inhibitor of COX-2 (e.g., celecoxib).
Contraindicated in neonates with necrotizing enterocolitis.
Renal Effects
Direct renal injury, including renal papillary necrosis, reported in patients receiving long-term NSAIA therapy.
Potential for overt renal decompensation. Increased risk of renal toxicity in patients with renal or hepatic impairment or heart failure, in geriatric patients, in patients with volume depletion, and in those receiving a diuretic, ACE inhibitor, or angiotensin II receptor antagonist. (See Renal Impairment under Cautions.)
Correct dehydration before initiating ibuprofen therapy.
Renal insufficiency (including oliguria), increases in BUN, increases in Scr, and renal failure reported in neonates. Decreases in urine output in ibuprofen-treated neonates noted on days 2–6 of life; compensatory increase in output noted on day 9.
Sensitivity Reactions
Hypersensitivity Reactions
Anaphylactoid reactions reported.
Immediate medical intervention and discontinuance for anaphylaxis.
Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps); caution in patients with asthma.
Dermatologic Reactions
Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) reported; can occur without warning. Discontinue at first appearance of rash or any other sign of hypersensitivity (e.g., blisters, fever, pruritus).
General Precautions
Do not use multiple ibuprofen-containing preparations concomitantly.
Hepatic Effects
Severe reactions including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure (sometimes fatal) reported rarely with NSAIAs.
Monitor for symptoms and/or signs suggesting liver dysfunction; monitor abnormal liver function test results. Discontinue if signs or symptoms of liver disease or systemic manifestations (e.g., eosinophilia, rash) occur.
Hematologic Effects
Anemia reported rarely. Determine hemoglobin concentration or hematocrit in patients receiving long-term therapy if signs or symptoms of anemia occur.
May inhibit platelet aggregation and prolong bleeding time.
Potential for spontaneous intraventricular hemorrhage in neonates. Observe premature infants for signs of bleeding.
Contraindicated in neonates who are bleeding and those with thrombocytopenia or coagulation defects.
Aseptic Meningitis
Aseptic meningitis reported rarely. Consider possibility that meningitis in a patient receiving ibuprofen is drug related.
Individuals with Phenylketonuria
Motrin® chewable tablets contain aspartame (NutraSweet®), which is metabolized in the GI tract to provide 3 or 6 mg of phenylalanine for each 50- or 100-mg tablet, respectively.
Advil® Children’s chewable tablets and Advil® Junior Strength chewable tablets contain aspartame, which is metabolized to provide 2.1 and 4.2 mg of phenylalanine for each tablet, respectively.
Diabetic Patients
Some commercially available preparations of ibuprofen may contain sucrose.
Hyperbilirubinemia
Ibuprofen can displace bilirubin from serum albumin; caution in patients with elevated total bilirubin concentrations.
Other Precautions
Not a substitute for corticosteroid therapy; not effective in the management of adrenal insufficiency.
May mask certain signs of infection.
Obtain CBC and chemistry profile periodically during long-term use.
Use of Fixed Combination
When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.
Specific Populations
Pregnancy
Category C. Avoid use in third trimester because of possible premature closure of the ductus arteriosus.
Lactation
Not detected in milk; however, studies were limited. Use not recommended.
Pediatric Use
Safety and efficacy established in neonates receiving the drug for PDA. However, long-term follow-up (>36 weeks postconception age) of these neonates has not been conducted. Effects of ibuprofen on neurodevelopmental outcome, growth, and other complications of prematurity (e.g., retinopathy of prematurity, chronic lung disease) not assessed.
Safety and efficacy of oral ibuprofen not established in infants <6 months of age.
Risk of overdosage and toxicity (including death) in children <2 years of age receiving OTC preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection. Such preparations also may contain analgesics and antipyretics. Limited evidence of efficacy for these preparations in this age group; appropriate dosages not established. Therefore, FDA recommends not to use such preparations in children <2 years of age; safety and efficacy in older children currently under evaluation. Because children 2–3 years of age also are at increased risk of overdosage and toxicity, some manufacturers of oral OTC cough and cold preparations recently agreed to voluntarily revise the product labeling to state that such preparations should not be used in children <4 years of age. During the transition period, some preparations on pharmacy shelves will have the new recommendation (“do not use in children <4 years of age”), while others will have the previous recommendation (“do not use in children <2 years of age”). FDA recommends that parents and caregivers adhere to dosage instructions and warnings on the product labeling that accompanies the preparation and consult a clinician about any concerns.
Geriatric Use
Geriatric patients appear to tolerate GI ulceration and bleeding less well than other individuals. Fatal adverse GI effects reported more frequently in geriatric patients than younger adults.
Renal Impairment
Use with caution in patients with renal disease. Use not recommended in patients with advanced renal disease; close monitoring of renal function advised if used.
Common Adverse Effects
With oral therapy, dizziness, epigastric pain, heartburn, nausea, rash.
With IV therapy, sepsis, anemia, bleeding, apnea, adverse GI effects, renal impairment, respiratory tract infection, dermatologic effects, hypoglycemia, hypocalcemia, respiratory failure.
Antagonism of the irreversible platelet-aggregation inhibitory effect of aspirin; may limit the cardioprotective effects of aspirin
Increased risk of GI ulceration and other complications
No consistent evidence that low-dose aspirin mitigates the increased risk of serious cardiovascular events associated with NSAIAs
Manufacturer states that concomitant use not recommended
Regular ibuprofen use not recommended in patients taking aspirin for cardiovascular prophylaxis
For occasional use with immediate-release low-dose aspirin: Administer single dose of ibuprofen 400 mg for self-medication at least 8 hours before or at least 30 minutes after aspirin
Enteric-coated low-dose aspirin: No recommendations regarding timing of administration with single dose of ibuprofen
Well absorbed following oral administration; peak plasma concentration usually attained within 1–2 hours.
Onset
Pain relief and/or antipyretic activity achieved within 1 hour.
Food
Food reduces peak plasma concentration by about 30–50% and delays time to reach peak plasma concentration by about 30–60 minutes but does not affect extent of absorption.
Distribution
Plasma Protein Binding
>99%.
Elimination
Metabolism
Extensively metabolized.
Elimination Route
Excreted mainly in urine as metabolites.
Half-life
1.8–2 hours.
Half-life 10-fold longer in neonates than in adults.
Stability
Storage
Oral
Capsules and Tablets
20–25°C.
Suspension
20–25°C.
Actions
Inhibits cyclooxygenase-1 (COX-1) and COX-2.
Pharmacologic actions similar to those of other prototypical NSAIAs; exhibits anti-inflammatory, analgesic, and antipyretic activity.
Permits closure of the ductus arteriosus in premature neonates by inhibiting prostaglandin synthesis.
Advice to Patients
Importance of reading the medication guide for NSAIAs that is provided each time the drug is dispensed.
When used for self-medication, importance of reading the product labeling.
When used for self-medication, importance of using the lowest effective dosage and of not exceeding the recommended dosage or duration of therapy.
When used for self medication, importance of reviewing the warning information provided by the manufacturer.
Risk of serious cardiovascular events with long-term use.
Risk of GI bleeding and ulceration.
Risk of serious skin reactions. Risk of anaphylactoid and other sensitivity reactions.
Risk of hepatotoxicity.
Importance of notifying clinician if signs and symptoms of a cardiovascular event (chest pain, dyspnea, weakness, slurred speech) occur.
Importance of notifying clinician if signs and symptoms of GI ulceration or bleeding, unexplained weight gain, or edema develops.
Importance of discontinuing ibuprofen and contacting clinician if rash or other signs of hypersensitivity (blisters, fever, pruritus) develop. Importance of seeking immediate medical attention if an anaphylactic reaction occurs.
Importance of discontinuing therapy and contacting clinician immediately if signs and symptoms of hepatotoxicity (nausea, fatigue, lethargy, pruritus, jaundice, upper right quadrant tenderness, flu-like symptoms) occur.
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. Importance of avoiding ibuprofen in late pregnancy (third trimester).
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.
Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
In response to concerns regarding the safety and efficacy of cough/cold preparations in young children, many OTC cough/cold preparations specifically formulated for infants have been voluntarily withdrawn from the US market. Therefore, some of the preparations described below may no longer be commercially available in the US.
Ibuprofen
Routes
Dosage Forms
Strengths
Brand Names
Manufacturer
Oral
Capsules, liquid-filled
200 mg
Advil® Liqui-Gels®
Wyeth
equivalent to 200 mg ibuprofen (as free acid and ibuprofen potassium)
Advil® Migraine®
Wyeth
Suspension
40 mg/mL*
Advil® Infants’ Concentrated Drops
Wyeth
Motrin® Drops
McNeil
Motrin® Infants’ Concentrated Drops
McNeil
100 mg/5 mL*
Advil® Children’s
Wyeth
Ibuprofen Oral Suspension
Motrin® Children’s
McNeil
Tablets
200 mg*
Motrin® IB Gelcaps®
McNeil
400 mg*
600 mg*
800 mg*
Tablets, chewable
50 mg
Advil® Children’s
Wyeth
Motrin® Children’s
McNeil
100 mg
Advil® Junior Strength Chewable Tablets
Wyeth
Motrin® (scored)
McNeil
Motrin® Junior Strength
McNeil
Tablets, film-coated
100 mg
Advil® Junior Strength Tablets
Wyeth
Motrin® Caplets® (scored)
McNeil
Motrin® Junior Strength Caplets®
McNeil
200 mg*
Advil® Caplets®
Wyeth
Advil® Gel Caplets
Wyeth
Advil® Tablets
Wyeth
Genpril® Caplets ®
Teva
Genpril® Tablets
Teva
Haltran®
Lee
Ibu-Tab®
Alra
Menadol® Captabs®
Watson
Midol® Cramp
Bayer
Motrin® IB Caplets®
McNeil
Motrin® IB Tablets
McNeil
Motrin® Migraine Pain Caplets®
McNeil
400 mg*
IBU®
Par
Ibu-Tab®
Alra
Motrin®
Pharmacia
600 mg*
IBU®
Par
Ibu-Tab®
Alra
Motrin®
Pharmacia
800 mg*
IBU®
Par
Ibu-Tab®
Alra
Motrin®
Pharmacia
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2009. For the most current and up-to-date pricing information, please visit www.drugstore.com. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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