Class: Other Nonsteroidal Anti-inflammatory Agents
CAS Number: 15687-271
Brands: Advil, Caldolor, Dristan, Genpril, Haltran, IBU, Ibu-Tab, Menadol, Midol, Motrin, NeoProfen, Vicoprofen
- Cardiovascular Risk
Possible increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI, stroke).192 210 Risk may increase with duration of use.192 210 Individuals with cardiovascular disease or risk factors for cardiovascular disease may be at increased risk.192 210 (See Cardiovascular Effects under Cautions.)
Contraindicated for the treatment of pain in the setting of CABG surgery.192 210
- GI Risk
Increased risk of serious (sometimes fatal) GI events (e.g., bleeding, ulceration, perforation of the stomach or intestine).192 210 Serious GI events can occur at any time and may not be preceded by warning signs and symptoms.192 210 Geriatric individuals are at greater risk for serious GI events.192 210 (See GI Effects under Cautions.)
Introduction
Prototypical NSAIA; propionic acid derivative.100 106
Uses for Ibuprofen
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.192 Use lowest effective dosage and shortest duration of therapy consistent with the patient’s treatment goals.192
Inflammatory Diseases
Symptomatic treatment of osteoarthritis and rheumatoid arthritis.100
Management of juvenile rheumatoid arthritis in children.106
Pericarditis
Reduction of pain, fever, and inflammation of pericarditis†;174 however, other drugs (i.e., aspirin) generally are preferred.174
Pain
Oral ibuprofen used for relief of mild to moderate pain in adults and children; IV ibuprofen used in adults for relief of mild to moderate pain and, in conjunction with opiates, for relief of moderate to severe pain.100 106 210
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.186
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.105 164 165 178 179 189
Dysmenorrhea
Symptomatic management of primary dysmenorrhea.100
Self-medication for the temporary relief of minor aches and pain associated with menstrual cramps.165
Fever
Reduction of fever in adults (oral or IV ibuprofen) and children (oral ibuprofen).106 210
Self-medication for reduction of fever in children and adults.164
Patent Ductus Arteriosus (PDA)
Treatment of PDA in premature neonates (designated an orphan drug by FDA for this use).198 206 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.198 Limited follow-up data available; reserve for neonates with clinically important PDA.198
Ibuprofen 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.192
Administration
Ibuprofen: Administer orally (for inflammatory diseases, pain, dysmenorrhea, or fever)100 106 164 or by IV infusion (for pain or fever).210
Ibuprofen lysine: Administer by IV infusion (for PDA).198
Oral Administration
If GI disturbances occur, administer with meals or milk.100
Pediatric Administration
Ibuprofen oral drops generally used in infants 6–23 months of age.164 Use the calibrated dosing device provided by the manufacturer for measurement of the dose.164
Pediatric oral suspension commonly used in children ≥2 years of age; 50-mg chewable tablets also may be used in this age group.164 178 186 Use the calibrated dosage cup provided by the manufacturer for measurement of the dose of the suspension.164
The 100-mg chewable or film-coated tablets may be used in children ≥6 years of age.164 178
IV Administration (Ibuprofen)
Ensure patient is well hydrated.210
Must be diluted prior to IV administration.210
Dilution
Dilute ibuprofen injection concentrate with an appropriate volume of 0.9% sodium chloride injection, 5% dextrose injection, or lactated Ringer’s injection to provide a solution containing ≤4 mg/mL.210
Rate of Administration
Administer dose over ≥30 minutes.210
IV Administration (Ibuprofen Lysine)
Administer by IV infusion using IV port nearest to the IV insertion site.198
Do not infuse simultaneously through same line as parenteral nutrition solutions.198 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.198
Avoid extravasation (irritating to extravascular tissues).198
Dilution
Dilute ibuprofen lysine injection with an appropriate volume of dextrose injection or sodium chloride injection.198
Administer within 30 minutes of preparation; discard any unused solution.198
Rate of Administration
Administer dose over 15 minutes.198
Dosage
Dosage of ibuprofen lysine expressed in terms of ibuprofen.198
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.192 Adjust dosage based on individual requirements and response; attempt to titrate to the lowest effective dosage.100 106 192
Pediatric Patients
Dosage in children should be guided by body weight.106
Inflammatory Diseases
Juvenile Rheumatoid Arthritis
Oral
30–40 mg/kg daily divided into 3 or 4 doses.106 20 mg/kg daily in divided doses may be adequate for children with mild disease.106
Pain
Oral
For mild to moderate pain in children 6 months to 12 years of age, 10 mg/kg every 6–8 hours.106 (See Pediatric Use under Cautions.)
Dose may be administered every 6–8 hours.164
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 |
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.a
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.106 (See Pediatric Use under Cautions.)
Dose may be administered every 6–8 hours.164
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 |
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.a
PDA
IV
Each course of therapy consists of 3 doses administered at 24-hour intervals.198
Base dosage on neonate’s birth weight.198
First dose is 10 mg/kg; second and third doses are 5 mg/kg each.198
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.198
If ductus arteriosus closes or is substantially constricted after completion of the first course, no further doses are necessary.198
If ductus arteriosus fails to close or reopens, a second course of ibuprofen, alternative pharmacologic therapy, or surgery may be needed.198
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.100
Pain
Oral
For mild to moderate pain, 400 mg every 4–6 hours as needed.100
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.165
For self-medication of migraine pain, 400 mg once in a 24-hour period.105
IV
Individuals ≥17 years of age: 400–800 mg every 6 hours as needed.210
Dysmenorrhea
Oral
400 mg every 4 hours as necessary; initiate at earliest onset of pain.100
For self-medication, 200 mg every 4–6 hours; may increase to 400 mg every 4–6 hours if necessary.165
Fever
Oral
For self-medication, 200 mg every 4–6 hours; may increase to 400 mg every 4–6 hours if needed.165
IV
Individuals ≥17 years of age: 400 mg initially; then 400 mg every 4–6 hours or 100–200 mg every 4 hours.210
Prescribing Limits
Pediatric Patients
Inflammatory Diseases
Juvenile Rheumatoid Arthritis
Oral
Maximum 50 mg/kg daily.106
Pain
Oral
For mild to moderate pain in children 6 months to 12 years of age, maximum 40 mg/kg daily.106
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.164 186 (See Pediatric Use under Cautions.) Self-medication should not exceed 3 days unless otherwise directed by a clinician.164
For self-medication of minor aches and pain in children ≥12 years of age, maximum 1.2 g daily.a Self-medication should not exceed 10 days unless otherwise directed by a clinician.a
Fever
Oral
Maximum 40 mg/kg daily in children 6 months to 12 years of age.106
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.164 186 (See Pediatric Use under Cautions.) Self-medication should not exceed 3 days unless otherwise directed by a clinician.164
For self-medication in children ≥12 years of age, maximum 1.2 g daily.a Self-medication should not exceed 3 days unless otherwise directed by a clinician.a
Adults
Inflammatory Diseases
Osteoarthritis or Rheumatoid Arthritis
Oral
Maximum 3.2 g daily.100
Pain
Oral
For mild to moderate pain, maximum 3.2 g daily.100
For self-medication of minor aches and pain, maximum 1.2 g daily.165 Self-medication should not exceed 10 days unless otherwise directed by a clinician.165
For self-medication of migraine pain, maximum 400 mg in a 24-hour period unless otherwise directed by a clinician.105
IV
Maximum 3.2 g in a 24-hour period.210
Dysmenorrhea
Oral
Maximum 3.2 g daily.100
For self-medication, maximum 1.2 g daily.165
Fever
Oral
For self-medication, maximum 1.2 g daily.165 Self-medication should not exceed 3 days unless otherwise directed by a clinician.165
IV
Maximum 3.2 g in a 24-hour period.210
Special Populations
Renal Impairment
Consider dosage reduction in patients with substantial renal impairment.100 106
Cautions for Ibuprofen
Contraindications
Known hypersensitivity to ibuprofen or any ingredient in the formulation.100 106 210
History of asthma, urticaria, or other sensitivity reaction precipitated by aspirin or other NSAIAs.100 106 210
Treatment of perioperative pain in the setting of CABG surgery.192 210
- IV Therapy for PDA
Known or suspected untreated infection.198
Bleeding, especially active intracranial hemorrhage or GI bleeding; thrombocytopenia; coagulation defects.198
Known or suspected necrotizing enterocolitis.198
Substantial renal impairment.198
Congenital heart disease if patency of the ductus arteriosus is necessary for pulmonary or systemic blood flow (e.g., pulmonary atresia, severe tetralogy of Fallot, severe coarctation of the aorta).198
Warnings/Precautions
Warnings
Cardiovascular Effects
Selective COX-2 inhibitors have been associated with increased risk of cardiovascular events (e.g., MI, stroke) in certain situations.197 Several prototypical NSAIAs also have been associated with increased risk of cardiovascular events.199 200 201 210 Current evidence suggests that use of ibuprofen might be associated with increased cardiovascular risk.199 201
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.192 210
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).197
No consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious adverse cardiovascular events associated with NSAIAs.192 197 210 (See Specific Drugs under Interactions.)
Hypertension and worsening of preexisting hypertension reported; either event may contribute to the increased incidence of cardiovascular events.192 210 Use with caution in patients with hypertension; monitor BP.192 210 Impaired response to certain diuretics may occur.192 (See Specific Drugs under Interactions.)
Fluid retention and edema reported.100 106 192 210 Caution in patients with fluid retention or heart failure.100 106 192 210
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.100 106 109 173 177 210
For patients at high risk for complications from NSAIA-induced GI ulceration (e.g., bleeding, perforation), consider concomitant use of misoprostol;154 157 173 175 alternatively, consider concomitant use of a proton-pump inhibitor (e.g., omeprazole)154 157 173 or use of an NSAIA that is a selective inhibitor of COX-2 (e.g., celecoxib).154
Contraindicated in neonates with necrotizing enterocolitis.198
Renal Effects
Direct renal injury, including renal papillary necrosis, reported in patients receiving long-term NSAIA therapy.100 106 210
Potential for overt renal decompensation.100 106 116 192 210 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.192 196 204 210 (See Renal Impairment under Cautions.)
Correct dehydration before initiating ibuprofen therapy.100 106 210
Renal insufficiency (including oliguria), increases in BUN, increases in Scr, and renal failure reported in neonates.198 Decreases in urine output in ibuprofen-treated neonates noted on days 2–6 of life; compensatory increase in output noted on day 9.198
Sensitivity Reactions
Hypersensitivity Reactions
Anaphylactoid reactions reported.100 106 210
Immediate medical intervention and discontinuance for anaphylaxis.100 106 210
Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps); caution in patients with asthma.100 106 210
Dermatologic Reactions
Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) reported; can occur without warning.192 210 Discontinue at first appearance of rash or any other sign of hypersensitivity (e.g., blisters, fever, pruritus).192 210
General Precautions
Do not use multiple ibuprofen-containing preparations concomitantly.165
Hepatic Effects
Severe reactions including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure (sometimes fatal) reported rarely with NSAIAs.100 106 210
Elevations of serum ALT or AST reported.100 106 210
Monitor for symptoms and/or signs suggesting liver dysfunction; monitor abnormal liver function test results.100 106 210 Discontinue if signs or symptoms of liver disease or systemic manifestations (e.g., eosinophilia, rash) occur.100 106 210
Hematologic Effects
Anemia reported rarely.100 210 Determine hemoglobin concentration or hematocrit in patients receiving long-term therapy if signs or symptoms of anemia occur.192 210
May inhibit platelet aggregation and prolong bleeding time.106 210
Potential for spontaneous intraventricular hemorrhage in neonates.198 Observe premature infants for signs of bleeding.198
Contraindicated in neonates who are bleeding and those with thrombocytopenia or coagulation defects.198
Aseptic Meningitis
Aseptic meningitis reported rarely.100 106 210 Consider possibility that meningitis in a patient receiving ibuprofen is drug related.100 106 210
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.106
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.178 179
Diabetic Patients
Some commercially available preparations of ibuprofen may contain sucrose.106
Hyperbilirubinemia
Ibuprofen can displace bilirubin from serum albumin; caution in patients with elevated total bilirubin concentrations.198
Ocular Effects
Visual disturbances reported: ophthalmic evaluation recommended if visual changes occur.210
Other Precautions
Not a substitute for corticosteroid therapy; not effective in the management of adrenal insufficiency.100 106
May mask certain signs of infection.100 106 198
Obtain CBC and chemistry profile periodically during long-term use.192
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.192 Avoid use in third trimester because of possible premature closure of the ductus arteriosus.106
Lactation
Not detected in milk; however, studies were limited.100 106 Use not recommended.100 106
Pediatric Use
Safety and efficacy of ibuprofen lysine established in neonates receiving the drug for PDA.198 However, long-term follow-up (>36 weeks postconception age) of these neonates has not been conducted.198 Effects of ibuprofen on neurodevelopmental outcome, growth, and other complications of prematurity (e.g., retinopathy of prematurity, chronic lung disease) not assessed.198
Safety and efficacy of oral ibuprofen not established in infants <6 months of age.106
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.207 208 Such preparations also may contain analgesics and antipyretics.207 Limited evidence of efficacy for these preparations in this age group; appropriate dosages not established.207 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.
Safety and efficacy of IV ibuprofen for relief of pain or reduction of fever not established in pediatric patients <17 years of age.210
Geriatric Use
Geriatric patients appear to tolerate GI ulceration and bleeding less well than other individuals.100 106 Fatal adverse GI effects reported more frequently in geriatric patients than younger adults.100 106
Experience in those ≥65 years of age insufficient to determine whether they respond differently to IV ibuprofen than do younger adults.210 Select dosage with caution, starting at the low end of the dosage range, because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.210
Renal Impairment
Use with caution in patients with renal disease.100 106 135 Use not recommended in patients with advanced renal disease; close monitoring of renal function advised if used.100 106
Common Adverse Effects
With oral ibuprofen therapy, dizziness, epigastric pain, heartburn, nausea, rash.100 106
With IV ibuprofen therapy, nausea, flatulence, vomiting, headache, hemorrhage, dizziness.210
With IV ibuprofen lysine therapy, sepsis, anemia, bleeding, apnea, adverse GI effects, renal impairment, respiratory tract infection, dermatologic effects, hypoglycemia, hypocalcemia, respiratory failure.198
Interactions for Ibuprofen
No evidence of enzyme induction.100
Specific Drugs
Drug | Interaction | Comments |
|---|---|---|
ACE inhibitors | Reduced BP response to ACE inhibitor106 135 136 137 138 139 140 141 210 Possible deterioration of renal function in individuals with renal impairment204 | Monitor BP136 210 |
Alcohol | Increased risk of GI bleeding158 160 162 163 165 | |
Angiotensin II receptor antagonists | Reduced BP response to angiotensin II receptor antagonist204 Possible deterioration of renal function in individuals with renal impairment204 | Monitor BP204 |
Antacids (aluminum- and magnesium-containing) | No effect on ibuprofen absorption100 | |
Aspirin | Antagonism of the irreversible platelet-aggregation inhibitory effect of aspirin; may limit the cardioprotective effects of aspirin 176 Increased risk of GI ulceration and other complications192 210 No consistent evidence that low-dose aspirin mitigates the increased risk of serious cardiovascular events associated with NSAIAs192 210 | Manufacturer states that concomitant use not recommended100 106 210 Regular ibuprofen use not recommended in patients taking aspirin for cardiovascular prophylaxisc 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 aspirin202 203 Enteric-coated low-dose aspirin: No recommendations regarding timing of administration with single dose of ibuprofen202 203 |
Diuretics (furosemide, thiazides) | Reduced natriuretic effects100 106 192 210 | Monitor for diuretic efficacy and renal failure192 210 |
H2 antagonists (cimetidine, ranitidine) | Serum ibuprofen concentrations not appreciably altered106 210 | |
Lithium | Increased plasma lithium concentrations118 119 120 121 122 123 124 125 210 | Monitor for lithium toxicity; monitor lithium concentrations; lithium dosage reduction may be required118 119 121 123 124 210 |
Methotrexate | Pharmacokinetics of methotrexate may be altered100 106 210 | Caution advised100 106 210 |
Warfarin | Reports of bleeding100 106 210 | Caution advised100 106 210 |
Ibuprofen Pharmacokinetics
Absorption
Bioavailability
Well absorbed following oral administration; peak plasma concentration usually attained within 1–2 hours.100 106
Onset
Pain relief and/or antipyretic activity achieved within 1 hour.106 107
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.100 106
Distribution
Plasma Protein Binding
>99%.106
Elimination
Metabolism
Extensively metabolized.100 106
Elimination Route
Excreted mainly in urine as metabolites.100 106
Half-life
1.8–2.4 hours.100 210
Half-life 10-fold longer in neonates than in adults.198
Stability
Storage
Oral
Capsules and Tablets
20–25°C.100 165
Suspension
20–25°C.106
Parenteral
Injection
20–25°C.210
ActionsActions
Inhibits cyclooxygenase-1 (COX-1) and COX-2.166 167 168 169 170 210
Pharmacologic actions similar to those of other prototypical NSAIAs; exhibits anti-inflammatory, analgesic, and antipyretic activity.100 106 166 167 168 169 170 210
Permits closure of the ductus arteriosus in premature neonates by inhibiting prostaglandin synthesis.198
Advice to Patients
Importance of reading the medication guide for NSAIAs that is provided each time the drug is dispensed.192
When used for self-medication, importance of reading the product labeling.164 194
When used for self-medication, importance of using the lowest effective dosage and of not exceeding the recommended dosage or duration of therapy.194 195
When used for self medication, importance of reviewing the warning information provided by the manufacturer.164 194
Risk of serious cardiovascular events with long-term use.192 210
Risk of GI bleeding and ulceration.100 106 210
Risk of serious skin reactions.192 210 Risk of anaphylactoid and other sensitivity reactions.100 106 192 210
Risk of hepatotoxicity.100 106 210
Importance of notifying clinician if signs and symptoms of a cardiovascular event (chest pain, dyspnea, weakness, slurred speech) occur.192 210
Importance of notifying clinician if signs and symptoms of GI ulceration or bleeding, unexplained weight gain, or edema develops.100 106 192 210
Importance of discontinuing ibuprofen and contacting clinician if rash or other signs of hypersensitivity (blisters, fever, pruritus) develop.192 210 Importance of seeking immediate medical attention if an anaphylactic reaction occurs.100 106 210
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.100 106 192 210
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.100 106 210 Importance of avoiding ibuprofen in late pregnancy (third trimester).100 106 210
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.100 106 210
Importance of informing patients of other important precautionary information.100 106 210 (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.209 Therefore, some of the preparations described below may no longer be commercially available in the US.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
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 | |||
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