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Ibuprofen

Pronunciation

Class: Other Nonsteroidal Anti-inflammatory Agents
CAS Number: 15687-271
Brands: Advil, Caldolor, Dristan, Genpril, Haltran, IBU, Ibu-Tab, Menadol, Midol, Motrin, NeoProfen, Reprexain, Vicoprofen

Warning(s)

  • 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

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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- or Weight-Based Dosage for Self-medication of Minor Aches and Pain in Children 6 Months to 11 Years of Age164186

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- or Weight-Based Dosage for Self-medication of Fever in Children 6 Months to 11 Years of Age164186

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

Actions

  • 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.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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

Parenteral

Injection concentrate, for IV use

100 mg/mL

Caldolor

Cumberland

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Ibuprofen Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Suspension

100 mg with Pseudoephedrine Hydrochloride 15 mg/5 mL

Motrin Children’s Cold

McNeil

Tablets

200 mg with Pseudoephedrine Hydrochloride 30 mg

Dristan Sinus Caplets

Wyeth

Tablets, film-coated

200 mg with Hydrocodone Bitartrate 2.5 mg*

Hydrocodone Bitartrate and Ibuprofen Film-coated Tablets (C-III)

Reprexain (C-III)

Hawthorn

200 mg with Hydrocodone Bitartrate 5 mg*

Hydrocodone Bitartrate and Ibuprofen Film-coated Tablets (C-III)

Reprexain (C-III)

Hawthorn

200 mg with Hydrocodone Bitartrate 7.5 mg*

Hydrocodone Bitartrate and Ibuprofen Film-coated Tablets (C-III)

Vicoprofen (C-III)

AbbVie

200 mg with Hydrocodone Bitartrate 10 mg*

Hydrocodone Bitartrate and Ibuprofen Film-coated Tablets (C-III)

Reprexain (C-III)

Hawthorn

200 mg with Pseudoephedrine Hydrochloride 30 mg

Advil Cold & Sinus Caplets

Wyeth

Advil Cold & Sinus Tablets

Wyeth

Advil Flu & Body Ache Caplets

Wyeth

Motrin Sinus Headache Caplets

McNeil

Ibuprofen Lysine

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

For injection, for IV use only

10 mg/mL(of ibuprofen)

NeoProfen

Lundbeck

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Advil 200MG Tablets (PFIZER CONSUMER HEALTHCARE): 100/$20.63 or 200/$32.58

Hydrocodone-Ibuprofen 7.5-200MG Tablets (AMNEAL PHARMACEUTICALS): 30/$33.99 or 90/$82.97

Ibuprofen 200MG Tablets (MAJOR PHARMACEUTICALS): 500/$16.99 or 1000/$25.99

Ibuprofen 400MG Tablets (DR.REDDY'S LABORATORIES): 30/$11.99 or 60/$16.97

Ibuprofen 600MG Tablets (DR.REDDY'S LABORATORIES): 90/$14.99 or 180/$21.98

Ibuprofen 800MG Tablets (DR.REDDY'S LABORATORIES): 30/$12.99 or 60/$14.97

Oxycodone-Ibuprofen 5-400MG Tablets (WATSON LABS): 20/$33.33 or 30/$49.99

Reprexain 10-200MG Tablets (HAWTHORN PHARMACEUTICALS): 100/$110.85 or 300/$313.72

Reprexain 2.5-200MG Tablets (HAWTHORN PHARMACEUTICALS): 100/$75.81 or 300/$205.77

Reprexain 5-200MG Tablets (HAWTHORN PHARMACEUTICALS): 100/$79.44 or 300/$215.31

Vicoprofen 7.5-200MG Tablets (ABBOTT): 30/$91.99 or 90/$249.98

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions August 28, 2014. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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