Ibuprofen

Description

Ibuprofen oral suspension USP contains ibuprofen as its active ingredient, a member of the propionic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Ibuprofen is a racemic mixture of +S- and -R-enantiomers, characterized as a white to off-white crystalline powder with a melting point of 74° to 77°C. It is practically insoluble in water, with a solubility of less than 0.1 mg/mL, but is readily soluble in organic solvents such as ethanol and acetone. The chemical name for ibuprofen is (±)-2-(p-Isobutylphenyl) propionic acid, and it has a molecular weight of 206.28 and a molecular formula of C13H18O2.

The ibuprofen oral suspension USP is a sucrose-sweetened, white to off-white, berry-flavored suspension that contains 100 mg of ibuprofen per 5 mL (20 mg/mL). The formulation includes inactive ingredients such as acesulfame potassium, natural and artificial berry flavor, citric acid anhydrous, glycerin, polysorbate 80, pregelatinized modified starch, purified water, sodium benzoate, sucrose, and xanthan gum. This product meets the USP Dissolution Test 2 criteria. The pKa of ibuprofen is 4.43 ± 0.03, and it has an n-octanol/water partition coefficient of 11.7 at pH 7.4.

Uses and Indications

Ibuprofen Oral Suspension is indicated for use in pediatric patients aged 6 months to 2 years for the following conditions: reduction of fever, relief of mild to moderate pain, and relief of signs and symptoms associated with juvenile arthritis.

In adult patients, Ibuprofen Oral Suspension is indicated for the treatment of primary dysmenorrhea and for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis.

There are no specific teratogenic or nonteratogenic effects associated with this medication.

Dosage and Administration

The lowest effective dose should be utilized for the shortest duration consistent with individual patient treatment goals. After assessing the response to initial therapy, healthcare professionals should adjust the dose and frequency to meet the specific needs of each patient.

For pediatric patients, the following dosing recommendations apply:

Fever Reduction:

• For baseline temperatures less than 102.5ºF, the recommended dose is 5 mg/kg.

• For baseline temperatures of 102.5ºF or greater, the recommended dose is 10 mg/kg.

• The duration of fever reduction typically lasts 6 to 8 hours.

• The maximum recommended daily dose is 40 mg/kg.

Analgesia:

• The recommended dosage is 10 mg/kg, administered every 6 to 8 hours.

• The maximum recommended daily dose is 40 mg/kg.

Juvenile Arthritis:

• The recommended dose ranges from 30 to 40 mg/kg/day, divided into three to four doses.

• Patients with milder disease may be treated with 20 mg/kg/day.

• Doses exceeding 50 mg/kg/day are not recommended.

For adult patients, the following dosing guidelines are provided:

Primary Dysmenorrhea:

• The recommended dose is 400 mg every 4 hours as necessary for pain relief.

Rheumatoid Arthritis and Osteoarthritis:

• The suggested dosage ranges from 1200 to 3200 mg daily, which can be administered as 300 mg four times daily or 400 mg, 600 mg, or 800 mg three to four times daily.

It is essential to individualize the dosage for each patient, adjusting based on symptom severity and response to therapy.

Contraindications

Ibuprofen oral suspension is contraindicated in patients with known hypersensitivity to ibuprofen. Additionally, it should not be administered to individuals who have a history of asthma, urticaria, or allergic-type reactions following the use of aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), as severe, potentially fatal, anaphylactic-like reactions have been reported in these patients. Furthermore, the use of ibuprofen is contraindicated in the context of coronary artery bypass graft (CABG) surgery.

Warnings and Precautions

Clinical trials have demonstrated that the use of COX-2 selective and nonselective NSAIDs, including ibuprofen, is associated with an increased risk of serious cardiovascular (CV) thrombotic events, such as myocardial infarction (MI) and stroke, which may be fatal. This risk is evident in both patients with and without known CV disease or risk factors; however, those with existing CV conditions or risk factors experience a higher absolute incidence of these events. Notably, the increased risk can manifest as early as the first weeks of treatment. Therefore, it is imperative to use the lowest effective dose for the shortest duration possible to mitigate the potential for adverse CV events. Patients should be educated on recognizing the signs and symptoms of serious CV events and the appropriate actions to take if they occur.

The concurrent administration of aspirin with an NSAID heightens the risk of serious gastrointestinal (GI) events. Two large, controlled clinical trials have indicated an increased incidence of MI and stroke in patients treated with NSAIDs within the first 10 to 14 days following coronary artery bypass graft (CABG) surgery. Additionally, observational studies have shown that NSAID use in the post-MI period correlates with an elevated risk of reinfarction, CV-related mortality, and all-cause mortality. Consequently, the use of ibuprofen in patients with a recent MI should be approached with caution, weighing the benefits against the risks.

NSAIDs are also known to potentially induce new hypertension or exacerbate pre-existing hypertension. Blood pressure should be closely monitored during the initiation of NSAID therapy and throughout the treatment duration. Furthermore, NSAID use has been linked to an increased risk of MI, hospitalization for heart failure, and mortality in patients with heart failure. Therefore, ibuprofen should be avoided in patients with severe heart failure unless the benefits clearly outweigh the risks.

Serious GI adverse events, including inflammation, bleeding, ulceration, and perforation of the GI tract, can occur with NSAID use and may be fatal. Prescribing NSAIDs requires extreme caution in patients with a history of ulcer disease or gastrointestinal bleeding, as these individuals have a more than tenfold increased risk of developing a GI bleed. Special care should also be taken when treating elderly or debilitated patients.

Long-term NSAID administration has been associated with renal complications, including renal papillary necrosis and other forms of renal injury. Patients at heightened risk for renal toxicity include those with impaired renal function, heart failure, liver dysfunction, those on diuretics and ACE inhibitors, and the elderly. Anaphylactoid reactions may occur even in patients without prior exposure to ibuprofen, necessitating immediate emergency assistance in such cases.

Serious skin adverse reactions, such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported with NSAID use and can be fatal. Patients should be informed of the signs and symptoms of serious skin reactions and advised to discontinue ibuprofen at the first indication of a rash or any other hypersensitivity signs. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has also been reported in NSAID users, with some cases being fatal or life-threatening. If DRESS symptoms arise, ibuprofen should be discontinued, and the patient should be evaluated immediately.

In pregnant women, the use of NSAIDs around 30 weeks of gestation and later is contraindicated due to the risk of premature closure of the fetal ductus arteriosus. Additionally, NSAID use from approximately 20 weeks of gestation onward may lead to fetal renal dysfunction, resulting in oligohydramnios and, in some instances, neonatal renal impairment.

Ibuprofen is not a substitute for corticosteroids and should not be used to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids can lead to exacerbation of the underlying condition; therefore, patients on prolonged corticosteroid therapy should have their medication tapered gradually if discontinuation is necessary.

Physicians should monitor patients for signs or symptoms of GI bleeding, and those on long-term NSAID treatment should have their complete blood count (CBC) and chemistry profile assessed periodically. If any clinical signs or symptoms indicative of liver or renal disease develop, ibuprofen should be discontinued promptly.

Emergency medical assistance should be sought in cases of anaphylactoid reactions. Patients should also be instructed to stop taking ibuprofen at the first appearance of a skin rash or any other sign of hypersensitivity, and to discontinue use and seek evaluation if symptoms of DRESS are present.

Side Effects

Patients may experience a range of adverse reactions while using this medication, which can be categorized by frequency and seriousness.

Common adverse reactions, occurring in 1 to 10% of patients, include abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, fluid retention, and various gastrointestinal symptoms such as abdominal pain, bloating, constipation, diarrhea, dyspepsia, epigastric pain, flatulence, heartburn, nausea, and vomiting. Other common reactions include headaches, increased bleeding time, nervousness, pruritus, rashes (including maculopapular), and tinnitus.

Occasionally reported adverse reactions encompass a broader spectrum of effects. In the body as a whole, patients may experience fever, infection, or sepsis. Cardiovascular effects may include congestive heart failure in patients with marginal cardiac function, hypertension, tachycardia, and syncope. Digestive system reactions can involve dry mouth, duodenitis, esophagitis, gastric or duodenal ulcers with bleeding and/or perforation, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice, melena, and rectal bleeding. Hematologic reactions may include ecchymosis, eosinophilia, leukopenia, purpura, stomatitis, and thrombocytopenia. Metabolic and nutritional changes such as weight fluctuations have also been noted.

Nervous system effects may manifest as anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, paresthesia, somnolence, tremors, and vertigo. Respiratory issues can include asthma and dyspnea. Skin reactions may involve alopecia, photosensitivity, and increased sweating. Additionally, patients may report blurred vision and various urogenital symptoms, including cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuria, and acute renal failure, particularly in those with pre-existing significantly impaired renal function.

Rare adverse reactions have also been documented. These include anaphylactic and anaphylactoid reactions, appetite changes, cardiovascular events such as arrhythmia, cerebrovascular accidents, hypotension, myocardial infarction, palpitations, and vasculitis. Digestive system reactions may be more severe, including eructation, gingival ulcers, hepatorenal syndrome, liver necrosis, liver failure, and pancreatitis. Hematologic concerns can escalate to agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, neutropenia, and pancytopenia. Metabolic disturbances such as hyperglycemia and nervous system effects including convulsions, coma, emotional lability, hallucinations, and aseptic meningitis have also been reported.

Respiratory complications may include apnea, respiratory depression, pneumonia, and rhinitis. Skin and appendage reactions can be severe, with reports of angioedema, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, fixed drug eruptions, urticaria, and vesiculobullous eruptions. Special senses may be affected, leading to amblyopia, conjunctivitis, dry eyes, and hearing impairment. Urogenital reactions may include azotemia, decreased creatinine clearance, glomerulitis, renal papillary necrosis, and tubular necrosis.

It is important to note that the use of NSAIDs is associated with an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may arise early in treatment and can increase with prolonged use. Additionally, NSAIDs pose a risk of serious gastrointestinal adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can also be fatal. These events can occur at any time during treatment and may present without warning symptoms, with elderly patients being at greater risk for serious gastrointestinal complications.

Drug Interactions

Concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs) and other medications may lead to significant drug interactions that require careful consideration and monitoring.

Antihypertensive Agents NSAIDs may diminish the antihypertensive effect of angiotensin-converting enzyme (ACE) inhibitors. Clinicians should monitor blood pressure in patients receiving both NSAIDs and ACE inhibitors to ensure therapeutic efficacy.

Antiplatelet Agents Pharmacodynamic studies indicate that ibuprofen can interfere with the antiplatelet activity of aspirin, particularly when ibuprofen (400 mg) is administered three times daily or prior to aspirin. This interaction is less pronounced if immediate-release low-dose aspirin is taken at least 2 hours before ibuprofen; however, this timing does not apply to enteric-coated low-dose aspirin. Due to the potential increased risk of cardiovascular events, patients taking low-dose aspirin for cardioprotection who require analgesics should consider alternative NSAIDs that do not affect aspirin's antiplatelet effect or non-NSAID analgesics when appropriate. The concomitant use of ibuprofen and aspirin is generally not recommended due to the risk of increased adverse effects.

Diuretics Clinical studies and post-marketing observations have shown that ibuprofen may reduce the natriuretic effect of furosemide and thiazide diuretics, likely due to inhibition of renal prostaglandin synthesis. Patients receiving NSAIDs alongside these diuretics should be closely monitored for signs of renal failure and to ensure diuretic efficacy.

Lithium Ibuprofen has been shown to elevate plasma lithium levels and decrease renal lithium clearance, with a mean increase of 15% in minimum lithium concentration and a 19% reduction in renal clearance during concurrent administration. Careful observation for signs of lithium toxicity is advised when these medications are used together.

Methotrexate NSAIDs may competitively inhibit the accumulation of methotrexate in renal tissues, potentially enhancing methotrexate toxicity. Caution is warranted when administering NSAIDs alongside methotrexate.

Anticoagulants While several short-term controlled studies have not demonstrated a significant effect of ibuprofen on prothrombin times or other clotting factors in patients on warfarin-type anticoagulants, there is a documented risk of bleeding when these drugs are used together. The synergistic effects of warfarin and NSAIDs increase the risk of serious gastrointestinal bleeding. Physicians should exercise caution when prescribing ibuprofen to patients on anticoagulants.

Packaging & NDC

The table below lists all NDC Code configurations of Ibuprofen, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

The safety and effectiveness of ibuprofen in pediatric patients below the age of 6 months have not been established. For children aged 6 months and older, dosing should be guided by body weight to ensure appropriate administration.

Geriatric Use

Caution should be exercised when treating elderly patients (65 years and older) with this medication, as with any nonsteroidal anti-inflammatory drugs (NSAIDs). It is important for healthcare providers to consider the increased risk of adverse effects in this population. Monitoring for potential side effects and adjusting dosages as necessary is recommended to ensure the safety and efficacy of treatment in geriatric patients.

Pregnancy

Use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen oral suspension, during pregnancy is associated with significant risks, particularly when used after approximately 20 weeks of gestation. The use of NSAIDs at about 30 weeks gestation or later increases the risk of premature closure of the fetal ductus arteriosus, which can lead to serious fetal complications. Additionally, NSAID use during the second and third trimesters has been linked to fetal renal dysfunction, resulting in oligohydramnios and, in some cases, neonatal renal impairment. These adverse outcomes may occur after days to weeks of treatment, although oligohydramnios has been reported as early as 48 hours after initiation of NSAID therapy.

Due to these risks, it is recommended that the use of ibuprofen oral suspension be limited to the lowest effective dose and shortest duration possible if necessary after 20 weeks of gestation. If treatment extends beyond 48 hours, monitoring with ultrasound for oligohydramnios should be considered. In cases where oligohydramnios is detected, discontinuation of ibuprofen oral suspension is advised, with follow-up according to clinical practice guidelines.

Reproductive studies in rats and rabbits have not shown evidence of developmental abnormalities; however, animal studies are not always predictive of human outcomes. Prostaglandins play a crucial role in fetal kidney development, and the administration of prostaglandin synthesis inhibitors like ibuprofen has been associated with impaired kidney development in animal models. The estimated background risk of major birth defects and miscarriage in the general U.S. population is 2 to 4% and 15 to 20%, respectively, but the specific background risk associated with ibuprofen use in pregnancy is unknown.

There are no adequate and well-controlled studies in pregnant women, and ibuprofen should only be used during pregnancy if the potential benefits justify the potential risks to the fetus. The effects of ibuprofen on labor and delivery are also unknown, and its administration is not recommended during these stages. Given the methodological limitations of existing postmarketing studies, including the lack of control groups and limited data on dosing and timing, the risk of adverse fetal and neonatal outcomes with maternal NSAID use remains uncertain.

Lactation

It is not known whether this drug is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants from ibuprofen, lactating mothers should consider the importance of the drug to their health when making a decision to either discontinue nursing or discontinue the drug.

Renal Impairment

Long-term administration of nonsteroidal anti-inflammatory drugs (NSAIDs) has been associated with renal papillary necrosis and other forms of renal injury. Renal toxicity may occur in patients where renal prostaglandins play a compensatory role in maintaining renal perfusion. In these individuals, the use of NSAIDs can lead to a dose-dependent reduction in prostaglandin formation and, consequently, renal blood flow, potentially precipitating overt renal decompensation.

Patients at the highest risk for these adverse reactions include those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy typically results in recovery to the pretreatment state.

There is no available information from controlled clinical studies regarding the use of ibuprofen in patients with advanced renal disease; therefore, treatment with ibuprofen is not recommended in this population. If ibuprofen therapy is deemed necessary, close monitoring of the patient's renal function is advised.

Additionally, the use of NSAIDs, including ibuprofen oral suspension, during pregnancy, particularly around 20 weeks gestation or later, may lead to fetal renal dysfunction, resulting in oligohydramnios and, in some cases, neonatal renal impairment. These adverse outcomes can manifest after days to weeks of treatment, although oligohydramnios has been infrequently reported as early as 48 hours after initiation of NSAID therapy. While oligohydramnios is often reversible upon discontinuation of treatment, if NSAID use is required between 20 and 30 weeks gestation, it is recommended to limit ibuprofen oral suspension to the lowest effective dose and shortest duration possible. Ultrasound monitoring of amniotic fluid should be considered if treatment extends beyond 48 hours, and ibuprofen oral suspension should be discontinued if oligohydramnios occurs, with follow-up conducted according to clinical practice.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics and increased risk of adverse effects when treated with nonsteroidal anti-inflammatory drugs (NSAIDs). Long-term administration of NSAIDs has been associated with renal papillary necrosis and other forms of renal injury, particularly in individuals where renal prostaglandins play a critical role in maintaining renal perfusion. In patients with compromised liver function, the administration of an NSAID may lead to a dose-dependent reduction in prostaglandin formation, which can subsequently decrease renal blood flow and potentially precipitate overt renal decompensation.

Patients at the highest risk for these adverse reactions include those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Therefore, it is crucial to exercise caution when considering NSAID therapy in this population.

Currently, there is no available information from controlled clinical studies regarding the use of ibuprofen in patients with advanced renal disease. Consequently, treatment with ibuprofen is not recommended for these patients. If ibuprofen therapy is deemed necessary, close monitoring of the patient's renal function is advised to mitigate potential risks. Discontinuation of NSAID therapy typically results in recovery to the pretreatment state, underscoring the importance of careful management in patients with hepatic impairment.

Overdosage

The toxicity associated with ibuprofen overdose is influenced by the quantity of the drug ingested and the time elapsed since ingestion; however, individual responses may vary, necessitating a case-by-case evaluation. Although serious toxicity and fatalities are rare, they have been documented in the medical literature.

Symptoms of Overdosage

The most commonly reported symptoms following ibuprofen overdose include abdominal pain, nausea, vomiting, lethargy, and drowsiness. Additional central nervous system manifestations may include headache, tinnitus, CNS depression, and seizures. In rare instances, more severe complications such as metabolic acidosis, coma, acute renal failure, and apnea—particularly in very young children—may occur. Cardiovascular effects, including hypotension, bradycardia, tachycardia, and atrial fibrillation, have also been noted.

Management of Overdosage

The management of acute ibuprofen overdose is primarily supportive. It may be necessary to address hypotension, acidosis, and gastrointestinal bleeding. In cases of acute overdose, gastric emptying should be performed, ideally through ipecac-induced emesis or gastric lavage, with emesis being most effective if initiated within 30 minutes of ingestion. The administration of activated charcoal orally may also assist in reducing the absorption and reabsorption of ibuprofen.

In pediatric patients, the estimated amount of ibuprofen ingested per body weight can aid in predicting the potential for toxicity, although each case must be evaluated individually. Ingestion of less than 100 mg/kg is generally considered unlikely to result in toxicity. For children who ingest between 100 to 200 mg/kg, management may involve induced emesis and a minimum observation period of four hours. Those ingesting 200 to 400 mg/kg should undergo immediate gastric emptying and at least four hours of observation in a healthcare facility. In cases where ingestion exceeds 400 mg/kg, immediate medical referral, careful observation, and appropriate supportive therapy are required. It is important to note that ipecac-induced emesis is not recommended for overdoses greater than 400 mg/kg due to the risk of convulsions and potential aspiration of gastric contents.

In adult patients, the reported dose ingested does not reliably predict the likelihood of toxicity. The necessity for referral and follow-up should be determined based on the specific circumstances surrounding the overdose. Symptomatic adults should be thoroughly evaluated, observed, and provided with supportive care as needed.

Nonclinical Toxicology

Use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen oral suspension, during pregnancy has been associated with teratogenic effects, particularly when administered around 30 weeks of gestation and later. The use of these medications can lead to premature closure of the fetal ductus arteriosus and fetal renal dysfunction, which may result in oligohydramnios and, in some instances, neonatal renal impairment. It is advised to avoid NSAID use in pregnant women during this period. If treatment with ibuprofen oral suspension is deemed necessary between approximately 20 weeks and 30 weeks of gestation, it should be limited to the lowest effective dose for the shortest duration possible. Ultrasound monitoring of amniotic fluid is recommended if treatment extends beyond 48 hours, and ibuprofen oral suspension should be discontinued if oligohydramnios is detected, with follow-up conducted according to clinical practice guidelines.

In addition to teratogenic effects, the use of NSAIDs, including ibuprofen oral suspension, at around 20 weeks of gestation or later may lead to fetal renal dysfunction, resulting in oligohydramnios and potential neonatal renal impairment. These adverse outcomes typically manifest after days to weeks of treatment; however, oligohydramnios has been infrequently reported as early as 48 hours following the initiation of NSAID therapy. Complications arising from prolonged oligohydramnios may include limb contractures and delayed lung maturation. In certain post-marketing cases of impaired neonatal renal function, invasive interventions such as exchange transfusion or dialysis were necessary.

Reproductive studies conducted in rats and rabbits have not indicated any developmental abnormalities; however, it is important to note that animal reproduction studies do not always predict human responses. Animal data suggest that prostaglandins play a crucial role in endometrial vascular permeability, blastocyst implantation, and decidualization. In studies involving animals, the administration of prostaglandin synthesis inhibitors, such as ibuprofen, has been linked to increased pre- and post-implantation loss. Furthermore, prostaglandins are essential for fetal kidney development, and published animal studies have reported that prostaglandin synthesis inhibitors can impair kidney development when administered at clinically relevant doses.

The estimated background risk of major birth defects and miscarriage in the indicated population(s) remains unknown. All pregnancies carry a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is approximately 2 to 4% and 15 to 20%, respectively.

Postmarketing Experience

Postmarketing experience has identified several adverse events associated with the use of ibuprofen. Anaphylactoid reactions have been reported in patients without known prior exposure to ibuprofen, necessitating emergency assistance in such cases. Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), have also been documented, with the potential for these events to occur without warning and to be fatal.

Additionally, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been observed in patients taking NSAIDs, including ibuprofen oral suspension, with some cases resulting in fatal or life-threatening outcomes. In two postmarketing clinical studies, a higher incidence of decreased hemoglobin levels was noted than previously reported, with a decrease of 1 gram or more occurring in 17.1% of 193 patients on a daily dose of 1600 mg for osteoarthritis and in 22.8% of 189 patients taking 2400 mg daily for rheumatoid arthritis. Positive stool occult blood tests and elevated serum creatinine levels were also reported in these studies.

Observational studies from the Danish National Registry indicated that patients treated with NSAIDs in the post-myocardial infarction (MI) period faced an increased risk of reinfarction, cardiovascular-related death, and all-cause mortality, beginning within the first week of treatment. Furthermore, maternal use of NSAIDs around 20 weeks of gestation or later has been associated with fetal renal dysfunction leading to oligohydramnios, and in some instances, neonatal renal impairment. These adverse outcomes typically manifest after days to weeks of treatment, with some cases of impaired neonatal renal function necessitating invasive procedures such as exchange transfusion or dialysis.

Patient Counseling

Patients should be informed of essential information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Healthcare providers should encourage patients to read the NSAID Medication Guide that accompanies each prescription dispensed.

Patients should be advised to be alert for symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their healthcare provider immediately.

It is important to inform patients that ibuprofen, like other NSAIDs, can cause gastrointestinal discomfort and, in rare cases, serious gastrointestinal side effects such as ulcers and bleeding, which may result in hospitalization or even death. Although serious gastrointestinal tract ulcerations and bleeding can occur without warning symptoms, patients should be vigilant for signs and symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis. Patients should be apprised of the importance of seeking medical advice upon observing any indicative signs or symptoms.

Patients should be advised to stop taking ibuprofen oral suspension immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible, as serious skin reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), may occur.

Healthcare providers should inform patients to be alert for symptoms of congestive heart failure, including shortness of breath, unexplained weight gain, or edema, and to contact their healthcare provider if such symptoms occur.

Patients should be informed of the warning signs and symptoms of hepatotoxicity, which may include nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms. If these occur, patients should be instructed to stop therapy and seek immediate medical attention.

Patients should also be made aware of the signs of an anaphylactoid reaction, such as difficulty breathing and swelling of the face or throat. If these symptoms occur, patients should be instructed to seek immediate emergency help.

Pregnant women should be informed to avoid the use of ibuprofen oral suspension and other NSAIDs starting at 30 weeks gestation due to the risk of premature closing of the fetal ductus arteriosus. If treatment with ibuprofen oral suspension is necessary for a pregnant woman between approximately 20 to 30 weeks gestation, she should be advised that monitoring for oligohydramnios may be required if treatment continues for longer than 48 hours.

Storage and Handling

The product is supplied in a well-closed container as defined by the United States Pharmacopeia (USP). It is essential to shake well before use to ensure proper mixing of the contents.

For optimal storage, the product should be maintained at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines. Proper adherence to these storage conditions is crucial for maintaining the integrity and efficacy of the product.

Additional Clinical Information

Clinicians are advised to monitor patients for signs or symptoms of gastrointestinal (GI) bleeding during treatment. For patients undergoing long-term therapy with nonsteroidal anti-inflammatory drugs (NSAIDs), it is recommended that complete blood counts (CBC) and chemistry profiles be checked periodically to assess for potential adverse effects.

In cases where patients exhibit clinical signs and symptoms indicative of liver or renal disease, such as eosinophilia or rash, or if abnormal liver function tests persist or worsen, ibuprofen should be discontinued promptly to prevent further complications.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Ibuprofen as submitted by Sun Pharmaceutical Industries, Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)