Ibuprofen

Description

Ibuprofen Oral Suspension USP, 100 mg/5 mL, contains ibuprofen as the 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 74º to 77ºC. It is practically insoluble in water (<0.1 mg/mL) but readily soluble in organic solvents such as ethanol and acetone. The chemical name for ibuprofen is (±)-2-(p-isobutylphenyl) propionic acid, with a molecular weight of 206.28 and a molecular formula of C13H18O2.

The suspension is formulated as a sweetened, orange-colored, berry-flavored liquid, containing 100 mg of ibuprofen per 5 mL (20 mg/mL). The inactive ingredients include anhydrous citric acid, artificial berry flavor, butylparaben, D&C red #33, FD&C yellow #6, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, and xanthan gum. Ibuprofen has a pKa of 4.43±0.03 and 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 reduction of fever and for the relief of mild to moderate pain. Additionally, it is indicated for the relief of signs and symptoms associated with juvenile arthritis in this age group.

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 teratogenic or nonteratogenic effects associated with the use of this medication.

Dosage and Administration

The lowest effective dose should be utilized for the shortest duration consistent with individual patient treatment goals. After observing the response to initial therapy, healthcare professionals are advised to 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.

Individualization of Dosage:

• Dosage should be tailored to each patient, with adjustments made based on the severity of symptoms. After achieving a satisfactory response, it is important to review and modify the patient's dose as necessary.

Contraindications

Ibuprofen Oral Suspension is contraindicated in patients with known hypersensitivity to ibuprofen. 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. Additionally, the use of Ibuprofen Oral Suspension is contraindicated in the context of coronary artery bypass graft (CABG) surgery.

Warnings and Precautions

Nonsteroidal anti-inflammatory drugs (NSAIDs), including Ibuprofen Oral Suspension, are associated with an increased risk of serious cardiovascular thrombotic events, such as myocardial infarction and stroke, which can be fatal. This risk may manifest early in treatment and is likely to escalate with prolonged use. It is important to note that Ibuprofen Oral Suspension is contraindicated in patients undergoing coronary artery bypass graft (CABG) surgery.

NSAIDs can also lead to significant gastrointestinal (GI) adverse events, including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which may be fatal. These serious adverse events can occur at any time, with or without warning symptoms. Additionally, NSAIDs, including Ibuprofen Oral Suspension, may result in the onset of new hypertension or exacerbate pre-existing hypertension. The Coxib and traditional NSAID Trialists’ Collaboration meta-analysis indicates that there is approximately a two-fold increase in hospitalizations for heart failure among patients treated with COX-2 selective or nonselective NSAIDs compared to those receiving placebo.

Anaphylactoid reactions can occur in patients who have not previously been exposed to Ibuprofen Oral Suspension, necessitating immediate emergency medical assistance in such cases. Furthermore, NSAIDs can cause severe skin reactions, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has also been reported in patients taking NSAIDs, including Ibuprofen Oral Suspension, with some cases being fatal or life-threatening.

Ibuprofen Oral Suspension is not a substitute for corticosteroids and should not be used to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to exacerbation of the underlying condition. For patients on prolonged corticosteroid therapy, a gradual tapering of the corticosteroid dosage is recommended if discontinuation is necessary. The pharmacological effects of Ibuprofen Oral Suspension in reducing fever and inflammation may obscure diagnostic signs that are critical for identifying complications in presumed noninfectious, painful conditions.

Healthcare professionals should monitor patients for signs or symptoms of GI bleeding. For those on long-term NSAID treatment, it is advisable to periodically check complete blood count (CBC) and chemistry profiles. If any clinical signs or symptoms indicative of liver or renal disease develop, or if systemic manifestations such as eosinophilia or rash occur, or if abnormal liver tests persist or worsen, Ibuprofen Oral Suspension should be discontinued.

Patients should be educated on the signs and symptoms of serious skin reactions and advised to discontinue the use of Ibuprofen Oral Suspension at the first appearance of a skin rash or any other indication of hypersensitivity. In the presence of symptoms suggestive of DRESS, it is imperative to discontinue Ibuprofen Oral Suspension and evaluate the patient immediately. Emergency medical help should be sought in cases of anaphylactoid reactions.

Side Effects

Patients receiving treatment with this medication may experience a range of adverse reactions. Common adverse reactions, occurring in 1-10% 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 such as asthma and dyspnea have been reported, along with skin reactions including alopecia, photosensitivity, and increased sweating. Special senses may be affected, leading to blurred vision. Urogenital reactions can include cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuria, and acute renal failure in patients 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 may involve agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, neutropenia, and pancytopenia. Metabolic issues such as hyperglycemia and nervous system effects including convulsions, coma, emotional lability, hallucinations, and aseptic meningitis have been reported.

Respiratory reactions can include apnea, respiratory depression, pneumonia, and rhinitis. Skin and appendage reactions may 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 also be affected, with reports of 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 the boxed warnings associated with this medication. Nonsteroidal anti-inflammatory drugs (NSAIDs) are associated with an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with the duration of use. Additionally, NSAIDs pose an increased 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 use and without warning symptoms, with elderly patients being at greater risk for serious gastrointestinal events.

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 and consider dosage adjustments as necessary.

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 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 be considered for NSAIDs that do not interfere with 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 can reduce the natriuretic effect of furosemide and thiazides, 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 reduce renal lithium clearance, with a mean increase of 15% in minimum lithium concentration and a 19% decrease 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, potentially enhancing its toxicity. Caution is warranted when administering NSAIDs in conjunction with 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 medications are used together. The synergistic effects of warfarin and NSAIDs on gastrointestinal bleeding necessitate caution in prescribing ibuprofen to patients on anticoagulants, as the risk of serious GI bleeding is higher in users of both drugs compared to those using either drug alone.

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 oral suspension have not been established in pediatric patients below the age of 6 months. 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 NSAID. Due to the increased likelihood of adverse reactions in this population, careful monitoring is recommended. Healthcare providers should consider the potential for heightened sensitivity to the medication and the risk of gastrointestinal, renal, and cardiovascular complications that may be more pronounced in geriatric patients. Dose adjustments may be necessary based on individual patient assessments and clinical response.

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 administration of NSAIDs at about 30 weeks of 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 this period has been linked to fetal renal dysfunction, resulting in oligohydramnios and, in some cases, neonatal renal impairment.

Due to these potential risks, it is recommended that the use of Ibuprofen Oral Suspension be limited in pregnant patients between 20 and 30 weeks of gestation. If NSAID treatment is deemed necessary during this time, it should be restricted to the lowest effective dose and shortest duration possible. Furthermore, if treatment extends beyond 48 hours, healthcare providers should consider monitoring with ultrasound for signs of oligohydramnios. Should oligohydramnios be detected, discontinuation of Ibuprofen Oral Suspension is advised, with follow-up according to standard clinical practice.

Data from observational studies regarding the risks of NSAID use in the first and second trimesters remain inconclusive. Animal studies have not shown evidence of developmental abnormalities; however, they are not always predictive of human outcomes. Prostaglandins, which are inhibited by NSAIDs, play a crucial role in various aspects of pregnancy, including endometrial vascular permeability and fetal kidney development. In animal studies, the use of prostaglandin synthesis inhibitors has been associated with increased pre- and post-implantation loss and impaired kidney development.

The estimated background risk of major birth defects and miscarriage in the general U.S. population is 2-4% and 15-20%, respectively. All pregnancies carry a background risk of adverse outcomes, and the specific risks associated with Ibuprofen Oral Suspension use in pregnant patients are not fully established. There are no adequate, well-controlled studies in pregnant women, and the use of Ibuprofen should only occur if the potential benefits justify the potential risks to the fetus.

Healthcare professionals should be aware that while some adverse outcomes, such as oligohydramnios, may be transient and reversible upon cessation of the drug, there have been reports of irreversible neonatal renal dysfunction requiring invasive interventions. The methodological limitations of existing studies, including the lack of control groups and variability in drug exposure, hinder the ability to reliably estimate the risks associated with maternal NSAID use. Therefore, caution is warranted when considering the use of Ibuprofen Oral Suspension in pregnant patients, particularly in the later stages of pregnancy.

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 Oral Suspension, lactating mothers should consider whether to discontinue breastfeeding or to discontinue the drug. This decision should take into account the importance of the drug to the mother.

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 Oral Suspension in patients with advanced renal disease; therefore, its use is not recommended in this population. If therapy with Ibuprofen Oral Suspension 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. 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 for the 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 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 Oral Suspension in patients with advanced renal disease. Consequently, treatment with Ibuprofen Oral Suspension is not recommended for patients with advanced renal disease. If therapy with Ibuprofen Oral Suspension is deemed necessary, close monitoring of the patient's renal function is advised to mitigate potential risks.

Overdosage

The toxicity associated with ibuprofen overdose is influenced by the quantity ingested and the time elapsed since ingestion; however, individual responses may vary, necessitating a case-by-case evaluation. While 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 reported.

Management of Overdosage

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

In pediatric patients, the estimated amount of ibuprofen ingested per body weight can provide insight into the potential for toxicity, although each case must be evaluated individually. Ingestions of less than 100 mg/kg are 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 is required, along with careful observation and appropriate supportive therapy. 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 aspiration of gastric contents.

In adult patients, the reported dose ingested does not reliably predict the severity of toxicity. Therefore, the need for referral and follow-up should be assessed based on the specific circumstances surrounding the overdose. Symptomatic adults should be thoroughly evaluated, observed, and provided with supportive care as necessary.

Nonclinical Toxicology

Use of nonsteroidal anti-inflammatory drugs (NSAIDs), including Ibuprofen Oral Suspension, has been associated with teratogenic effects, particularly concerning fetal renal function and ductus arteriosus closure. Administration of NSAIDs during pregnancy, especially around 30 weeks gestation and later, poses a risk of premature closure of the fetal ductus arteriosus. Additionally, the use of NSAIDs at approximately 20 weeks gestation or later may lead to fetal renal dysfunction, resulting in oligohydramnios and, in some instances, neonatal renal impairment. These adverse effects can manifest after days to weeks of treatment, although oligohydramnios has been reported as early as 48 hours following the initiation of NSAID therapy.

In animal studies, the administration of prostaglandin synthesis inhibitors, such as ibuprofen, has resulted in increased pre- and post-implantation loss. Prostaglandins play a crucial role in fetal kidney development, and evidence from published animal studies indicates that prostaglandin synthesis inhibitors can impair kidney development when given at clinically relevant doses.

Data from observational studies regarding other potential embryofetal risks associated with NSAID use during the first or second trimesters of pregnancy remain inconclusive. Animal reproductive studies conducted in rats and rabbits have not shown evidence of developmental abnormalities; however, it is important to note that animal reproduction studies do not always predict human responses.

No controlled clinical study data are available regarding the use of Ibuprofen Oral Suspension in patients with advanced renal disease. Consequently, the use of Ibuprofen Oral Suspension is not recommended in this patient population. If therapy with Ibuprofen Oral Suspension is deemed necessary, close monitoring of renal function is advised.

Postmarketing Experience

Postmarketing experience has identified several adverse events associated with the use of Ibuprofen Oral Suspension, reported voluntarily or through surveillance programs.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been documented in patients taking NSAIDs, including Ibuprofen Oral Suspension. Some cases have been fatal or life-threatening. DRESS typically presents with symptoms such as fever, rash, lymphadenopathy, and/or facial swelling, although other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis. Eosinophilia is often present, and early signs of hypersensitivity may occur even in the absence of a rash. It is advised to discontinue Ibuprofen Oral Suspension and evaluate the patient immediately if such symptoms arise.

Serious skin reactions have also been reported, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Fixed drug eruption (FDE) and its severe variant, generalized bullous fixed drug eruption (GBFDE), have been associated with NSAID use. These serious skin events may occur without warning, and patients should be informed of the signs and symptoms, with instructions to discontinue the medication at the first appearance of a rash or any other hypersensitivity signs. Ibuprofen Oral Suspension is contraindicated in individuals with a history of serious skin reactions to NSAIDs.

Anaphylactoid reactions have been reported in patients without prior exposure to Ibuprofen Oral Suspension. The medication should not be administered to patients with the aspirin triad, which is characterized by asthma, rhinitis, and severe bronchospasm following NSAID use. Emergency assistance should be sought if an anaphylactoid reaction occurs.

Renal effects have been observed with long-term NSAID use, including renal papillary necrosis and other forms of renal injury. Patients with compromised renal function, heart failure, liver dysfunction, those on diuretics and ACE inhibitors, and the elderly are at increased risk. The administration of NSAIDs may lead to a dose-dependent reduction in renal blood flow, potentially resulting in renal decompensation. Discontinuation of NSAID therapy typically allows for recovery to the pretreatment state.

Fetal toxicity has been associated with NSAID use, including Ibuprofen Oral Suspension, leading to premature closure of the fetal ductus arteriosus and fetal renal dysfunction, which may result in oligohydramnios and neonatal renal impairment. Due to these risks, it is recommended to limit the dose and duration of Ibuprofen Oral Suspension use between approximately 20 and 30 weeks of gestation and to avoid its use after 30 weeks of gestation.

Patient Counseling

Healthcare providers should advise patients to remain vigilant for symptoms indicative of cardiovascular thrombotic events, such as chest pain, shortness of breath, weakness, or slurring of speech. Patients should be instructed to report any of these symptoms to their healthcare provider immediately.

It is important to inform patients that Ibuprofen Oral Suspension, like other nonsteroidal anti-inflammatory drugs (NSAIDs), may cause gastrointestinal discomfort and, in rare cases, serious gastrointestinal side effects, including ulcers and bleeding, which could lead to hospitalization or even death. Patients should be made aware that serious gastrointestinal tract ulcerations and bleeding can occur without warning symptoms. They should be encouraged to be alert for signs and symptoms of ulcerations and bleeding, such as epigastric pain, dyspepsia, melena, and hematemesis, and to seek medical advice if they observe any of these indicative signs.

Patients should also be informed about the risk of serious skin reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). They should be advised to discontinue Ibuprofen Oral Suspension immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible.

Additionally, healthcare providers should instruct patients to be aware of the 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 must be informed about 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 symptoms occur, patients should be instructed to stop therapy and seek immediate medical attention.

It is crucial to educate patients on the signs of an anaphylactoid reaction, such as difficulty breathing and swelling of the face or throat. Patients should be advised to seek immediate emergency help if they experience these symptoms.

Finally, healthcare providers should inform pregnant women to avoid the use of Ibuprofen Oral Suspension and other NSAIDs starting at 30 weeks gestation due to the risk of premature closure 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 well-closed containers and should be stored at a temperature range of 20 to 25ºC (68 to 77ºF), in accordance with USP Controlled Room Temperature guidelines. It is imperative to avoid freezing the product. Prior to use, the container must be shaken well to ensure proper mixing.

Additional Clinical Information

Clinicians should be vigilant in monitoring patients for signs or symptoms of gastrointestinal (GI) bleeding, as serious ulcerations and bleeding may occur without warning. For patients undergoing long-term treatment with nonsteroidal anti-inflammatory drugs (NSAIDs), it is recommended that complete blood counts (CBC) and chemistry profiles be checked periodically to assess for potential complications.

In cases where patients exhibit clinical signs and symptoms indicative of liver or renal disease, or if systemic manifestations such as eosinophilia or rash develop, it is crucial to discontinue Ibuprofen Oral Suspension. Additionally, if abnormal liver function tests persist or worsen, the medication should also be stopped to prevent further complications.

FDA Insert (PDF)

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

View full prescribing information (PDF)