Ibuprofen

Description

The active ingredient in Ibuprofen Oral Suspension USP, 100 mg/5 mL is ibuprofen, a member of the propionic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Ibuprofen is a racemic mixture of +S- and -R-enantiomers. It appears as a white to off-white crystalline powder with a melting point of 74º to 77ºC. The compound is practically insoluble in water (<0.1 mg/mL) but is readily soluble in organic solvents such as ethanol and acetone. Ibuprofen has a pKa of 4.43±0.03 and an n-octanol/water partition coefficient of 11.7 at pH 7.4. The chemical name for ibuprofen is (±)-2-(p-isobutylphenyl) propionic acid, with a molecular weight of 206.28 and a molecular formula of C13H18O2. Ibuprofen Oral Suspension is a sweetened, orange-colored, berry-flavored suspension containing 100 mg of ibuprofen in 5 mL (20 mg/mL). 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.

Uses and Indications

Ibuprofen Oral Suspension is indicated for use in pediatric patients and adults for the management of various conditions.

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

In adults, this formulation 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 Ibuprofen Oral Suspension.

Dosage and Administration

Healthcare professionals should carefully consider the potential benefits and risks of Ibuprofen Oral Suspension, as well as other treatment options, before initiating therapy. It is recommended to use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. After assessing the response to initial therapy, the dose and frequency of Ibuprofen Oral Suspension should be adjusted to meet the specific needs of the patient.

In pediatric patients aged 6 months to 2 years, the following dosing guidelines apply:

Fever Reduction:

• For the reduction of fever:

  • Administer 5 mg/kg if the baseline temperature is less than 102.5ºF.

  • Administer 10 mg/kg if the baseline temperature is 102.5ºF or greater.

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

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

Analgesia:

• For relief of mild to moderate pain:

  • Administer 10 mg/kg every 6 to 8 hours.

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

Juvenile Arthritis:

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

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

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

In adult patients, the following dosing recommendations are provided:

Primary Dysmenorrhea:

• For the treatment of primary dysmenorrhea, administer 400 mg every 4 hours as needed 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:

• The dosage of Ibuprofen Oral Suspension should be individualized based on the severity of symptoms, allowing for adjustments to be made as necessary.

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 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 has indicated a two-fold increase in hospitalizations for heart failure among patients treated with COX-2 selective and nonselective NSAIDs compared to those receiving placebo.

Anaphylactoid reactions can occur in patients who have not previously been exposed to Ibuprofen Oral Suspension. In such cases, emergency medical assistance should be sought immediately. 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 disease. For patients on prolonged corticosteroid therapy, a gradual tapering of the corticosteroid dosage is recommended if discontinuation is necessary. Additionally, 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, particularly those on long-term NSAID treatment. Regular monitoring of complete blood count (CBC) and chemistry profiles is advised. 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 informed about 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, the use of Ibuprofen Oral Suspension should be stopped immediately, and the patient should be evaluated without delay. Emergency medical help should be sought in cases of anaphylactoid reactions.

Side Effects

Patients receiving treatment may experience a range of adverse reactions, which can be categorized by frequency and seriousness.

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 can include congestive heart failure in patients with marginal cardiac function, hypertension, tachycardia, and syncope. Digestive system reactions may 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 include ecchymosis, eosinophilia, leukopenia, purpura, stomatitis, and thrombocytopenia. Metabolic and nutritional changes such as weight fluctuations have also been noted.

Nervous system effects can manifest as anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, paresthesia, somnolence, tremors, and vertigo. Respiratory issues may include asthma and dyspnea. Skin reactions can involve alopecia, photosensitivity, and increased sweating. Special senses may be affected, leading to blurred vision. Urogenital reactions 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 reported. 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 include eructation, gingival ulcers, hepatorenal syndrome, liver necrosis, liver failure, and pancreatitis. Hematologic reactions can involve agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, neutropenia, and pancytopenia. Metabolic reactions may include hyperglycemia. Neurological effects can range from convulsions and coma to emotional lability and hallucinations, as well as aseptic meningitis. Respiratory reactions may include apnea, respiratory depression, pneumonia, and rhinitis. Skin and appendage reactions can be severe, including angioedema, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, fixed drug eruptions, urticaria, and vesiculobullous eruptions. Special senses may be affected by amblyopia, conjunctivitis, dry eyes, and hearing impairment. Urogenital reactions can include azotemia, decreased creatinine clearance, glomerulitis, renal papillary necrosis, and tubular necrosis.

Warnings associated with treatment include an increased risk of serious cardiovascular thrombotic events, such as myocardial infarction and stroke, which can be fatal. There is also an increased risk of serious gastrointestinal adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.

It is important to note that anaphylactoid reactions may occur in patients without known prior exposure to Ibuprofen Oral Suspension. Serious skin adverse reactions, such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, can occur and may be fatal. Additionally, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs like Ibuprofen Oral Suspension, with some events being fatal or life-threatening.

Drug Interactions

The concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs) and certain antihypertensive agents, particularly ACE inhibitors, may result in a diminished antihypertensive effect. Clinicians should consider monitoring blood pressure and adjusting the dosage of the antihypertensive medication as necessary.

When ibuprofen is administered alongside aspirin, it can interfere with the antiplatelet activity of aspirin, particularly if ibuprofen is taken prior to aspirin. It is advisable to space the administration of these medications to mitigate this interaction.

Ibuprofen has been shown to reduce the natriuretic effect of diuretics such as furosemide and thiazides. Close monitoring of renal function is recommended in patients receiving this combination to prevent potential renal failure.

Additionally, ibuprofen can elevate plasma lithium levels by reducing its renal clearance, which increases the risk of lithium toxicity. Regular monitoring of lithium levels is warranted in patients taking both ibuprofen and lithium.

The use of NSAIDs may enhance the toxicity of methotrexate through competitive inhibition of its accumulation. Caution should be exercised when these drugs are used concurrently, and monitoring for signs of methotrexate toxicity is recommended.

Finally, caution is advised when administering ibuprofen to patients on warfarin due to an increased risk of serious gastrointestinal bleeding. Regular monitoring of coagulation parameters is recommended to ensure patient safety.

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 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 drug (NSAID). 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 may be warranted 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 in the later stages of gestation. Administration of NSAIDs around 30 weeks of gestation or later can lead to premature closure of the fetal ductus arteriosus, a critical vessel in fetal circulation. Additionally, the use of NSAIDs at approximately 20 weeks of gestation or later has been linked to fetal renal dysfunction, which may result in oligohydramnios and, in some instances, neonatal renal impairment.

Due to these potential risks, it is recommended that the use of Ibuprofen Oral Suspension be limited to the lowest effective dose and the shortest duration possible if necessary after 20 weeks of gestation. 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.

The estimated background risk of major birth defects and miscarriage in the general U.S. population is 2-4% and 15-20%, respectively; however, the specific background risk associated with NSAID use during pregnancy remains unknown. While animal studies have not demonstrated developmental abnormalities, they have indicated that prostaglandins play a crucial role in fetal kidney development and implantation processes. In these studies, the use of prostaglandin synthesis inhibitors like ibuprofen has been associated with increased pre- and post-implantation loss and impaired kidney development at clinically relevant doses.

There are no adequate, well-controlled studies in pregnant women to establish the safety of Ibuprofen Oral Suspension. Therefore, it should only be used during pregnancy if the potential benefits justify the potential risks to the fetus. Published literature indicates that adverse outcomes, such as fetal renal dysfunction leading to oligohydramnios, may occur after days to weeks of NSAID treatment, although some cases of oligohydramnios have been reported as early as 48 hours after initiation. The reversibility of oligohydramnios upon cessation of the drug has been noted, but there are also reports of irreversible neonatal renal dysfunction requiring invasive interventions.

Given the methodological limitations of existing postmarketing studies, including the absence of control groups and limited data on dosing and duration, a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal NSAID use cannot be established. Furthermore, the applicability of reported risks to full-term infants exposed to NSAIDs through maternal use remains uncertain, as most safety data involve preterm infants. Therefore, caution is warranted when considering the use of Ibuprofen Oral Suspension in pregnant patients.

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 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 effects 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 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. In patients with compromised liver function, the administration of an NSAID may lead to a dose-dependent reduction in prostaglandin formation, which is critical for maintaining renal blood flow. This reduction can precipitate overt renal decompensation, particularly in patients who also have impaired renal function, heart failure, or are taking diuretics and ACE inhibitors, as well as in the elderly.

Due to the lack of controlled clinical studies regarding the use of Ibuprofen Oral Suspension in patients with advanced renal disease, treatment with this formulation is not recommended for such patients. If therapy with Ibuprofen Oral Suspension is deemed necessary, it is essential to closely monitor the patient's renal function throughout the treatment period. Discontinuation of NSAID therapy typically results in recovery to the pretreatment state, underscoring the importance of careful management in this patient population.

Overdosage

The toxicity associated with ibuprofen overdose is contingent upon the quantity ingested and the duration since ingestion. Serious toxicity and fatalities have been documented in cases of overdose.

Common Symptoms Patients experiencing ibuprofen overdose may present with a range of symptoms, including abdominal pain, nausea, vomiting, lethargy, drowsiness, headache, tinnitus, central nervous system (CNS) depression, and seizures. In rare instances, more severe complications such as metabolic acidosis, coma, acute renal failure, and apnea may occur, particularly in very young children. Additionally, cardiovascular effects, including hypotension, bradycardia, tachycardia, and atrial fibrillation, have been reported.

Pediatric Considerations In children, ingestion of less than 100 mg/kg of ibuprofen is generally not expected to result in toxicity. However, for those ingesting between 100 to 200 mg/kg, observation for a minimum of four hours is recommended. For children who consume between 200 to 400 mg/kg, immediate gastric emptying should be performed, followed by at least four hours of observation in a healthcare facility. In cases where children ingest more than 400 mg/kg, immediate medical referral is necessary, and careful observation is warranted. It is important to note that ipecac-induced emesis is not advised due to the potential risk of convulsions.

Adult Considerations In adults, the history of the ingested dose does not reliably predict the severity of toxicity. Therefore, symptomatic adults should undergo thorough evaluation and supportive care.

Management Strategies The management of acute ibuprofen overdose is primarily supportive. This includes addressing hypotension, metabolic acidosis, and any gastrointestinal bleeding that may arise. Emesis is most effective when initiated within 30 minutes of ingestion, while the administration of activated charcoal may be beneficial in reducing absorption if given orally.

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 around 30 weeks of gestation and later is contraindicated due to an increased risk of premature closure of the fetal ductus arteriosus. Additionally, the use of NSAIDs at approximately 20 weeks of gestation or later may lead to fetal renal dysfunction, resulting in oligohydramnios and, in some instances, neonatal renal impairment. These adverse effects may manifest after days to weeks of treatment, although oligohydramnios has been reported as early as 48 hours following the initiation of NSAID therapy. In certain postmarketing cases of impaired neonatal renal function, invasive interventions such as exchange transfusion or dialysis were necessary.

Regarding non-teratogenic effects, observational studies on the embryofetal risks of NSAID use during the first or second trimesters of pregnancy have yielded inconclusive results. Animal reproductive studies conducted in rats and rabbits did not indicate developmental abnormalities; however, the predictive value of animal studies for human outcomes remains uncertain. Prostaglandins play a critical role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, 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.

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

In animal pharmacology and toxicology studies, NSAIDs have been associated with an increased incidence of dystocia, delayed parturition, and decreased pup survival in rats. The effects of Ibuprofen Oral Suspension on labor and delivery in pregnant women remain unknown; therefore, its administration during labor and delivery is not recommended.

Postmarketing Experience

Postmarketing experience has identified several significant 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 resulted in fatal or life-threatening outcomes. 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 frequently observed, and the disorder's variable presentation may involve additional organ systems. Early signs of hypersensitivity, such as fever or lymphadenopathy, may occur even in the absence of a rash. Patients exhibiting these symptoms should discontinue Ibuprofen Oral Suspension and undergo immediate evaluation.

Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), have also been reported with NSAIDs, including Ibuprofen Oral Suspension. These serious events can arise without warning. Patients should be informed of the signs and symptoms of serious skin reactions and advised to discontinue the medication at the first appearance of a skin rash or any other indication of hypersensitivity. Ibuprofen Oral Suspension is contraindicated in individuals with a history of serious skin reactions to NSAIDs.

Anaphylactoid reactions may occur in patients without prior exposure to Ibuprofen Oral Suspension. The medication should not be administered to patients with the aspirin triad, a symptom complex typically seen in asthmatic individuals who experience rhinitis with or without nasal polyps, or who may suffer severe bronchospasm after taking aspirin or other NSAIDs. Emergency assistance should be sought in the event of an anaphylactoid reaction.

The use of NSAIDs, including Ibuprofen Oral Suspension, has been associated with the premature closure of the fetal ductus arteriosus and fetal renal dysfunction, potentially leading to oligohydramnios and, in some cases, 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.

In two postmarketing clinical studies, a higher incidence of decreased hemoglobin levels was observed than previously reported. A decrease in hemoglobin of 1 gram or more was noted in 17.1% of 193 patients taking 1600 mg of ibuprofen daily for osteoarthritis, and in 22.8% of 189 patients taking 2400 mg daily for rheumatoid arthritis. Additionally, positive stool occult blood tests and elevated serum creatinine levels were recorded in these studies.

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 (GI) discomfort and, in rare cases, serious GI side effects, including ulcers and bleeding, which could lead to hospitalization or even death. Patients should be made aware that serious GI tract ulcerations and bleeding can occur without warning symptoms. They should be alert for signs and symptoms of ulcerations and bleeding, such as epigastric pain, dyspepsia, melena, and hematemesis, and should seek medical advice if they observe any of these indicative signs.

Patients should be instructed to discontinue the use of Ibuprofen Oral Suspension immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible.

Healthcare providers should also inform 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 educated 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.

Additionally, patients should be informed about the signs of an anaphylactoid reaction, such as difficulty breathing and swelling of the face or throat. In the event of these symptoms, patients should be advised to seek immediate emergency help.

Pregnant women should be cautioned 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 can occur unexpectedly. For patients undergoing long-term treatment with nonsteroidal anti-inflammatory drugs (NSAIDs), it is recommended that complete blood counts (CBC) and chemistry profiles be assessed periodically to ensure safety.

In cases where patients exhibit clinical signs and symptoms indicative of liver or renal disease, such as eosinophilia or rash, or if there is a persistence or worsening of abnormal liver tests, it is advised that Ibuprofen Oral Suspension be discontinued promptly.

FDA Insert (PDF)

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

View full prescribing information (PDF)