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 pKa of ibuprofen is 4.43±0.03, and it has an n-octanol/water partition coefficient of 11.7 at pH 7.4.

The formulation of Ibuprofen Oral Suspension is a sweetened, orange-colored, berry-flavored suspension containing 100 mg of ibuprofen per 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 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

Pediatric patients requiring fever reduction should receive a recommended dose of 5 mg/kg if the baseline temperature is less than 102.5ºF, and 10 mg/kg if the baseline temperature is 102.5ºF or greater. The duration of fever reduction typically lasts for 6 to 8 hours. The maximum daily dose for pediatric patients is capped at 40 mg/kg.

For analgesia in pediatric patients, the recommended dosage is 10 mg/kg administered every 6 to 8 hours, with the same maximum daily limit of 40 mg/kg. In cases of juvenile arthritis, the recommended dose ranges from 30 to 40 mg/kg/day, divided into three to four doses. Patients exhibiting milder disease may be treated with a lower dose of 20 mg/kg/day. It is advised that doses exceeding 50 mg/kg/day are not recommended.

In adult patients experiencing primary dysmenorrhea, a dose of 400 mg may be taken every 4 hours as necessary. For those with rheumatoid arthritis and osteoarthritis, the suggested daily dosage ranges from 1200 to 3200 mg, which can be administered as 300 mg four times daily (q.i.d.) or in divided doses of 400 mg, 600 mg, or 800 mg three to four times daily (t.i.d. or q.i.d.).

It is essential to individualize the dosage for each patient, adjusting based on the severity of symptoms and the patient's 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 and 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 crucial to note that Ibuprofen Oral Suspension is contraindicated in patients undergoing coronary artery bypass graft (CABG) surgery.

In addition to cardiovascular risks, NSAIDs pose a significant threat of serious gastrointestinal adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can also be fatal. These gastrointestinal complications can occur at any time during treatment and may arise without warning symptoms. Elderly patients are particularly vulnerable to these serious gastrointestinal events and should be monitored closely.

Ibuprofen Oral Suspension is not intended to replace corticosteroids or to address corticosteroid insufficiency. Abrupt cessation of corticosteroids can lead to exacerbation of the underlying condition. Therefore, patients receiving prolonged corticosteroid therapy should have their medication tapered gradually if discontinuation is deemed necessary.

The pharmacological effects of Ibuprofen Oral Suspension in alleviating fever and inflammation may obscure the clinical signs that are critical for diagnosing complications in presumed noninfectious, painful conditions.

To ensure safe use, healthcare professionals should monitor patients for signs or symptoms indicative of gastrointestinal bleeding, given the risk of serious GI tract ulcerations and bleeding that can occur without prior warning. For patients on long-term NSAID therapy, it is recommended to periodically assess complete blood count (CBC) and chemistry profiles. If any clinical signs or symptoms suggestive of liver or renal disease develop, or if systemic manifestations such as eosinophilia or rash occur, or if abnormal liver function tests persist or worsen, the use of Ibuprofen Oral Suspension should be discontinued promptly.

Side Effects

Patients receiving treatment with this medication 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 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, and cardiovascular events such as arrhythmia, cerebrovascular accidents, hypotension, myocardial infarction, palpitations, and vasculitis. Digestive system reactions may be 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 disturbances such as hyperglycemia have been noted, as well as serious nervous system effects including convulsions, coma, emotional lability, hallucinations, and aseptic meningitis.

Respiratory complications 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 adverse reactions can 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 arise early in treatment and may increase with prolonged 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. Such 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 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, it is advisable for patients taking low-dose aspirin for cardioprotection to consider alternative analgesics that do not interfere with aspirin's antiplatelet effect, or to use 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 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 warranted when these medications are used together.

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

Anticoagulants While several short-term 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 on gastrointestinal bleeding necessitate caution in prescribing ibuprofen to patients on anticoagulants, as the risk of serious GI bleeding is elevated in this population.

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 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 complications associated with NSAID use in geriatric patients. Appropriate dose adjustments may be necessary based on individual patient assessments and clinical response.

Pregnancy

Use of NSAIDs, including Ibuprofen Oral Suspension, during pregnancy is associated with significant risks, particularly when administered around 20 to 30 weeks of gestation. 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 cases, neonatal renal impairment. Therefore, 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 at around 30 weeks of gestation and later in pregnancy.

Observational studies have shown that the use of NSAIDs at about 30 weeks gestation or later increases the risk of premature closure of the fetal ductus arteriosus. Additionally, the use of NSAIDs at around 20 weeks gestation or later has been linked to fetal renal dysfunction leading to oligohydramnios, with some instances of neonatal renal impairment reported. These adverse outcomes typically occur after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after initiation of NSAID therapy. While many cases of decreased amniotic fluid have been transient and reversible upon cessation of the drug, there have been limited reports of irreversible neonatal renal dysfunction, some requiring invasive procedures such as exchange transfusion or dialysis.

Data from animal studies indicate that prostaglandins play a crucial role in fetal kidney development and that the administration of prostaglandin synthesis inhibitors like ibuprofen can impair this development. However, the relevance of animal data to human pregnancy outcomes is uncertain, and the estimated background risk of major birth defects and miscarriage in the general population remains unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is approximately 2-4% and 15-20%, respectively.

There are no adequate, 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. If NSAID treatment is deemed necessary after 20 weeks of gestation, it is advised to use the lowest effective dose for the shortest duration possible. If treatment extends beyond 48 hours, monitoring with ultrasound for oligohydramnios should be considered. In the event that oligohydramnios occurs, ibuprofen should be discontinued, and follow-up should be conducted according to clinical practice guidelines.

Due to methodological limitations in postmarketing studies, including the lack of control groups and limited information regarding dose, duration, and timing of drug exposure, establishing a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal NSAID use remains challenging. Furthermore, the safety data on neonatal outcomes primarily involve preterm infants, raising questions about the generalizability of reported risks to full-term infants exposed to NSAIDs through maternal use.

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

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

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 complications such as hypotension, acidosis, and gastrointestinal bleeding. 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.

Pediatric Considerations

In pediatric patients, the amount of ibuprofen ingested relative to body weight can help predict 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 include 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.

Adult Considerations

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 the fetal ductus arteriosus and renal function. 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.

Observational studies regarding other potential embryofetal risks associated with NSAID use during the first or second trimesters of pregnancy have yielded inconclusive results. Animal reproductive studies conducted in rats and rabbits have not indicated 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.

There are no adequate, well-controlled studies in pregnant women. Ibuprofen should be utilized during pregnancy only if the potential benefits outweigh the potential risks to the fetus. The estimated background risk of major birth defects and miscarriage in the indicated population is 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 2-4% and 15-20%, respectively.

In animal studies involving NSAIDs, including ibuprofen, there was an increased incidence of dystocia, delayed parturition, and decreased pup survival. The effects of Ibuprofen Oral Suspension on labor and delivery in pregnant women remain unknown; therefore, its administration is not recommended during labor and delivery.

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 may present with symptoms such as fever, rash, lymphadenopathy, and/or facial swelling, along with potential involvement of other organ systems. Eosinophilia is frequently observed, and early signs of hypersensitivity may occur even in the absence of a rash. Immediate discontinuation of Ibuprofen Oral Suspension and patient evaluation are recommended upon the appearance of such symptoms.

Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported in association with NSAID use, including Ibuprofen Oral Suspension. These reactions can be fatal and may occur without warning. Fixed drug eruptions (FDE), including generalized bullous fixed drug eruption (GBFDE), have also been noted, with the potential for life-threatening outcomes. Patients should be informed of the signs and symptoms of serious skin reactions and advised to discontinue the medication at the first indication of a rash or 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 in the event of an anaphylactoid reaction.

Gastrointestinal adverse events, including inflammation, bleeding, ulceration, and perforation of the gastrointestinal tract, have been associated with NSAID use, including Ibuprofen Oral Suspension. These serious events can occur unexpectedly, with only a minority of patients exhibiting symptoms prior to a serious upper GI event. The incidence of upper GI ulcers, bleeding, or perforation is approximately 1% in patients treated for 3-6 months and increases to 2-4% in those treated for one year or longer. Even short-term use carries risks for serious gastrointestinal complications.

Long-term use of NSAIDs has been linked to renal effects, including renal papillary necrosis and other forms of renal injury. Patients with compromised renal function, heart failure, liver dysfunction, those on diuretics or ACE inhibitors, and the elderly are at increased risk for renal toxicity. Discontinuation of NSAID therapy typically leads to recovery to the pretreatment state.

Fetal toxicity has been observed with NSAID use, including Ibuprofen Oral Suspension, leading to premature closure of the fetal ductus arteriosus and renal dysfunction, which may result in oligohydramnios and neonatal renal impairment. It is advised to limit the dose and duration of Ibuprofen Oral Suspension use between 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 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 also be made aware of the potential for 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 these symptoms arise.

Finally, healthcare providers should inform pregnant women to avoid the use of Ibuprofen Oral Suspension and other NSAIDs starting at 30 weeks of 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 of 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 20ºC to 25ºC (68ºF to 77ºF), in accordance with USP Controlled Room Temperature guidelines. It is essential 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 there is a risk of serious GI tract ulcerations and bleeding associated with the use of Ibuprofen Oral Suspension.

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 adverse effects. Additionally, if patients exhibit clinical signs and symptoms indicative of liver or renal disease, or if systemic manifestations such as eosinophilia or rash occur, or if abnormal liver tests persist or worsen, the use of Ibuprofen Oral Suspension should be discontinued.

FDA Insert (PDF)

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

View full prescribing information (PDF)