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 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 specific teratogenic or nonteratogenic effects associated with this medication.

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 administration 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 children with a baseline temperature less than 102.5ºF, the recommended dose is 5 mg/kg.

• For those with a baseline temperature 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 daily dose should not exceed 40 mg/kg.

Analgesia:

• For the relief of mild to moderate pain, the recommended dosage is 10 mg/kg administered every 6 to 8 hours.

• The maximum daily dose should not exceed 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, a dose of 400 mg may be administered 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:

• The dosage of Ibuprofen Oral Suspension should be tailored to each patient. Adjustments may be made to lower or raise the dose based on the severity of symptoms.

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.

In addition to cardiovascular risks, NSAIDs can lead to serious gastrointestinal adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which may 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.

Ibuprofen Oral Suspension is not intended to replace corticosteroids or to address corticosteroid insufficiency. Abrupt cessation of corticosteroids can result in exacerbation of the underlying condition. Therefore, patients receiving long-term 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 necessary for diagnosing complications in presumed noninfectious, painful conditions.

Healthcare professionals should monitor patients for signs or symptoms indicative of gastrointestinal bleeding. For those on long-term NSAID therapy, it is recommended that a complete blood count (CBC) and a chemistry profile be conducted periodically. Should any clinical signs or symptoms suggestive of liver or renal disease arise, 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.

In the event of an anaphylactoid reaction, immediate emergency medical assistance should be sought. Patients should be educated on the signs and symptoms of serious skin reactions. If any skin rash or other signs of hypersensitivity appear, the use of Ibuprofen Oral Suspension should be halted, and the patient should contact their healthcare provider. Additionally, if symptoms consistent with Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) are observed, the medication should be discontinued, and the patient should be evaluated 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 can include asthma and dyspnea. Skin reactions may involve 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 various 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 reactions can be serious, with reports of agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, neutropenia, and pancytopenia. Metabolic reactions may include hyperglycemia.

Nervous system reactions can be particularly severe, with reports of convulsions, coma, emotional lability, hallucinations, and aseptic meningitis. Respiratory reactions may include apnea, respiratory depression, pneumonia, and rhinitis. Skin and appendage reactions can be serious, including angioedema, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, urticaria, and vesiculobullous eruptions. Special senses may be affected by amblyopia, conjunctivitis, dry eyes, and hearing impairment. Urogenital reactions may include azotemia, decreased creatinine clearance, glomerulitis, renal papillary necrosis, and tubular necrosis.

The use of this medication carries boxed warnings regarding cardiovascular thrombotic events and gastrointestinal risks. 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 without warning symptoms, with elderly patients being at greater risk.

Patients should be aware that anaphylactoid reactions may occur even in those without prior exposure to the medication, necessitating immediate medical attention in such cases. Serious skin adverse events, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, can occur without warning, and the medication should be discontinued at the first sign of a rash or any other hypersensitivity indication. Furthermore, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs, with some cases being fatal or life-threatening. Early manifestations of hypersensitivity may occur even in the absence of a rash.

Drug Interactions

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

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

Antiplatelet Agents Pharmacodynamic studies indicate that ibuprofen can interfere with the antiplatelet activity of aspirin, particularly when ibuprofen is administered prior to enteric-coated low-dose aspirin. This interaction persists even with a once-daily regimen of ibuprofen at 400 mg. To mitigate this effect, it is advisable to administer immediate-release low-dose aspirin at least 2 hours before ibuprofen. However, this timing does not apply to enteric-coated formulations. Given the potential increased risk of cardiovascular events, patients taking low-dose aspirin for cardioprotection who require analgesics should consider alternative NSAIDs that do not interfere with aspirin's antiplatelet effect or non-NSAID analgesics when appropriate.

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

Lithium Ibuprofen has been shown to elevate plasma lithium levels and reduce renal lithium clearance, with a mean increase in minimum lithium concentration of 15% and a 19% decrease in renal clearance during concurrent administration. Careful observation for signs of lithium toxicity is recommended when these drugs 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 alongside methotrexate.

Anticoagulants While several short-term controlled studies have not demonstrated a significant effect of ibuprofen on prothrombin times or other clotting factors in patients on warfarin-type anticoagulants, there is a documented risk of bleeding when these 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 gastrointestinal 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 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 risk of adverse effects associated with nonsteroidal anti-inflammatory drugs in this population, careful monitoring and consideration of individual patient factors are essential. It is important for healthcare providers to assess the potential benefits and risks before initiating therapy in geriatric patients.

Pregnancy

Use of nonsteroidal anti-inflammatory drugs (NSAIDs), including Ibuprofen Oral Suspension, during pregnancy is associated with specific risks that healthcare professionals should consider. Administration of NSAIDs around 30 weeks of gestation or later can lead to premature closure of the fetal ductus arteriosus, which may have significant implications for fetal cardiovascular health. Additionally, the use of NSAIDs at approximately 20 weeks of gestation or later has been linked to fetal renal dysfunction, potentially resulting in oligohydramnios and, in some instances, neonatal renal impairment.

Given these 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, monitoring with ultrasound for oligohydramnios is advised. Should oligohydramnios be detected, discontinuation of Ibuprofen Oral Suspension should be considered, with follow-up according to clinical practice guidelines.

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. Observational studies regarding potential embryofetal risks during the first and second trimesters have yielded inconclusive results. Animal studies indicate that prostaglandins play a crucial role in various reproductive processes, and the use of prostaglandin synthesis inhibitors like ibuprofen has been associated with increased pre- and post-implantation loss and impaired kidney development.

While some reports suggest that adverse outcomes such as neonatal renal dysfunction may occur without preceding oligohydramnios, the methodological limitations of existing studies—including the absence of control groups and variability in drug exposure—hinder the ability to establish a reliable risk estimate for fetal and neonatal outcomes associated with maternal NSAID use. Furthermore, the safety data primarily involve preterm infants, raising questions about the applicability of these findings to full-term infants exposed to NSAIDs in utero. 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 the importance of the drug to their health when making a decision to either discontinue nursing or discontinue the drug.

Renal Impairment

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

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

There is no available information from controlled clinical studies regarding the use of Ibuprofen 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 administered 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 risk of renal toxicity is heightened, particularly in those who rely on renal prostaglandins for the maintenance of renal perfusion.

The use of NSAIDs in this population 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 greatest risk for these adverse reactions include those with impaired renal function, heart failure, liver dysfunction, individuals taking diuretics and ACE inhibitors, and the elderly.

Due to these risks, careful monitoring of renal function is recommended for patients with hepatic impairment who are prescribed NSAIDs. Should any signs of renal decompensation occur, discontinuation of NSAID therapy is typically followed by recovery to the pretreatment state. It is essential for healthcare providers to assess the individual risk factors and consider alternative therapies when necessary for patients with compromised liver function.

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.

In pediatric patients, the estimated amount of ibuprofen ingested per 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, careful observation, and appropriate supportive therapy are required. Ipecac-induced emesis is contraindicated in 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 likelihood of toxicity. The necessity for referral and follow-up should be determined based on the specific circumstances surrounding the overdose. Symptomatic adults should be thoroughly evaluated, observed, and provided with supportive care as needed.

Nonclinical Toxicology

The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including Ibuprofen Oral Suspension, in pregnant women is associated with significant teratogenic effects, particularly when administered around 30 weeks of gestation and later. At this stage, NSAIDs may increase the risk of premature closure of the fetal ductus arteriosus. Furthermore, the use of NSAIDs during pregnancy, especially from approximately 20 weeks gestation onward, has been linked to fetal renal dysfunction, which can lead to oligohydramnios and, in some instances, neonatal renal impairment. These adverse outcomes may manifest after days to weeks of treatment, although oligohydramnios has been infrequently reported as early as 48 hours following the initiation of NSAID therapy. While oligohydramnios is often reversible upon discontinuation of treatment, prolonged cases may result in complications such as limb contractures and delayed lung maturation.

The background risk of major birth defects and miscarriage in the indicated populations remains unknown. It is acknowledged that all pregnancies carry a baseline 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. Animal studies have demonstrated that the administration of prostaglandin synthesis inhibitors, such as ibuprofen, can lead to increased pre- and post-implantation loss. Prostaglandins play a crucial role in fetal kidney development, and published animal studies indicate that prostaglandin synthesis inhibitors may impair kidney development when given at clinically relevant doses.

In animal pharmacology and toxicology studies involving NSAIDs, including ibuprofen, there was an observed increase in the 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 during labor and delivery is not recommended.

Postmarketing Experience

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

Anaphylactoid reactions may occur in patients without known prior exposure to Ibuprofen Oral Suspension. It is contraindicated in patients with the aspirin triad, a symptom complex typically observed in asthmatic patients who experience rhinitis with or without nasal polyps, or who may exhibit severe bronchospasm after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).

Serious skin adverse events, including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported, with some cases being fatal. These serious events may occur without warning. Additionally, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been documented in patients taking NSAIDs, including Ibuprofen Oral Suspension, with some cases resulting in fatal or life-threatening outcomes. DRESS typically presents with symptoms such as fever, rash, lymphadenopathy, and/or facial swelling.

The use of NSAIDs, including Ibuprofen Oral Suspension, during pregnancy, particularly at around 30 weeks gestation or later, has been associated with an increased risk of premature closure of the fetal ductus arteriosus. Furthermore, use during approximately 20 weeks gestation or later may lead to fetal renal dysfunction, resulting in oligohydramnios and, in some instances, neonatal renal impairment. These adverse outcomes have been observed after days to weeks of treatment, with some cases necessitating invasive procedures such as exchange transfusion or dialysis for impaired neonatal renal function.

In two postmarketing clinical studies, a higher incidence of decreased hemoglobin levels was noted compared to previous reports. A decrease in hemoglobin of 1 gram or more was observed in 17.1% of 193 patients receiving 1600 mg of ibuprofen daily for osteoarthritis, and in 22.8% of 189 patients taking 2400 mg of ibuprofen daily for rheumatoid arthritis. Additionally, positive stool occult blood tests and elevated serum creatinine levels were also reported 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 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 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 cautioned 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 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 on 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 arise, patients should be instructed to stop therapy and seek immediate medical attention.

It is crucial to inform patients about the signs of an anaphylactoid reaction, such as difficulty breathing and swelling of the face or throat. Patients should be instructed to seek immediate emergency help if these symptoms occur.

For pregnant women, it is essential to advise them 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 informed 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). It is important to avoid freezing the product to maintain its integrity. Prior to use, the container should 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, such as eosinophilia or rash, or if abnormal liver tests persist or worsen, 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 PINNACLE PHARMA LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)