Ibuprofen

Description

Ibuprofen oral suspension USP 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 75° to 78°C. It is practically insoluble in water (< 0.1 mg/mL) but exhibits high solubility in alcohol, methanol, chloroform, and acetone, with slight solubility in ethyl acetate. The compound has a pKa of 3.6 and an n-octanol/water partition coefficient of 3.3. 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 formulation of Ibuprofen oral suspension USP is a light orange to orange colored, berry-flavored suspension containing 100 mg of ibuprofen USP per 5 mL (20 mg/mL). Inactive ingredients include acesulfame potassium, artificial raspberry flavor, citric acid anhydrous, D&C yellow No. 10, FD&C red No. 40, glycerin, hypromellose, polysorbate 80, pregelatinized starch (potato), purified water, sodium benzoate, sucrose, and xanthan gum.

Uses and Indications

Ibuprofen Oral Suspension is indicated for use in pediatric patients and adults for 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 relief of signs and symptoms associated with juvenile arthritis.

In adults, this medication 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

Pediatric patients requiring fever reduction should receive a recommended dose of 5 mg/kg if the baseline temperature is less than 102.5ºF, or 10 mg/kg if the baseline temperature is 102.5ºF or greater. The duration of fever reduction typically lasts for 6 to 8 hours, with a maximum daily dose not exceeding 40 mg/kg.

For analgesia, the recommended dosage for pediatric patients 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 mg/kg/day to 40 mg/kg/day, divided into three to four doses. Patients with milder disease may be treated with a lower dose of 20 mg/kg/day. It is important to note that doses exceeding 50 mg/kg/day are not recommended.

In adult patients, the dosage for primary dysmenorrhea is 400 mg every 4 hours as necessary. For rheumatoid arthritis and osteoarthritis, the suggested daily dosage ranges from 1200 mg to 3200 mg, which can be administered as 300 mg four times a day (q.i.d.) or as 400 mg, 600 mg, or 800 mg three to four times a day (t.i.d. or q.i.d.).

Dosage should be individualized for each patient, with adjustments made based on the severity of symptoms to ensure optimal therapeutic outcomes.

Contraindications

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

Caution is advised when considering ibuprofen for patients with preexisting asthma, particularly those with aspirin-sensitive asthma.

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 also pose a significant risk of serious gastrointestinal adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during treatment and may present without warning symptoms. Elderly patients are particularly vulnerable to these serious gastrointestinal complications.

Anaphylactoid reactions may occur in individuals without prior exposure to ibuprofen. In such cases, immediate emergency medical assistance should be sought. Additionally, serious skin adverse reactions, including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal, have been reported. Patients should be informed of the signs and symptoms of serious skin reactions and advised to discontinue ibuprofen oral suspension at the first indication of a skin rash or any other sign of hypersensitivity.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has also been documented in patients taking NSAIDs like ibuprofen oral suspension. If any signs or symptoms indicative of DRESS arise, ibuprofen should be discontinued immediately, and the patient should be evaluated without delay.

Ibuprofen is not a substitute for corticosteroids and should not be used to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to exacerbation of the underlying condition. For patients on prolonged corticosteroid therapy, a gradual tapering of the corticosteroid dosage is recommended if discontinuation is necessary.

Patients exhibiting symptoms or signs suggestive of liver dysfunction, or those with abnormal liver test results, should be closely monitored for the development of more severe hepatic reactions while on ibuprofen therapy. If clinical signs and symptoms consistent with liver disease develop, ibuprofen should be discontinued.

For patients on long-term NSAID treatment, including ibuprofen, it is advisable to periodically check hemoglobin or hematocrit levels, especially if any signs or symptoms of anemia are present. Physicians should also monitor for signs or symptoms of gastrointestinal bleeding in these patients. Regular laboratory assessments, including a complete blood count (CBC) and a chemistry profile, should be conducted. If any clinical signs or symptoms consistent with liver or renal disease develop, or if abnormal liver tests persist or worsen, ibuprofen should be discontinued.

In cases of anaphylactoid reactions, immediate emergency medical help is essential. Patients should be instructed to discontinue ibuprofen oral suspension at the first appearance of a skin rash or any other sign of hypersensitivity. If signs or symptoms of DRESS are present, ibuprofen oral suspension should be stopped, and the patient should be evaluated promptly.

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

Occasionally reported adverse reactions encompass a broader spectrum of effects. Systemic reactions may include fever, infection, and sepsis. Cardiovascular effects can manifest as 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. Hematological reactions include ecchymosis, eosinophilia, leukopenia, purpura, stomatitis, and thrombocytopenia. Metabolic and nutritional changes such as weight fluctuations have also been noted.

Nervous system effects may present as anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, paresthesia, somnolence, tremors, and vertigo. Respiratory issues can include asthma and dyspnea. Skin reactions may involve alopecia, photosensitivity, and increased sweating. Additionally, 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 reported. These include anaphylactic and anaphylactoid reactions, appetite changes, arrhythmias, cerebrovascular accidents, hypotension, myocardial infarction, palpitations, and vasculitis within the cardiovascular system. Digestive system reactions may be more severe, including eructation, gingival ulcers, hepatorenal syndrome, liver necrosis, liver failure, and pancreatitis. Hematological concerns may involve agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, neutropenia, and pancytopenia. Metabolic reactions such as hyperglycemia and nervous system effects including convulsions, coma, emotional lability, hallucinations, and aseptic meningitis have been documented. Respiratory complications may include apnea, respiratory depression, pneumonia, and rhinitis. Skin reactions can be particularly serious, 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, leading to amblyopia, conjunctivitis, dry eyes, and hearing impairment. Urogenital reactions may include azotemia, decreased creatinine clearance, glomerulitis, renal papillary necrosis, and tubular necrosis.

The treatment carries boxed warnings regarding the 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, there is an increased risk of serious gastrointestinal adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can also be fatal and may occur at any time during treatment without warning symptoms.

Warnings associated with the treatment include the potential for serious cardiovascular thrombotic events, the onset of new hypertension or worsening of pre-existing hypertension, and an increased risk of hospitalization for heart failure and fluid retention. Serious skin reactions, such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, may occur. Patients may also experience borderline elevations of liver tests, with rare cases of severe hepatic reactions reported. Hematological effects, including anemia and prolonged bleeding time, may occur, necessitating monitoring for patients on long-term treatment.

Drug Interactions

Concomitant use of certain medications with ibuprofen may lead to significant drug interactions, which can affect therapeutic outcomes and increase the risk of adverse effects. The following interactions have been identified:

Pharmacodynamic Interactions

• ACE-Inhibitors: Nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, may reduce the antihypertensive effect of ACE-inhibitors. Clinicians should consider this interaction when prescribing NSAIDs to patients who are concurrently taking ACE-inhibitors.

• Aspirin: Ibuprofen has been shown to interfere with the antiplatelet activity of aspirin, particularly when ibuprofen is administered before aspirin. This interaction is significant with both immediate-release and enteric-coated low-dose aspirin. To mitigate this risk, it is advisable to administer immediate-release low-dose aspirin at least 2 hours prior to ibuprofen. However, this timing does not apply to enteric-coated formulations. For patients requiring analgesics while on low-dose aspirin for cardioprotection, alternative NSAIDs that do not affect aspirin's antiplatelet effect or non-NSAID analgesics should be considered.

• Warfarin: While short-term studies have not demonstrated a significant effect of ibuprofen on prothrombin times in patients on warfarin, there is a documented risk of increased 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.

Pharmacokinetic Interactions

• Diuretics: Ibuprofen may diminish the natriuretic effect of diuretics such as furosemide and thiazides, likely due to the inhibition of renal prostaglandin synthesis. Patients receiving concomitant therapy should be closely monitored for signs of renal impairment and to ensure the efficacy of diuretics.

• Lithium: The administration of ibuprofen has been associated with increased plasma lithium levels and decreased renal clearance of lithium. Specifically, a study indicated a 15% increase in mean minimum lithium concentration and a 19% reduction in renal clearance. Careful monitoring for signs of lithium toxicity is recommended when these drugs are used together.

• Methotrexate: NSAIDs, including ibuprofen, may competitively inhibit the accumulation of methotrexate, potentially enhancing its toxicity. Caution is advised when administering NSAIDs in conjunction with methotrexate.

In summary, careful consideration and monitoring are essential when ibuprofen is prescribed alongside these medications to mitigate potential interactions and ensure patient safety.

Packaging & NDC

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

Pediatric Use

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

Geriatric Use

Caution should be exercised when treating elderly patients (65 years and older) with this medication, as with any nonsteroidal anti-inflammatory drugs (NSAIDs). It is important for healthcare providers to consider the increased risk of adverse effects in this population. Monitoring for potential side effects and adjusting dosages as necessary 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 specific risks that healthcare professionals should consider. The use of NSAIDs, particularly after approximately 30 weeks of gestation, is linked to an increased risk of premature closure of the fetal ductus arteriosus. Additionally, administration of NSAIDs at around 20 weeks of gestation or later has been associated with fetal renal dysfunction, which can lead to oligohydramnios and, in some cases, neonatal renal impairment.

To mitigate 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 should be considered. In instances where oligohydramnios is detected, discontinuation of ibuprofen oral suspension is advised, followed by appropriate clinical follow-up.

Data from observational studies regarding the potential embryofetal risks of NSAID use during the first and second trimesters remain inconclusive. Animal reproductive studies have not demonstrated developmental abnormalities; however, these studies are not always predictive of human outcomes. Prostaglandins play a crucial role in various aspects of pregnancy, including endometrial vascular permeability and fetal kidney development. In animal studies, the use of prostaglandin synthesis inhibitors 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, and ibuprofen should only be used during pregnancy if the potential benefits justify the potential risks to the fetus. The estimated background risk of major birth defects and miscarriage in the general U.S. population is 2 to 4% and 15 to 20%, respectively. Given the methodological limitations of existing postmarketing studies, including the lack of control groups and limited information on dosing and timing, establishing a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal NSAID use remains challenging. Therefore, healthcare professionals should exercise caution and consider these factors when prescribing ibuprofen oral suspension to 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, 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. In patients with reduced kidney function, renal prostaglandins play a compensatory role in maintaining renal perfusion. The use of NSAIDs in these patients may lead to a dose-dependent reduction in prostaglandin formation, which can subsequently decrease renal blood flow and precipitate overt renal decompensation. Patients at the highest risk for these adverse effects include those with impaired renal function, heart failure, liver dysfunction, individuals taking diuretics and ACE inhibitors, and the elderly. Typically, discontinuation of NSAID therapy results in recovery to the pretreatment state.

For patients with advanced renal disease, there is a lack of controlled clinical study data regarding the use of ibuprofen. Consequently, treatment with ibuprofen is not recommended for these patients. If ibuprofen therapy is deemed necessary, close monitoring of renal function is advised.

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 population.

Due to the lack of controlled clinical studies regarding the use of ibuprofen in patients with advanced renal disease, treatment with ibuprofen is not recommended for these individuals. If ibuprofen therapy is deemed necessary, it is essential to closely monitor the patient's renal function throughout the course of treatment. Discontinuation of NSAID therapy typically results in recovery to the pretreatment state, underscoring the importance of careful management in patients with hepatic impairment.

Overdosage

The toxicity associated with ibuprofen overdose is influenced by the quantity of the drug ingested and the time elapsed since ingestion; however, individual responses may vary significantly. Therefore, it is essential to evaluate each case on an individual basis.

Although serious toxicity and fatalities are rare, they have been documented in the medical literature. The most commonly reported symptoms of ibuprofen overdose include abdominal pain, nausea, vomiting, lethargy, and drowsiness. Additional central nervous system symptoms may manifest as 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 acute ibuprofen overdose is primarily supportive. It may be necessary to address hypotension, acidosis, and gastrointestinal bleeding. In cases of acute overdose, gastric emptying should be performed, ideally through ipecac-induced emesis or gastric lavage. Emesis is most effective when initiated within 30 minutes of ingestion. The administration of activated charcoal orally may also assist in reducing both the absorption and reabsorption of ibuprofen.

In pediatric patients, the estimated amount of ibuprofen ingested per body weight can provide insight into the potential for toxicity, although each case must be assessed 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 potential aspiration of gastric contents.

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

Nonclinical Toxicology

Use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen oral suspension, during pregnancy has been associated with teratogenic effects, particularly concerning fetal renal function and ductus arteriosus closure. Specifically, NSAID use can lead to premature closure of the fetal ductus arteriosus and fetal renal dysfunction, which may result in oligohydramnios and, in some instances, neonatal renal impairment. Observational studies regarding other potential embryofetal risks associated with NSAID use in women during the first or second trimesters of pregnancy have yielded inconclusive results. Although animal reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities, it is important to note that findings from animal studies are not always predictive of human outcomes.

Prostaglandins play a critical role in various reproductive processes, including 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 indicate that prostaglandin synthesis inhibitors can impair kidney development when administered at clinically relevant doses.

The use of NSAIDs, including ibuprofen oral suspension, is contraindicated in pregnant women at approximately 30 weeks gestation and later due to the increased risk of premature closure of the fetal ductus arteriosus. Additionally, the use of NSAIDs during pregnancy, particularly around 20 weeks gestation or later, may lead to fetal renal dysfunction, resulting in oligohydramnios and potential 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. While oligohydramnios is often reversible upon discontinuation of treatment, prolonged cases may lead to complications such as limb contractures and delayed lung maturation. In some instances of impaired neonatal renal function, invasive interventions such as exchange transfusion or dialysis have been necessary.

If NSAID treatment is deemed essential between approximately 20 weeks and 30 weeks gestation, it is recommended to limit the use of 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 appropriate follow-up according to clinical practice.

No controlled clinical studies have provided information regarding the use of ibuprofen in patients with advanced renal disease. Therefore, treatment with ibuprofen is not recommended for these patients. If ibuprofen therapy is initiated, close monitoring of renal function is advised.

In animal studies, the administration of prostaglandin synthesis inhibitors, such as ibuprofen, has resulted in increased pre- and post-implantation loss. Additionally, published animal studies have reported that these inhibitors can impair kidney development when given at clinically relevant doses.

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 ibuprofen. Some cases have resulted in fatal or life-threatening outcomes. DRESS may present with symptoms such as fever, rash, lymphadenopathy, and/or facial swelling, and can also involve other clinical manifestations including hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis. Eosinophilia is frequently observed, and early signs of hypersensitivity may occur even in the absence of a rash. It is advised that ibuprofen oral suspension be discontinued and the patient evaluated immediately if any early manifestations of hypersensitivity are noted.

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. These reactions can be fatal and may occur without warning. Fixed drug eruption (FDE) and its severe variant, generalized bullous fixed drug eruption (GBFDE), have also been observed. Patients should be informed of the signs and symptoms of serious skin reactions and advised to discontinue ibuprofen oral suspension at the first appearance of a skin rash or any other sign of hypersensitivity. The use of ibuprofen oral suspension is contraindicated in individuals with a history of serious skin reactions to NSAIDs.

Fetal toxicity has been associated with the use of ibuprofen oral suspension, particularly concerning the premature closure of the fetal ductus arteriosus and fetal renal dysfunction, which can lead 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.

Oligohydramnios and neonatal renal impairment have been reported following the use of ibuprofen oral suspension at around 20 weeks of gestation or later. These adverse outcomes may occur 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, complications from prolonged oligohydramnios can include limb contractures and delayed lung maturation. In some cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis have been necessary.

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 documented in these studies.

Patient Counseling

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

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

Gastrointestinal Risks Ibuprofen, like other NSAIDs, can cause gastrointestinal discomfort and, in rare cases, serious gastrointestinal side effects such as ulcers and bleeding, which may result in hospitalization or even death. Although serious gastrointestinal tract ulcerations and bleeding can occur without warning symptoms, patients should be vigilant for signs and symptoms of ulcerations and bleeding. They should seek medical advice if they observe any indicative signs or symptoms, including epigastric pain, dyspepsia, melena, or hematemesis. Patients should be apprised of the importance of this follow-up.

Serious Skin Reactions Patients should be advised to stop taking ibuprofen oral suspension immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible.

Heart Failure and Edema Patients should be alert for symptoms of congestive heart failure, including shortness of breath, unexplained weight gain, or edema. They should be instructed to contact their healthcare provider if such symptoms occur.

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

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

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

Storage and Handling

The product is supplied in a well-closed container as defined by the United States Pharmacopeia (USP). It is essential to store the product at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines. Prior to use, the product must be shaken well to ensure proper consistency and efficacy.

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 NSAIDs. For patients undergoing long-term treatment with NSAIDs, it is recommended that complete blood counts (CBC) and chemistry profiles be checked periodically to assess for potential adverse effects.

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

FDA Insert (PDF)

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

View full prescribing information (PDF)