Ibuprofen

Description

The active ingredient in ibuprofen oral suspension USP is ibuprofen, a member of the propionic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Ibuprofen is a racemic mixture of +S- and -R-enantiomers. It appears as a white to off-white crystalline powder with a melting point of 74° to 77°C. The compound is practically insoluble in water (< 0.1 mg/mL) but is readily soluble in organic solvents such as ethanol and acetone. Ibuprofen has a pKa of 4.43 ± 0.03 and an n-octanol/water partition coefficient of 11.7 at pH 7.4. The chemical name for ibuprofen is (±)-2-(p-Isobutylphenyl) propionic acid, with a molecular weight of 206.28 and a molecular formula of C13H18O2. Ibuprofen oral suspension USP is a sucrose-sweetened, white to off-white, berry-flavored suspension containing 100 mg of ibuprofen in 5 mL (20 mg/mL). Inactive ingredients include acesulfame potassium, berry flavor natural & artificial, citric acid anhydrous, glycerin, pregelatinized modified starch, polysorbate 80, sodium benzoate, purified water, sucrose, 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 teratogenic or nonteratogenic effects associated with the use of 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 should be adjusted to meet the specific needs of the patient.

Pediatric Patients:

For fever reduction, the recommended dosing is as follows:

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

• Administer 10 mg/kg if the baseline temperature is 102.5ºF or greater.The duration of fever reduction typically lasts for 6 to 8 hours, with a maximum daily dose not exceeding 40 mg/kg.

For analgesia, the recommended dosage is 10 mg/kg, to be given every 6 to 8 hours, with a maximum daily dose also capped at 40 mg/kg.

In the case of juvenile arthritis, the recommended dosing is 30 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. Doses exceeding 50 mg/kg/day are not recommended.

Adults:

For primary dysmenorrhea, the recommended dose is 400 mg every 4 hours as necessary for pain relief.

For rheumatoid arthritis and osteoarthritis, the suggested dosage ranges from 1200 to 3200 mg daily, 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.).

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 is contraindicated in the context of coronary artery bypass graft (CABG) surgery.

Warnings and Precautions

Patients receiving NSAIDs, including ibuprofen, should be aware of the potential for serious cardiovascular thrombotic events, such as myocardial infarction (MI) and stroke, which may be fatal. Clinical trials have demonstrated an increased risk of these events, with the relative increase being similar in individuals with and without known cardiovascular (CV) disease or risk factors. However, patients with existing CV disease or risk factors exhibit a higher absolute incidence of serious CV thrombotic events. This risk is particularly pronounced at higher doses of NSAIDs.

Additionally, NSAIDs, including ibuprofen, may lead to the onset of new hypertension or exacerbate pre-existing hypertension. Serious gastrointestinal (GI) adverse events, such as inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, can also occur and may be fatal. Long-term use of NSAIDs has been associated with renal complications, including renal papillary necrosis and other forms of renal injury.

Anaphylactoid reactions can occur in patients who have not previously been exposed to ibuprofen. Furthermore, serious skin reactions, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported and can be fatal. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has also been documented in patients taking NSAIDs such as ibuprofen oral suspension. It is crucial to avoid the use of NSAIDs, including ibuprofen oral suspension, in pregnant women at approximately 30 weeks of gestation and later due to the risk of premature closure of the fetal ductus arteriosus.

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 medication is recommended if discontinuation is necessary.

Healthcare professionals should monitor patients on long-term NSAID therapy for signs or symptoms of GI bleeding. Regular laboratory assessments, including complete blood count (CBC) and chemistry profile, should be conducted periodically. If any clinical signs or symptoms indicative of liver or renal disease develop, ibuprofen should be discontinued immediately.

In the event of an anaphylactoid reaction, emergency medical assistance should be sought without delay. Patients should be educated on 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 indication of hypersensitivity. If symptoms consistent with DRESS arise, 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. In the body as a whole, patients may experience fever, infection, or sepsis. Cardiovascular effects can include congestive heart failure in patients with marginal cardiac function, hypertension, tachycardia, and syncope. Digestive system reactions may involve dry mouth, duodenitis, esophagitis, gastric or duodenal ulcers with bleeding and/or perforation, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice, melena, and rectal bleeding. Hemic and lymphatic system reactions include ecchymosis, eosinophilia, leukopenia, purpura, stomatitis, and thrombocytopenia. Metabolic and nutritional changes may manifest as weight changes.

Nervous system reactions can include anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, paresthesia, somnolence, tremors, and vertigo. Respiratory system reactions may involve asthma and dyspnea. Skin and appendage reactions can include alopecia, photosensitivity, and increased sweating. Special senses may be affected, leading to blurred vision. Urogenital system reactions may 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. In the body as a whole, these may include anaphylactic and anaphylactoid reactions, as well as appetite changes. Cardiovascular rare events can consist of arrhythmia, cerebrovascular accident, hypotension, myocardial infarction, palpitations, and vasculitis. Digestive system rare reactions may involve eructation, gingival ulcer, hepatorenal syndrome, liver necrosis, liver failure, and pancreatitis. Hemic and lymphatic system rare reactions include agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, neutropenia, and pancytopenia. Metabolic and nutritional rare reactions may present as hyperglycemia.

Nervous system rare reactions can include convulsions, coma, emotional liability, hallucinations, and aseptic meningitis. Respiratory rare reactions may involve apnea, respiratory depression, pneumonia, and rhinitis. Skin and appendage rare reactions can include angioedema, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson Syndrome, fixed drug eruption, urticaria, and vesiculobullous eruptions. Special senses may be affected by amblyopia, conjunctivitis, dry eyes, and hearing impairment. Urogenital rare reactions may include azotemia, decreased creatinine clearance, glomerulitis, renal papillary necrosis, and tubular necrosis.

Patients should be aware of the increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, associated with nonsteroidal anti-inflammatory drugs (NSAIDs). This risk may arise early in treatment and can escalate with prolonged use. Additionally, NSAIDs pose an increased risk of serious gastrointestinal adverse events, such as bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events may occur at any time during treatment without warning symptoms, with elderly patients being at greater risk.

Anaphylactoid reactions may occur in patients without prior exposure to ibuprofen, and it is contraindicated in patients with the aspirin triad. Emergency assistance should be sought in the event of an anaphylactoid reaction. Serious skin adverse reactions, including exfoliative dermatitis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis, which can be fatal, may occur. Ibuprofen should be discontinued at the first sign of a skin rash or any other indication of hypersensitivity.

Drug Interactions

NSAIDs, including ibuprofen, have several clinically significant interactions that warrant careful consideration and monitoring.

Antihypertensive Agents NSAIDs may diminish the antihypertensive effect of ACE inhibitors. It is essential to monitor blood pressure in patients who are concurrently using both medications to ensure effective management of hypertension.

Antiplatelet Agents Ibuprofen can interfere with the antiplatelet activity of aspirin, particularly when ibuprofen is administered prior to aspirin. This interaction may elevate the risk of cardiovascular events, and patients should be advised to take these medications at different times to mitigate this risk.

Diuretics Ibuprofen has the potential to reduce the natriuretic effect of furosemide and thiazide diuretics, which could lead to renal failure. Close monitoring of renal function is recommended for patients receiving these medications together.

Lithium The use of ibuprofen can elevate plasma lithium levels and decrease its renal clearance, thereby increasing the risk of lithium toxicity. Careful monitoring of lithium levels is advised when these drugs are used concurrently.

Methotrexate NSAIDs may competitively inhibit the accumulation of methotrexate, potentially enhancing its toxicity. Caution is recommended when these agents are used together, and monitoring for signs of methotrexate toxicity should be considered.

Anticoagulants Caution is advised when administering ibuprofen to patients on warfarin due to the increased risk of serious gastrointestinal bleeding resulting from the synergistic effects of both drugs. Regular monitoring for signs of bleeding is recommended in these patients.

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

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 significant risks, particularly when used after approximately 20 weeks of gestation. The administration of NSAIDs at about 30 weeks gestation or later can lead to premature closure of the fetal ductus arteriosus, which may have serious implications for fetal cardiovascular health. Additionally, NSAID use during this period has been linked to fetal renal dysfunction, resulting in oligohydramnios and, in some cases, neonatal renal impairment.

Healthcare professionals are advised to limit the dose and duration of ibuprofen oral suspension use between approximately 20 and 30 weeks of gestation. If NSAID treatment is deemed necessary after 20 weeks, it should be restricted to the lowest effective dose for the shortest duration possible. Monitoring with ultrasound for oligohydramnios is recommended if treatment extends beyond 48 hours. Should oligohydramnios be detected, ibuprofen oral suspension should be discontinued, and appropriate follow-up should be conducted according to clinical practice guidelines.

Data from observational studies regarding other potential embryo-fetal risks associated with NSAID use during the first and second trimesters remain inconclusive. Although reproductive studies in rats and rabbits have not shown evidence of developmental abnormalities, animal studies may not accurately predict human responses. Prostaglandins play a crucial role in various reproductive processes, and inhibition of prostaglandin synthesis by NSAIDs like ibuprofen has been associated with increased pre- and post-implantation loss and impaired kidney development in animal models.

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. However, the specific background risk associated with ibuprofen use in pregnancy is unknown. There are no adequate and 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 effects of ibuprofen on labor and delivery are not well understood, and its use is not recommended during these stages. Given the potential for serious adverse outcomes, healthcare providers should exercise caution and consider alternative therapies when managing pain or inflammation in pregnant patients.

Lactation

It is not known whether this drug is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants from ibuprofen, 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 in patients with advanced renal disease; therefore, treatment with ibuprofen is not recommended in this population. If ibuprofen therapy 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 of NSAID therapy. 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 to the lowest effective dose and shortest duration possible. Ultrasound monitoring of amniotic fluid should be considered if ibuprofen treatment extends beyond 48 hours, and ibuprofen should be discontinued if oligohydramnios occurs, with follow-up conducted according to clinical practice.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics and increased risk of adverse effects when treated with nonsteroidal anti-inflammatory drugs (NSAIDs). Long-term administration of NSAIDs has been associated with renal papillary necrosis and other forms of renal injury, particularly in individuals where renal prostaglandins play a critical role in maintaining renal perfusion. In patients with compromised liver function, the administration of an NSAID may lead to a dose-dependent reduction in prostaglandin formation, which can subsequently decrease renal blood flow and potentially precipitate overt renal decompensation.

Patients at the highest risk for these adverse reactions include those with impaired renal function, heart failure, liver dysfunction, individuals taking diuretics and ACE inhibitors, and the elderly. Therefore, it is crucial to exercise caution when considering NSAID therapy in this population.

Currently, there is no available information from controlled clinical studies regarding the use of ibuprofen in patients with advanced renal disease. Consequently, treatment with ibuprofen is not recommended for these patients. If ibuprofen therapy is deemed necessary, close monitoring of the patient's renal function is advised to mitigate potential risks. 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 contingent upon the quantity ingested and the duration since ingestion. Serious toxicity and fatalities have been documented in cases of overdose.

Symptoms of Overdosage Clinical manifestations of ibuprofen overdose may include abdominal pain, nausea, vomiting, lethargy, drowsiness, headache, tinnitus, central nervous system (CNS) depression, seizures, metabolic acidosis, coma, acute renal failure, and apnea.

Dosage Considerations Ingestion of less than 100 mg/kg of ibuprofen is generally considered unlikely to result in toxicity. However, doses between 100 to 200 mg/kg may necessitate observation. For doses ranging from 200 to 400 mg/kg, immediate gastric emptying and observation are required. In cases where ingestion exceeds 400 mg/kg, immediate medical referral is essential.

Management Recommendations Ipecac-induced emesis is contraindicated for overdoses greater than 400 mg/kg due to the heightened risk of convulsions and aspiration. The management of acute ibuprofen overdose is primarily supportive, focusing on the treatment of hypotension, acidosis, and gastrointestinal bleeding as needed.

Orally administered activated charcoal may be beneficial in reducing the absorption and reabsorption of ibuprofen if administered within one hour of ingestion. It is important to note that in adults, the history of the ingested dose does not reliably predict toxicity; therefore, symptomatic adults should undergo careful evaluation and supportive care.

Nonclinical Toxicology

Use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen oral suspension, during pregnancy has been associated with teratogenic effects, particularly when administered around 30 weeks of gestation and later. 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 instances, neonatal renal impairment. Adverse outcomes related to fetal renal dysfunction 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. In certain postmarketing cases of impaired neonatal renal function, invasive interventions such as exchange transfusion or dialysis were necessary.

Reproductive studies conducted in rats and rabbits have not indicated developmental abnormalities; however, the predictive value of animal reproduction studies for human response 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 given at clinically relevant doses.

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

The estimated background risk of major birth defects and miscarriage in the indicated population is unknown. It is acknowledged that 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 to 4% and 15 to 20%, respectively.

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. Some cases have been fatal or life-threatening. DRESS typically presents with symptoms such as fever, rash, lymphadenopathy, and/or facial swelling, and may also involve other clinical manifestations like hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis. Eosinophilia is often present, and early signs of hypersensitivity may occur even in the absence of a rash. It is advised to discontinue ibuprofen oral suspension and evaluate the patient immediately if such symptoms arise.

Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported in association with NSAID use, which can be fatal. Fixed drug eruption (FDE) may also occur, with a severe variant known as generalized bullous fixed drug eruption (GBFDE) that can be life-threatening. 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 rash or any other hypersensitivity signs. Ibuprofen is contraindicated in patients with a history of serious skin reactions to NSAIDs.

Anaphylactoid reactions have been observed in patients without prior exposure to ibuprofen. It is contraindicated in patients with the aspirin triad, which typically affects asthmatic individuals who may experience severe bronchospasm after taking aspirin or other NSAIDs.

Hypertension has been noted as a potential adverse effect of NSAIDs, including ibuprofen, which may lead to new onset or worsening of pre-existing hypertension, contributing to an increased incidence of cardiovascular events. Patients on thiazides or loop diuretics may experience impaired responses to these therapies when NSAIDs are used. Close monitoring of blood pressure is recommended during the initiation and throughout the course of NSAID therapy.

Gastrointestinal effects, including serious adverse events such as inflammation, bleeding, ulceration, and perforation of the gastrointestinal tract, have been reported. These events can occur unexpectedly and may be fatal. Approximately 1% of patients treated with NSAIDs for 3 to 6 months may experience upper GI ulcers, gross bleeding, or perforation, with risks increasing with longer treatment duration. Even short-term use carries risks.

Renal effects have been associated with long-term NSAID administration, leading to renal papillary necrosis and other forms of renal injury. Patients with compromised renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly are at greater risk. Discontinuation of NSAID therapy typically results in recovery to the pretreatment state.

Fetal toxicity has been reported with the use of NSAIDs, including ibuprofen oral suspension, which can lead to premature closure of the fetal ductus arteriosus and fetal renal dysfunction, potentially resulting in oligohydramnios and neonatal renal impairment. Due to these risks, it is recommended to limit the dose and duration of ibuprofen oral suspension use between approximately 20 and 30 weeks of gestation and to avoid its use after 30 weeks of gestation.

Patient Counseling

Patients should be advised to remain vigilant for symptoms indicative of cardiovascular thrombotic events, such as 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.

It is important to inform patients that ibuprofen, 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 be counseled 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, patients should be made aware of the symptoms of congestive heart failure, including shortness of breath, unexplained weight gain, or edema, and should be instructed to contact their healthcare provider if such symptoms occur.

It is essential to inform patients 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.

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

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

Storage and Handling

The product is supplied in a well-closed container as defined by the United States Pharmacopeia (USP). It is essential to shake well before use to ensure proper mixing of the contents.

For optimal storage, the product should be maintained at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines. Proper adherence to these storage conditions is crucial for maintaining the integrity and efficacy of the product.

Additional Clinical Information

Clinicians are advised to monitor patients for any signs or symptoms indicative of gastrointestinal (GI) bleeding during treatment. For patients undergoing long-term therapy with nonsteroidal anti-inflammatory drugs (NSAIDs), it is recommended that complete blood counts (CBC) and chemistry profiles be assessed periodically to ensure safety and efficacy.

In cases where patients exhibit clinical signs and symptoms suggestive of liver or renal disease, or if systemic manifestations such as eosinophilia or rash occur, ibuprofen should be discontinued. Additionally, if abnormal liver function tests persist or worsen, immediate cessation of the medication is warranted.

FDA Insert (PDF)

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

View full prescribing information (PDF)