Ibuprofen

Description

Ibuprofen tablets contain the active ingredient ibuprofen, which is (±)-2-(p-isobutylphenyl) propionic acid. Ibuprofen appears as a white powder with a melting point of 74-77° C. It is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. Ibuprofen is available in 400 mg, 600 mg, and 800 mg tablets for oral administration. The inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, hypromellose 2910, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, povidone k-90, sodium lauryl sulphate, and titanium dioxide.

Uses and Indications

Ibuprofen tablets are indicated for the relief of the signs and symptoms associated with rheumatoid arthritis and osteoarthritis. Additionally, these tablets are indicated for the relief of mild to moderate pain and for the treatment of primary dysmenorrhea.

Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in pediatric populations have not been conducted. Therefore, healthcare professionals should exercise caution when considering the use of ibuprofen in children.

Dosage and Administration

Healthcare professionals should carefully consider the potential benefits and risks of ibuprofen tablets and 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 with ibuprofen tablets, the dose and frequency should be adjusted to meet the specific needs of the patient. The total daily dose should not exceed 3200 mg. In cases where gastrointestinal complaints arise, ibuprofen tablets should be administered with meals or milk to mitigate these effects.

For the management of rheumatoid arthritis and osteoarthritis, including flare-ups of chronic disease, the suggested dosage ranges from 1200 mg to 3200 mg daily. This can be achieved through various dosing regimens, such as 300 mg four times a day, or 400 mg, 600 mg, or 800 mg three to four times a day. The dosage should be tailored to each patient, with adjustments made based on the severity of symptoms at the initiation of therapy or in response to treatment. It is noted that patients with rheumatoid arthritis may require higher doses compared to those with osteoarthritis.

In chronic conditions, a therapeutic response to ibuprofen tablets may be observed within a few days to a week, but is most commonly seen by two weeks. Once a satisfactory response is achieved, the patient's dosage should be reviewed and adjusted as necessary.

For the treatment of mild to moderate pain, ibuprofen tablets may be administered at a dose of 400 mg every 4 to 6 hours as needed for pain relief. In the case of dysmenorrhea, treatment should commence at the earliest onset of pain, with ibuprofen tablets given at a dose of 400 mg every 4 hours as necessary for relief. The smallest effective dose that provides acceptable control should always be employed.

Contraindications

Ibuprofen tablets are contraindicated in patients with known hypersensitivity to ibuprofen. They 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 tablets 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

Non-steroidal anti-inflammatory drugs (NSAIDs), including Ibuprofen Tablets, 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. Ibuprofen Tablets are contraindicated in patients undergoing coronary artery bypass graft (CABG) surgery.

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

Patients with known cardiovascular disease or risk factors are at a higher absolute incidence of serious cardiovascular thrombotic events. Therefore, the use of Ibuprofen Tablets should be avoided in patients with a recent myocardial infarction unless the anticipated benefits outweigh the risks of recurrent cardiovascular thrombotic events. Continuous monitoring for signs of cardiac ischemia is recommended in these patients.

NSAIDs can also induce new hypertension or exacerbate preexisting hypertension. Blood pressure should be closely monitored during the initiation of NSAID therapy and throughout the treatment duration. Additionally, the use of Ibuprofen Tablets in patients with severe heart failure should be approached with caution, as the benefits must outweigh the risks of worsening heart failure. Patients should be monitored for signs of deteriorating heart failure.

Serious skin adverse events, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), may occur without prior warning. Discontinuation of Ibuprofen Tablets is advised at the first sign of a skin rash or any other indication of hypersensitivity. Anaphylactoid reactions can occur in patients without previous exposure to ibuprofen; therefore, emergency medical assistance should be sought immediately if such a reaction occurs. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has also been reported in NSAID users. If any signs or symptoms of DRESS are observed, ibuprofen tablets should be discontinued, and the patient should be evaluated promptly.

The use of NSAIDs in pregnant women, particularly those at approximately 30 weeks gestation and later, should be avoided due to the risk of premature closure of the fetal ductus arteriosus.

Ibuprofen Tablets are not a substitute for corticosteroids and should not be used to treat corticosteroid insufficiency. For patients on prolonged corticosteroid therapy, a gradual tapering of corticosteroids is recommended if discontinuation is decided.

Patients undergoing long-term NSAID treatment should have their hemoglobin or hematocrit levels monitored if they exhibit any signs or symptoms of anemia. Additionally, those receiving ibuprofen tablets who may be affected by changes in platelet function should be closely monitored.

Physicians should remain vigilant for signs or symptoms of gastrointestinal bleeding in patients on long-term NSAID therapy. Regular monitoring of complete blood count (CBC) and chemistry profiles is advised for these patients. If clinical signs or symptoms indicative of liver or renal disease develop, ibuprofen tablets should be discontinued.

Emergency medical help should be sought in cases of anaphylactoid reactions. Patients should also discontinue ibuprofen tablets if they experience clinical signs and symptoms consistent with liver disease or if systemic manifestations such as eosinophilia or rash occur. In the event of oligohydramnios, ibuprofen tablets should be stopped, and follow-up should be conducted according to clinical practice guidelines.

Side Effects

Patients receiving non-steroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, may experience a range of adverse reactions. Serious adverse reactions include cardiovascular thrombotic events, such as myocardial infarction and stroke, which can be fatal. These events may occur early in treatment and the risk may increase with prolonged use. Additionally, NSAIDs are associated with serious gastrointestinal risks, including bleeding, ulceration, and perforation of the stomach or intestines, which can also be fatal. Elderly patients are particularly at greater risk for these gastrointestinal events.

Common gastrointestinal adverse reactions reported in clinical trials include nausea, epigastric pain, heartburn, diarrhea, and abdominal distress, with some patients experiencing nausea and vomiting, indigestion, constipation, and abdominal cramps or pain. Serious gastrointestinal complications such as gastric or duodenal ulcers with bleeding or perforation, gastrointestinal hemorrhage, and pancreatitis have also been noted.

Central nervous system reactions may include dizziness, headache, and nervousness, with more serious effects such as depression, insomnia, confusion, emotional liability, and somnolence reported. Rarely, aseptic meningitis with fever and coma, as well as hallucinations and pseudo-tumor cerebri, have been observed.

Dermatologic reactions can range from mild rashes and pruritus to severe conditions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and photoallergic skin reactions. Hematologic adverse reactions include neutropenia, agranulocytosis, aplastic anemia, and thrombocytopenia, with bleeding episodes such as epistaxis and menorrhagia also reported.

Metabolic and endocrine effects may manifest as decreased appetite, gynecomastia, hypoglycemic reactions, and acidosis. Cardiovascular effects include edema and fluid retention, which generally respond promptly to drug discontinuation, as well as congestive heart failure in patients with marginal cardiac function, elevated blood pressure, and arrhythmias.

Allergic reactions can present as anaphylaxis, bronchospasm, serum sickness, and angioedema. Renal adverse reactions include acute renal failure, decreased creatinine clearance, and renal papillary necrosis. Miscellaneous reactions such as dry eyes and mouth, gingival ulcer, and rhinitis have also been reported.

In clinical trials, the incidence of reported side effects was higher at doses of 3200 mg/day compared to doses of 2400 mg or less, although the increases were slight and remained within the ranges reported. Adverse reactions occurring in 3% to 9% of patients treated with ibuprofen are marked with an asterisk, while those occurring in less than 3% are unmarked.

It is important to note that anaphylactoid reactions may occur in patients without prior exposure to ibuprofen. Long-term administration of NSAIDs has been associated with renal toxicity, and the use of these medications during pregnancy may lead to fetal toxicity, including premature closure of the fetal ductus arteriosus and renal dysfunction.

Drug Interactions

The co-administration of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, with various medications may lead to significant drug interactions that warrant careful consideration.

Antihypertensive Agents NSAIDs may diminish the antihypertensive effect of angiotensin-converting enzyme (ACE) inhibitors. Clinicians should monitor blood pressure closely and consider dosage adjustments of the antihypertensive medication as necessary.

Antiplatelet Agents Ibuprofen can interfere with the antiplatelet activity of aspirin, particularly when ibuprofen is administered prior to aspirin. This interaction may increase the risk of cardiovascular events; therefore, alternative analgesics should be considered in patients requiring antiplatelet therapy.

Diuretics The use of ibuprofen may reduce the natriuretic effect of furosemide and thiazide diuretics. Close monitoring for renal function is advised, as this interaction may lead to renal failure.

Lithium Ibuprofen has been shown to elevate plasma lithium levels and reduce its renal clearance, thereby increasing the risk of lithium toxicity. Regular monitoring of lithium levels is recommended for patients receiving this combination.

Methotrexate NSAIDs may enhance the toxicity of methotrexate. Caution is advised when these agents are used concurrently, and monitoring for signs of toxicity should be implemented.

Anticoagulants Co-administration of ibuprofen with warfarin-type anticoagulants may increase the risk of serious gastrointestinal bleeding. Clinicians should assess the need for additional monitoring of coagulation parameters and consider alternative pain management strategies.

H2-Receptor Antagonists The co-administration of cimetidine or ranitidine with ibuprofen does not significantly affect ibuprofen serum concentrations, indicating that no dosage adjustments are necessary for ibuprofen in this context.

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 tablets in pediatric patients have not been established. Therefore, caution should be exercised when considering the use of ibuprofen in this population. Further studies are needed to determine appropriate dosing and outcomes in children.

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 tablets, 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 is a critical vessel for fetal circulation. Additionally, NSAID use during this period has been linked to fetal renal dysfunction, resulting in oligohydramnios and, in some instances, neonatal renal impairment.

Healthcare professionals are advised to limit the dose and duration of ibuprofen tablets 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. Should treatment with ibuprofen tablets extend beyond 48 hours, monitoring for oligohydramnios via ultrasound is recommended. In cases where oligohydramnios is detected, ibuprofen tablets should be discontinued, and follow-up should be conducted according to clinical practice guidelines.

Data from observational studies regarding the risks of NSAID use during the first and second trimesters remain inconclusive. In the general U.S. population, the background rate for major malformations in clinically recognized pregnancies is 2-4%, with a pregnancy loss rate of 15-20%, regardless of drug exposure. Animal studies have not shown evidence of developmental abnormalities; however, these studies are not always predictive of human outcomes. 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.

Furthermore, animal data indicate that prostaglandins play a crucial role in endometrial vascular permeability, blastocyst implantation, and decidualization. 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.

Published literature indicates that adverse outcomes, such as fetal renal dysfunction leading to oligohydramnios, may occur after days to weeks of NSAID treatment, although oligohydramnios has been reported as early as 48 hours post-initiation. While many cases of decreased amniotic fluid were transient and reversible upon cessation of the drug, there have been reports of irreversible neonatal renal dysfunction requiring invasive interventions.

Due to methodological limitations in postmarketing studies, including the absence of control groups and limited data on dosage and timing, establishing a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal NSAID use remains challenging. The generalizability of reported risks to full-term infants exposed to NSAIDs through maternal use is also uncertain, as most safety data pertain to preterm infants.

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 tablets, 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 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 may lead to a dose-dependent reduction in prostaglandin formation, which can subsequently decrease renal blood flow and 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. In cases where NSAID therapy is initiated, close monitoring of renal function is advisable. 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 tablets in patients with advanced renal disease; therefore, treatment with ibuprofen tablets is not recommended in this population. If ibuprofen tablet therapy is deemed necessary, it should be approached with caution, and renal function should be closely monitored.

Additionally, the use of NSAIDs, including ibuprofen tablets, 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 may occur after days to weeks of treatment, although oligohydramnios has been infrequently reported as early as 48 hours after initiation. If NSAID treatment is required between 20 and 30 weeks of gestation, it is recommended to limit ibuprofen tablets to the lowest effective dose and shortest duration possible. Ultrasound monitoring of amniotic fluid should be considered if treatment extends beyond 48 hours, and ibuprofen tablets should be discontinued if oligohydramnios occurs, with follow-up according to clinical practice.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics and increased risk of adverse effects when treated with 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 tablets in patients with advanced renal disease. Consequently, treatment with ibuprofen tablets is not recommended for patients with advanced renal disease. If therapy with ibuprofen tablets is deemed necessary, close monitoring of 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 patient management.

Overdosage

In cases of ibuprofen overdosage, clinical manifestations can vary significantly based on the amount ingested and the timing of intervention.

A notable case involved a 19-month-old child who ingested between 7 to 10 ibuprofen tablets (400 mg). This child presented with apneic and cyanotic symptoms, necessitating oxygen supplementation and intravenous fluids. Blood analysis conducted approximately 8½ hours post-ingestion revealed a serum ibuprofen concentration of 102.9 mcg/mL.

Conversely, in two separate instances, children weighing around 10 kg ingested approximately 120 mg/kg of ibuprofen without exhibiting acute intoxication symptoms. Notably, one of these children had a blood level of 700 mcg/mL measured 90 minutes after ingestion, indicating that significant variability in response can occur.

In an adult case, a 19-year-old male consumed 8,000 mg of ibuprofen over several hours. He experienced dizziness but ultimately recovered following parenteral hydration and three days of bed rest, highlighting the importance of supportive care in managing overdose situations.

For the management of acute ibuprofen overdosage, it is critical to initiate decontamination measures promptly. If the ingestion occurred within the last hour, the stomach should be emptied through vomiting or gastric lavage, as little drug will likely be recovered after this timeframe. The administration of oral activated charcoal may also be beneficial in reducing further absorption of the drug.

Given the acidic nature of ibuprofen, administering alkali and inducing diuresis may enhance urinary excretion of the drug. Continuous monitoring for signs of toxicity is essential, and supportive measures should be implemented as needed to ensure patient safety and recovery.

Nonclinical Toxicology

Use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen tablets, during pregnancy, particularly after approximately 20 weeks of gestation, has been associated with an increased risk of fetal renal dysfunction, which may lead to oligohydramnios and, in some instances, neonatal renal impairment. Furthermore, administration of NSAIDs around 30 weeks gestation or later may elevate the risk of premature closure of the fetal ductus arteriosus. Observational studies regarding other potential embryo-fetal risks associated with NSAID use during the first or second trimesters of pregnancy have yielded inconclusive results.

In animal reproductive studies conducted in rats and rabbits, no evidence of developmental abnormalities was observed. However, it is important to note that animal reproduction studies do not always predict human responses. Data suggest that prostaglandins play a crucial role in fetal kidney development, and the use of prostaglandin synthesis inhibitors, such as ibuprofen, has been linked to increased pre- and post-implantation loss in animal studies.

Oligohydramnios, while often reversible upon discontinuation of treatment, can lead to complications such as limb contractures and delayed lung maturation if prolonged. In certain postmarketing cases of impaired neonatal renal function, invasive interventions, including exchange transfusion or dialysis, were necessary.

No controlled clinical study data are available regarding the use of ibuprofen tablets in patients with advanced renal disease. Consequently, the use of ibuprofen tablets is not recommended for patients with advanced renal disease.

In animal studies, the administration of prostaglandin synthesis inhibitors, including ibuprofen, has been shown to impair kidney development when given at clinically relevant doses, further underscoring the importance of prostaglandins in this developmental process.

Postmarketing Experience

Postmarketing experience has identified several adverse events associated with the use of ibuprofen tablets, 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 resulted in fatal or life-threatening outcomes. DRESS typically presents with symptoms such as fever, rash, lymphadenopathy, and/or facial swelling, but may also involve other clinical manifestations like 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. Immediate discontinuation of ibuprofen tablets is advised if such symptoms arise.

Anaphylactoid reactions have been reported in patients without prior exposure to ibuprofen tablets. The use of ibuprofen is contraindicated in patients with the aspirin triad, a symptom complex that may occur in asthmatic individuals who experience severe bronchospasm or rhinitis after taking aspirin or other 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 events can occur unexpectedly, and patients should be educated on the signs and symptoms of serious skin reactions, with immediate discontinuation of the drug recommended upon the appearance of any rash or hypersensitivity signs.

Long-term use of NSAIDs has been associated with renal papillary necrosis and other forms of renal injury. Renal toxicity may occur in patients who rely on renal prostaglandins for maintaining renal perfusion, leading to a dose-dependent reduction in prostaglandin formation and subsequent renal blood flow. Patients at higher risk include those with impaired renal function, heart failure, liver dysfunction, those on diuretics and ACE inhibitors, and the elderly. Typically, discontinuation of NSAID therapy results in recovery to the pretreatment state.

Observational studies from the Danish National Registry indicate that patients treated with NSAIDs in the post-myocardial infarction (MI) period face an increased risk of reinfarction, cardiovascular-related death, and all-cause mortality, beginning within the first week of treatment. The incidence of death in NSAID-treated patients during the first year post-MI was reported at 20 per 100 person-years, compared to 12 per 100 person-years in non-NSAID exposed patients. Although the absolute mortality rate decreased after the first year, the relative risk of death in NSAID users remained elevated for at least four years of follow-up.

The use of NSAIDs, including ibuprofen tablets, has been linked to premature closure of the fetal ductus arteriosus and fetal renal dysfunction, potentially leading to oligohydramnios and, in some instances, neonatal renal impairment. Studies and postmarketing reports indicate that maternal NSAID use around 20 weeks gestation or later is associated with these adverse outcomes, typically manifesting after days to weeks of treatment. Oligohydramnios has been infrequently reported as early as 48 hours after initiation of NSAID therapy. While many cases of decreased amniotic fluid were transient and reversible upon cessation of the drug, there have been limited reports of irreversible neonatal renal dysfunction, with some cases necessitating invasive treatments such as exchange transfusion or dialysis.

Patient Counseling

Patients should be informed of the symptoms associated with cardiovascular thrombotic events, which include chest pain, shortness of breath, weakness, or slurring of speech. They should be advised to report any of these symptoms to their healthcare provider immediately.

It is important for patients to understand that ibuprofen tablets may lead to serious cardiovascular side effects, such as myocardial infarction (MI) or stroke, potentially resulting in hospitalization or death. Patients should remain vigilant for signs and symptoms of these events and seek medical advice if they experience any indicative signs.

Patients should also be made aware that ibuprofen tablets can cause gastrointestinal discomfort and, in rare cases, serious gastrointestinal side effects, including ulcers and bleeding, which may necessitate hospitalization or could be fatal. They should be instructed to recognize signs and symptoms of ulcerations and bleeding, such as epigastric pain, dyspepsia, melena, and hematemesis, and to contact their healthcare provider if they observe any of these symptoms.

Healthcare providers should advise patients to discontinue ibuprofen tablets immediately if they develop any type of rash or fever and to reach out to their healthcare provider as soon as possible.

Patients should be alert for 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.

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

Additionally, patients should be educated on 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 instructed to seek immediate emergency help.

Pregnant women should be advised to avoid the use of ibuprofen tablets and other NSAIDs starting at 30 weeks gestation due to the risk of premature closure of the fetal ductus arteriosus. If treatment with ibuprofen tablets is necessary for a pregnant woman between approximately 20 to 30 weeks 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 various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20º to 25ºC (68º to 77ºF), in accordance with USP Controlled Room Temperature guidelines. Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40ºC (104ºF). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

Clinicians should be vigilant in monitoring patients for signs or symptoms of gastrointestinal (GI) bleeding, as there is a risk of serious GI tract ulcerations and bleeding associated with the use of ibuprofen. For patients undergoing long-term treatment with nonsteroidal anti-inflammatory drugs (NSAIDs), it is recommended that complete blood counts (CBC) and chemistry profiles be checked periodically to assess for potential adverse effects.

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

FDA Insert (PDF)

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

View full prescribing information (PDF)