Ibuprofen

Description

Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is chemically defined as (±)-2-(p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point ranging from 74° to 77°C. It exhibits very slight solubility in water, with a solubility of less than 1 mg/mL, but is readily soluble in organic solvents such as ethanol and acetone.

These tablets are classified as a nonsteroidal anti-inflammatory drug (NSAID) and are available in dosages of 400 mg, 600 mg, and 800 mg for oral administration. The inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, stearic acid, 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.

Limitations of Use: Controlled clinical trials to establish the safety and effectiveness of Ibuprofen Tablets in pediatric patients have not been conducted. Therefore, the use of this medication in children is not recommended.

Dosage and Administration

For the management of rheumatoid arthritis and osteoarthritis, including flare-ups of chronic disease, the recommended dosage of ibuprofen is between 1200 mg to 3200 mg daily, administered as 400 mg, 600 mg, or 800 mg three to four times a day (tid or qid). Individual patient responses may vary, with some patients demonstrating a more favorable response to a total daily dose of 3200 mg compared to 2400 mg.

In cases of mild to moderate pain, ibuprofen may be administered at a dosage of 400 mg every 4 to 6 hours as needed for pain relief. For the treatment of dysmenorrhea, it is advised to initiate treatment at the earliest onset of pain, with ibuprofen tablets given at a dose of 400 mg every 4 hours as necessary for relief.

It is critical not to exceed a total daily dose of 3200 mg. In instances where gastrointestinal complaints arise, ibuprofen tablets should be taken with meals or milk to mitigate discomfort.

Dosing adjustments should be made based on the patient's response to initial therapy. The dosage and frequency may be tailored to meet the individual needs of each patient, allowing for increases or decreases in dosage depending on the severity of symptoms.

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 other allergic-type reactions following the use of aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs). Additionally, the use of ibuprofen tablets is contraindicated in the context of coronary artery bypass graft (CABG) surgery.

Patients with asthma may have aspirin-sensitive asthma; therefore, ibuprofen tablets should not be given to those with this specific form of aspirin sensitivity.

Warnings and Precautions

Nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen tablets, are associated with significant risks that healthcare professionals must consider when prescribing and monitoring treatment.

Cardiovascular Risks NSAIDs are linked to an increased risk of serious cardiovascular thrombotic events, such as myocardial infarction and stroke, which can be fatal. This risk may manifest early in treatment and is likely to escalate with prolonged use. It is crucial to avoid the use of ibuprofen tablets in patients undergoing coronary artery bypass graft (CABG) surgery due to contraindications.

Gastrointestinal Adverse Events The use of NSAIDs can lead to severe gastrointestinal complications, including bleeding, ulceration, and perforation of the stomach or intestines, which may be fatal. These events can occur at any time during treatment, often without warning symptoms. Elderly patients are particularly vulnerable to these serious gastrointestinal events and should be monitored closely.

Hypersensitivity Reactions Anaphylactoid reactions may occur in patients who have not previously been exposed to ibuprofen tablets. In such cases, immediate emergency medical assistance should be sought. Additionally, serious skin reactions, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported. Patients should discontinue ibuprofen tablets at the first sign of a skin rash or any indication of hypersensitivity.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) DRESS has been documented in patients taking NSAIDs, including ibuprofen tablets. If any signs or symptoms indicative of DRESS arise, the use of ibuprofen tablets should be discontinued, and the patient should be evaluated promptly.

Pregnancy Considerations The use of NSAIDs, including ibuprofen tablets, is contraindicated in pregnant women at approximately 30 weeks of gestation and later due to the risk of premature closure of the fetal ductus arteriosus.

General Precautions Patients undergoing prolonged corticosteroid therapy should have their medication tapered gradually if discontinuation is necessary. For those on long-term NSAID treatment, including ibuprofen tablets, it is recommended to monitor hemoglobin or hematocrit levels if any signs or symptoms of anemia are present. Additionally, patients who may be adversely affected by changes in platelet function should be closely monitored.

Laboratory Monitoring Healthcare providers should routinely monitor for signs or symptoms of gastrointestinal bleeding in patients receiving long-term NSAID therapy. Periodic checks of complete blood count (CBC) and chemistry profiles are advised for these patients. If any clinical signs or symptoms consistent with liver or renal disease develop, ibuprofen tablets should be discontinued immediately.

Emergency Medical Help Patients should be instructed to seek immediate emergency assistance if they experience signs of an anaphylactoid reaction, such as difficulty breathing or swelling of the face or throat.

Discontinuation and Reporting Symptoms Patients must be advised to stop taking ibuprofen tablets immediately if they develop any rash or fever and to contact their healthcare provider without delay. They should also be informed about the warning signs of hepatotoxicity, including nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and flu-like symptoms. If these symptoms occur, patients should discontinue therapy and seek immediate medical attention.

Side Effects

Patients may experience a range of adverse reactions while using this medication, which can be categorized by incidence and seriousness.

Serious adverse reactions include cardiovascular thrombotic events, such as myocardial infarction and stroke, which can be fatal. The risk of these events may increase early in treatment and with prolonged use. Additionally, there is a significant risk of serious gastrointestinal adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can also be fatal. These gastrointestinal events can occur at any time during treatment and may present without warning symptoms. Elderly patients are particularly at greater risk for these serious gastrointestinal complications.

Common adverse reactions, occurring in greater than 1% but less than 3% of patients, include gastrointestinal symptoms such as nausea, epigastric pain, heartburn, diarrhea, abdominal distress, and constipation. Central nervous system effects may manifest as dizziness, headache, and nervousness. Dermatologic reactions may include rash (including maculopapular types) and pruritus. Other common reactions involve the special senses, such as tinnitus, and metabolic/endocrine issues like decreased appetite. Cardiovascular reactions may present as edema and fluid retention, which generally respond promptly to discontinuation of the drug.

Adverse reactions with a precise incidence unknown but occurring in less than 1% of patients include serious gastrointestinal conditions such as gastric or duodenal ulcers with bleeding and/or perforation, gastrointestinal hemorrhage, and pancreatitis. Central nervous system effects may include depression, insomnia, confusion, emotional liability, and aseptic meningitis with fever and coma. Dermatologic reactions may involve vesiculobullous eruptions, urticaria, erythema multiforme, and alopecia. Hematologic reactions can include neutropenia, agranulocytosis, aplastic anemia, and thrombocytopenia. Cardiovascular issues may consist of congestive heart failure in patients with marginal cardiac function, elevated blood pressure, and palpitations. Renal adverse reactions may include acute renal failure and decreased creatinine clearance.

There are also adverse reactions with an unknown causal relationship, including central nervous system effects such as paresthesias, hallucinations, and dream abnormalities. Dermatologic reactions may involve toxic epidermal necrolysis and photoallergic skin reactions. Cardiovascular issues may include arrhythmias, while hematologic reactions can present as bleeding episodes. Metabolic/endocrine reactions may include gynecomastia and hypoglycemic reactions.

Post-marketing experience has revealed additional skin and appendage reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and fixed drug eruption.

Patients should be monitored for these adverse reactions, and any serious symptoms should prompt immediate medical attention.

Drug Interactions

Concomitant use of certain medications with ibuprofen may lead to significant drug interactions, which can affect therapeutic outcomes and patient safety. 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 Pharmacodynamic studies indicate that ibuprofen can interfere with the antiplatelet activity of aspirin, particularly when ibuprofen is administered shortly before aspirin. This interaction is noted with both enteric-coated and immediate-release 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. Given the potential for increased cardiovascular events due to this interaction, alternative analgesics that do not affect aspirin's antiplatelet effect should be considered for patients using low-dose aspirin for cardioprotection.

Warfarin-Type Anticoagulants While short-term studies have not shown significant effects of ibuprofen on prothrombin times in patients taking coumarin-type anticoagulants, there is a documented risk of increased bleeding. Therefore, caution is warranted when ibuprofen is prescribed to patients on anticoagulants, as the combined use may elevate the risk of serious gastrointestinal bleeding.

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 Concomitant administration of ibuprofen has been shown to elevate plasma lithium levels and decrease 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 medications are used together.

Methotrexate NSAIDs, including ibuprofen, may competitively inhibit the accumulation of methotrexate, potentially enhancing its toxicity. Caution is advised when administering NSAIDs alongside methotrexate.

Other Interactions

H-2 Antagonists Studies involving cimetidine or ranitidine co-administered with ibuprofen have shown no significant impact on ibuprofen serum concentrations, indicating that these H-2 antagonists do not alter the pharmacokinetics of ibuprofen.

In summary, careful consideration and monitoring are essential when ibuprofen is used in conjunction with the aforementioned drug classes to mitigate potential adverse effects and ensure therapeutic efficacy.

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 tablets in pediatric patients have not been established. Therefore, healthcare professionals should exercise caution 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 in the later stages of gestation. Administration of NSAIDs around 30 weeks of gestation or later can lead to premature closure of the fetal ductus arteriosus, which is a critical vessel for fetal circulation. Additionally, the use of NSAIDs from approximately 20 weeks of gestation onward has been linked to fetal renal dysfunction, resulting in oligohydramnios and, in some instances, neonatal renal impairment.

Due to these potential risks, it is recommended that the use of ibuprofen tablets be limited in dose and duration between approximately 20 and 30 weeks of gestation, and avoided entirely after 30 weeks. 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 extend beyond 48 hours, monitoring with ultrasound for oligohydramnios is advised. In cases where oligohydramnios is detected, discontinuation of ibuprofen tablets should be considered, followed by appropriate clinical follow-up.

While observational studies have provided inconclusive data regarding other embryofetal risks associated with NSAID use during the first and second trimesters, animal studies have indicated that prostaglandins play a crucial role in various reproductive processes, including fetal kidney development. In these 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.

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, there are no adequate, well-controlled studies in pregnant women to establish a definitive risk profile for ibuprofen tablets. Therefore, the use of ibuprofen during pregnancy should only occur if the potential benefits outweigh the risks to the fetus.

Published literature has documented cases of maternal NSAID use leading to neonatal renal dysfunction, with some instances requiring invasive interventions such as dialysis. The methodological limitations of existing studies, including the absence of control groups and variability in drug exposure, hinder the ability to accurately assess the risk of adverse fetal and neonatal outcomes. Furthermore, the effects of ibuprofen tablets on labor and delivery remain unknown, and caution is warranted when considering NSAID use 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 tablets, lactating mothers should consider the importance of the drug to their health when making a decision to either discontinue breastfeeding 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 effects 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 NSAID treatment is deemed necessary during pregnancy, particularly between 20 and 30 weeks gestation, it is important to limit the use of 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 administered 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 use of NSAIDs 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, careful monitoring of renal function is recommended in patients with hepatic impairment who are prescribed NSAIDs. Should any signs of renal toxicity arise, discontinuation of NSAID therapy is typically followed by recovery to the pretreatment state. It is essential for healthcare providers to assess liver function and consider the potential need for dosage adjustments or alternative therapies in this patient population.

Overdosage

Approximately 1½ hours following the ingestion of 7 to 10 ibuprofen tablets (400 mg) by a 19-month-old child weighing 12 kg, the patient presented to the hospital emergency room in a state of apnea and cyanosis, responding only to painful stimuli. This stimulus was sufficient to induce respiration. Upon admission, the child received oxygen and parenteral fluids, and a greenish-yellow fluid was aspirated from the stomach, revealing no evidence of ibuprofen. Two hours post-ingestion, the child's condition appeared stable; however, she continued to respond solely to painful stimuli and experienced intermittent apnea lasting 5 to 10 seconds. The patient was subsequently admitted to intensive care, where sodium bicarbonate, along with infusions of dextrose and normal saline, was administered. By four hours after ingestion, the child could be easily aroused, sit independently, and respond to verbal commands. A blood level of ibuprofen measured 102.9 mcg/mL approximately 8½ hours post-ingestion. By the 12-hour mark, the child appeared to have fully recovered. In two additional reported cases involving children weighing approximately 10 kg who accidentally ingested approximately 120 mg/kg of ibuprofen, no signs of acute intoxication or late sequelae were observed. Notably, one child's blood level was recorded at 700 mcg/mL 90 minutes after ingestion, approximately ten times the peak levels noted in absorption-excretion studies.

In another case, a 19-year-old male ingested 8,000 mg of ibuprofen over several hours and subsequently reported dizziness, with nystagmus observed during examination. Following hospitalization, the patient received parenteral hydration and underwent three days of bed rest, ultimately recovering without any reported sequelae.

In instances of acute ibuprofen overdosage, it is recommended that the stomach be emptied through vomiting or gastric lavage; however, it should be noted that minimal drug recovery is likely if more than one hour has passed since ingestion. Given the acidic nature of ibuprofen and its urinary excretion, administering alkali and inducing diuresis may be theoretically beneficial. Supportive measures should be implemented, and the use of oral activated charcoal may assist in reducing both the absorption and reabsorption of ibuprofen tablets.

Nonclinical Toxicology

Teratogenic effects associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen tablets, have been observed in pregnant women, particularly around 30 weeks of gestation and later. The use of these medications during this period increases the risk of premature closure of the fetal ductus arteriosus. Additionally, NSAID use from approximately 20 weeks gestation onward may lead to fetal renal dysfunction, resulting in oligohydramnios and, in some instances, neonatal renal impairment. These adverse effects can 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 may be reversible upon discontinuation of treatment, prolonged cases can lead to complications such as limb contractures and delayed lung maturation. In certain postmarketing reports of impaired neonatal renal function, invasive interventions like exchange transfusion or dialysis were necessary.

When NSAID treatment is deemed necessary between 20 and 30 weeks of gestation, it is recommended to limit the use of ibuprofen tablets to the lowest effective dose for the shortest duration possible. Ultrasound monitoring of amniotic fluid is advised if treatment extends beyond 48 hours, and ibuprofen tablets should be discontinued if oligohydramnios occurs, with appropriate follow-up according to clinical practice.

Non-teratogenic effects have been evaluated in reproductive studies conducted in rats and rabbits, which did not reveal evidence of developmental abnormalities. However, it is important to note that animal reproduction studies may not always predict human responses. Prostaglandins play a crucial role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, the administration of prostaglandin synthesis inhibitors, such as ibuprofen, has been associated with 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.

Data from observational studies regarding potential embryofetal risks associated with NSAID use during the first or second trimesters of pregnancy remain inconclusive. 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 between 2% to 4% and 15% to 20%, respectively.

Postmarketing Experience

Postmarketing experience has identified several adverse events associated with the use of ibuprofen tablets, reported voluntarily or through surveillance programs.

Anaphylactoid reactions may occur in patients without prior exposure to ibuprofen, necessitating immediate medical attention in such cases. Serious skin adverse events, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported, with the potential for fatal outcomes. These events may arise unexpectedly.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has also been documented in patients using NSAIDs, including ibuprofen, with some cases resulting in fatalities or life-threatening conditions. Additionally, the use of NSAIDs, such as ibuprofen, around 30 weeks of gestation or later has been linked to premature closure of the fetal ductus arteriosus. Furthermore, administration of NSAIDs at approximately 20 weeks of gestation or later may lead to fetal renal dysfunction, resulting in oligohydramnios and, in certain instances, neonatal renal impairment. In cases of impaired neonatal renal function, invasive interventions like exchange transfusion or dialysis have been necessary.

In clinical studies, a higher incidence of decreased hemoglobin levels was observed than previously reported, with a decrease of 1 gram or more noted in 17.1% of patients taking 1600 mg of ibuprofen daily and in 22.8% of those on 2400 mg daily. Positive stool occult blood tests and elevated serum creatinine levels were also recorded in these studies.

Serious gastrointestinal (GI) adverse events, including inflammation, bleeding, ulceration, and perforation of the gastrointestinal tract, have been reported and can occur at any time, with or without warning symptoms. The risk of serious GI events is heightened with prolonged NSAID therapy, although even short-term use carries risks.

Reports indicate that NSAIDs may reduce the antihypertensive effects of ACE inhibitors. Clinical studies and postmarketing observations have shown that ibuprofen can diminish the natriuretic effect of furosemide and thiazides in some patients. Additionally, ibuprofen has been associated with elevated plasma lithium levels and reduced renal clearance of lithium in studies involving normal volunteers. While several short-term controlled studies did not demonstrate significant effects of ibuprofen on prothrombin times or other clotting factors in individuals on coumarin-type anticoagulants, instances of bleeding have been reported when ibuprofen and other NSAIDs were administered concurrently with anticoagulants.

Patient Counseling

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

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

It is important to inform patients that ibuprofen tablets, 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 and 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, including epigastric pain, dyspepsia, melena, and hematemesis. Patients should be apprised of the importance of seeking medical advice upon observing any indicative signs or symptoms.

Patients should be advised to stop taking ibuprofen tablets immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible. Additionally, patients should be alert for symptoms of congestive heart failure, including shortness of breath, unexplained weight gain, or edema, and should contact their healthcare provider if such symptoms occur.

Healthcare providers should inform patients of the warning signs and symptoms of hepatotoxicity, such as 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.

Patients should also be informed of the signs of an anaphylactoid reaction, including difficulty breathing and swelling of the face or throat. If these symptoms occur, 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 closing 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 a tight, light-resistant container as defined by the United States Pharmacopeia (USP). It should be stored at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines. Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F).

Additional Clinical Information

Physicians are advised to monitor patients for signs or symptoms of gastrointestinal (GI) bleeding, particularly in those undergoing long-term treatment with NSAIDs, who should have their complete blood count (CBC) and chemistry profile checked periodically. If patients exhibit clinical signs consistent with liver or renal disease, or if systemic manifestations such as eosinophilia or rash occur, ibuprofen tablets should be discontinued, especially if abnormal liver tests persist or worsen.

Patients should be counseled to remain vigilant for symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report these immediately to their healthcare provider. They should also be aware of signs of ulcerations and bleeding, such as epigastric pain, dyspepsia, melena, and hematemesis, and seek medical advice if these occur. Additionally, patients must stop taking ibuprofen if they develop any rash or fever and contact their healthcare provider. Symptoms of congestive heart failure, hepatotoxicity (e.g., nausea, fatigue, jaundice), and anaphylactoid reactions (e.g., difficulty breathing, swelling) should prompt immediate medical attention. Pregnant women are advised to avoid ibuprofen and other NSAIDs starting at 30 weeks gestation due to the risk of premature closure of the fetal ductus arteriosus, and those requiring treatment between 20 to 30 weeks should be monitored for oligohydramnios if treatment exceeds 48 hours.

FDA Insert (PDF)

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

View full prescribing information (PDF)