Ibuprofen

Description

Ibuprofen Tablets, USP contain the active ingredient ibuprofen, which is chemically defined as (±)-2-(p-isobutylphenyl) propionic acid. Ibuprofen appears as 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. The structural formula of ibuprofen is provided below.

These tablets are classified as a nonsteroidal anti-inflammatory drug (NSAID) and are formulated for oral administration, with each tablet containing 800 mg of ibuprofen. The formulation includes several inactive ingredients: Colloidal Silicon Dioxide, Corn Starch, Hydroxypropyl Cellulose, Hypromellose, Lactose Anhydrous, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, and Titanium Dioxide.

Uses and Indications

Ibuprofen Tablets are indicated for the relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. This medication is also 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 children have not been conducted. Therefore, the use of this medication in pediatric populations 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. This can be administered as 300 mg four times a day (qid) or in higher doses of 400 mg, 600 mg, or 800 mg three to four times a day (tid or qid).

In cases of mild to moderate pain, a dosage of 400 mg may be taken every 4 to 6 hours as needed for pain relief. For the treatment of dysmenorrhea, Ibuprofen Tablets should be initiated at the earliest onset of pain, with a recommended dose of 400 mg every 4 hours as necessary for relief.

It is important to note that the total daily dose should not exceed 3200 mg. To minimize gastrointestinal discomfort, it is advisable to administer Ibuprofen Tablets with meals or milk.

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

Contraindications

Ibuprofen Tablets are contraindicated in patients with known hypersensitivity to ibuprofen. Additionally, the use of Ibuprofen Tablets is not recommended for individuals who have a history of asthma, urticaria, or allergic-type reactions following the administration of aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), as severe, potentially fatal, anaphylactic-like reactions have been reported in these patients.

Furthermore, Ibuprofen Tablets are contraindicated in the context of coronary artery bypass graft (CABG) surgery.

Warnings and Precautions

Cardiovascular effects associated with nonsteroidal anti-inflammatory drugs (NSAIDs) include an increased risk of serious thrombotic events, such as myocardial infarction and stroke, which may be fatal. This risk can manifest early in treatment and may escalate with prolonged use. Patients with pre-existing cardiovascular disease or risk factors are at a higher absolute incidence of these serious events. Therefore, the use of Ibuprofen Tablets is contraindicated in patients with a recent myocardial infarction unless the anticipated benefits outweigh the risks of recurrent cardiovascular thrombotic events. If Ibuprofen is administered, it is imperative to monitor patients for signs of cardiac ischemia.

Hypertension is another concern, as NSAIDs can lead to the onset of new hypertension or exacerbate existing hypertension. Blood pressure should be closely monitored during the initiation of NSAID therapy and throughout the treatment duration.

In patients with severe heart failure, the use of Ibuprofen Tablets should be avoided unless the benefits are deemed to outweigh the risks of exacerbating heart failure. Continuous monitoring for signs of worsening heart failure is recommended if the medication is used.

Gastrointestinal adverse events are a significant risk with NSAID use, including inflammation, bleeding, ulceration, and perforation of the gastrointestinal tract, which can be fatal. These events may occur at any time, with or without warning symptoms. Both patients and healthcare providers should remain vigilant for signs and symptoms of gastrointestinal ulcerations and bleeding during NSAID therapy. If a serious gastrointestinal event is suspected, the NSAID should be discontinued until such an event is ruled out.

Long-term NSAID administration has been associated with renal complications, including renal papillary necrosis and other forms of renal injury. Typically, discontinuation of NSAID therapy leads to recovery to the pretreatment state.

Anaphylactoid reactions may occur, and emergency medical assistance should be sought immediately in such cases. Patients should be informed about the signs and symptoms of serious skin reactions and advised to discontinue Ibuprofen Tablets at the first appearance of a skin rash or any other indication of hypersensitivity.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) is another serious condition that requires immediate attention. If any signs or symptoms of DRESS are observed, Ibuprofen Tablets should be discontinued, and the patient should be evaluated promptly.

Fetal toxicity is a critical consideration, particularly in pregnant women. The use of NSAIDs, including Ibuprofen Tablets, should be avoided in women at approximately 30 weeks of gestation and later due to the risk of premature closure of the fetal ductus arteriosus. If NSAID treatment is necessary between 20 and 30 weeks of gestation, it should be limited to the lowest effective dose for the shortest duration possible. Ibuprofen Tablets should be discontinued if oligohydramnios occurs, with follow-up according to clinical practice guidelines.

In summary, healthcare professionals must exercise caution when prescribing Ibuprofen Tablets, ensuring that patients are monitored for the aforementioned risks and complications.

Side Effects

Patients may experience a range of adverse reactions while using the medication, categorized by incidence and seriousness.

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, vomiting, indigestion, constipation, abdominal cramps, and bloating. Central nervous system effects may manifest as dizziness, headache, and nervousness. Dermatologic reactions can include rash (including maculopapular types) and pruritus. Additionally, patients may report tinnitus, decreased appetite, edema, and fluid retention, which generally resolves upon discontinuation of the drug.

Serious adverse reactions, with a precise incidence unknown but occurring in less than 1% of patients, may include gastrointestinal complications such as gastric or duodenal ulcers with bleeding or perforation, gastrointestinal hemorrhage, melena, gastritis, hepatitis, jaundice, and pancreatitis. Central nervous system effects may also be serious, including depression, insomnia, confusion, emotional liability, somnolence, and aseptic meningitis with fever and coma. Dermatologic reactions can be severe, with reports of vesiculobullous eruptions, urticaria, erythema multiforme, Stevens-Johnson syndrome, and alopecia.

Hematologic adverse reactions may include neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia (sometimes Coombs positive), thrombocytopenia with or without purpura, eosinophilia, and decreases in hemoglobin and hematocrit. Metabolic and endocrine reactions may involve gynecomastia, hypoglycemic reactions, and acidosis. Cardiovascular issues may arise, including congestive heart failure in patients with marginal cardiac function, elevated blood pressure, and palpitations.

Additional adverse reactions with a causal relationship unknown, occurring in less than 1% of patients, may include bleeding episodes such as epistaxis and menorrhagia, renal complications like acute renal failure, decreased creatinine clearance, polyuria, azotemia, cystitis, and hematuria. Miscellaneous reactions may consist of dry eyes and mouth, gingival ulcers, and rhinitis.

Postmarketing experience has revealed serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and fixed drug eruption.

Warnings associated with the medication include an increased risk of serious cardiovascular thrombotic events, such as myocardial infarction and stroke, which can be fatal. There is also an increased risk of serious gastrointestinal adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.

Anaphylactoid reactions may occur in patients without prior exposure to the medication. Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, can be fatal. Additionally, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs, with some events being fatal or life-threatening.

Fetal toxicity is a concern, with risks including premature closure of the fetal ductus arteriosus and fetal renal dysfunction, potentially leading to oligohydramnios and neonatal renal impairment.

Drug Interactions

Concomitant use of certain medications with Ibuprofen Tablets may lead to significant drug interactions, categorized primarily into pharmacodynamic and pharmacokinetic interactions.

Pharmacodynamic Interactions

ACE-Inhibitors: Nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, may reduce the antihypertensive effect of ACE-inhibitors. Clinicians should consider this interaction in patients receiving both medications.

Aspirin: The antiplatelet activity of aspirin may be compromised when ibuprofen is administered, particularly at a dosage of 400 mg three times daily, and especially if ibuprofen is taken prior to aspirin. This interaction is less pronounced if immediate-release low-dose aspirin is taken at least 2 hours before ibuprofen. However, this timing does not apply to enteric-coated low-dose aspirin. Due to the potential increased risk of cardiovascular events, it is advisable to consider alternative analgesics that do not interfere with aspirin's antiplatelet effect for patients using low-dose aspirin for cardioprotection. Co-administration of ibuprofen with aspirin may also reduce ibuprofen's protein binding, although its clearance remains unchanged. The clinical significance of this interaction is not fully understood, but the concurrent use of ibuprofen and aspirin is generally not recommended due to the risk of increased adverse effects.

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

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

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

Warfarin-type Anticoagulants: While short-term studies have not shown significant effects of ibuprofen on prothrombin times or clotting factors in patients on coumarin-type anticoagulants, there is a documented risk of bleeding when these medications are used together. The combined use of warfarin and NSAIDs may increase the risk of serious gastrointestinal bleeding. Physicians should exercise caution when prescribing ibuprofen to patients on anticoagulants.

Pharmacokinetic Interactions

H-2 Antagonists: Co-administration of ibuprofen with H-2 antagonists such as cimetidine or ranitidine has not demonstrated any significant impact on ibuprofen serum concentrations in studies involving human volunteers.

In summary, careful consideration and monitoring are warranted when ibuprofen is used in conjunction with these medications 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, caution should be exercised when considering the use of this medication in children. Further studies are needed to determine appropriate dosing and outcomes in this population.

Geriatric Use

Caution should be exercised when treating elderly patients, specifically those aged 65 years and older. Due to the potential for altered pharmacokinetics and increased sensitivity to medications in this population, careful consideration of dosage adjustments and monitoring is essential. Healthcare providers are advised to assess the individual health status and comorbidities of geriatric patients to ensure safe and effective treatment. Regular monitoring for adverse effects and therapeutic efficacy is recommended to mitigate risks associated with medication use in this age group.

Pregnancy

Use of NSAIDs, including Ibuprofen Tablets, during pregnancy is associated with significant risks, particularly when administered around 20 to 30 weeks of gestation. 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 cases, neonatal renal impairment. Therefore, it is recommended to limit the dose and duration of Ibuprofen Tablets use between approximately 20 and 30 weeks of gestation, and to avoid their use at around 30 weeks of gestation and later in pregnancy.

Observational studies have indicated that the use of NSAIDs at about 30 weeks gestation or later increases the risk of premature closure of the fetal ductus arteriosus. Additionally, the use of NSAIDs at about 20 weeks gestation or later has been associated with fetal renal dysfunction leading to oligohydramnios, with some reports of neonatal renal impairment. These adverse outcomes typically manifest after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after initiation of NSAID therapy. In many instances, the decrease in amniotic fluid was transient and reversible upon cessation of the drug; however, there have been limited case reports of irreversible neonatal renal dysfunction, some of which required invasive procedures such as exchange transfusion or dialysis.

Reproductive studies in rats and rabbits have not demonstrated evidence of developmental abnormalities; however, animal reproduction studies are not always predictive of human response. Prostaglandins play a crucial role in endometrial vascular permeability, blastocyst implantation, and decidualization, and their synthesis inhibitors, such as ibuprofen, have been shown to impair kidney development at clinically relevant doses. The estimated background risk of major birth defects and miscarriage in the U.S. general population is 2% to 4% and 15% to 20%, respectively, but the specific background risk associated with Ibuprofen Tablets is unknown.

Due to the potential risks, if an NSAID is deemed necessary at about 20 weeks gestation or later, it is advised to use the lowest effective dose for the shortest duration possible. If treatment with Ibuprofen Tablets extends beyond 48 hours, monitoring with ultrasound for oligohydramnios should be considered. Should oligohydramnios occur, discontinuation of Ibuprofen Tablets and appropriate follow-up according to clinical practice is recommended. There are no adequate, well-controlled studies in pregnant women, and Ibuprofen Tablets should only be used during pregnancy if the potential benefits justify the potential risks to the fetus. The effects of Ibuprofen Tablets on labor and delivery in pregnant women remain unknown.

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 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. 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 therapy with Ibuprofen Tablets is deemed necessary, close monitoring of the patient's renal function is advised.

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. 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 Tablets to the lowest effective dose for the shortest duration possible. Ultrasound monitoring of amniotic fluid should be considered if treatment extends beyond 48 hours, and Ibuprofen Tablets should be discontinued if oligohydramnios occurs, with follow-up conducted according to clinical practice.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In cases of ibuprofen overdosage, clinical manifestations can vary significantly based on the amount ingested and the time elapsed since ingestion.

Clinical Presentation

A notable case involved a 19-month-old child who ingested between 7 to 10 ibuprofen tablets (400 mg each). Approximately 1½ hours post-ingestion, the child presented to the emergency department in an apneic and cyanotic state, responding only to painful stimuli. Despite this, the stimulus was sufficient to induce respiration. Initial management included the administration of oxygen and parenteral fluids, with a greenish-yellow fluid aspirated from the stomach, revealing no evidence of ibuprofen. Two hours after ingestion, the child's condition stabilized, although she continued to respond solely to painful stimuli and experienced intermittent apnea lasting 5 to 10 seconds. Following admission to intensive care, sodium bicarbonate, along with dextrose and normal saline infusions, were administered. By four hours post-ingestion, the child was more alert, able to sit independently, and responsive to verbal commands. A blood level of ibuprofen measured at 102.9 mcg/mL approximately 8½ hours after ingestion indicated significant exposure. Remarkably, by 12 hours post-ingestion, the child appeared to have fully recovered.

In two additional cases involving children weighing approximately 10 kg who accidentally ingested about 120 mg/kg of ibuprofen, no signs of acute intoxication or late sequelae were observed. One child exhibited a blood level of 700 mcg/mL 90 minutes after ingestion, which is approximately ten times the peak levels noted in absorption-excretion studies.

Another case involved a 19-year-old male who ingested 8,000 mg of ibuprofen over several hours. He presented with dizziness and nystagmus. Following hospitalization, he received parenteral hydration and was placed on bed rest for three days, after which he recovered without any reported sequelae.

Management Recommendations

In instances of acute ibuprofen overdosage, it is recommended to empty the stomach through vomiting or gastric lavage; however, it should be noted that minimal drug recovery is expected 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 beneficial. Supportive measures should be prioritized, and the use of oral activated charcoal may assist in reducing both absorption and reabsorption of ibuprofen.

Healthcare professionals should remain vigilant for potential symptoms and manage accordingly, ensuring that supportive care is provided throughout the treatment process.

Nonclinical Toxicology

Use of nonsteroidal anti-inflammatory drugs (NSAIDs), including Ibuprofen Tablets, during pregnancy has been associated with several teratogenic effects. Administration of NSAIDs around 30 weeks gestation or later increases the risk of premature closure of the fetal ductus arteriosus. Additionally, the use of these medications from approximately 20 weeks gestation onward has been linked to fetal renal dysfunction, which can lead to oligohydramnios and, in some instances, neonatal renal impairment. Animal studies indicate that prostaglandins play a crucial role in fetal kidney development, and inhibitors of prostaglandin synthesis have been shown to adversely affect kidney development when given at clinically relevant doses.

Due to the potential risks, it is advised to avoid the use of NSAIDs, including Ibuprofen Tablets, in pregnant women at around 30 weeks gestation and later. If NSAID treatment is deemed necessary between 20 and 30 weeks 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 should be considered if treatment with Ibuprofen Tablets extends beyond 48 hours. Should oligohydramnios occur, discontinuation of Ibuprofen Tablets is advised, with follow-up according to established clinical practices.

Reproductive studies conducted in rats and rabbits have not shown evidence of developmental abnormalities; however, it is important to note that animal reproduction studies do not always predict human responses. In animal studies, the administration of prostaglandin synthesis inhibitors, such as ibuprofen, has resulted in increased pre- and post-implantation loss.

Prostaglandins are known to play a significant role in endometrial vascular permeability, blastocyst implantation, and decidualization. Furthermore, published animal studies have reported that prostaglandin synthesis inhibitors can impair kidney development when administered at clinically relevant doses.

Postmarketing Experience

Anemia has been reported in patients receiving NSAIDs, including Ibuprofen Tablets. This condition may arise from factors such as fluid retention, occult or gross gastrointestinal blood loss, or an incompletely characterized effect on erythropoiesis. It is recommended that patients undergoing long-term treatment with NSAIDs, including Ibuprofen Tablets, have their hemoglobin or hematocrit levels monitored if they exhibit any signs or symptoms of anemia.

In two postmarketing clinical studies, the incidence of decreased hemoglobin levels was found to be higher than previously documented. A decrease in hemoglobin of 1 gram or more was observed in 17.1% of 193 patients taking 1600 mg of ibuprofen daily for osteoarthritis, and in 22.8% of 189 patients taking 2400 mg of ibuprofen daily for rheumatoid arthritis. Additionally, positive stool occult blood tests and elevated serum creatinine levels were noted in these studies.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients using NSAIDs, including Ibuprofen Tablets. Some cases of DRESS have resulted in fatal or life-threatening outcomes. This syndrome typically presents with symptoms such as fever, rash, lymphadenopathy, and/or facial swelling, and may also include manifestations such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis. Symptoms of DRESS can sometimes mimic those of an acute viral infection, and eosinophilia is frequently observed.

A limited number of case reports have documented maternal NSAID use associated with neonatal renal dysfunction in the absence of oligohydramnios, with some cases resulting in irreversible damage. Certain instances of neonatal renal dysfunction necessitated invasive treatments, including exchange transfusion or dialysis.

Patient Counseling

Patients should be informed of essential information before initiating therapy with an NSAID, such as Ibuprofen Tablets, and periodically throughout the course of treatment. It is important for patients to read the NSAID Medication Guide that accompanies each prescription dispensed.

Healthcare providers should advise patients to be vigilant 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.

Patients should be made aware that Ibuprofen Tablets, like other NSAIDs, can cause gastrointestinal (GI) discomfort and, in rare cases, serious GI side effects such as ulcers and bleeding, which may lead to hospitalization or even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for signs and symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis. They should be encouraged to seek medical advice upon observing any indicative signs or symptoms and understand the importance of follow-up.

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

It is crucial for patients to 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 occur, patients should be instructed to stop therapy and seek immediate medical attention.

Patients should also be made aware of the signs of an anaphylactoid reaction, such as difficulty breathing and swelling of the face or throat. In such cases, they should be instructed to seek immediate emergency help.

Pregnant women should be informed 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 advised that monitoring for oligohydramnios may be required if treatment continues for longer than 48 hours.

Healthcare providers should monitor patients for signs or symptoms of GI bleeding, as serious GI tract ulcerations and bleeding can occur without warning symptoms. Furthermore, patients on long-term treatment with NSAIDs should have their complete blood count (CBC) and chemistry profile checked periodically. If clinical signs and symptoms consistent with liver or renal disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash), or if abnormal liver tests persist or worsen, Ibuprofen Tablets should be discontinued.

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 controlled room temperature of 20° to 25°C (68° to 77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F).

Additional Clinical Information

Physicians should monitor patients on long-term NSAID treatment for signs or symptoms of gastrointestinal bleeding and periodically check complete blood count (CBC) and chemistry profiles. If patients exhibit clinical signs consistent with liver or renal disease, systemic manifestations such as eosinophilia or rash, or if abnormal liver tests persist or worsen, Ibuprofen Tablets should be discontinued.

Patients should be counseled to remain vigilant for symptoms of cardiovascular thrombotic events, including chest pain and shortness of breath, and to report these to their healthcare provider immediately. They should also be aware of signs of ulcerations and bleeding, such as epigastric pain and melena, and seek medical advice if these occur. Immediate discontinuation of Ibuprofen Tablets is advised if any rash or fever develops, and patients should contact their healthcare provider. Additionally, they should monitor for symptoms of congestive heart failure and hepatotoxicity, and seek emergency help for signs of an anaphylactoid reaction. Pregnant women should avoid Ibuprofen Tablets 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 gestation 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 of New York LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)