Ibuprofen

Description

Ibuprofen tablets contain the active ingredient ibuprofen, which is chemically defined as (±) - 2 - (p - isobutylphenyl) propionic acid. The active compound 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, while being 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 formulation includes several inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, magnesium stearate, and an Opadry II coating that contains hypromellose, polyethylene glycol, sodium citrate, lactose monohydrate, and titanium dioxide.

Uses and Indications

Ibuprofen tablets are indicated for the relief of the signs and symptoms of 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 children have not been conducted. Therefore, the use of ibuprofen in pediatric populations should be approached with caution.

Dosage and Administration

Healthcare professionals should carefully evaluate the potential benefits and risks associated with ibuprofen tablets, considering alternative treatment options before initiating therapy. It is recommended to use the lowest effective dose for the shortest duration that aligns with individual patient treatment goals.

Following the initial therapy with ibuprofen tablets, the dose and frequency should be adjusted based on the patient's response. 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 discomfort.

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, typically administered as 400 mg, 600 mg, or 800 mg three to four times daily (tid or qid). Dosing should be individualized, with adjustments made according to the severity of symptoms at the initiation of therapy or in response to treatment efficacy.

It is noted that patients with rheumatoid arthritis may require higher doses of ibuprofen tablets compared to those with osteoarthritis. The smallest effective dose that provides adequate symptom control should be utilized.

For the treatment of mild to moderate pain, a dosage of 400 mg may be administered every 4 to 6 hours as needed for pain relief.

In the case 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 effective pain relief.

Contraindications

Ibuprofen tablets are contraindicated in patients with known hypersensitivity to ibuprofen. Additionally, the use of ibuprofen 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 documented in these patients. Furthermore, ibuprofen tablets are contraindicated in the context of coronary artery bypass graft (CABG) surgery.

Warnings and Precautions

Increased risk of serious cardiovascular thrombotic events, including myocardial infarction (MI) and stroke, has been associated with the use of NSAIDs. These events can be fatal and may occur early in treatment, with the risk potentially increasing with the duration of use. To minimize the risk of adverse cardiovascular events, it is recommended to use the lowest effective dose for the shortest duration possible. Healthcare professionals should inform patients about the symptoms of serious cardiovascular events and the appropriate steps to take if they occur. Caution is advised in patients with a recent MI; the benefits must outweigh the risks, and monitoring for signs of cardiac ischemia is essential. Additionally, NSAIDs may lead to new hypertension or exacerbate pre-existing hypertension; therefore, blood pressure should be monitored closely. In patients with severe heart failure, NSAID use should be avoided unless the benefits outweigh the risks, with vigilant monitoring for signs of worsening heart failure.

NSAIDs are also associated with serious gastrointestinal adverse events, 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. To reduce the risk of gastrointestinal complications, it is advisable to use the lowest effective dose for the shortest duration possible. Healthcare providers should remain alert for signs and symptoms of gastrointestinal ulcerations and bleeding during NSAID therapy, and the NSAID should be discontinued if a serious gastrointestinal event is suspected.

Long-term administration of NSAIDs can lead to renal injury, particularly in patients with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. The use of ibuprofen is not recommended in patients with advanced renal disease, and close monitoring of renal function is advisable if treatment is initiated.

Anaphylactoid reactions may occur in patients without prior exposure to NSAIDs. In such cases, emergency medical assistance should be sought immediately. Serious skin adverse events, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), can occur without warning. It is crucial to discontinue use at the first appearance of a skin rash or any sign of hypersensitivity.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs. If signs or symptoms of DRESS are present, ibuprofen should be discontinued, and the patient should be evaluated immediately.

In pregnant women, the use of NSAIDs should be avoided around 30 weeks of gestation and later due to the risk of premature closure of the fetal ductus arteriosus. Additionally, the use of NSAIDs around 20 weeks of gestation or later may lead to fetal renal dysfunction, resulting in oligohydramnios; treatment should be discontinued if oligohydramnios occurs.

Emergency medical help should be sought in cases of anaphylactoid reactions, and ibuprofen should be discontinued and the patient evaluated immediately if signs or symptoms of DRESS are present.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication, categorized by seriousness and frequency.

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, serious gastrointestinal adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, can also be fatal and may occur at any time during treatment without warning symptoms. Other serious reactions include anaphylaxis, renal papillary necrosis, and severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

Common gastrointestinal adverse reactions reported include nausea, epigastric pain, heartburn, diarrhea, and abdominal distress. Other gastrointestinal issues such as constipation, abdominal cramps, bloating, and flatulence may also occur. More severe gastrointestinal complications, including gastric or duodenal ulcers with bleeding or perforation, gastrointestinal hemorrhage, melena, gastritis, hepatitis, jaundice, abnormal liver function tests, and pancreatitis, have been observed.

Central nervous system reactions may manifest as dizziness, headache, nervousness, depression, insomnia, confusion, emotional liability, and somnolence. In rare cases, aseptic meningitis with fever and coma has been reported.

Dermatologic reactions include rash (including maculopapular types), pruritus, vesiculobullous eruptions, urticaria, erythema multiforme, alopecia, and photoallergic skin reactions. Serious skin reactions such as exfoliative dermatitis and toxic epidermal necrolysis have also been noted.

Adverse reactions affecting special senses may include tinnitus, hearing loss, amblyopia (blurred and/or diminished vision), conjunctivitis, diplopia, optic neuritis, and cataracts.

Hematologic adverse reactions can include neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia (sometimes Coombs positive), thrombocytopenia with or without purpura, eosinophilia, and decreases in hemoglobin and hematocrit. Bleeding episodes, such as epistaxis and menorrhagia, have also been reported.

Metabolic and endocrine reactions may involve decreased appetite, gynecomastia, hypoglycemic reactions, and acidosis.

Cardiovascular reactions include edema, fluid retention (which generally responds promptly to drug discontinuation), congestive heart failure in patients with marginal cardiac function, elevated blood pressure, palpitations, and arrhythmias (including sinus tachycardia and sinus bradycardia).

Allergic reactions may present as a syndrome of abdominal pain, fever, chills, nausea, and vomiting, as well as bronchospasm, serum sickness, lupus erythematosus syndrome, Henoch-Schonlein vasculitis, and angioedema.

Renal adverse reactions can include acute renal failure, decreased creatinine clearance, polyuria, azotemia, cystitis, hematuria, and renal papillary necrosis.

Miscellaneous reactions reported include dry eyes and mouth, gingival ulcer, and rhinitis.

Patients should be monitored for these adverse reactions, and any serious or concerning symptoms should be reported to a healthcare provider immediately.

Drug Interactions

Concomitant use of certain medications with ibuprofen 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 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. This interaction is particularly pronounced when ibuprofen (400 mg three times daily) is administered concurrently with enteric-coated low-dose aspirin, even if ibuprofen is taken once daily. 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.

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 NSAID therapy should be monitored closely for signs of renal impairment and to ensure the efficacy of diuretics.

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 can increase the risk of serious gastrointestinal bleeding. Caution is advised when prescribing ibuprofen to patients on anticoagulants.

Pharmacokinetic Interactions

Lithium Ibuprofen has been shown to elevate plasma lithium levels and decrease renal clearance of lithium, with a mean increase in minimum lithium concentration of 15% and a 19% reduction in renal clearance. This interaction is attributed to the inhibition of renal prostaglandin synthesis. Patients receiving both ibuprofen and lithium should be closely monitored for signs of lithium toxicity.

Methotrexate NSAIDs, including ibuprofen, may competitively inhibit the accumulation of methotrexate, potentially enhancing its toxicity. Caution is warranted when these drugs are used together.

H-2 Antagonists Co-administration of ibuprofen with H-2 antagonists such as cimetidine or ranitidine does not appear to significantly affect ibuprofen serum concentrations, indicating no major pharmacokinetic interaction.

In summary, careful consideration and monitoring are essential when ibuprofen is prescribed alongside 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

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

Healthcare professionals are advised to limit the use of ibuprofen tablets between 20 and 30 weeks of gestation to the lowest effective dose and shortest duration necessary. If treatment with ibuprofen tablets extends beyond 48 hours, monitoring for oligohydramnios via ultrasound is recommended. Should oligohydramnios be detected, discontinuation of ibuprofen tablets should be considered, followed by appropriate clinical follow-up.

Data from observational studies regarding the risks of NSAID use during the first and second trimesters remain inconclusive. While animal studies have not demonstrated developmental abnormalities, they have indicated that prostaglandins play a crucial role in various reproductive processes, including fetal kidney development. In these studies, the administration 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 2-4% and 15-20%, respectively. However, the specific background risk associated with NSAID use in pregnant patients is not well defined. There are no adequate, well-controlled studies in pregnant women, and ibuprofen tablets should only be used during pregnancy if the potential benefits outweigh the risks to the fetus.

Published literature indicates that adverse outcomes, such as fetal renal dysfunction leading to oligohydramnios, may occur after days to weeks of NSAID treatment, although some cases of oligohydramnios have been reported as early as 48 hours after initiation. While many instances of decreased amniotic fluid have been transient and reversible upon cessation of the drug, there are 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 dosing and timing, establishing a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal NSAID use remains challenging. Furthermore, the generalizability of reported risks to full-term infants exposed to NSAIDs through maternal use is uncertain, as most safety data involve preterm infants. Therefore, caution is warranted when considering NSAID use in pregnant patients, particularly in the later stages of pregnancy.

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 reactions include those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly.

Due to the lack of controlled clinical studies regarding the use of ibuprofen tablets in patients with advanced renal disease, treatment with ibuprofen is not recommended in this population. If ibuprofen therapy is deemed necessary, close monitoring of renal function is advised.

Additionally, the use of NSAIDs, including ibuprofen tablets, during pregnancy, particularly around 20 weeks gestation or later, may result in fetal renal dysfunction, leading to oligohydramnios and, in some cases, neonatal renal impairment. These adverse outcomes may occur after days to weeks of treatment, although oligohydramnios has been 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 use 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. Discontinuation of NSAID therapy is typically followed by recovery to the pretreatment state.

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 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, 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 initiation of ibuprofen tablet therapy 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

Approximately 1½ hours following the ingestion of 7 to 10 ibuprofen tablets (400 mg) by a 19-month-old child weighing 12 kg, the child 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 child 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, and by 12 hours, the child showed complete recovery.

In two additional cases involving children, each weighing approximately 10 kg, accidental acute ingestion of approximately 120 mg/kg of ibuprofen resulted in no signs of acute intoxication or late sequelae. Notably, one child's blood level was recorded at 700 mcg/mL 90 minutes after ingestion, which is about ten times the peak levels observed in absorption-excretion studies.

A case involving a 19-year-old male who ingested 8,000 mg of ibuprofen over several hours reported dizziness, with nystagmus noted 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 overdosage, it is recommended that the stomach be emptied 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 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

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 may increase the risk of premature closure of the fetal ductus arteriosus. Additionally, use of these medications at approximately 20 weeks gestation or later can lead to fetal renal dysfunction, resulting in oligohydramnios and, in some instances, neonatal renal impairment. Animal studies have demonstrated that prostaglandin synthesis inhibitors, such as ibuprofen, can cause increased pre- and post-implantation loss. Prostaglandins play a crucial role in fetal kidney development, and published animal studies indicate that the use of prostaglandin synthesis inhibitors at clinically relevant doses can impair kidney development.

Oligohydramnios, a potential consequence of NSAID use, is often reversible upon discontinuation of treatment; however, prolonged oligohydramnios may lead to complications such as limb contractures and delayed lung maturation. In certain postmarketing cases of impaired neonatal renal function, invasive interventions, including exchange transfusion or dialysis, have been necessary.

Reproductive studies conducted in rats and rabbits have not shown evidence of developmental abnormalities; however, it is important to note that animal reproduction studies may not always predict human responses. The estimated background risk of major birth defects and miscarriage in the indicated population(s) remains unknown. 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 2-4% and 15-20%, respectively.

Data from observational studies regarding potential embryofetal risks associated with NSAID use during the first or second trimesters of pregnancy are inconclusive. In rat studies involving NSAIDs, similar to other drugs that inhibit prostaglandin synthesis, there was an increased incidence of dystocia, delayed parturition, and decreased pup survival. The effects of ibuprofen tablets on labor and delivery in pregnant women remain unknown.

Postmarketing Experience

Postmarketing experience has identified several important safety concerns associated with ibuprofen tablets. Anaphylactoid reactions have been reported in patients without known prior exposure to the medication, necessitating immediate medical attention in such cases. Serious skin adverse events, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), have also been associated with the use of NSAIDs, including ibuprofen, and may occur without prior warning, with potential fatal outcomes.

Additionally, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been documented in patients taking NSAIDs, with some cases resulting in fatal or life-threatening conditions. In two postmarketing 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 193 patients taking 1600 mg of ibuprofen daily for osteoarthritis, and in 22.8% of 189 patients taking 2400 mg daily for rheumatoid arthritis. These studies also reported positive stool occult blood tests and elevated serum creatinine levels.

Observational studies from the Danish National Registry indicated that patients treated with NSAIDs during the post-myocardial infarction (MI) period faced an increased risk of reinfarction, cardiovascular-related death, and all-cause mortality starting within the first week of treatment. Furthermore, published studies and postmarketing reports have linked maternal NSAID use at approximately 20 weeks gestation or later with fetal renal dysfunction, leading to oligohydramnios and, in some instances, neonatal renal impairment.

Patient Counseling

Patients should be informed of essential information before initiating therapy with an NSAID, such as ibuprofen, and periodically during the course of ongoing therapy. It is important to encourage patients to read the NSAID Medication Guide that accompanies each prescription dispensed.

Healthcare providers should advise patients 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.

Patients should be made aware 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. They should be apprised of the importance of seeking medical advice upon observing any indicative signs or symptoms.

Additionally, patients should be informed that ibuprofen tablets can cause serious skin side effects, such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which may also result in hospitalization and death. Although serious skin reactions may occur without warning, patients should be alert for signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching. They should be instructed to seek medical advice if they observe 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. Furthermore, they should be alert for symptoms of congestive heart failure, including shortness of breath, unexplained weight gain, or edema, and to contact their healthcare provider if such symptoms occur.

It is crucial to inform patients of the warning signs and symptoms of hepatotoxicity, which may include nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms. If these occur, patients should be instructed to stop therapy and seek immediate medical attention.

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

Finally, healthcare providers should inform pregnant women 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.

Storage and Handling

The product is supplied in accordance with the following specifications. It should be stored at a temperature range of 20° to 25°C (68° to 77°F), in compliance with USP Controlled Room Temperature guidelines. Proper storage conditions are essential to maintain the integrity and efficacy of the product.

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 is advised if any rash or fever develops, and patients should contact their healthcare provider. Additionally, they should be informed about symptoms of congestive heart failure, hepatotoxicity, and anaphylactoid reactions, and instructed to seek immediate medical attention if these symptoms arise. Pregnant women should 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 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 Strides Pharma Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)