Ibuprofen

Description

Ibuprofen tablets 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 of 74-77° C. It is characterized by very slight solubility in water (less than 1 mg/mL) and 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 in dosages of 400 mg, 600 mg, and 800 mg. The formulation includes several inactive ingredients: silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycols, polyvinyl alcohol, pregelatinized starch, talc, 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 consider the potential benefits and risks of ibuprofen tablets and other treatment options before initiating therapy. It is recommended to use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

After assessing the response to initial therapy with ibuprofen tablets, the dose and frequency should be adjusted to meet the specific needs of the patient. The total daily dose should not exceed 3200 mg. In cases where gastrointestinal complaints arise, ibuprofen tablets should be administered with meals or milk to mitigate these effects.

For the management of rheumatoid arthritis and osteoarthritis, the suggested dosage ranges from 1200 mg to 3200 mg daily. This can be administered as 300 mg four times a day (qid) or as 400 mg, 600 mg, or 800 mg three to four times a day (tid or qid). It is important to tailor the dose to each patient, with adjustments made based on the severity of symptoms at the initiation of therapy or in response to treatment.

In general, patients with rheumatoid arthritis may require higher doses of ibuprofen tablets compared to those with osteoarthritis. The smallest effective dose that provides acceptable control should be utilized.

For the relief of mild to moderate pain, a dose of 400 mg may be taken every 4 to 6 hours as needed. In the case of dysmenorrhea, ibuprofen tablets should be administered at a dose of 400 mg every 4 hours as necessary for pain relief.

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

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. Patients with existing cardiovascular disease or risk factors are at a heightened risk for these adverse events. It is crucial to monitor patients closely, particularly those with known cardiovascular conditions.

Gastrointestinal Risks The use of NSAIDs can lead to severe gastrointestinal complications, including bleeding, ulceration, and perforation of the stomach or intestines, which may occur without warning and can be fatal. Elderly patients are particularly vulnerable to these serious gastrointestinal events. Physicians should remain vigilant for signs or symptoms of gastrointestinal bleeding in patients undergoing long-term NSAID therapy. Regular monitoring of complete blood count (CBC) and chemistry profiles is recommended for these patients.

Hypertension NSAIDs, including ibuprofen, may contribute to the onset of new hypertension or exacerbate pre-existing hypertension. Clinicians should assess blood pressure regularly in patients receiving NSAID treatment.

Anaphylactoid Reactions and Skin Reactions Anaphylactoid reactions can occur in patients without prior exposure to ibuprofen. In such cases, immediate emergency medical assistance should be sought. Additionally, NSAIDs can cause serious skin reactions, including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be advised to discontinue ibuprofen tablets at the first sign of a skin rash or any other indication of hypersensitivity. If symptoms consistent with Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) arise, ibuprofen 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 Ibuprofen tablets are not a substitute for corticosteroids and should not be used to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids can lead to exacerbation of the underlying condition. Furthermore, the pharmacological effects of ibuprofen in reducing fever and inflammation may obscure diagnostic signs that are critical for identifying complications in presumed noninfectious, painful conditions.

Monitoring Recommendations Healthcare providers should periodically check CBC and chemistry profiles for patients on long-term NSAID therapy. If any clinical signs or symptoms indicative of liver or renal disease develop, ibuprofen tablets should be discontinued immediately.

In summary, careful consideration of these warnings and precautions is essential for the safe use of ibuprofen tablets in clinical practice.

Side Effects

Patients receiving treatment with this medication may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

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, particularly in elderly patients who are at greater risk.

Gastrointestinal adverse reactions commonly reported include nausea, epigastric pain, heartburn, diarrhea, and abdominal distress. Other gastrointestinal issues may involve nausea and vomiting, indigestion, constipation, abdominal cramps or pain, and fullness of the gastrointestinal tract characterized by bloating and flatulence. Serious gastrointestinal complications such as gastric or duodenal ulcers with bleeding and/or perforation, gastrointestinal hemorrhage, melena, gastritis, hepatitis, jaundice, abnormal liver function tests, and pancreatitis have also been observed.

Central nervous system reactions may include dizziness, headache, and nervousness, with more serious effects such as depression, insomnia, confusion, emotional liability, somnolence, and aseptic meningitis potentially leading to fever and coma. Other reported symptoms include paresthesias, hallucinations, dream abnormalities, and pseudo-tumor cerebri.

Dermatologic reactions can range from common rashes, including maculopapular types and pruritus, to more severe conditions such as vesiculobullous eruptions, urticaria, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Postmarketing experiences have noted exfoliative dermatitis and fixed drug eruptions.

Adverse reactions affecting special senses include tinnitus, hearing loss, amblyopia, conjunctivitis, diplopia, optic neuritis, and cataracts.

Hematologic adverse reactions may involve neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia (sometimes Coombs positive), and thrombocytopenia with or without purpura. Patients may also experience bleeding episodes, such as epistaxis and menorrhagia.

Metabolic and endocrine reactions include decreased appetite, gynecomastia, hypoglycemic reactions, and acidosis.

Cardiovascular reactions may manifest as edema and fluid retention, which generally respond promptly to drug discontinuation. Other cardiovascular concerns include congestive heart failure in patients with marginal cardiac function, elevated blood pressure, palpitations, and arrhythmias such as sinus tachycardia and sinus bradycardia.

Allergic reactions can present as a syndrome of abdominal pain, fever, chills, nausea, and vomiting, as well as anaphylaxis and bronchospasm. Other allergic conditions reported include serum sickness, lupus erythematosus syndrome, Henoch-Schonlein vasculitis, and angioedema.

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

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

In summary, the adverse reactions associated with this medication encompass a wide range of systems and severities, necessitating careful monitoring and management of patients during treatment.

Drug Interactions

Concomitant use of certain medications with ibuprofen may lead to significant drug interactions, which can affect therapeutic outcomes and 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 monitor blood pressure in patients receiving both medications.

• Aspirin:

  • Ibuprofen may interfere with the antiplatelet activity of aspirin, particularly when ibuprofen is administered shortly before aspirin. This interaction is more pronounced with enteric-coated low-dose aspirin. To mitigate this risk, it is advisable to administer immediate-release low-dose aspirin at least 2 hours prior to ibuprofen.

  • Due to the potential for increased cardiovascular events, patients taking low-dose aspirin for cardioprotection who require analgesics should consider alternative NSAIDs that do not affect aspirin's antiplatelet effect or non-NSAID analgesics when appropriate.

  • Co-administration of ibuprofen with aspirin may reduce the protein binding of ibuprofen, although it does not alter the clearance of free ibuprofen. The clinical significance of this interaction remains unclear, but concomitant use 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 should be closely monitored for signs of renal failure and to ensure diuretic efficacy during concurrent therapy.

• Warfarin-type Anticoagulants: While short-term studies have not shown significant effects on prothrombin times or clotting factors when ibuprofen is used with coumarin-type anticoagulants, caution is warranted. The combination may increase the risk of gastrointestinal bleeding, which is synergistic, thus necessitating careful monitoring of patients on both medications.

Pharmacokinetic Interactions

• Lithium: 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 during concurrent administration. Patients should be monitored for signs of lithium toxicity 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.

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

In summary, careful consideration and monitoring are essential 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

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 is recommended to ensure the safety and efficacy of treatment in geriatric patients.

Pregnancy

Use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen tablets, during pregnancy is associated with significant risks, particularly when used after approximately 20 weeks of gestation. The administration of NSAIDs at about 30 weeks gestation or later increases the risk of premature closure of the fetal ductus arteriosus, which can lead to serious fetal complications. 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 to the lowest effective dose and shortest duration possible if treatment is deemed necessary after 20 weeks of gestation. If treatment extends beyond 48 hours, monitoring with ultrasound for oligohydramnios 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 associated with NSAID use in 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 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 2-4% and 15-20%, respectively. However, the specific background risk associated with NSAID use in pregnancy 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 justify the potential 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 limited case reports of irreversible neonatal renal dysfunction requiring invasive interventions.

Due to methodological limitations in postmarketing studies, including the absence of control groups and insufficient data on dosage and duration of exposure, establishing a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal NSAID use remains challenging. Consequently, the generalizability of reported risks to full-term infants exposed to NSAIDs through maternal use is uncertain.

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; therefore, the use of NSAIDs may lead to a dose-dependent reduction in prostaglandin formation and, subsequently, renal blood flow. This can precipitate overt renal decompensation, particularly in patients at greatest risk, including those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly.

Discontinuation of NSAID therapy typically results in recovery to the pretreatment state. However, there is no available information from controlled clinical studies regarding the use of ibuprofen tablets in patients with advanced renal disease, and treatment with ibuprofen tablets is not recommended in this population. If initiation of ibuprofen tablet therapy 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 can occur after days to weeks of treatment, although oligohydramnios has been infrequently reported as early as 48 hours after NSAID initiation. If NSAID treatment is required between approximately 20 and 30 weeks of gestation, it is recommended to limit ibuprofen tablet 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.

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 compensatory 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 renal decompensation.

Patients at the highest risk for these adverse reactions include those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. 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 these patients. If therapy with ibuprofen tablets is deemed necessary, close monitoring of renal function is advised to mitigate the risk of renal complications. Discontinuation of NSAID therapy typically results in recovery to the pretreatment state, underscoring the importance of careful patient management.

Overdosage

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

Clinical Presentation and Symptoms A notable case involved a 19-month-old child who ingested between 7 to 10 ibuprofen tablets (400 mg). 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 painful stimulus was sufficient to induce respiration. Upon examination, a greenish-yellow fluid was aspirated from the stomach, with no evidence of ibuprofen detected. 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, the child received sodium bicarbonate, dextrose, and normal saline infusions. By four hours post-ingestion, she was more alert, able to sit independently, and responsive to verbal commands. Blood analysis revealed an ibuprofen level of 102.9 µg/mL approximately 8½ hours after ingestion, and by 12 hours, the child appeared to have fully recovered.

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

A separate case involving a 19-year-old male who ingested 8,000 mg of ibuprofen over several hours reported dizziness, with nystagmus observed during examination. After receiving parenteral hydration and three days of bed rest, he recovered without any reported sequelae.

Management of Overdosage In instances of acute ibuprofen overdosage, it is recommended that the stomach be emptied through vomiting or gastric lavage; however, it is important to note 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 implemented, and the use of oral activated charcoal may assist in reducing both the absorption and reabsorption of ibuprofen tablets.

Healthcare professionals should remain vigilant in monitoring patients for potential symptoms and provide appropriate supportive care as needed.

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 NSAIDs during this period increases the risk of premature closure of the fetal ductus arteriosus. Additionally, the administration of NSAIDs at approximately 20 weeks of gestation or later 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 infrequently reported as early as 48 hours following the initiation of NSAID therapy. While oligohydramnios may often 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.

Reproductive studies conducted in rats and rabbits have not indicated developmental abnormalities; however, the predictive value of animal reproduction studies for human outcomes remains uncertain. 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 have reported that prostaglandin synthesis inhibitors can impair kidney development when administered at clinically relevant doses.

The estimated background risk of major birth defects and miscarriage for the indicated population is 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 approximately 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 remain inconclusive. In animal studies, the administration of prostaglandin synthesis inhibitors, such as ibuprofen, has been linked to increased pre- and post-implantation loss, further underscoring the importance of prostaglandins in fetal kidney development.

Postmarketing Experience

During postapproval use of ibuprofen, the following adverse reactions have been identified. These reactions were reported voluntarily from a population of uncertain size, making it challenging to reliably estimate their frequency or establish a causal relationship to drug exposure.

Skin and appendages-related adverse reactions include exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and fixed drug eruption (FDE).

Patient Counseling

Patients should be informed of essential information before initiating therapy with an NSAID, such as ibuprofen, 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 discomfort and, in rare cases, serious gastrointestinal side effects such as ulcers and bleeding, which may lead to hospitalization or even death. Although serious gastrointestinal tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for signs and symptoms such as 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.

Additionally, patients should be informed that ibuprofen tablets can lead to serious skin side effects, including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which may also result in hospitalization or death. Patients should be vigilant for signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and should seek medical advice if they observe any indicative signs or symptoms. They 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.

Patients should also 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.

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

Patients should be educated on the signs of an anaphylactoid reaction, such as difficulty breathing and swelling of the face or throat, and should be instructed to seek immediate emergency help if these symptoms arise.

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

Finally, healthcare providers should monitor patients for signs or symptoms of gastrointestinal bleeding, as serious gastrointestinal tract ulcerations and bleeding can occur without warning symptoms. 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 well-closed containers to ensure integrity and stability. 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. Proper storage conditions are essential to maintain the quality and efficacy of the product.

Additional Clinical Information

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

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

FDA Insert (PDF)

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

View full prescribing information (PDF)