Ibuprofen

Description

Ibuprofen is presented in a dosage form of 800 mg per capsule. The capsules are white in color and measure 19 mm in size. The formulation includes several inactive ingredients: silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, unspecified polyethylene glycol, polyvinyl alcohol, pregelatinized corn starch, talc, and titanium dioxide.

Uses and Indications

This drug is indicated for use in specific patient populations as determined by clinical guidelines. Healthcare professionals should evaluate the appropriateness of this medication based on individual patient needs and conditions.

Limitations of use have not been explicitly defined in the provided information. Therefore, it is essential for healthcare providers to consider the absence of detailed indications and usage information when prescribing this drug.

Further information regarding teratogenic and nonteratogenic effects is not available in the current data set. Healthcare professionals are advised to consult additional resources or clinical studies to understand the full safety profile of this medication.

Dosage and Administration

The recommended dosage for the medication is 600 mg, administered in the form of white to off-white, capsule-shaped, biconvex, film-coated tablets, which are debossed with '122' on one side and plain on the other side.

Healthcare professionals should ensure that the tablets are taken as directed, although specific details regarding the route, method, and frequency of administration are not provided in the available information. It is essential to follow established clinical guidelines and consider individual patient factors when determining the appropriate administration regimen.

Contraindications

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence provided in the available data. Therefore, no explicit conditions or situations have been identified in which the product should not be used.

Warnings and Precautions

There are currently no specific warnings or precautions associated with the use of this medication. Healthcare professionals are advised to remain vigilant and monitor patients for any unforeseen reactions or complications that may arise during treatment.

As there are no recommended laboratory tests or specific instructions for emergency medical assistance or discontinuation of the medication, it is essential for healthcare providers to exercise clinical judgment and consider individual patient circumstances when prescribing this treatment. Regular follow-up and patient assessment are encouraged to ensure safety and efficacy.

Side Effects

Serious adverse reactions associated with the use of ibuprofen include cardiovascular thrombotic events, such as myocardial infarction and stroke, which may be fatal. Patients should be aware of the increased risk of these serious cardiovascular events.

Common adverse reactions reported in clinical trials include nausea, vomiting, diarrhea, constipation, dizziness, headache, and rash. These reactions were observed with varying frequencies among participants.

Less common adverse reactions include abdominal pain, dyspepsia, flatulence, tinnitus, and edema. While these reactions are not as frequently reported, they may still occur in some patients.

Rare adverse reactions have also been documented, including anaphylactic reactions, severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis, hepatic failure, renal failure, gastrointestinal bleeding, hemolytic anemia, and aseptic meningitis. Patients should be monitored for these serious conditions.

Allergic reactions, including anaphylaxis, may occur in some individuals.

Postmarketing experience has revealed additional adverse reactions, including cardiovascular events, gastrointestinal perforation, hepatic dysfunction, and renal impairment. These reactions highlight the importance of careful monitoring during ibuprofen therapy, especially in patients with pre-existing conditions that may predispose them to these adverse effects.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

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

Pediatric use of ibuprofen is not specified in the provided text. There are no recommended age ranges, dosing differences, safety concerns, or special precautions for children mentioned. Healthcare professionals should refer to additional resources or clinical guidelines for further information regarding the use of ibuprofen in pediatric patients.

Geriatric Use

Elderly patients may exhibit an increased sensitivity to the side effects of ibuprofen. Due to the potential for reduced kidney function in this population, dosage adjustments may be necessary to mitigate the risk of adverse effects.

Furthermore, the safety and efficacy of ibuprofen in geriatric patients have not been established through clinical studies. Therefore, caution is advised when prescribing this medication to elderly patients, and careful monitoring is recommended to ensure their safety and well-being.

Pregnancy

The use of ibuprofen during pregnancy is contraindicated, especially in the third trimester. Administration of ibuprofen may pose risks to the fetus, including potential cardiovascular and renal complications. Healthcare providers are advised to avoid prescribing ibuprofen during pregnancy unless the benefits clearly outweigh the associated risks.

When considering ibuprofen for pregnant patients, special precautions should be taken, particularly concerning the timing and dosage. Dosage modifications may be necessary, and healthcare providers should be consulted to ensure appropriate management tailored to the individual patient's needs.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment may require dosage adjustments to ensure safety and efficacy. It is essential to monitor renal function tests in these individuals to assess their kidney status. A reduced dose may be necessary for patients with decreased creatinine clearance to avoid potential toxicity. Additionally, caution is advised when administering ibuprofen to patients with renal impairment, as their altered pharmacokinetics may increase the risk of adverse effects.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established 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 the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate supportive care in the event of an overdose.

Nonclinical Toxicology

In animal studies, no teratogenic effects were observed; however, adverse developmental outcomes were noted at doses associated with maternal toxicity. Specifically, ibuprofen has been shown to cause gastrointestinal toxicity, renal toxicity, and reproductive toxicity in nonclinical studies.

While there was no increase in fetal malformations when ibuprofen was administered during pregnancy, there were indications of fetal harm at high doses, which suggests potential risks to fetal development. These findings underscore the importance of careful consideration of dosing and maternal health when using ibuprofen during pregnancy.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of ibuprofen. Reports have included gastrointestinal bleeding, renal impairment, and hypersensitivity reactions, which encompass anaphylaxis. Additionally, skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been documented.

Cardiovascular events, including myocardial infarction and stroke, have also been reported in association with ibuprofen use. Furthermore, liver enzyme elevations have been observed in some patients during postmarketing surveillance. Notably, cases of aseptic meningitis have been reported in patients receiving ibuprofen, particularly among those with systemic lupus erythematosus.

Patient Counseling

Patients should be advised to take ibuprofen with food or milk to minimize gastrointestinal irritation. It is important for patients to be informed about the potential for gastrointestinal bleeding, particularly if they have a history of ulcers or gastrointestinal bleeding. Healthcare providers should instruct patients to avoid alcohol while taking ibuprofen, as it may increase the risk of stomach bleeding.

Patients should be advised to consult their healthcare provider if they experience any signs of allergic reactions, such as rash, itching, or difficulty breathing. Additionally, they should be informed to seek medical attention if they experience symptoms of liver problems, including yellowing of the skin or eyes, dark urine, or persistent nausea.

Healthcare providers should emphasize the importance of keeping this medication out of the reach of children and advise patients to seek emergency medical help in the event of an overdose. Patients should also be instructed to inform their healthcare provider if they are pregnant, plan to become pregnant, or are breastfeeding.

Finally, patients should be advised to inform their healthcare provider of any other medications they are taking to avoid potential drug interactions.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It should be stored at room temperature, within the range of 20°C to 25°C (68°F to 77°F).

To ensure the integrity of the product, it must be protected from light exposure. Additionally, it is crucial to keep the container tightly closed to maintain its quality and efficacy. Proper adherence to these storage and handling guidelines is necessary for optimal product performance.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

FDA Insert (PDF)

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

View full prescribing information (PDF)