Ibuprofen

Description

Ibuprofen Tablets, 200 mg, are nonsteroidal anti-inflammatory drug (NSAID) formulations indicated for the relief of pain and reduction of fever. Each tablet is capsule-shaped and coated for ease of swallowing. The product is available in a carton containing 100 coated caplets, with the National Drug Code (NDC) 52605-120-01. The labeling for both the carton and bottle identifies the product as Thrulife Ibuprofen Tablets USP, 200 mg.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including backache, headache, menstrual cramps, minor pain of arthritis, muscular aches, the common cold, and toothache. Additionally, it is indicated for the temporary reduction of fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and older are advised to take 1 caplet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 caplet, a dosage of 2 caplets may be administered. It is imperative that the total daily dosage does not exceed 6 caplets within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is recommended to consult a doctor for appropriate dosing guidance.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any pain reliever or fever reducer. Additionally, administration is contraindicated immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

Ibuprofen may elicit severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response may include asthma (wheezing), blisters, facial swelling, hives, rash, shock, and skin reddening. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of stomach bleeding. The likelihood of experiencing this adverse effect is heightened in certain populations, including individuals aged 60 years or older, those with a history of severe stomach ulcers or bleeding disorders, and patients concurrently using anticoagulants or steroid medications. Additionally, the risk increases for individuals taking other NSAIDs (such as aspirin, ibuprofen, or naproxen) or consuming three or more alcoholic beverages daily while using this product. Prolonged use or exceeding the recommended dosage may further elevate the risk of stomach bleeding.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: feeling faint, vomiting blood, or experiencing bloody or black stools, which are potential indicators of stomach bleeding; worsening pain that persists beyond 10 days; fever that intensifies or lasts more than 3 days; exacerbation of stomach pain or upset; noticeable redness or swelling in the affected area; or the emergence of any new symptoms.

In cases of suspected overdose, immediate medical attention is required. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, some of which can be serious.

Severe allergic reactions have been reported, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may include asthma (wheezing), blisters, facial swelling, hives, rash, shock, and skin reddening. In the event of an allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

The use of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for potential stomach bleeding. The risk of this serious adverse effect is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily while using the product, or exceed the recommended dosage or duration of use.

Patients should be instructed to stop using ibuprofen and consult a healthcare professional if they experience symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, or passing black or bloody stools. Additionally, they should seek medical advice if pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, stomach discomfort increases or continues, redness or swelling occurs in the painful area, or any new symptoms arise.

Before using ibuprofen, patients should consult a doctor if they have a history of serious side effects from pain relievers or fever reducers, ongoing stomach issues (such as heartburn or stomach pain), ulcers, bleeding disorders, high blood pressure, heart or kidney disease, have taken a diuretic, or are 60 years of age or older.

Furthermore, patients should seek guidance from a doctor or pharmacist if they are currently taking other NSAIDs (either prescription or over-the-counter), anticoagulants, or steroid medications, are under medical care for serious conditions, or are using aspirin for cardiovascular protection, as ibuprofen may diminish the effectiveness of aspirin in these contexts.

Drug Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attacks or strokes. Therefore, concurrent use of ibuprofen with aspirin for these indications should be approached with caution.

The concomitant use of ibuprofen with anticoagulants or steroid medications may elevate the risk of gastrointestinal bleeding. It is advisable to monitor patients closely for signs of bleeding and consider dosage adjustments or alternative therapies as necessary.

Additionally, the use of other nonsteroidal anti-inflammatory drugs (NSAIDs), whether prescription or over-the-counter, should be discussed with a healthcare professional prior to initiation. This is to ensure safety and to evaluate the need for any adjustments in therapy.

Packaging & NDC

Below are the non-prescription pack sizes of Ibuprofen. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 1 caplet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 caplet, a dose of 2 caplets may be administered. It is important to note that the maximum dosage should not exceed 6 caplets in a 24-hour period, unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of stomach bleeding associated with the use of this medication. It is essential for healthcare providers to exercise caution when prescribing this treatment to geriatric patients.

Before initiating therapy, it is advisable for elderly patients to consult with their healthcare provider, especially if they are 60 years of age or older. This precautionary measure is crucial to ensure appropriate monitoring and to evaluate the potential risks versus benefits of the medication in this population.

Healthcare providers should remain vigilant regarding the safety profile of the medication in elderly patients and consider any necessary dose adjustments or additional monitoring to mitigate the risk of adverse effects.

Pregnancy

Pregnant patients are advised to consult a healthcare professional prior to using this medication. It is particularly important to avoid the use of ibuprofen during the last trimester of pregnancy unless specifically directed by a physician. The use of ibuprofen in this period may pose risks to the developing fetus and could lead to complications during delivery. Therefore, careful consideration and professional guidance are essential for women of childbearing potential when contemplating the use of this medication during pregnancy.

Lactation

Lactating mothers are advised to consult a healthcare professional before using this medication. It is particularly important to avoid the use of ibuprofen during the last three months of pregnancy unless explicitly directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data provided regarding the excretion of ibuprofen in breast milk or its effects on breastfed infants. Therefore, healthcare providers should carefully consider the potential risks and benefits when recommending this medication to lactating mothers.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

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 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 available information.

Overdosage

Overdosage of ibuprofen can result in significant health risks. Healthcare professionals should be aware of the potential symptoms and management strategies associated with such incidents.

Symptoms of Overdose Patients experiencing an ibuprofen overdose may present with a range of symptoms, including nausea, vomiting, stomach pain, drowsiness, headache, and confusion. These symptoms can vary in severity depending on the amount ingested and the individual’s health status.

Severe Complications In more severe cases, an overdose can lead to critical complications such as kidney failure, liver damage, and gastrointestinal bleeding. These conditions require immediate medical intervention and can have serious long-term consequences if not addressed promptly.

Recommended Actions If an overdose is suspected, it is imperative to seek emergency medical attention without delay. Prompt evaluation and treatment are essential to mitigate the risks associated with ibuprofen overdosage and to manage any arising complications effectively.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no specific details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. These include gastrointestinal bleeding, renal impairment, hepatic impairment, anaphylactic reactions, and skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis. Additionally, cardiovascular events, including heart attack and stroke, have been reported.

Further safety updates from postmarketing experience indicate an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke. There is also a noted risk of serious gastrointestinal adverse events, which may include bleeding, ulceration, and perforation of the stomach or intestines. These gastrointestinal events can occur at any time during use and may present without warning symptoms.

Reports of adverse reactions have been received; however, the frequency of these events remains unknown.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. Patients should be informed of the signs of potential stomach bleeding, which include feeling faint, vomiting blood, or experiencing bloody or black stools. They should be counseled to monitor their pain levels, and if pain worsens or persists for more than 10 days, or if fever intensifies or lasts longer than 3 days, they should contact their healthcare provider.

Patients should also be made aware that if they experience worsening stomach pain or upset, or if they notice redness or swelling in a painful area, they should report these symptoms. Any new symptoms that arise should be discussed with their healthcare provider.

To minimize gastrointestinal discomfort, patients are advised to take the medication with food or milk. It is important to inform patients that long-term continuous use of the medication may increase the risk of heart attack or stroke.

Healthcare providers should inquire about the patient's medical history, particularly if they have experienced problems or serious side effects from pain relievers or fever reducers, or if they have a history of stomach issues such as ulcers, heartburn, or persistent stomach pain. Patients with bleeding problems, high blood pressure, heart or kidney disease, or those who have taken diuretics should be closely monitored.

Special attention should be given to patients aged 60 or older, as well as those taking other medications containing NSAIDs, blood thinners (anticoagulants), or steroids. Patients under a physician's care for serious conditions should be advised to discuss their medication regimen with their healthcare provider. Additionally, patients taking aspirin for heart attack or stroke prevention should be informed that ibuprofen may diminish the effectiveness of aspirin.

Finally, healthcare providers should encourage patients to disclose all medications they are currently taking to ensure safe and effective use of the medication.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the seal under the bottle cap is broken or missing, as this may compromise the product's safety and effectiveness. Proper handling and storage conditions are essential to ensure the quality of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to consult a health professional prior to use if they are pregnant or breastfeeding. It is particularly crucial to avoid ibuprofen during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Information (PDF)

This file contains official product information for Ibuprofen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)