Ibuprofen

Description

Ibuprofen Tablets USP contain 200 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. Each bottle contains 100 tablets. The product is identified by the National Drug Code (NDC) 70729-291-12.

Uses and Indications

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

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and not exceed the directed amount. The smallest effective dose should be utilized to manage symptoms effectively.

For adults and children aged 12 years and older, the recommended dosage is 1 tablet taken orally every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 tablet, a maximum of 2 tablets may be administered. However, the total dosage must not exceed 6 tablets within a 24-hour period unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a physician before administration.

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 cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. 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 is associated with an increased risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are concurrently using blood thinners (anticoagulants) or steroid medications, are taking other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use.

NSAIDs, with the exception of aspirin, are linked to an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in individuals who use these medications in excess of the recommended dosage or for extended periods.

Healthcare professionals should advise patients to consult a physician prior to use if any of the following conditions apply: a history of stomach bleeding, previous adverse reactions to pain relievers or fever reducers, a history of gastrointestinal issues such as heartburn, or pre-existing conditions including high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Additionally, patients taking diuretics should seek medical advice before use.

Patients should also be cautioned to consult a doctor or pharmacist before using ibuprofen if they are under medical care for any serious condition, are taking aspirin for the prevention of heart attack or stroke (as ibuprofen may diminish the cardioprotective effects of aspirin), or are using any other medications.

In the event of an allergic reaction, it is crucial to stop using the product and seek emergency medical help immediately. In cases of overdose, medical assistance should be sought or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Patients should discontinue use and contact a healthcare provider if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical attention. Patients should also seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs in the affected area, or if any new symptoms arise.

Side Effects

Patients using ibuprofen should be aware of potential adverse reactions, which can range from serious to common.

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

The use of ibuprofen carries a risk of severe stomach bleeding, particularly in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily, or exceed the recommended dosage or duration of use. Patients should be vigilant for signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additionally, ibuprofen is associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened when the medication is used in excess of the recommended dosage or for prolonged periods. Patients should seek medical advice if they experience symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Common adverse reactions may include worsening pain that lasts longer than 10 days, fever that persists beyond three days, or the presence of redness or swelling in the affected area. Patients are encouraged to consult a healthcare professional if any new symptoms arise.

Before using ibuprofen, patients should consult a doctor if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also advisable to seek medical guidance if they are under a doctor's care for any serious condition, are taking aspirin for cardiovascular protection, or are using any other medications.

Drug Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. It is advisable to avoid concurrent use of ibuprofen with aspirin in patients who are taking aspirin for cardiovascular protection. Monitoring for efficacy of aspirin therapy is recommended if ibuprofen must be used in such patients.

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 tablet every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to 1 tablet, 2 tablets may be administered. It is important not to exceed 6 tablets within a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding when using this medication. It is essential for healthcare providers to exercise caution and monitor these patients closely for any signs of gastrointestinal bleeding.

Additionally, the risk of serious cardiovascular events, including heart attack, heart failure, and stroke, is heightened in elderly patients who exceed the recommended dosage or duration of use. Therefore, it is crucial to adhere strictly to prescribed dosages and treatment timelines.

Healthcare providers should advise elderly patients to consult with a physician prior to use if they have a history of stomach ulcers or bleeding problems. This precaution is vital to ensure the safe administration of the medication and to mitigate potential risks associated with its use in this population.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. It is especially important to avoid the use of ibuprofen during the last trimester unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should weigh the potential benefits against the risks when considering the use of this medication in pregnant patients.

Lactation

Lactating mothers are advised to consult a health professional before using this medication while breastfeeding. It is particularly important to avoid the use of ibuprofen during the last three months of pregnancy unless specifically directed by a healthcare provider, 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, caution is recommended when considering the use of this medication in lactating individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke, as these factors may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication. It is essential to assess liver function prior to initiating treatment and to monitor liver function periodically during therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary, and careful consideration should be given to the severity of hepatic impairment when determining the appropriate dose. Patients with significant liver disease may require closer monitoring for efficacy and safety, as the risk of adverse effects may be increased.

Additionally, patients with a history of liver cirrhosis should be evaluated for potential drug interactions and contraindications, particularly if they also have comorbid conditions such as high blood pressure, heart disease, kidney disease, asthma, or a history of stroke. Regular assessment of liver function tests is recommended to ensure ongoing safety and effectiveness of the treatment regimen in this population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial to mitigate potential adverse effects associated with an overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may arise during the course of treatment.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings 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 ibuprofen. Reports include gastrointestinal bleeding, renal impairment, and elevations in liver enzymes. Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been documented. Additionally, cases of cardiovascular events, including myocardial infarction and stroke, have been reported. Some patients have experienced allergic reactions, including anaphylaxis and angioedema. Furthermore, elevated blood pressure has been noted in certain patients using ibuprofen.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. Patients should be informed to take the medication with food or milk if they experience stomach upset.

It is essential for healthcare providers to encourage patients to consult a doctor before use if any of the following conditions apply: a history of stomach bleeding, previous serious side effects from pain relievers or fever reducers, or existing stomach issues such as heartburn. Additionally, patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also seek medical advice prior to use. Patients taking diuretics should be particularly cautious and consult their healthcare provider.

Patients should be instructed to ask a doctor or pharmacist before using the medication if they are under medical care for any serious condition, taking aspirin for heart attack or stroke (as ibuprofen may reduce the effectiveness of aspirin), or using any other medications.

Healthcare providers should inform patients to discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Furthermore, patients should be advised to stop use and seek medical attention if they exhibit symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling.

Patients should also be counseled to stop using the medication and consult a healthcare provider if their pain worsens or persists for more than 10 days, if their fever worsens or lasts more than 3 days, if there is redness or swelling in the painful area, or if any new symptoms arise.

Storage and Handling

The product is supplied in various configurations, with specific NDC numbers available for reference. It should be stored at a temperature range of 20˚-25˚C (68˚-77˚F) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40˚C (104˚F).

For proper identification, the expiration date and lot number can be found on the end flap of the carton. It is essential to adhere to the "use by" expiration date indicated on the package, which includes the vial card, vial label, and the label itself.

Additional Clinical Information

No further data are available.

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)