Ibuprofen

Description

Ibuprofen Tablets contain 200 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. These tablets are designed for oral administration and are available in a coated form. The product is supplied in a bulk package containing 1000 coated tablets, allowing for convenient dispensing and use. Ibuprofen is comparable to the active ingredient found in ADVIL®.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, minor pain of arthritis, toothache, backache, the common cold, and menstrual cramps. 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 tablet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 tablet, a dosage of 2 tablets may be administered. It is imperative that the total daily dosage does 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 recommended to consult a doctor for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, it should not be administered immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response may 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 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.

Furthermore, NSAIDs, excluding 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 the medication in excess of the recommended dosage or for extended periods.

In cases of overdose, immediate medical attention is required. Healthcare professionals should advise patients to contact a Poison Control Center or seek emergency medical help without delay (1-800-222-1222).

Patients should be instructed to discontinue use and consult a physician if they experience any signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. 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 may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Severe allergic reactions have been reported, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a significant risk of severe stomach bleeding. This risk is heightened 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 while using the product, or exceed the recommended dosage or duration of use.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who use the medication in excess of the recommended guidelines.

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

Before using ibuprofen, patients should consult a healthcare provider if they have a history of serious side effects from pain relievers or fever reducers, if the stomach bleeding warning applies to them, or if they have a history of stomach issues such as heartburn. Those with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also seek medical advice prior to use. Additionally, patients taking diuretics or aspirin for heart attack or stroke should consult a healthcare professional, as ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. This interaction is particularly relevant for patients who are prescribed aspirin for these indications, as the concurrent use of ibuprofen could potentially reduce the efficacy of aspirin therapy.

Patients are advised to consult with a healthcare professional, such as a doctor or pharmacist, prior to using ibuprofen if they are currently taking any other medications. This precaution is essential to ensure safe and effective use of ibuprofen in conjunction with other therapies, as potential interactions may vary based on individual patient circumstances and medication regimens.

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 while symptoms persist. If pain or fever does not adequately respond to 1 tablet, 2 tablets may be administered. It is important not to exceed 6 tablets in 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 consider this heightened risk when prescribing and monitoring treatment in this population.

Additionally, nonsteroidal anti-inflammatory drugs (NSAIDs), with the exception of aspirin, are associated with an elevated risk of cardiovascular events, including heart attack, heart failure, and stroke. This risk is further amplified in elderly patients who exceed the recommended dosage or duration of use. Therefore, careful assessment of the benefits and risks, along with appropriate dosage adjustments and close monitoring, is advised for geriatric patients receiving NSAID therapy.

Pregnancy

Pregnant patients and women of childbearing potential should consult a healthcare professional before using this medication. The use of ibuprofen is particularly cautioned against after 20 weeks of pregnancy, as it may pose risks to the unborn child and lead to complications during delivery. It is essential for healthcare providers to evaluate the necessity and potential risks associated with ibuprofen use in this population. Additionally, breastfeeding patients should also seek medical advice prior to use.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of ibuprofen at 20 weeks of gestation or later unless specifically 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 weigh the potential benefits against any risks when considering the use of this medication in lactating mothers.

Renal Impairment

Patients with renal impairment may require careful consideration regarding dosing adjustments and monitoring. It is essential to assess renal function prior to initiating treatment, particularly in those with a history of kidney disease or other comorbidities such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke. Regular monitoring of renal function is recommended to ensure the safe and effective use of the medication in this population. Adjustments to the dosing regimen may be necessary based on the degree of renal impairment to mitigate the risk of adverse effects and optimize therapeutic outcomes.

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 parameters throughout the course of therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects due to impaired drug metabolism. Close monitoring of liver function tests is recommended to ensure safety and efficacy.

Additionally, patients with a history of liver disease, including cirrhosis, should be evaluated for potential contraindications related to their hepatic status. It is advised that healthcare providers consider the overall clinical picture, including any coexisting conditions such as high blood pressure, heart disease, kidney disease, asthma, or a history of stroke, when determining the appropriate treatment regimen for patients with compromised liver function.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential to determine the appropriate course of action.

Management procedures may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement emergency protocols as necessary to ensure patient safety and optimal outcomes.

Nonclinical Toxicology

It is especially important not to use ibuprofen at 20 weeks or later in 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 details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

During postmarketing use of ibuprofen, the following adverse reactions have been reported voluntarily or through surveillance programs:

Allergic reactions have been noted, including cases of anaphylaxis and serious skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Cardiovascular events, including heart attack and stroke, have also been documented. Gastrointestinal complications, such as bleeding, ulceration, and perforation, have been reported.

Liver injury, characterized by elevated liver enzymes and hepatitis, has been observed, along with renal injury, which includes acute renal failure and interstitial nephritis. Hematologic reactions, such as thrombocytopenia and aplastic anemia, have been identified. Central nervous system effects, including headache, dizziness, and aseptic meningitis, have been reported. Additionally, respiratory reactions, particularly asthma exacerbation, and various skin reactions, including rash, pruritus, and urticaria, have been documented.

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. It is recommended that patients take the medication with food or milk if they experience stomach upset.

Patients should be encouraged to consult with their doctor prior to use if they have experienced problems or serious side effects from pain relievers or fever reducers. Additionally, it is important for patients to discuss with their healthcare provider if the warning regarding stomach bleeding applies to them, especially if they have a history of stomach issues such as heartburn.

Healthcare providers should also inquire about the patient's medical history, specifically if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if they have previously suffered a stroke. Patients taking diuretics should be advised to consult their doctor before using the medication.

Furthermore, patients should be informed to speak with their doctor or pharmacist if they are taking aspirin for heart attack or stroke, as ibuprofen may reduce the effectiveness of aspirin in these cases. It is also prudent for patients to consult their healthcare provider or pharmacist if they are under care for any serious condition or if they are taking any other medications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20-25°C (68-77°F). Care should be taken to avoid exposure to high humidity and excessive heat, particularly temperatures exceeding 40°C (104°F). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

Patients aged 12 years and older are advised to take one tablet of the medication orally every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to one tablet, two tablets may be taken; however, the total dosage should not exceed six tablets within a 24-hour period unless directed by a healthcare professional. For children under 12 years, consultation with a doctor is recommended prior to administration.

Clinicians should counsel patients on the importance of consulting a healthcare professional if they are pregnant or breastfeeding, particularly noting that ibuprofen should generally be avoided after 20 weeks of pregnancy unless specifically directed by a doctor due to potential risks to the unborn child or complications during delivery. Additionally, patients should be reminded to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose.

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)