Ibuprofen

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the text.

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 known allergy to ibuprofen or any other pain reliever/fever reducer, due to the risk of severe allergic reactions. Additionally, the product should not be administered immediately before or after heart surgery, as it may interfere with postoperative recovery and increase the risk of complications.

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

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 carries a 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 taking anticoagulants or steroid medications, are using 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, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is amplified when the medication is used in excess of the recommended dosage or for prolonged periods.

Healthcare professionals should advise patients to consult a physician prior to using ibuprofen if they have experienced problems or serious side effects from pain relievers or fever reducers, if the stomach bleeding warning is applicable, or if they have a history of gastrointestinal issues such as heartburn. Additionally, patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should seek medical advice before use. Patients taking diuretics should also consult a healthcare provider.

It is crucial for patients to discuss their use of aspirin for heart attack or stroke prevention with their healthcare provider, as ibuprofen may diminish the cardioprotective effects of aspirin. Furthermore, patients under medical supervision for serious conditions or those taking other medications should seek guidance from a doctor or pharmacist before using ibuprofen.

In the event of an allergic reaction, patients should stop taking ibuprofen and seek emergency medical help immediately. In cases of overdose, it is essential to contact a Poison Control Center or seek medical assistance without delay (1-800-222-1222).

Patients should discontinue use and contact their 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, they should seek medical attention if they exhibit symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling. Patients should also consult a physician if their 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 this product 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 hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, patients should discontinue use immediately and seek medical assistance.

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a 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, or exceed the recommended dosage or duration of use. Patients should be vigilant for signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

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 dosage or for extended periods.

Patients are advised to stop using the product and consult a healthcare professional if they experience any of the following: worsening pain lasting more than 10 days, fever that worsens or persists beyond three days, redness or swelling in the affected area, or the emergence of any new symptoms. Signs indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention.

Before using this product, 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 conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also advisable to seek medical advice if taking aspirin for heart attack or stroke, as ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

Ibuprofen may interact with several classes of medications, leading to significant clinical effects that warrant careful consideration.

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and Aspirin Ibuprofen has the potential to diminish the cardioprotective effects of aspirin when both medications are taken concurrently for the prevention of heart attack or stroke. It is advisable to avoid the simultaneous use of ibuprofen and aspirin for these indications to ensure optimal therapeutic outcomes.

Anticoagulants and Corticosteroids The concomitant use of ibuprofen with anticoagulants or corticosteroids may elevate the risk of gastrointestinal bleeding. Clinicians should monitor patients closely for signs of bleeding and consider dosage adjustments or alternative therapies as necessary to mitigate this risk.

General Risks Associated with NSAIDs The use of NSAIDs, including ibuprofen, is associated with an increased risk of cardiovascular events such as heart attack, heart failure, and stroke. This risk is particularly pronounced when ibuprofen is used in higher doses or for extended periods. It is recommended that healthcare providers assess the necessity of ibuprofen therapy and consider the lowest effective dose for the shortest duration possible to minimize these risks.

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 within a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. Therefore, it is essential to monitor these patients closely for any signs of gastrointestinal bleeding.

In managing treatment for geriatric patients, it is recommended to prescribe the smallest effective dose and to avoid exceeding the recommended dosage. This precaution is particularly important given the heightened sensitivity of older adults to potential adverse effects. Regular assessment and vigilance in monitoring are advised to ensure the safety and well-being of elderly patients during treatment.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of ibuprofen after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully consider the potential risks and benefits when prescribing this medication to pregnant patients, especially in the later stages of pregnancy.

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 this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use during lactation.

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 should consult a healthcare professional prior to use, particularly if they have a history of liver cirrhosis. It is essential for these patients to discuss their liver function status, as compromised liver function may influence the safety and efficacy of the treatment. Monitoring of liver function may be warranted in this population to ensure appropriate management and to mitigate potential risks associated with the use of the medication.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved, and it is essential to monitor the patient closely for any signs of adverse reactions.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should ensure that the patient is stabilized and may need to implement specific protocols based on the substance taken. Continuous assessment and monitoring of vital signs are recommended to guide further treatment decisions.

In summary, prompt action and appropriate medical intervention are vital in the management of overdose cases to mitigate potential complications and ensure patient safety.

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

Postmarketing experience has identified several adverse reactions associated with the use of the product. These include gastrointestinal bleeding, renal impairment, liver enzyme elevations, and hypersensitivity reactions, which may manifest as anaphylaxis. Additionally, skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported. Cardiovascular events, including heart attack and stroke, have also been noted.

Further safety information derived from postmarketing data indicates occurrences of elevated blood pressure, fluid retention, and exacerbation of heart failure. It is advised that healthcare professionals monitor patients for these adverse reactions, particularly in individuals with pre-existing conditions or those concurrently using other medications that may heighten the risk of such events.

Patient Counseling

Patients should be advised to keep this medication out of reach of children. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients must be informed not to use this medication if they have ever experienced an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, it should not be used right before or after heart surgery.

Healthcare providers should instruct patients to stop using the medication 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 stomach pain that does not improve. Patients should also be advised to seek medical attention if they exhibit symptoms of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs.

Patients should be counseled to discontinue use and consult a healthcare professional 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.

When using this product, patients should take it with food or milk if they experience stomach upset. It is important for patients to ask a doctor before use if they have a history of problems or serious side effects from taking pain relievers or fever reducers, or if the stomach bleeding warning applies to them.

Patients with a history of stomach problems, such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also consult a doctor before use. Furthermore, patients taking a diuretic or those under a doctor's care for any serious condition should seek medical advice prior to using this medication.

Lastly, patients should be encouraged to consult a doctor or pharmacist before use if they are taking aspirin for heart attack or stroke, as ibuprofen may diminish the benefits of aspirin. It is also advisable for patients to discuss any other medications they are taking with their healthcare provider or pharmacist.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25ºC (68-77ºF) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

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)