Ibuprofen

Description

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) with a dosage strength of 200 mg per softgel. It is indicated for the relief of pain and reduction of fever. Each package contains 80 liquid-filled capsules, designed for oral administration.

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

The medication should be administered orally, with capsules taken every 4 to 6 hours as needed while symptoms persist. For adults and children aged 12 years and older, the recommended dosage is 1 capsule per administration. If pain or fever does not adequately respond to 1 capsule, a maximum of 2 capsules may be taken. It is imperative that the total dosage does not exceed 6 capsules 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 doctor before administration. The smallest effective dose should always be utilized, and patients should not exceed the recommended dosage.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any other 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 induce 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.

As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries a risk of severe gastrointestinal bleeding. This risk 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. Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is amplified with prolonged or excessive use.

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

Furthermore, it is essential for patients to inform their healthcare provider or pharmacist if they are under treatment for any serious medical condition, are using aspirin for cardiovascular protection, or are taking any other medications.

In the case of an allergic reaction, patients must stop using ibuprofen and seek emergency medical help immediately. In instances of overdose, it is crucial to contact a Poison Control Center or seek medical assistance without delay.

Patients should discontinue use and consult a physician if they experience any side effects, which can be reported to the FDA at 1-800-FDA-1088. Signs of potential gastrointestinal bleeding include feeling faint, vomiting blood, passing bloody or black stools, or experiencing 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. Additionally, 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, patients should seek medical advice promptly.

Side Effects

Patients may experience a range of adverse reactions associated with the use of ibuprofen. Serious adverse reactions include severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters, particularly in individuals with a known allergy to aspirin.

Additionally, ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for the potential of severe stomach bleeding. The risk of this serious adverse reaction 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.

The use of NSAIDs, excluding aspirin, is also 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 directed dosage or for prolonged periods.

Patients are advised to discontinue use and consult a healthcare professional if they experience any side effects, especially signs indicative of stomach bleeding such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Symptoms suggestive 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 pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 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 stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also important for patients taking diuretics or those under medical care for serious conditions to seek guidance prior to use. Additionally, patients taking aspirin for heart attack or stroke should be aware that 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.

Pharmacodynamic Interactions

• Aspirin: The concurrent use of ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. It is advisable for patients to consult their healthcare provider regarding the timing and necessity of these medications.

• Anticoagulants and Steroids: The use of ibuprofen in conjunction with anticoagulants or steroid medications increases the risk of gastrointestinal bleeding. Patients should be closely monitored for signs of bleeding and may require dosage adjustments or alternative therapies.

• Other NSAIDs: Co-administration of ibuprofen with other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and over-the-counter options such as aspirin and naproxen, heightens the risk of stomach bleeding. It is recommended that patients avoid using multiple NSAIDs simultaneously.

Pharmacokinetic Interactions

• Diuretics: Patients on diuretic therapy should seek medical advice before initiating ibuprofen, as the combination may lead to reduced diuretic efficacy or increased risk of renal impairment. Monitoring of renal function and blood pressure may be necessary during concurrent use.

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 capsule every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 capsule, 2 capsules may be administered. It is important not to exceed 6 capsules 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. This risk necessitates careful consideration when prescribing and monitoring treatment in this population. The warning regarding stomach bleeding is specifically applicable to individuals within this age group.

Additionally, the risk of cardiovascular events, including heart attack, heart failure, and stroke, is heightened in geriatric patients who exceed the recommended dosage or duration of use. Therefore, it is crucial for healthcare providers to evaluate the appropriateness of treatment regimens in elderly patients, ensuring that they adhere to prescribed guidelines.

Furthermore, it is advisable for elderly patients to consult with their healthcare provider prior to use if they have a history of high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or prior stroke, as these conditions may be more prevalent in this demographic. Close monitoring and potential dose adjustments may be warranted to mitigate risks and ensure patient safety.

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 during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of ibuprofen during the last three months of pregnancy 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 available 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 while breastfeeding.

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. 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, as timely medical support can significantly influence outcomes. Symptoms of overdose 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 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

During postmarketing use of ibuprofen, various adverse reactions have been reported voluntarily or through surveillance programs. These include allergic reactions such as anaphylaxis and serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Cardiovascular events, including heart attack and stroke, have also been noted.

Gastrointestinal complications such as bleeding, ulceration, and perforation have been documented. Reports of liver damage, including hepatitis and liver failure, have emerged. Additionally, renal toxicity, characterized by acute kidney injury and interstitial nephritis, has been observed. Hematologic reactions, including thrombocytopenia and aplastic anemia, have been reported as well.

Exacerbation of asthma and other respiratory conditions has been noted among users. Other reactions include dizziness, headache, and tinnitus.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed to stop using the medication and consult a doctor if they experience any side effects. They may also report side effects to the FDA at 1-800-FDA-1088. It is important to instruct patients to discontinue use and seek medical attention if they notice signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve.

Additionally, patients should be advised to stop use and consult a doctor 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. They should also be instructed to seek medical advice if their pain worsens or persists for more than 10 days, if their fever worsens or lasts more than 3 days, or if there is redness or swelling in the area of pain. Patients should be encouraged to report any new symptoms to their healthcare provider.

When using this product, patients should take it with food or milk if they experience stomach upset. Healthcare providers should ask patients if the stomach bleeding warning applies to them and advise them to consult a doctor before use if they have a history of stomach problems, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke.

Patients should also be advised to consult a doctor before use if they are taking a diuretic or if they are under a doctor's care for any serious condition. Furthermore, it is important to inform patients to speak with a doctor or pharmacist before using this medication if they are taking aspirin for heart attack or stroke, as ibuprofen may reduce the effectiveness of aspirin. Lastly, patients should be encouraged to consult a doctor or pharmacist before use if they are taking any other medications.

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 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F), to maintain product integrity. Proper storage conditions are crucial for ensuring the efficacy and safety of the product.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid ibuprofen during the last three months 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)