Ibuprofen

Description

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) available in the form of coated caplets. Each tablet contains 200 mg of ibuprofen, which serves as a pain reliever and fever reducer. The product is packaged in a container containing 100 capsule-shaped tablets.

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

Adults and children aged 12 years and over 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 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 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 a risk of severe stomach bleeding. The likelihood of experiencing 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.

NSAIDs, with the exception of aspirin, are linked to an increased risk of heart attack, heart failure, and stroke, which can be fatal. The risk is particularly elevated in patients who use these medications in excess of the recommended dosage or for prolonged 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 healthcare provider if any side effects occur. Side effects can be reported to the FDA at 1-800-FDA-1088. Additionally, medical advice should be sought if any of the following signs of stomach bleeding are observed: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. 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 develop.

Side Effects

Patients may experience a range of adverse reactions while using this product, which contains ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID).

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 this NSAID is associated with an increased 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, NSAIDs, excluding aspirin, have been linked to an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened with prolonged use or higher than recommended dosages. Patients should seek medical attention if they experience symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Patients are advised to discontinue use and consult a healthcare professional if they experience any adverse effects, if pain worsens or persists beyond 10 days, if fever worsens or lasts more than three days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

Before using this product, 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 recommended to seek medical advice 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 interact with several classes of medications, leading to significant clinical effects that warrant careful consideration.

Interactions with Antiplatelet Agents: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 in patients requiring aspirin for cardiovascular protection.

Interactions with Anticoagulants and Corticosteroids:The concomitant use of ibuprofen with anticoagulants or corticosteroids increases the risk of gastrointestinal bleeding. Clinicians should monitor patients closely for signs of bleeding and consider dosage adjustments or alternative therapies when prescribing ibuprofen alongside these agents.

Cardiovascular Risks with NSAIDs:The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, is associated with an elevated risk of cardiovascular events such as heart attack, heart failure, and stroke. This risk is particularly pronounced when NSAIDs are 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 mitigate 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 and children 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 not to exceed 6 caplets within a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, are at an increased risk of severe stomach bleeding. This risk is further heightened in individuals who have a history of stomach ulcers or bleeding problems, are concurrently using blood-thinning medications (anticoagulants) or steroid drugs, or are taking other medications that contain prescription or nonprescription nonsteroidal anti-inflammatory drugs (NSAIDs).

Additionally, the risk of stomach bleeding is amplified in geriatric patients who consume three or more alcoholic drinks daily while using this product, or who exceed the recommended dosage or duration of use.

Healthcare providers should exercise caution when prescribing this product to elderly patients, ensuring appropriate monitoring and consideration of potential drug interactions and contraindications. Dose modifications may be necessary based on the individual patient's health status and concurrent medication use.

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 prior to 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 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 are advised to call the Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial in mitigating 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 as they arise.

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 develop as a result of the overdose.

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

Adverse events have been reported voluntarily and through surveillance programs following the use of the product. Side effects may occur, and individuals are encouraged to report any adverse reactions to the FDA at 1-800-FDA-1088.

Reports have included symptoms indicative of serious conditions. Symptoms of stomach bleeding 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 may include chest pain, difficulty breathing, unilateral weakness, slurred speech, and leg swelling.

Other reported concerns involve pain that worsens or persists beyond 10 days, fever that intensifies or lasts more than 3 days, and the presence of redness or swelling in the area of pain. The emergence of any new symptoms has also been noted in postmarketing reports.

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 instructed 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 inform 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 made aware to stop use and consult a doctor 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 swelling in the legs. They should also be advised to seek medical advice if their pain worsens or persists for more than 10 days, if their fever intensifies or lasts longer 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 be counseled to take it with food or milk if they experience stomach upset. It is essential for patients to consult a doctor before use if the warning regarding stomach bleeding applies to them, or if they have a history of stomach problems such as heartburn. Patients should also be advised to seek medical advice if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke.

Furthermore, patients should be encouraged 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. It is also 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 diminish the benefits of aspirin. Lastly, patients should be advised 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 should be stored at a controlled room temperature of 20° to 25°C (68° to 77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). Proper storage conditions are essential to maintain the integrity and efficacy 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 trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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)