Ibuprofen

Description

The product is identified by the SPL code 34089-3 and is described as a 600R-Timely-Ibuprofen Caplet, packaged in a quantity of 50 caplets per label.

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 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 is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, the product 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 such reactions 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 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 increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk escalates with the use of higher doses or prolonged treatment.

Healthcare professionals should advise patients to discontinue use and consult a physician 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, patients should seek medical attention if they exhibit symptoms of a heart problem or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling. Patients should also be instructed to consult a healthcare provider 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.

In cases of overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Side Effects

Patients may experience a range of adverse reactions associated with the use of 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.

There is a significant risk of severe stomach bleeding associated with the use of this NSAID, especially 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, the use of NSAIDs, excluding aspirin, has been linked to an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened when the medication is used in higher doses or for extended periods. 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.

Common adverse reactions may include worsening pain lasting more than 10 days, fever persisting beyond three days, redness or swelling in the affected area, or the emergence of any new symptoms.

Patients are advised to consult a healthcare professional prior to use if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a previous stroke. It is also recommended that patients under a doctor's care for any serious condition or those taking aspirin for cardiovascular protection consult with a healthcare provider, 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.

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 for these indications to ensure optimal therapeutic outcomes.

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 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, specifically those aged 60 and older, are at an increased risk of severe stomach bleeding. It is essential for healthcare providers to advise these patients to consult a physician prior to use if they have a history of stomach issues, such as heartburn, or if they have comorbid conditions including high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke.

Additionally, the risk of heart attack and stroke is heightened in geriatric patients who exceed the recommended dosage or duration of use. Therefore, careful monitoring and adherence to prescribed dosages are crucial in this population to mitigate potential adverse effects.

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 evaluate the potential benefits and risks when considering the use of ibuprofen in pregnant patients, especially in the later stages of pregnancy.

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 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, healthcare providers should weigh the potential benefits against the risks when considering this medication for lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Continuous assessment and supportive care are critical in managing the patient's condition effectively.

Healthcare professionals are encouraged to consult local poison control centers or toxicology experts for guidance on the management of overdose cases, ensuring that appropriate interventions are undertaken promptly.

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 reported voluntarily or through surveillance programs.

Cardiovascular events, including heart attack and stroke, have been noted. Gastrointestinal complications such as bleeding, ulceration, and perforation have also been reported. Renal toxicity, encompassing acute renal failure, has been observed, alongside hepatic toxicity characterized by elevated liver enzymes and instances of liver failure.

Severe allergic reactions, including anaphylaxis and angioedema, have been documented. Additionally, skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported. Other serious adverse reactions include respiratory and hematologic reactions.

Patient Counseling

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

Patients must be informed not to use this medication if they have a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, it should not be used immediately before or after heart surgery.

Healthcare providers should counsel 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. Patients should also be advised to stop use and seek medical attention if they exhibit symptoms indicative of a heart problem 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 instructed to stop using the medication 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 be advised to take it with food or milk if they experience stomach upset. Healthcare providers should encourage patients to consult a doctor before use if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them.

Patients should also be advised to seek medical advice before using this medication if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is important to recommend that patients 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, patients should be informed to consult a doctor or pharmacist before using this medication if they are taking aspirin for heart attack or stroke, as ibuprofen may diminish the effectiveness of aspirin. Lastly, patients should be encouraged to discuss any other medications they are taking with their healthcare provider or pharmacist prior to use.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at a controlled room temperature of 20-25°C (68-77°F) to maintain its efficacy and safety.

To ensure proper handling, the product should be kept out of reach of children. Additionally, it is important to discard the product after opening to prevent any potential contamination or degradation.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. It is particularly critical to avoid ibuprofen after 20 weeks 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)