Ibuprofen

Description

Ibuprofen 200 mg is presented as a round, brown tablet. It is available in various packaging configurations, including bottles and cartons. The product is offered in the following quantities: 24, 50, 100, 200, and 500 tablets per container. The labeling for the product includes specific identifiers for each packaging type, such as "601R-Rite Aid-Ibuprofen" followed by the dosage and form.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including backache, headache, menstrual cramps, minor pain of arthritis, muscular aches, the common cold, and toothache. 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, due to the risk of severe hypersensitivity 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.

Warnings and Precautions

Ibuprofen is associated with several significant warnings and precautions that healthcare professionals must consider to ensure patient safety.

Allergy Alert Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction can include asthma (wheezing), blisters, facial swelling, hives, rash, shock, and skin reddening. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

Stomach Bleeding Warning As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries a risk of stomach bleeding. This risk is heightened in patients who meet any of the following criteria: those aged 60 years or older, individuals with a history of stomach ulcers or bleeding disorders, patients concurrently using anticoagulants or steroid medications, those taking other NSAIDs (including aspirin, ibuprofen, naproxen, or others), individuals consuming three or more alcoholic beverages daily while using this product, or those exceeding the recommended dosage or duration of use.

Heart Attack and Stroke Warning The use of NSAIDs, excluding aspirin, is associated with 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 beyond the recommended duration.

Monitoring and Consultation Healthcare professionals should advise patients to discontinue ibuprofen and consult a physician if they experience any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, patients should seek medical advice if they exhibit signs of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Patients should also be instructed to stop use and consult a healthcare provider if pain worsens or persists beyond 10 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs in the affected area, or if any new symptoms arise.

Emergency Medical Help In cases of overdose, immediate medical attention is required. Patients or caregivers should contact a Poison Control Center or seek emergency medical help without delay (1-800-222-1222).

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Serious adverse reactions include severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may manifest as asthma (wheezing), blisters, facial swelling, hives, rash, shock, or skin reddening. Additionally, the use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a risk of stomach bleeding, 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.

The risk of cardiovascular events, including heart attack, heart failure, and stroke, is also heightened with NSAID use, excluding aspirin. These events can be fatal and are more likely to occur with prolonged use or higher than recommended dosages.

Common adverse reactions may include gastrointestinal symptoms such as stomach pain, which may indicate potential bleeding. Patients should be advised to discontinue use and seek medical attention if they experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or 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 consultation.

Patients are encouraged to consult a healthcare professional prior to using ibuprofen 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 pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Furthermore, individuals taking aspirin for cardiovascular protection should seek medical advice, as ibuprofen may diminish the efficacy of aspirin in this context.

In clinical trials and postmarketing experiences, it is essential for patients to monitor their symptoms closely and report any new or worsening conditions, including pain lasting more than 10 days or fever persisting beyond three days, as well as any redness or swelling in the affected area.

Drug Interactions

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

Interactions with 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 this purpose to ensure optimal therapeutic outcomes.

Interactions with Anticoagulants and Steroids The concomitant use of ibuprofen with anticoagulants or steroid medications increases 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.

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 NSAID 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 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, particularly those aged 60 and older, are at an increased risk for stomach bleeding. This heightened risk necessitates careful monitoring and consideration when prescribing medications that may contribute to gastrointestinal complications.

Additionally, the risk of serious cardiovascular events, including heart attack, heart failure, and stroke, is elevated in older adults, especially when medications are used in excess or for prolonged periods. Therefore, it is crucial to adhere strictly to prescribed dosages and durations to mitigate these risks.

For elderly patients who experience stomach upset, it is recommended that medications be taken with food or milk, as this may help alleviate gastrointestinal discomfort, which can be more pronounced in this population.

When prescribing to geriatric patients, the smallest effective dose should be utilized. This precaution is particularly important given the potential for increased sensitivity to medications and the presence of comorbidities.

Healthcare providers should also advise elderly patients to consult with their physician if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or a previous stroke. These conditions are more prevalent in older adults and may influence the safety and efficacy of 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 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 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 this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use in lactating individuals.

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 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 initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that particular substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

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

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs.

Allergic reactions have been noted, including cases of anaphylaxis and serious skin reactions. Gastrointestinal events such as bleeding, ulceration, and perforation have also been reported. Cardiovascular events, including heart attack and stroke, have been documented. Additionally, renal adverse events, specifically acute kidney injury, have been observed. Hepatic adverse events, including elevations in liver enzymes and instances of hepatitis, have been recorded. Central nervous system effects, such as dizziness and headache, have also been reported.

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 assistance or contact a Poison Control Center immediately 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 instruct 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 stomach pain that does not improve. 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 counseled to stop use and consult a doctor 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. It is important for patients to consult a doctor before use if they have experienced problems or serious side effects from pain relievers or fever reducers in the past. They should also seek medical advice if the warning regarding stomach bleeding applies to them, or if they have a history of stomach issues, such as heartburn.

Patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should be encouraged to consult a doctor before using this medication. Additionally, patients taking diuretics or aspirin for heart attack or stroke should discuss their use of ibuprofen with a healthcare provider, as it may diminish the benefits of aspirin. Lastly, patients under a doctor's care for any serious condition or those taking any other medications should also consult a doctor or pharmacist prior to use.

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 should be ensured to prevent any degradation of the product.

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)