Ibuprofen

Description

No specific description details, including chemical name, physical characteristics, or inactive ingredients, are available for SPL code 34089-3.

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, minor pains of arthritis, muscular aches, and discomfort related to the common cold. Additionally, this drug is indicated for the temporary reduction of fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should adhere strictly to the recommended dosage and not exceed the directed amount. The smallest effective dose should be utilized to manage symptoms effectively.

For adults and children 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, a maximum of 2 tablets may be taken. However, it is imperative not to exceed 6 tablets 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.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

This product may cause a severe allergic reaction, particularly in individuals with a known allergy to aspirin. Symptoms of an allergic reaction 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.

The 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.

This product should not be used by individuals who have previously experienced an allergic reaction to any pain reliever or fever reducer, or in the perioperative period surrounding heart surgery.

Healthcare professionals should advise patients to consult a physician prior to use if any of the following conditions apply: a history of stomach bleeding, previous adverse reactions to pain relievers or fever reducers, gastrointestinal issues such as heartburn, or pre-existing conditions including high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma.

Patients should also be counseled to seek guidance from their doctor or pharmacist if they are under medical care for any serious condition, are taking aspirin for cardiovascular protection (as ibuprofen may diminish the efficacy of aspirin), or are using any other medications.

When administering this product, it is recommended to take it with food or milk to mitigate gastrointestinal irritation. It is important to note that exceeding the recommended dosage or duration of use may increase the risk of heart attack or stroke.

Patients should be instructed to discontinue use and consult a physician if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, or if pain worsens or lasts longer than 10 days. Additionally, if fever worsens or persists beyond three days, or if redness or swelling occurs in the affected area, medical advice should be sought. Any new symptoms that arise should also prompt a consultation with a healthcare provider.

For pregnant or breastfeeding individuals, it is essential to consult a healthcare professional before use. Special caution is warranted during the last trimester of pregnancy, as ibuprofen may pose risks to the unborn child or lead to complications during delivery.

Side Effects

This product may cause severe allergic reactions, 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 product is associated with a 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 while using this product, or exceed the recommended dosage or duration of use.

Patients should not use this product if they have previously experienced an allergic reaction to any pain reliever or fever reducer, or if they are scheduled for heart surgery. It is advisable for patients to consult a healthcare professional before using this product if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, or if they are under medical care for any serious condition. Additionally, patients taking aspirin for heart attack or stroke should be aware that ibuprofen may diminish the effectiveness of aspirin.

While using this product, it is recommended to take it with food or milk to mitigate gastrointestinal irritation. Patients should be aware that exceeding the recommended dosage or duration may increase the risk of heart attack or stroke.

Patients are advised to discontinue use and seek medical attention if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, or if pain worsens or lasts more than 10 days. Additionally, if fever worsens or lasts more than three days, or if redness or swelling occurs in the painful area, medical consultation is warranted.

For pregnant or breastfeeding individuals, it is crucial to consult a healthcare professional before use. The use of ibuprofen during the last three months of pregnancy is particularly discouraged unless specifically directed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. Therefore, it is advisable to avoid concurrent use of ibuprofen with aspirin in patients who are taking aspirin for these indications.

The concomitant use of ibuprofen with anticoagulants or steroid medications significantly elevates the risk of gastrointestinal bleeding. Clinicians should exercise caution and consider monitoring patients closely for signs of gastrointestinal complications when these medications are prescribed together.

Additionally, the use of ibuprofen alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), whether prescription or over-the-counter, such as aspirin or naproxen, further increases the risk of stomach bleeding. It is recommended that healthcare providers assess the necessity of multiple NSAID therapies and consider alternative pain management strategies to mitigate this risk.

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

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing medications that may exacerbate this risk in this population.

Monitoring for gastrointestinal adverse effects is recommended, and dose adjustments should be considered based on the individual patient's health status and concurrent medications. Careful assessment of the benefits and risks is crucial when treating geriatric patients to ensure their safety and well-being.

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. Healthcare providers should carefully evaluate the potential benefits and risks when considering the use of this medication 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 during the last three months of pregnancy unless specifically directed by a doctor, 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 ibuprofen in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication in lactating individuals.

Renal Impairment

Patients with renal impairment may require careful consideration regarding dosing adjustments and monitoring. It is essential to assess renal function prior to initiating treatment, particularly in those with a history of kidney disease. Patients with reduced kidney function may experience altered drug clearance, necessitating modifications to the standard dosing regimen. Regular monitoring of renal function is advised to ensure safety and efficacy in this population. Additionally, healthcare professionals should remain vigilant for potential adverse effects associated with the use of this medication in patients with compromised renal function.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication. It is essential to assess liver function prior to initiating treatment. In patients with significant liver disease, particularly those with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity.

Monitoring of liver function tests is recommended throughout the treatment course to ensure safety and efficacy. Patients with compromised liver function should be closely observed for any signs of adverse reactions or changes in clinical status.

Due to the potential for increased risk of side effects, it is advised that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, particularly in those with advanced liver disease.

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.

Additionally, it is recommended to consult local poison control centers or toxicology experts for guidance on specific management protocols and interventions tailored to the substance involved.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of pregnancy unless definitely directed 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 detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the medication. Reports have included gastrointestinal bleeding, renal impairment, and hypersensitivity reactions, which encompass anaphylaxis and angioedema. Additionally, skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been documented.

Cardiovascular events, including myocardial infarction and stroke, have also been reported in association with the medication. Liver enzyme elevations were noted in some patients during postmarketing surveillance. Furthermore, cases of aseptic meningitis have been observed, particularly in patients with systemic lupus erythematosus. Rare instances of serious skin reactions, including exfoliative dermatitis and erythema multiforme, have been reported as well.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center. Patients should be made aware of the signs of overdose and the urgency of obtaining assistance to ensure their safety and well-being.

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 20-25 °C (68-77 °F). Care must be taken to avoid exposure to excessive heat, as temperatures above 40 °C (104 °F) may compromise the integrity of the product.

Additionally, it is imperative that the product is not used if the imprinted safety seal under the cap is broken or missing, as this may indicate potential tampering or contamination. Proper handling and storage conditions are essential to ensure the product's efficacy and safety.

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.

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)