Ibuprofen

Description

No description information is available for the specified drug.

Uses and Indications

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

For adults and children aged 12 years and older, the recommended dosage is as follows: administer 1 captet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 captet, a maximum of 2 captets may be taken. However, the total dosage must not exceed 6 captets 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 for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, it should not be administered immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of such reactions 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.

Patients should refrain from using ibuprofen if they have a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer. Additionally, ibuprofen should not be administered immediately before or after heart surgery due to potential complications.

Healthcare professionals should advise patients to discontinue ibuprofen and consult a physician if they experience any signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Furthermore, patients should seek medical attention if they exhibit symptoms suggestive of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling. It is also recommended to stop taking ibuprofen 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 suspected overdose, immediate medical help 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 while using ibuprofen, which can vary in seriousness and frequency.

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. In the event of an allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be vigilant for signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Additionally, symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling, warrant immediate medical consultation. If pain persists for more than 10 days, fever worsens or lasts more than 3 days, or if redness or swelling occurs in the painful area, patients should seek medical advice. The emergence of any new symptoms should also prompt a consultation with a healthcare provider.

Before using ibuprofen, patients with a history of serious side effects from pain relievers or fever reducers, or those for whom the stomach bleeding warning is applicable, should consult a doctor. This includes individuals with a history of stomach problems, such as heartburn, as well as those with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Patients taking diuretics should also seek medical advice prior to use.

Furthermore, it is recommended that patients taking aspirin for the prevention of heart attack or stroke consult a healthcare professional, as ibuprofen may diminish the cardioprotective effects of aspirin. Patients under medical care for any serious condition or those taking other medications should also discuss ibuprofen use with their doctor or pharmacist.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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 captet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 captet, a dose of 2 captets may be administered. It is important not to exceed 6 captets within 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 when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). It is essential for healthcare providers to assess the appropriateness of this medication in geriatric patients, especially if they have a history of conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a previous stroke.

Healthcare providers should advise elderly patients to take this product with food or milk to mitigate potential stomach upset. Additionally, patients should be instructed 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, or experiencing persistent stomach pain.

It is important to note that NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke. This risk is further elevated in elderly patients who exceed the recommended dosage or duration of use. Therefore, careful monitoring and consideration of dose modifications may be warranted in this population to ensure safety and efficacy.

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 consider the potential benefits and risks when prescribing this medication to pregnant patients, especially in the later stages of pregnancy.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. 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 carefully consider the potential risks and benefits when recommending this medication to 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

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data does not preclude the need for careful evaluation of each patient's unique circumstances.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, altered mental status, cardiovascular instability, or gastrointestinal disturbances.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or toxicology experts for further guidance on the management of overdose cases.

In summary, while specific overdosage data is not available, healthcare professionals should exercise caution and be prepared to respond promptly to any suspected overdose situations.

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 non-teratogenic effects have been specified. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports indicate occurrences of gastrointestinal bleeding, renal impairment, and elevations in liver enzymes. Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been documented.

Additionally, cardiovascular events such as myocardial infarction and stroke have been reported. Cases of anaphylactic reactions, including angioedema and bronchospasm, have been associated with ibuprofen use. Hepatic reactions, including hepatitis and jaundice, have been noted in the postmarketing data. Furthermore, hypersensitivity reactions, including rash and urticaria, have been reported.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial for patients to understand the importance of prompt action in such situations.

Additionally, healthcare providers should recommend that patients take the medication with food or milk if they experience any stomach upset. This guidance can help mitigate gastrointestinal discomfort and enhance the overall tolerability of the treatment.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20 to 25°C (68 to 77°F) to maintain its integrity and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it must not be utilized if the neck wrap or foil inner seal is broken or missing, as this may compromise the product's safety and effectiveness. Proper handling and storage conditions are essential to ensure the quality of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health 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)