Ibuprofen

Description

IBUPROFEN Capsules contain 200 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. These capsules are designed in a smaller size while maintaining the same strength as standard formulations. Each bottle contains 80 softgels, which are liquid-filled capsules, providing an alternative dosage form for patients. This product is comparable to the active ingredient found in Advil® LIQUI-GELS®.

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, 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 capsule every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 capsule, a maximum of 2 capsules may be administered. However, it is imperative not to exceed a total of 6 capsules within a 24-hour period unless specifically 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 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 is associated with several significant warnings and precautions that healthcare professionals must consider to ensure patient safety.

Allergic Reactions Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can 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.

Gastrointestinal Risks As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries a risk of severe stomach bleeding. This risk 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, or exceed the recommended dosage or duration of use.

Cardiovascular Risks 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 higher dosages or prolonged use beyond the recommended guidelines.

General Precautions Healthcare providers should advise patients to consult a physician prior to using ibuprofen if any of the following conditions apply: a history of stomach bleeding, adverse reactions to pain relievers or fever reducers, gastrointestinal issues such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Additionally, patients taking diuretics should seek medical advice before use. It is also essential to consult a doctor or pharmacist if the patient is under treatment for any serious condition, is using aspirin for cardiovascular protection, or is taking any other medications.

Emergency Medical Assistance In the event of an allergic reaction, patients should stop using ibuprofen and seek immediate medical help. In cases of overdose, it is crucial to contact a Poison Control Center or seek medical assistance without delay.

Discontinuation and Consultation Patients should discontinue use and contact a healthcare provider if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Additionally, symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical attention. Patients should also seek medical advice if pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, redness or swelling occurs in the affected area, or any new symptoms arise.

Side Effects

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

The use of ibuprofen 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, or exceed the recommended dosage or duration of use. Signs of stomach bleeding that warrant immediate medical attention include feeling faint, vomiting blood, having bloody or black stools, and experiencing persistent stomach pain.

Additionally, ibuprofen carries warnings regarding an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened when the medication is used in excess of the recommended dosage or for prolonged periods. Patients should seek medical advice 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, and the presence of redness or swelling in the affected area. Patients are advised to consult a healthcare professional if any new symptoms arise.

Before using ibuprofen, patients should seek medical advice 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 that patients under a doctor's care for serious conditions or those taking aspirin for cardiovascular protection consult with a healthcare provider, as ibuprofen may diminish the effectiveness of aspirin.

Drug Interactions

Ibuprofen has the potential to diminish the cardioprotective effects of aspirin when both medications are administered concurrently for the prevention of heart attack or stroke. It is advisable to consider alternative analgesics that do not interfere with aspirin's efficacy in these clinical scenarios. Monitoring for cardiovascular outcomes may be warranted in patients receiving both medications.

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 capsule every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 capsule, 2 capsules may be administered. It is important to note that the maximum dosage should not exceed 6 capsules within a 24-hour period unless otherwise 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 this medication to geriatric patients, especially if they have a history of gastrointestinal 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.

Before initiating treatment, healthcare providers should inquire about the presence of any of these risk factors in elderly patients. Close monitoring for signs of gastrointestinal bleeding is recommended in this population to ensure patient safety and to mitigate potential adverse effects.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, especially if they are in the later stages of pregnancy or breastfeeding. It is particularly important to avoid the use of ibuprofen after 20 weeks of gestation unless explicitly directed by a physician. The use of ibuprofen during this period may be associated with potential delivery complications and adverse fetal outcomes. Therefore, healthcare providers should carefully evaluate the risks and benefits before recommending this medication to pregnant patients.

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 lead to delivery complications for the unborn child. 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 risks and benefits when recommending this medication to lactating mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or stroke. It is essential to monitor for any signs of stomach bleeding and to discontinue use if such symptoms occur. Additionally, patients with a history of problems or serious side effects from pain relievers or fever reducers should exercise caution. Those taking diuretics should also seek medical advice before initiating treatment.

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. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to assess the patient for any signs of toxicity or distress.

Management of an overdose should be guided by established protocols, which may include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to ensure appropriate interventions are implemented in a timely manner.

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 delivery 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 associated with the use of the product. Reports of allergic reactions have been documented, including hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Serious gastrointestinal events, such as bleeding, ulceration, and perforation of the stomach or intestines, have also been reported, particularly in patients with certain risk factors for stomach bleeding.

Additionally, there is an increased risk of cardiovascular events, including heart attack, heart failure, and stroke, associated with NSAID use. Cases of renal toxicity, including acute kidney injury and chronic kidney disease, have been observed. Liver enzyme elevations and instances of hepatitis have been reported as well.

Skin reactions, including serious conditions such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been noted in the postmarketing data. Overall, these findings reflect the range of adverse events reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is important to inform patients that taking the medication with food or milk may help alleviate any stomach upset that occurs.

Patients should be encouraged to consult with their doctor before using this medication if they have a history of stomach bleeding or if they have experienced problems or serious side effects from pain relievers or fever reducers. Additionally, those with a history of stomach issues, such as heartburn, should also seek medical advice prior to use.

Healthcare providers should remind patients to discuss their medical history with their doctor, particularly if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if they have previously suffered a stroke. It is also crucial for patients taking diuretics to consult their doctor before using this medication.

Patients under a doctor's care for any serious condition should be advised to speak with their doctor or pharmacist before use. Furthermore, those taking aspirin for heart attack or stroke should be informed that ibuprofen may reduce the effectiveness of aspirin, and they should consult with their healthcare provider before using this medication. Lastly, patients should be encouraged to discuss any other medications they are taking with their doctor or pharmacist to ensure safe use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). Care must be taken to avoid exposure to excessive heat, specifically temperatures above 40°C (104°F). Additionally, the product must be protected from light to maintain its integrity and efficacy.

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 crucial to avoid ibuprofen after 20 weeks of pregnancy unless specifically directed by a physician, as it may lead to delivery complications or affect the unborn child.

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)