Ibuprofen

Description

Ibuprofen Tablets contain 200 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. This formulation is comparable to the active ingredient found in Advil®. The tablets are designed for oral administration and are characterized by their specific dosage strength, providing a targeted approach to managing mild to moderate pain and fever.

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

Adults and children aged 12 years and older 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 of this product is contraindicated in patients with a known allergy to any other pain reliever or fever reducer. Additionally, it should not be used immediately before or after heart surgery due to potential complications.

Patients with a history of serious side effects from pain relievers or fever reducers, those with conditions related to stomach bleeding, or individuals with a history of stomach problems such as heartburn should avoid this product. It is also contraindicated in patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Furthermore, individuals taking diuretics should not use this product without consulting a healthcare professional.

The use of this product is contraindicated in patients taking aspirin for heart attack or stroke, as ibuprofen may diminish the cardioprotective effects of aspirin. Patients under medical care for serious conditions or those taking other medications should seek advice from a healthcare provider before use.

Increased risk of heart attack or stroke may occur if the product is used in excess of the recommended dosage or for an extended duration.

Pregnant or breastfeeding individuals should consult a healthcare professional prior to use, particularly during the last trimester of pregnancy, as ibuprofen may pose risks to the unborn child or lead to complications during delivery.

Warnings and Precautions

Ibuprofen may elicit severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of such reactions include hives, facial swelling, 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 carries a risk of severe stomach bleeding. The likelihood of experiencing this adverse effect is heightened in patients who meet any of the following criteria: individuals aged 60 years or older, those with a history of stomach ulcers or bleeding disorders, patients concurrently using anticoagulants or steroid medications, individuals taking other NSAIDs (whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen), and those consuming three or more alcoholic beverages daily while using this product. Additionally, the risk increases if the medication is taken in higher doses or for an extended duration beyond the recommended guidelines.

Healthcare professionals should advise patients to discontinue use and consult a physician if they experience any signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain that does not improve. Patients should also seek medical advice if pain worsens or lasts longer than 10 days, if fever intensifies or persists beyond three days, if redness or swelling occurs in the affected area, or if any new symptoms arise.

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 should be aware of potential adverse reactions, which can range from serious to common.

Severe allergic reactions may occur, 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.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), 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 problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily, or use other NSAIDs concurrently. Patients should discontinue use and seek medical attention if they experience signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain that worsens or lasts longer than 10 days. Additionally, if fever persists for more than three days, or if redness or swelling occurs in the painful area, medical advice should be sought.

Patients with a history of serious side effects from pain relievers or fever reducers, those with existing stomach problems such as heartburn, and individuals with high blood pressure, heart disease, liver cirrhosis, or kidney disease should consult a doctor before using ibuprofen. Asthmatic patients and those taking diuretics should also seek medical advice prior to use.

It is important to note that ibuprofen may diminish the cardioprotective effects of aspirin when taken concurrently for heart attack or stroke prevention. Patients under medical care for serious conditions or those taking other medications should consult a healthcare professional before using ibuprofen.

To mitigate gastrointestinal discomfort, ibuprofen should be taken with food or milk. The risk of heart attack or stroke may increase if the medication is used in excess or for prolonged periods.

Pregnant or breastfeeding patients are advised to consult a healthcare professional before use, particularly during the last trimester of pregnancy, as ibuprofen may pose risks to the unborn child or lead to complications during delivery.

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 for healthcare professionals 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 who require 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 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 years and older, may have an increased risk of stomach bleeding. Healthcare providers should exercise caution when prescribing medications that may exacerbate this risk in this population. It is advisable to closely monitor these patients for any signs of gastrointestinal bleeding and to consider appropriate dose adjustments or alternative therapies as necessary to ensure their safety.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. The use of ibuprofen during the last trimester is contraindicated 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.

Lactation

Lactating mothers are advised to consult a health professional prior to 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 ibuprofen in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication while breastfeeding.

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 this medication. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical support can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care, monitoring of vital signs, and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate potential complications associated with overdose.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or 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 current information.

Postmarketing Experience

During postmarketing surveillance of ibuprofen, various adverse reactions have been reported voluntarily. These include anaphylactic reactions and serious skin reactions, such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Hepatic reactions, including liver failure and hepatitis, as well as renal reactions, notably acute renal failure, have also been documented.

Cardiovascular events, including myocardial infarction and stroke, have been reported alongside gastrointestinal complications such as bleeding and ulceration. Additionally, asthma exacerbation, hypertension, edema, dizziness, tinnitus, rash, and other hypersensitivity reactions have been noted.

It is important to recognize that these reactions may not be directly related to the use of ibuprofen but have been observed in patients taking the medication.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical help or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial for patients who are pregnant or breastfeeding to consult a health professional before using this medication. Specifically, patients should be informed that ibuprofen should not be used during the last three months of pregnancy unless explicitly directed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery.

Patients should also be encouraged to discuss their medical history with their healthcare provider before using this medication, particularly if they have experienced problems or serious side effects from pain relievers or fever reducers in the past. It is important to inquire whether the patient has a history of stomach issues, such as heartburn, or if the stomach bleeding warning applies to them. Additionally, patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should consult their doctor prior to use.

Patients taking diuretics or aspirin for heart attack or stroke should also seek advice from their doctor or pharmacist, as ibuprofen may interfere with the effectiveness of aspirin. Furthermore, patients under a doctor's care for any serious condition or those taking other medications should be advised to consult their healthcare provider before using this product.

To minimize the risk of stomach upset, patients should be instructed to take the medication with food or milk. It is essential to inform patients that exceeding the recommended dosage or duration of use may increase the risk of heart attack or stroke.

Patients should be advised to discontinue use and consult a doctor if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. They should also seek medical advice if pain worsens or lasts more than 10 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

Storage and Handling

The product is supplied in a carton configuration, with specific details regarding lot number and expiration date available on the end panel. It is essential to store the product at a temperature range of 20-25°C (68-77°F). Care should be taken to avoid exposure to high humidity and excessive heat, which should not exceed 40°C (104°F). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

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)