Ibuprofen

Description

Ibuprofen Tablets USP are nonsteroidal anti-inflammatory drug (NSAID) formulations available in 200 mg dosage strength. These tablets serve as a pain reliever and fever reducer. The product is presented in a capsule-shaped form and is available in packages containing 250 or 500 coated caplets. The formulation does not include any ingredients derived from gluten-containing grains such as wheat, barley, or rye. It is essential to ensure that the foil inner seal is intact prior to use. Users are advised to read all product information thoroughly before administration.

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 caplet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 caplet, a dosage of 2 caplets may be administered. It is imperative that the total daily dosage does not exceed 6 caplets 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 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 may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response 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.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with an increased risk of severe stomach bleeding. The likelihood of such an event 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 while using this product, or exceed the recommended dosage or duration of use.

NSAIDs, excluding aspirin, are also linked to an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in individuals who use the medication in excess of the recommended dosage or for extended periods.

In cases of overdose, immediate medical attention is required. Healthcare professionals should advise patients to contact a Poison Control Center (1-800-222-1222) without delay.

Patients should be instructed to discontinue use and consult a physician if they experience any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. Patients should also seek medical advice 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.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product, which contains an NSAID. Serious adverse reactions include severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters, particularly in individuals with a known allergy to aspirin.

Another serious concern is the potential for severe stomach bleeding, which is more likely in patients who are aged 60 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 be vigilant for signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additionally, 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 is heightened when the medication is used in excess of the recommended dosage or for prolonged periods. Patients should seek medical attention if they experience symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Common adverse reactions may include gastrointestinal discomfort, and patients are advised to discontinue 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 painful area, or if any new symptoms arise.

Patients with a history of serious side effects from pain relievers or fever reducers, those with pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke, should consult a healthcare provider before use. It is also recommended that patients taking aspirin for cardiovascular protection consult a doctor, as ibuprofen may diminish the cardioprotective effects 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 monitor patients closely for any signs of reduced efficacy of aspirin in such scenarios. Consideration should be given to the timing of administration, as taking ibuprofen at least 30 minutes after or 8 hours before aspirin may help mitigate this interaction.

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 children aged 12 years and older, the recommended dosing is 1 caplet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 caplet, 2 caplets may be administered. It is important not to exceed 6 caplets 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 and women of childbearing potential should consult a healthcare professional before using this medication. The use of ibuprofen is particularly cautioned against after 20 weeks of gestation unless explicitly directed by a physician. Administration during this period may pose risks to the developing fetus and could lead to complications during delivery. Therefore, careful consideration and professional guidance are essential for the safe use of this medication in pregnant individuals.

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 pregnancy 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 ibuprofen 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 and consider individual patient factors when prescribing to patients with reduced kidney function, as no specific recommendations or clinical findings are provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

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, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of antidotes or specific treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

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 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 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

Reports of serious adverse reactions have been received during postmarketing use of ibuprofen. These include cardiovascular events such as heart attack and stroke. Additionally, gastrointestinal complications such as bleeding, ulceration, and perforation have been documented. Severe allergic reactions, including anaphylaxis and angioedema, have also been reported. Cases of liver injury, encompassing hepatitis and liver failure, have been noted. Renal toxicity, including acute kidney injury and nephrotic syndrome, has been observed. Furthermore, serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, 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 recommended that patients take the medication with food or milk if they experience stomach upset.

Patients should be encouraged to consult with their healthcare provider before using this medication if they have experienced problems or serious side effects from pain relievers or fever reducers in the past. Additionally, it is important for patients to discuss their medical history with their healthcare provider, particularly if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them.

Healthcare providers should also inquire about any existing conditions that may affect the use of this medication, including high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Patients taking diuretics should be advised to consult their healthcare provider prior to use.

Furthermore, patients should be informed to speak with their doctor or pharmacist if they are taking aspirin for heart attack or stroke, as ibuprofen may diminish the protective effects of aspirin. It is also prudent for patients to consult their healthcare provider or pharmacist if they are under care for any serious condition or if they are taking any other medications.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a temperature range of 20-25°C (68-77°F), in accordance with USP Controlled Room Temperature guidelines. Care should be taken to avoid exposure to high humidity and excessive heat, particularly temperatures exceeding 40°C (104°F).

Additionally, the integrity of the product must be ensured; therefore, it should not be used if the foil inner seal is broken or missing. Proper handling and storage conditions are crucial to maintain the product's efficacy and safety.

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)