Ibuprofen

Description

Ibuprofen caplets are formulated as capsule-shaped tablets containing 200 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) recognized for its pain-relieving and fever-reducing properties. These tablets serve as a therapeutic alternative, comparable to the active ingredient found in Advil®.

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 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, 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 use of ibuprofen, an NSAID, carries a significant risk of severe stomach bleeding. This risk is notably elevated 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.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. The likelihood of these serious cardiovascular events is heightened when the medication is used in excess of the recommended dosage or for prolonged periods.

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

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 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 an increased 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 may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additionally, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, has been linked to an elevated 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 are advised to discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding, symptoms indicative of heart problems or stroke (such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling), worsening pain lasting more than 10 days, fever persisting beyond 3 days, redness or swelling in the affected area, or the emergence of any new symptoms.

Before using ibuprofen, patients should seek medical advice if they have a history of adverse reactions to pain relievers or fever reducers, if the stomach bleeding warning is applicable, or if they have conditions such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also recommended to consult a healthcare provider if the patient is taking a diuretic or aspirin for cardiovascular protection, as ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

The concomitant use of aspirin and ibuprofen may diminish the cardioprotective effects of aspirin, particularly in patients using aspirin for the prevention of heart attacks or strokes. It is advisable for patients to consult a healthcare professional prior to initiating ibuprofen if they are already taking aspirin.

Increased risk of gastrointestinal bleeding is associated with the concurrent use of ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter medications such as aspirin, ibuprofen, and naproxen. Patients should be monitored closely for signs of gastrointestinal complications if these medications are used together.

Patients with pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should seek medical advice before using ibuprofen. Additionally, individuals taking diuretics are advised to consult a healthcare provider prior to use, as potential interactions may necessitate dosage adjustments or increased monitoring.

For patients with a history of gastrointestinal issues, including heartburn, it is recommended to consult a healthcare professional before using ibuprofen to mitigate the risk of exacerbating these conditions.

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 and adults aged 12 years and older, the recommended dosage is 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 dose of 2 caplets may be administered. It is important to note that the maximum dosage should not exceed 6 caplets 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 stomach bleeding when using this medication. Therefore, it is essential to exercise caution and monitor for any signs of gastrointestinal bleeding in this population.

Additionally, the risk of heart attack and stroke is heightened in elderly patients who use the medication in excess of the recommended dosage or for prolonged periods. It is crucial for healthcare providers to ensure that geriatric patients adhere to the prescribed dosage and duration to mitigate these risks.

To minimize potential adverse effects, the smallest effective dose should be utilized in elderly patients. Regular assessment and monitoring are recommended to ensure safety and efficacy in this demographic.

Pregnancy

Pregnant patients and women of childbearing potential 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 explicitly directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. The potential fetal impacts and associated risks necessitate careful consideration and professional guidance in these circumstances.

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 healthcare provider, 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 during lactation.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke, as these factors may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal function and associated health conditions.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication. It is essential to assess liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended to ensure patient safety and therapeutic efficacy.

Additionally, patients with a history of liver disease, such as cirrhosis, should be evaluated for potential contraindications related to their hepatic condition. It is advised that healthcare providers exercise caution when prescribing this medication to individuals with compromised liver function, particularly those with severe hepatic impairment.

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 are advised to call the Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial in mitigating potential adverse effects associated with an overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms as they arise.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may develop as a result of the overdose.

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 reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, cases of stomach bleeding have been noted, particularly in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, or individuals taking anticoagulant or steroid medications. There is also an increased risk of heart attack, heart failure, and stroke associated with prolonged use or higher than directed doses.

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 the patient's history of high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or previous strokes, as these conditions may necessitate caution when using this medication. Patients taking diuretics should be advised to consult their healthcare provider prior to use.

Furthermore, patients should be informed that if they are taking aspirin for the prevention of heart attack or stroke, they should discuss this with their healthcare provider or pharmacist, as ibuprofen may reduce the effectiveness of aspirin. It is also prudent for patients to seek advice from 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 various package configurations, with specific NDC numbers available for reference. It should be stored in a controlled environment, maintaining a temperature range of 68-77°F (20-25°C). Care should be taken to avoid exposure to high humidity and excessive heat, which should not exceed 104°F (40°C). For traceability, the lot number and expiration date can be found on the end panel of the packaging.

Additional Clinical Information

Patients should take the medication orally, with a recommended dosage of one caplet every 4 to 6 hours while symptoms persist. If pain or fever does not adequately respond to one caplet, two caplets may be taken. However, patients should not exceed six caplets in a 24-hour period unless directed by a healthcare professional.

Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional before use. It is particularly important to avoid ibuprofen after 20 weeks of pregnancy unless specifically directed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery. Additionally, patients should keep the medication out of reach of children and seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose.

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)