Ibuprofen

Description

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) available in tablet form, with each tablet containing 200 mg of ibuprofen. This formulation serves as a pain reliever and fever reducer. The product is packaged in a bottle containing 100 tablets. It is important to note that the packaging includes a tamper-evident feature; the product should not be used if the imprinted safety seal under the cap is broken or missing. Ibuprofen is distributed by Cardinal Health, located in Dublin, Ohio 43017. For further information, visit www.myleader.com or contact 1-800-200-6313. All rights are reserved by Cardinal Health, and the trademarks associated with the brand include CARDINAL HEALTH, the Cardinal Health logo, LEADER, and the Leader logo.

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, 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 effectively.

For adults and children 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, a dose of 2 tablets may be administered. However, the total daily dosage must 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 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 may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction may include rash, hives, facial swelling, skin reddening, asthma (wheezing), shock, 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 under certain conditions, including prolonged use beyond the recommended duration, concurrent use of anticoagulants or steroid medications, being aged 60 years or older, having a history of stomach ulcers or bleeding disorders, consuming three or more alcoholic beverages daily while using this product, or taking other medications that contain NSAIDs, such as aspirin, ibuprofen, or naproxen.

Healthcare professionals should be aware that NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is amplified when the medication is used in excess of the recommended dosage or for an extended period.

Prior to initiating treatment, it is advisable for patients to consult a healthcare provider if any of the following conditions apply: a history of stomach bleeding, previous stomach issues such as heartburn, current use of diuretics, or pre-existing conditions including high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Additionally, patients with a history of adverse reactions to pain relievers or fever reducers should seek medical advice before use.

In the event of an overdose, immediate medical attention should be sought, or the Poison Control Center should be contacted without delay.

Patients should be instructed to discontinue use and contact their healthcare provider if they experience any signs of stomach bleeding, which may manifest as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, such as chest pain, slurred speech, leg swelling, difficulty breathing, or weakness on one side of the body, warrant immediate medical evaluation. Furthermore, 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, patients should seek medical advice promptly.

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 rash, hives, facial swelling, skin reddening, asthma (wheezing), shock, 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 take higher doses or use the medication for extended periods, those on anticoagulants or steroid medications, individuals aged 60 or older, and patients with a history of stomach ulcers or bleeding problems. Additionally, consuming three or more alcoholic drinks daily while using ibuprofen or taking other NSAIDs (including aspirin, ibuprofen, or naproxen) can further increase this risk.

Patients should be vigilant for signs of stomach bleeding, which may manifest as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Furthermore, symptoms indicative of heart problems or stroke, such as chest pain, slurred speech, leg swelling, difficulty breathing, or weakness on one side of the body, warrant immediate medical attention. Patients are advised to discontinue use and consult a healthcare provider if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than three days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

The risk of heart attack, heart failure, and stroke is also associated with NSAID use, including ibuprofen, particularly when used in excess or for prolonged periods.

Before using ibuprofen, patients should consult a healthcare provider if they have a history of stomach problems, such as heartburn, or if they are taking diuretics, have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also important for patients under a doctor's care for serious conditions or those taking aspirin for heart attack or stroke to seek medical advice, as ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

Ibuprofen may interact with several classes of medications, leading to significant clinical effects that warrant careful consideration.

Antiplatelet Agents Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. It is advisable for patients to consult their healthcare provider regarding the concurrent use of these medications.

Anticoagulants and Corticosteroids The concomitant use of ibuprofen with anticoagulants or steroid medications increases the risk of gastrointestinal bleeding. Patients should be monitored closely for signs of bleeding and may require dosage adjustments or alternative therapies.

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) The use of NSAIDs, including ibuprofen, is associated with an elevated risk of cardiovascular events such as heart attack, heart failure, and stroke, particularly when used in higher doses or for extended periods. Patients should adhere to recommended dosages and durations of therapy.

Diuretics Patients on diuretics are advised to consult their healthcare provider prior to initiating ibuprofen therapy, as this combination may necessitate monitoring or dosage adjustments.

Pre-existing Conditions Individuals with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should seek medical advice before using ibuprofen. These conditions may increase the risk of adverse effects, and careful monitoring may be required.

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 and older, are at an increased risk of severe stomach bleeding when using this product. It is essential for healthcare providers to exercise caution when prescribing to this population, as the likelihood of adverse effects and complications may be heightened.

Due to these safety concerns, careful monitoring of geriatric patients is recommended. Providers should consider potential dose adjustments and closely observe for any signs of gastrointestinal bleeding or other side effects. The overall health status and comorbidities of elderly patients should also be taken into account to ensure safe and effective use of the product.

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 gestation 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 risks and benefits when prescribing this medication to pregnant patients.

Lactation

Lactating mothers are advised to consult a health professional before using this medication while breastfeeding. 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 ibuprofen in breast milk or its effects on breastfed infants. Therefore, healthcare providers should weigh the potential benefits against the risks when considering this medication for lactating mothers.

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 renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

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 aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

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 text.

Postmarketing Experience

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

Additionally, there have been cases of cardiovascular events, including myocardial infarction and stroke. Some patients have experienced allergic reactions, which include anaphylaxis and angioedema. Elevated blood pressure has been reported in patients taking ibuprofen, and instances of gastrointestinal perforation have been noted, particularly among individuals with a history of gastrointestinal issues.

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 recommended that patients take the medication with food or milk if they experience stomach upset.

Patients should be instructed to discontinue use and consult a doctor if they notice any signs of stomach bleeding, which may include feeling faint, having bloody or black stools, vomiting blood, or experiencing stomach pain that does not improve. Additionally, they should stop use and seek medical advice if they experience symptoms indicative of heart problems or stroke, such as chest pain, slurred speech, leg swelling, trouble breathing, or weakness on one side of the body.

Patients should also be informed to stop use and consult a doctor if their pain worsens or persists for more than 10 days, if their fever worsens or lasts more than 3 days, or if there is redness or swelling in the area of pain. They should be encouraged to report any new symptoms that arise.

Before initiating treatment, patients should be advised to consult a doctor if the warning regarding stomach bleeding applies to them, or if they have a history of stomach issues, such as heartburn. It is also important for patients to discuss their use of diuretics, as well as any history of high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or previous strokes with their healthcare provider.

Patients should be cautioned to seek medical advice before use if they have experienced problems or serious side effects from pain relievers or fever reducers in the past. Furthermore, they should consult a doctor or pharmacist if they are under care for any serious condition or if they are taking aspirin for heart attack or stroke, as ibuprofen may diminish the effectiveness of aspirin in these cases. Lastly, patients should be encouraged to discuss any other medications they are taking with their healthcare provider or pharmacist prior to use.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It is essential to store the product at a temperature range of 20º-25ºC (68º-77ºF) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40ºC (104ºF).

For proper inventory management, users are advised to check the end flap of the packaging for the expiration date and lot number, ensuring that the product is used within its designated shelf life.

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 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)