Ibuprofen

Description

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. Each tablet contains 200 mg of ibuprofen. The product is supplied in a package containing 30 tablets.

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 administration guidelines. The smallest effective dose should be utilized, and the duration of use should not exceed 10 days unless otherwise directed by a healthcare professional.

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 maximum of 2 tablets may be taken. However, the total daily dosage must not exceed 6 tablets within a 24-hour period unless specifically instructed by a physician.

For children under 12 years of age, it is advised to consult a healthcare professional 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, the product should not be administered immediately before or after heart surgery due to potential complications.

Exceeding the recommended dosage or duration of use may increase the risk of heart attack or stroke, further supporting the need for caution in these scenarios.

Warnings and Precautions

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.

As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries the risk of severe gastrointestinal bleeding. The likelihood of this adverse effect 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. Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is amplified with prolonged or excessive use.

General precautions should be observed. Ibuprofen should not be used by individuals who have previously experienced an allergic reaction to any pain reliever or fever reducer. It is contraindicated for use immediately before or after heart surgery. Healthcare professionals should be consulted prior to use if the patient has a history of stomach bleeding, has experienced serious side effects from pain relievers or fever reducers, suffers from gastrointestinal issues such as heartburn, has high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, or is taking a diuretic. Additionally, patients under a physician's care for serious conditions or those taking aspirin for cardiovascular protection should seek advice, as ibuprofen may diminish the cardioprotective effects of aspirin.

In the event of an overdose, immediate medical attention is required, and contacting a Poison Control Center (1-800-222-1222) is advised.

Patients should discontinue use and consult a healthcare provider if they experience any signs of gastrointestinal bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Furthermore, if pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, stomach discomfort increases, redness or swelling occurs in the affected area, or any new symptoms arise, medical advice should be sought promptly.

Side Effects

Patients may experience a range of adverse reactions associated with the use of ibuprofen, which is classified as a nonsteroidal anti-inflammatory drug (NSAID).

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.

There is a significant risk of severe stomach bleeding associated with the use of ibuprofen, especially 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 be vigilant for signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. If any of these symptoms occur, patients are advised to discontinue use and consult a healthcare professional.

Additionally, the use of NSAIDs, including ibuprofen, has been 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 advice prior to using ibuprofen if they have a history of stomach bleeding, have experienced serious side effects from pain relievers or fever reducers, suffer from stomach issues such as heartburn, or have pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It is also recommended that patients consult a healthcare provider if they are under medical care for any serious condition or are taking aspirin for cardiovascular protection, as ibuprofen may diminish the effectiveness of aspirin in this context.

In clinical trials and postmarketing experiences, patients have reported various adverse reactions, and it is essential for individuals to monitor their health and report any new or worsening symptoms to their healthcare provider.

Drug Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. It is advisable to avoid concurrent use of these medications unless directed by a healthcare professional.

The concomitant use of anticoagulants or steroid medications with ibuprofen is associated with an increased risk of gastrointestinal bleeding. Patients receiving these combinations should be monitored closely for signs of bleeding and may require dosage adjustments or alternative therapies.

Additionally, exceeding the recommended dosage or duration of ibuprofen therapy may elevate the risk of cardiovascular events, including heart attack or stroke. It is essential for healthcare providers to counsel patients on adhering to prescribed dosages and treatment durations to mitigate these risks.

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, may have an increased risk of severe 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 those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of ibuprofen during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery.

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 during the last three months of pregnancy 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 provided regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use in lactating mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or asthma. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the patient's overall health status and the severity of their kidney disease.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have conditions such as liver cirrhosis. It is essential for these patients to receive appropriate medical guidance to assess the potential risks and benefits associated with the use of this medication. Monitoring of liver function may be necessary to ensure safety and efficacy in this population. Adjustments to dosage or treatment regimens may be required based on the severity of hepatic impairment and the patient's overall health status.

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 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 during the course of treatment.

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 detailed findings 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 ibuprofen. Reports include gastrointestinal bleeding, renal impairment, and cardiovascular events. Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been documented. Additionally, cases of liver enzyme elevations and liver failure have been reported.

Anaphylactic reactions, including angioedema and bronchospasm, have been noted in the postmarketing data. Furthermore, there have been reports of hypertension and heart failure linked to ibuprofen use. Postmarketing surveillance has indicated an increased risk of myocardial infarction and stroke with prolonged use of the medication.

Patient Counseling

Patients should be advised to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Patients must be informed not to use this medication if they have a history of allergic reactions to any other pain reliever or fever reducer. Additionally, it should not be used immediately before or after heart surgery.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Patients should also be advised to stop use and seek medical advice if their pain worsens or persists for more than 10 days, if their fever increases or lasts longer than 3 days, if stomach pain or upset worsens or lasts, if there is redness or swelling in the painful area, or if any new symptoms arise.

When using this product, patients should be counseled to take it with food or milk if they experience stomach upset. It is important to inform patients that the risk of heart attack or stroke may increase if they exceed the recommended dosage or duration of use.

Patients should be encouraged to consult a doctor before using this medication if the warning regarding stomach bleeding applies to them, or if they have experienced serious side effects from pain relievers or fever reducers in the past. They should also seek medical advice if they have stomach issues such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma.

Furthermore, patients should be advised to consult a doctor before use if they are taking a diuretic, or if they are under a doctor's care for any serious condition. It is also important to inform patients to speak with a doctor or pharmacist before using this medication if they are taking aspirin for heart attack or stroke, as ibuprofen may reduce the effectiveness of aspirin. Lastly, patients should be reminded to consult a doctor or pharmacist before using this medication if they are taking any other drugs.

Storage and Handling

The product is supplied in a carton that should be retained for reference. 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 excessive heat, specifically temperatures exceeding 40°C (104°F). Prior to use, healthcare professionals are advised to read all warnings and directions provided.

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 three months 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)