Ibuprofen

Description

No description information is available for the drug.

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

Adults and children aged 12 years and over 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 is contraindicated in patients with a history of allergic reactions to any pain reliever or fever reducer. Additionally, the product 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 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 causing severe stomach bleeding. The likelihood of this adverse effect is heightened in certain populations, including individuals aged 60 years or older, those with a history of stomach ulcers or bleeding disorders, and patients concurrently using blood thinners (anticoagulants) or steroid medications. Additionally, the risk increases for individuals taking other NSAIDs, such as aspirin, ibuprofen, or naproxen, or for those consuming three or more alcoholic beverages daily while using this product. It is crucial to adhere to the recommended dosage and duration of use to mitigate these risks.

Healthcare professionals should advise patients to consult a physician prior to using ibuprofen if any of the following conditions apply: a history of stomach bleeding, adverse reactions to pain relievers or fever reducers, gastrointestinal issues such as heartburn, or pre-existing conditions including high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Patients taking diuretics should also seek medical advice before use.

Furthermore, it is essential for patients to inform their healthcare provider or pharmacist if they are under treatment for any serious medical condition, are using aspirin for cardiovascular protection, or are taking any other medications, as ibuprofen may interfere with the efficacy of aspirin.

In the event of an allergic reaction, patients must stop using ibuprofen and seek emergency medical help immediately. In cases of overdose, prompt medical attention or contact with a Poison Control Center is necessary.

Patients should discontinue use and consult a physician if they experience any side effects, including but not limited to signs of stomach bleeding such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, 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, medical advice should be sought. Side effects may be reported to the FDA at 1-800-FDA-1088.

Side Effects

Patients may experience a range of adverse reactions while using this product, which contains ibuprofen, 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 this NSAID, 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 are advised to discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, if pain worsens or lasts longer than 10 days, if fever intensifies or persists beyond three days, if redness or swelling occurs in the painful area, or if any new symptoms arise, medical advice should be sought.

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

Patients are encouraged to report any side effects to the FDA at 1-800-FDA-1088.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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 severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor elderly patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit ratio is essential in this population to ensure safe and effective use of the medication.

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. There is a particular concern regarding the use of ibuprofen during the last three months of pregnancy, as it may pose risks to the unborn child or lead to complications during delivery. Therefore, caution is warranted when considering the use of this medication in lactating individuals.

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 a history of liver cirrhosis. It is essential to assess liver function and consider potential risks associated with the use of this medication in individuals with compromised liver function. Monitoring of liver parameters may be warranted to ensure safety and efficacy in this patient population. Adjustments to dosage or treatment regimens may be necessary 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. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the symptoms of 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. Healthcare providers should monitor the patient closely and provide interventions as necessary based on the clinical presentation. It is advisable to have access to the specific antidotes or treatment protocols relevant to the substance involved in the overdose.

In summary, timely medical intervention and appropriate management strategies are vital in addressing overdose situations effectively.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of 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 or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

No specific postmarketing experience details are available in the insert text. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be informed that if they experience stomach upset, the medication can be taken with food or milk to alleviate discomfort. It is important to communicate that using more than the directed dose or using the medication for longer than recommended may increase the risk of heart attack or stroke.

Healthcare providers should discuss the potential side effects with patients, encouraging them to report any adverse effects to the FDA at 1-800-FDA-1088. Patients should be made aware of the signs of stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. They should also be advised to seek medical attention 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 appear.

Patients should be encouraged to consult a doctor before use if they have a history of stomach bleeding, have experienced serious side effects from pain relievers or fever reducers, or have any stomach problems such as heartburn. Additionally, those with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, or who are taking a diuretic, should also seek medical advice prior to use.

Finally, healthcare providers should recommend that patients ask a doctor or pharmacist before using the medication if they are under a doctor's care for any serious condition, are taking aspirin for heart attack or stroke (as ibuprofen may reduce the effectiveness of aspirin), or are taking any other medications.

Storage and Handling

The product is supplied in packaging that includes relevant NDC numbers. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). To ensure access to complete product information, it is recommended to retain the carton.

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)