Ibuprofen

Description

FIRST STREET® (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 and is presented in a capsule-shaped form. The product is packaged as 100 coated caplets. The National Drug Code (NDC) for this formulation is 61504-110-03.

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 its use in this context.

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 a risk of severe gastrointestinal bleeding. This risk 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.

Patients should refrain from using ibuprofen if they have previously experienced an allergic reaction to ibuprofen or any other pain reliever or fever reducer. It is also contraindicated for use immediately before or after cardiac surgery. Prior to initiating treatment, patients should consult a healthcare provider if they have experienced adverse effects from pain relievers or fever reducers, if the warning regarding stomach bleeding is applicable, or if they have a history of gastrointestinal issues such as heartburn. Additional caution is warranted for individuals with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke, as well as those taking diuretics.

Healthcare professionals should advise patients to consult a doctor or pharmacist before using ibuprofen if they are taking aspirin for cardiovascular protection, as ibuprofen may diminish the cardioprotective effects of aspirin. Patients under medical supervision for serious conditions or those taking other medications should also seek guidance prior to use.

In the event of an allergic reaction, it is crucial to stop using ibuprofen and seek emergency medical help immediately. In cases of overdose, medical assistance should be sought or the Poison Control Center contacted at 1-800-222-1222.

Patients should discontinue use and contact 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. Additionally, symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical attention. 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.

The use of this NSAID is also associated with an increased risk of severe stomach bleeding, 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 exceed the recommended dosage or duration of use. Signs of stomach bleeding that warrant immediate medical attention include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additionally, there is a warning regarding the increased risk of heart attack, heart failure, and stroke associated with NSAID use, excluding aspirin. This risk is heightened when the medication is used in excess of the recommended dosage or for prolonged periods. Patients should seek medical advice if they experience symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Common adverse reactions may include worsening pain lasting more than 10 days, fever persisting beyond three days, or the presence of redness or swelling in the affected area. Patients are advised to consult a healthcare professional if any new symptoms arise.

Before using this product, patients should consult a doctor if they have a history of serious side effects from pain relievers or fever reducers, if the stomach bleeding warning applies to them, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also recommended to seek medical advice if taking aspirin for heart attack or stroke, as ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

The use of ibuprofen is associated with several important drug interactions that may impact patient safety and treatment efficacy.

Interactions with Aspirin Ibuprofen may diminish the cardioprotective effects of aspirin when both medications are taken concurrently for the prevention of heart attack or stroke. It is advisable to consider alternative analgesics that do not interfere with aspirin's efficacy in these contexts.

Interactions with Anticoagulants and Steroids Co-administration of ibuprofen with anticoagulants or steroid medications significantly elevates the risk of gastrointestinal bleeding. Clinicians should exercise caution and consider monitoring for signs of bleeding in patients receiving these combinations. Dose adjustments may be necessary based on the individual patient's risk factors.

Cardiovascular Risks with NSAIDs The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, is associated with an increased risk of cardiovascular events such as heart attack, heart failure, and stroke. This risk is particularly pronounced when NSAIDs are used in higher doses or for extended periods. It is recommended that healthcare providers evaluate the necessity of NSAID therapy and consider alternative treatments, especially in patients with pre-existing cardiovascular conditions. Regular monitoring of cardiovascular status may be warranted in these cases.

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 children aged 12 years and older, the recommended dosage 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 within 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 this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor these 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 treatment.

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

Lactation

Lactating mothers are advised to consult a health professional before using this medication while breastfeeding. There is limited data on the excretion of this medication in breast milk and its effects on breastfed infants. Caution is particularly warranted during the last three months of pregnancy, as the use of ibuprofen in this period may lead to complications for the unborn child or during delivery. Therefore, healthcare providers should carefully evaluate the risks and benefits before recommending this medication to 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 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 status to ensure safety and efficacy.

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. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical support can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care, monitoring of vital signs, and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate potential complications associated with overdose.

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 details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Adverse events have been reported voluntarily and through surveillance programs. Side effects may occur, and individuals are encouraged to report any adverse events to the FDA at 1-800-FDA-1088.

In cases of potential stomach bleeding, individuals should discontinue use and consult a healthcare professional if they experience any of the following symptoms: feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve.

Additionally, individuals should seek medical advice if they exhibit symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs.

It is advised to stop use and consult a doctor if pain worsens or persists for more than 10 days, if fever intensifies or lasts longer than 3 days, if redness or swelling occurs in the affected area, or if any new symptoms arise.

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 immediately or contact a Poison Control Center at 1-800-222-1222.

Patients should be informed to take the medication with food or milk if they experience stomach upset. They should be cautioned to stop use and consult a doctor if they notice 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.

Additionally, patients should be made aware to discontinue use and seek medical attention if they experience symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or swelling in the legs. They should also be advised to stop use if their pain worsens or persists for more than 10 days, if their fever worsens or lasts more than 3 days, if there is redness or swelling in the painful area, or if any new symptoms arise.

Patients should be encouraged to consult a doctor before using the medication if they have a history of problems or serious side effects from pain relievers or fever reducers, or if the stomach bleeding warning applies to them. It is important to discuss any history of stomach problems, such as heartburn, as well as conditions like high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke.

Patients taking diuretics should also be advised to consult a doctor before use. Furthermore, they should be informed to speak with a doctor or pharmacist if they are taking aspirin for heart attack or stroke, as ibuprofen may reduce the effectiveness of aspirin. Lastly, patients under a doctor's care for any serious condition or those taking any other medications should be encouraged to seek guidance from a healthcare professional before using this medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled 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), to maintain product integrity. Proper storage conditions are crucial for ensuring the efficacy and safety of the product.

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)