Ibuprofen

Description

HONEYWELL IBUPROFEN TABLET is formulated to contain 200 mg of ibuprofen per tablet. The chemical name for ibuprofen is (RS)-2-(4-(2-methylpropyl)phenyl)propanoic acid, with a molecular weight of 206.29 g/mol. The structural formula is C13H18O2. This dosage form is presented as a tablet, characterized by its solid appearance suitable for oral administration.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with the common cold, headache, minor pain of arthritis, toothache, backache, muscular aches, and menstrual cramps. Additionally, it is indicated for the temporary reduction of fever.

Limitations of Use: This drug is not intended for the treatment of severe pain or for prolonged use without medical supervision.

Dosage and Administration

Adults and children aged 12 years and older 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 of this product is contraindicated in patients with a history of allergic reactions to ibuprofen or any other pain reliever or fever reducer, due to the potential for severe hypersensitivity reactions. Additionally, the product should not be administered immediately before or after heart surgery, as it may interfere with postoperative recovery and increase the risk of complications.

Warnings and Precautions

Severe allergic reactions to ibuprofen may occur, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction 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.

The use of ibuprofen, a nonsteroidal anti-inflammatory drug (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 at 1-800-222-1222 without delay.

Patients should be instructed to discontinue use and consult a healthcare provider if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also 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 may experience a range of adverse reactions, which can vary in severity 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, or are concurrently taking blood-thinning medications or steroids. The risk is further elevated in those consuming three or more alcoholic drinks daily while using this product or in patients who exceed the recommended dosage or duration of use.

Additionally, nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, have been linked to 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 are advised to discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Symptoms indicative of heart problems or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention. Furthermore, patients should seek medical advice 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.

Before using ibuprofen, patients should consult a healthcare provider 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 advice if taking a diuretic or if under a doctor's care for any serious condition.

Patients taking aspirin for heart attack or stroke should be aware that ibuprofen may diminish the cardioprotective effects of aspirin and should consult a healthcare professional before use.

Drug Interactions

The concomitant use of ibuprofen with aspirin for the prevention of heart attack or stroke may diminish the cardioprotective effects of aspirin. It is advisable to avoid the simultaneous administration of these medications to ensure optimal therapeutic outcomes.

When ibuprofen is used in conjunction with anticoagulants or steroid medications, there is an elevated risk of gastrointestinal bleeding. Clinicians should exercise caution and consider monitoring patients closely for signs of bleeding when these drugs are prescribed together.

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 assess the necessity of NSAID therapy and consider alternative treatments when appropriate, especially in patients with pre-existing cardiovascular conditions.

No specific laboratory test interactions have been identified in the available data.

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 for symptom relief. If pain or fever does not adequately respond to 1 tablet, 2 tablets may be administered. It is important not to exceed 6 tablets within a 24-hour period unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients, especially if they have a history of gastrointestinal issues or if the stomach bleeding warning applies to them.

In such cases, it is advisable for patients to consult with their healthcare provider prior to use. To minimize the risk of adverse effects, the smallest effective dose should be utilized in this population. Continuous monitoring for signs of gastrointestinal bleeding is recommended to ensure patient safety.

Pregnancy

Pregnant patients are advised to consult a healthcare professional prior to 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. The potential adverse effects on fetal outcomes and maternal health necessitate careful consideration and professional guidance in the management of pain or inflammation during pregnancy.

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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as per established protocols. Consultation with a poison control center or a medical toxicologist may also be beneficial in managing the situation effectively.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for guiding treatment decisions and ensuring patient safety.

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 have been identified in the available data. Additionally, there are no specific details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has revealed reports of serious adverse reactions, including gastrointestinal bleeding, hepatic injury, renal impairment, anaphylactic reactions, and skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis. Additionally, cardiovascular events, including myocardial infarction and stroke, have been documented.

Other adverse reactions reported in the postmarketing setting include dizziness, headache, nausea, vomiting, diarrhea, constipation, rash, and edema.

Further safety information indicates an increased risk of cardiovascular events associated with prolonged use, as well as a potential for renal toxicity, particularly in patients with pre-existing renal conditions. It is important to note that reports of adverse reactions may not accurately reflect the true incidence of these events, as they are based on voluntary reports.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose.

Patients should be instructed to take the medication with food or milk if they experience stomach upset. It is important for healthcare providers to inquire whether patients have experienced problems or serious side effects from taking pain relievers or fever reducers in the past.

Providers should discuss the stomach bleeding warning with patients, particularly if they have a history of stomach problems, such as heartburn. Additionally, patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should be made aware of the potential risks associated with the medication.

Patients taking a diuretic should be advised to consult with their healthcare provider before using this medication. Furthermore, it is essential to recommend that patients ask their doctor before use if they are taking aspirin for heart attack or stroke, as ibuprofen may reduce the effectiveness of aspirin.

Lastly, healthcare providers should encourage patients to consult their doctor before using this medication if they are under medical care for any serious condition or if they are taking any other drugs.

Storage and Handling

The product is supplied in tamper-evident, child-resistant packets. Each packet must remain intact; therefore, it should not be used if the printed packet is torn or punctured.

Storage conditions require the product to be maintained at a temperature range of 20ºC to 25ºC (68ºF to 77ºF). Opened or torn packets should not be used to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally. Patients are advised to take it with food or milk if they experience stomach upset. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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)