Ibuprofen

Description

2011 Globe Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) formulated as a tablet for oral administration. Each tablet contains 200 mg of ibuprofen. The product is packaged in a quantity of 50 tablets per unit. The chemical structure of ibuprofen is characterized by its molecular weight, which is 206.28 g/mol. The formulation is designed to provide effective relief from pain and inflammation.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including 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.

There are no teratogenic or nonteratogenic effects associated with this drug.

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. Additionally, administration is contraindicated in the perioperative period surrounding heart surgery due to potential 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.

Healthcare professionals should advise patients to discontinue use and consult a physician if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Furthermore, patients should seek medical attention if they exhibit symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Patients should also be instructed to consult a healthcare provider if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if there is redness or swelling in the affected area, or if any new symptoms arise. Regular monitoring and assessment of these parameters are essential for the safe use of ibuprofen.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. 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 nonsteroidal anti-inflammatory drug (NSAID) carries a significant 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.

Additionally, NSAIDs, excluding aspirin, are 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 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 this product, 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 a history of stomach issues such as heartburn. Those with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also seek medical advice prior to use. Additionally, patients taking diuretics or aspirin for heart attack or stroke should consult a healthcare professional, as ibuprofen may diminish the effectiveness of aspirin.

Drug Interactions

The concomitant use of ibuprofen with aspirin, particularly in the context of cardiovascular events such as heart attack or stroke, may diminish the therapeutic efficacy of aspirin. This interaction is clinically significant and should be considered when prescribing these medications together.

Patients with a known allergy to aspirin may experience severe allergic reactions when taking ibuprofen. Caution is advised in this population to prevent potential adverse effects.

The use of ibuprofen in conjunction with anticoagulants or steroid medications significantly elevates the risk of gastrointestinal bleeding. It is recommended that healthcare providers closely monitor patients who are prescribed these combinations and consider appropriate dosage adjustments or alternative therapies to mitigate this risk.

Furthermore, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, is associated with an increased risk of cardiovascular events such as heart attack or stroke. This risk is particularly pronounced when NSAIDs are used in higher doses or for extended periods. Clinicians should evaluate the necessity of NSAID therapy in patients with cardiovascular risk factors and consider regular monitoring of these patients during treatment.

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 4-6 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 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 for severe stomach bleeding. Therefore, it is recommended to use the smallest effective dose for this population to minimize potential adverse effects.

Special precautions should be exercised for geriatric patients who have a history of stomach ulcers or bleeding problems. Additionally, those who are concurrently taking blood-thinning medications (anticoagulants), steroid drugs, or other nonsteroidal anti-inflammatory drugs (NSAIDs), whether prescription or nonprescription, should be closely monitored.

Elderly patients who consume three or more alcoholic drinks daily while using this product may also face heightened risks. It is crucial to ensure that these patients do not exceed the recommended dosage or duration of treatment to avoid complications.

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. The use of ibuprofen in this period may pose risks to the developing fetus and could lead to complications during delivery. Therefore, careful consideration and professional guidance are essential for women of childbearing potential when contemplating the use of this medication during pregnancy.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. It is particularly important to avoid the use of ibuprofen during the last trimester of pregnancy unless explicitly directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data available regarding the excretion of ibuprofen in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication while breastfeeding.

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 this patient population.

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

Overdosage of ibuprofen can lead to significant health risks and serious harm. Healthcare professionals should be aware of the potential symptoms associated with an overdose, which may include nausea, vomiting, stomach pain, drowsiness, headache, and confusion.

In the event of an overdose, it is imperative to seek immediate medical attention. Healthcare providers should advise patients or caregivers to contact a Poison Control Center for further guidance and management. Prompt intervention is crucial to mitigate the effects of ibuprofen overdosage and to ensure appropriate treatment is administered.

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

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, there have been reports of severe stomach bleeding, particularly in individuals aged 60 years or older, those with a history of stomach ulcers or bleeding problems, patients taking blood-thinning (anticoagulant) or steroid medications, individuals using other nonsteroidal anti-inflammatory drugs (NSAIDs), those consuming three or more alcoholic drinks daily, or patients exceeding the recommended dosage. Furthermore, there is an increased risk of heart attack, heart failure, and stroke associated with prolonged use or higher than directed doses.

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 encourage patients to consult a doctor before use if they have experienced problems or serious side effects from pain relievers or fever reducers, if the stomach bleeding warning applies to them, or if they have a history of stomach issues such as heartburn. Additionally, patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should be advised to seek medical guidance prior to use. Those taking diuretics should also consult a healthcare professional.

Patients should be informed to ask a doctor or pharmacist before using the medication if they are taking aspirin for heart attack or stroke, as ibuprofen may reduce the effectiveness of aspirin. Furthermore, patients under a doctor's care for any serious condition or those taking any other medications should be encouraged to seek advice prior to use.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Patients should also be advised to seek medical attention if they exhibit symptoms of heart problems or stroke, including chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling.

Patients should be counseled to stop using the medication and consult a healthcare provider if their pain worsens or lasts 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.

Storage and Handling

The product is supplied in tamper-evident, child-resistant packets. It is essential to inspect the packaging prior to use; do not utilize any packets that are torn or punctured, as this may compromise the integrity of the product.

For optimal storage, maintain the product at a temperature range of 20ºC to 25ºC (68ºF to 77ºF). Ensure that the storage environment is secure and that the packets remain unopened until ready for use.

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)