Ibuprofen

Description

No relevant information is available for SPL code 34089-3.

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 is contraindicated in patients with a history of allergic reactions to ibuprofen or any other 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 is associated with several significant warnings and precautions that healthcare professionals must consider to ensure patient safety.

Allergy Alert Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction 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.

Stomach Bleeding Warning As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries a risk of severe stomach bleeding. This risk is heightened in patients who meet any of the following criteria: those aged 60 years or older, individuals with a history of stomach ulcers or bleeding disorders, patients concurrently using anticoagulants or steroid medications, those taking other NSAIDs (including aspirin, ibuprofen, naproxen, or others), individuals consuming three or more alcoholic beverages daily while using this product, or those who exceed the recommended dosage or duration of use.

Heart Attack and Stroke Warning The use of NSAIDs, excluding aspirin, is associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in patients who use ibuprofen in excess of the recommended dosage or for extended periods.

Monitoring and Consultation Healthcare professionals should advise patients to discontinue use and consult a physician if they experience any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, patients should seek medical advice 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 stop use and consult a healthcare provider 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.

In cases of an allergic reaction, immediate cessation of ibuprofen and prompt medical attention are essential.

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.

Additionally, the use of this NSAID carries a warning for potential severe stomach bleeding, with an increased risk in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, individuals taking anticoagulants or steroid medications, and those consuming three or more alcoholic drinks daily while using this product. Symptoms indicative of stomach bleeding include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

The risk of cardiovascular events, such as heart attack, heart failure, and stroke, is also heightened with NSAID use, particularly if the medication is taken in higher doses or for extended periods. Patients should be vigilant for symptoms of heart problems or stroke, which may include chest pain, difficulty breathing, weakness on one side of the body, slurred speech, or leg swelling.

Common adverse reactions may include gastrointestinal discomfort, and patients are advised to discontinue use and consult a healthcare provider if pain worsens or persists beyond 10 days, if fever worsens or lasts more than three days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

Patients should seek medical advice prior to using this product 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 that patients consult a healthcare professional if they are taking aspirin for cardiovascular protection, as ibuprofen may diminish the effectiveness of aspirin in this context.

Drug Interactions

Ibuprofen has the potential to diminish the cardioprotective effects of aspirin when both medications are administered concurrently for the prevention of heart attack or stroke. It is advisable for healthcare professionals to consider this interaction when prescribing ibuprofen to patients who are also taking aspirin for cardiovascular protection. Monitoring for efficacy and potential alternative therapies may be warranted in such cases.

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

Packaging & NDC

Below are the non-prescription pack sizes of Ibuprofen (ibuprofen tablets usp, 200mg). 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 caplet every 4 to 6 hours as needed for symptom relief. 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, are at an increased risk for severe stomach bleeding. This heightened risk necessitates careful monitoring and consideration when prescribing medications that may contribute to gastrointestinal complications.

Additionally, the risk of cardiovascular events, including heart attack, heart failure, and stroke, is elevated in older adults, especially when medications are used in excess or for prolonged periods. Therefore, it is crucial to adhere strictly to prescribed dosages and duration of therapy in this population.

For elderly patients who experience stomach upset, it is recommended that medications be taken with food or milk to mitigate gastrointestinal discomfort, as this demographic may have more sensitive stomachs.

Furthermore, the smallest effective dose should be utilized in geriatric patients to minimize potential adverse effects. This precaution is particularly important given the increased likelihood of comorbid conditions in older adults.

Healthcare providers should also advise elderly patients to consult a physician if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or a previous stroke, as these conditions are more prevalent in this age group and may influence treatment decisions.

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 gestation 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, especially in the later stages of 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 at 20 weeks of gestation or later unless specifically directed by a physician, 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 ibuprofen in breast milk or its effects on breastfed infants. Therefore, healthcare providers should weigh the potential benefits against the risks when considering this medication for lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider 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 initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

Nonclinical Toxicology

It is especially important not to use ibuprofen at 20 weeks or later in 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 details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

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, cases of stomach bleeding have been noted, particularly in patients who are older, have a history of stomach ulcers or bleeding problems, or are concurrently using other NSAIDs or anticoagulants. There is also an increased risk of heart attack, heart failure, and stroke associated with NSAID use, especially when utilized at higher doses or for extended durations beyond the recommended guidelines.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients must be informed not to use this medication if they have ever experienced an allergic reaction to ibuprofen or any other pain reliever or fever reducer. Additionally, it should not be used right before or after heart surgery.

Healthcare providers should instruct patients to stop using the medication 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 seek medical attention if they exhibit symptoms 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.

Patients should be counseled to discontinue use and consult a doctor 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.

When using this product, patients should be advised to take it with food or milk if they experience stomach upset. It is important for patients to consult a doctor before use 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.

Patients with a history of stomach problems, such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also be encouraged to seek medical advice before using this medication. Furthermore, patients taking a diuretic or those who are under a doctor's care for any serious condition should consult their healthcare provider prior to use.

Lastly, patients should be informed to speak with a doctor or pharmacist before using this medication if they are taking aspirin for heart attack or stroke, as ibuprofen may diminish the benefits of aspirin. It is also advisable for patients to consult a healthcare professional if they are taking any other medications.

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 20-25ºC (68-77ºF) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent exposure to extreme temperatures, which may compromise the product's quality.

Additional Clinical Information

No further data are available.

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)