Ibuprofen

Description

SPL code 34089-3 corresponds to a pharmaceutical product packaged in a blister containing 30 tablets. The formulation and specific characteristics of the tablets are not detailed in the provided information.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with 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 aged 12 years and older are advised to take 1 tablet orally every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 tablet, a dose of 2 tablets may be administered. It is imperative that the total dosage does not exceed 6 tablets within a 24-hour period unless specifically directed by a healthcare professional.

For children under 12 years of age, consultation with a doctor is recommended prior to administration. It is essential to adhere to the prescribed dosage and not exceed the recommended amount. The smallest effective dose should be utilized, and treatment should not extend beyond 10 days unless otherwise directed by a healthcare provider.

Contraindications

Use of this product is contraindicated in the following situations:

• Patients with a history of allergic reactions to any pain reliever or fever reducer, including but not limited to aspirin, due to the risk of severe allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters.

• Patients undergoing heart surgery, as use is contraindicated right before or after the procedure due to potential complications.

Additionally, caution is advised as this product contains an NSAID, which may increase the risk of severe stomach bleeding, particularly in individuals who are 60 years or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroids, are using other NSAIDs, or consume three or more alcoholic drinks daily while using this product.

Warnings and Precautions

Patients should not use this product if they have a history of allergic reactions to any other pain reliever or fever reducer. Additionally, it is contraindicated for use immediately before or after heart surgery.

Allergy Alert 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 and seek immediate medical assistance.

Stomach Bleeding Warning This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is increased in patients who meet any of the following criteria:

• Are aged 60 years or older

• Have a history of stomach ulcers or bleeding disorders

• Are concurrently taking anticoagulants or steroid medications

• Are using other medications that contain NSAIDs, including prescription or over-the-counter options such as aspirin, ibuprofen, or naproxen

• Consume three or more alcoholic beverages daily while using this product

• Exceed the recommended dosage or duration of use

General Precautions Healthcare professionals should advise patients to consult a physician prior to using this product if they are:

• Taking aspirin for the prevention of heart attack or stroke, as ibuprofen may diminish the cardioprotective effects of aspirin

• Under medical supervision for any serious health condition

• Currently taking any other medications

Emergency Medical Help In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Monitoring and Discontinuation Patients should be instructed to stop using this product and consult a healthcare provider if they experience any of the following signs indicative of stomach bleeding:

• Feeling faint

• Vomiting blood

• Passing bloody or black stools

• Experiencing persistent stomach pain

• Noticing worsening pain that lasts longer than 10 days

• Observing a fever that worsens or persists beyond three days

• Noticing redness or swelling in the affected area

• Experiencing any new or unusual symptoms

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions. Notably, the use of this medication is contraindicated in individuals with a history of allergic reactions to any other pain reliever or fever reducer, as well as in those who have undergone heart surgery immediately before or after the procedure.

A significant concern is the risk of severe allergic reactions, particularly in patients with known allergies to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, patients are advised to discontinue use and seek immediate medical assistance.

Additionally, this product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a warning for the potential of severe stomach bleeding. The risk of this adverse reaction is heightened in patients who are 60 years of age 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. Patients should also be cautious if they are taking other medications that contain NSAIDs, such as aspirin, ibuprofen, or naproxen, or if they exceed the recommended dosage or duration of use.

Patients are advised to stop using the product and consult a healthcare professional 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. Additional symptoms warranting medical consultation include worsening pain lasting more than 10 days, fever persisting for more than 3 days, redness or swelling in the painful area, or the emergence of any new symptoms.

Drug Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. Therefore, concurrent use of ibuprofen with aspirin for this indication is not recommended.

Additionally, the concomitant use of ibuprofen with anticoagulants, steroids, or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin or naproxen increases the risk of gastrointestinal bleeding. It is advisable to monitor patients closely for signs of gastrointestinal complications when these medications are used together. Adjustments in dosage or alternative therapies should be considered based on the clinical scenario and patient risk factors.

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 and older, are at an increased risk of severe stomach bleeding when using this medication. Therefore, caution is advised when prescribing to this population.

To mitigate the risk of gastrointestinal upset, it is recommended that ibuprofen be taken with food or milk. Additionally, healthcare providers should ensure that the smallest effective dose is utilized for geriatric patients. It is also important to advise that the duration of use should not exceed 10 days unless directed by a physician, to further minimize potential adverse effects.

Close monitoring of elderly patients is essential to ensure safety and efficacy while using this medication.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. It is crucial to avoid the use of ibuprofen during the last trimester 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 necessitate careful consideration and professional guidance in managing pain or inflammation in pregnant individuals.

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 ibuprofen in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication in lactating individuals.

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 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 help 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 and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and effective recovery.

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 identified several adverse reactions reported voluntarily or through surveillance programs. These include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

Additionally, it has been noted that the risk of severe stomach bleeding may be increased in specific patient populations. This includes individuals who are age 60 or older, those with a history of stomach ulcers or bleeding problems, patients taking blood-thinning (anticoagulant) or steroid medications, individuals using other drugs containing prescription or nonprescription nonsteroidal anti-inflammatory drugs (NSAIDs), those consuming three or more alcoholic drinks daily while using this product, or patients who take the medication for longer than directed.

Patient Counseling

Healthcare providers should advise patients 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 informed that if they experience any signs of an allergic reaction, they must stop using the medication and seek medical help without delay.

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 be instructed to report if their pain worsens or persists for more than 10 days, if their fever intensifies or lasts more than 3 days, if there is redness or swelling in the painful area, or if any new symptoms arise.

It is important to counsel patients to take the medication with food or milk if they experience stomach upset. Additionally, they should be informed 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 encourage patients to consult with a doctor before use if they are taking aspirin to prevent heart attack or stroke, as ibuprofen may diminish the effectiveness of aspirin. Patients under a doctor's care for any serious condition or those taking other medications should also be advised to seek medical guidance prior to using this medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20-25°C (68-77°F). Care should be taken to avoid high humidity and excessive heat, with temperatures not exceeding 40°C (104°F). Proper storage conditions are essential to maintain the integrity 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)