Advil

Description

Advil® LIQUI•GELS® are solubilized ibuprofen capsules, each containing 200 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. The product is presented in a dosage form of liquid-filled capsules, with a total of 20 capsules per carton. The packaging is identified by the code 000068421 on the front carton.

Uses and Indications

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

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and not exceed the directed amount. The smallest effective dose should be utilized to manage symptoms effectively.

For adults and children aged 12 years and older, the recommended dosage is 1 capsule every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 capsule, a maximum of 2 capsules may be administered. However, it is imperative not to exceed 6 capsules within a 24-hour period unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a doctor for appropriate dosing recommendations.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to 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 pose risks to surgical outcomes and patient safety.

Warnings and Precautions

Ibuprofen may cause 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.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with an increased risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are concurrently using blood thinners (anticoagulants) or steroid medications, are taking other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily, or exceed the recommended dosage or duration of use.

NSAIDs, with the exception of aspirin, are linked to an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in individuals who use these medications in excess of the recommended dosage or for extended periods.

Healthcare professionals should advise patients to consult a physician prior to using ibuprofen if any of the following conditions apply: a history of stomach bleeding, previous adverse reactions to pain relievers or fever reducers, gastrointestinal issues such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, a history of stroke, or if they are taking diuretics. Additionally, patients should seek guidance from a doctor or pharmacist if they are under medical care for serious conditions, are using aspirin for cardiovascular protection, or are taking any other medications.

In the case of an overdose, immediate medical attention should be sought, or the Poison Control Center should be contacted.

Patients are advised to discontinue use and consult a physician if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, passing bloody or black stools, or persistent stomach pain. Symptoms indicative of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, 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 seriousness 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, as a nonsteroidal anti-inflammatory drug (NSAID), carries a significant risk of severe stomach bleeding. This risk is heightened 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 while using the 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 particularly pronounced in patients who use the medication 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 3 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 stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also important for patients to inform their healthcare provider if they are taking diuretics or if they are under medical care for any serious condition. Additionally, patients taking aspirin for heart attack or stroke should be aware that ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

Ibuprofen may interact with several classes of medications, leading to potential clinical effects that warrant careful consideration.

Pharmacodynamic Interactions

The concomitant use of ibuprofen with blood-thinning agents (anticoagulants) or steroid medications may elevate the risk of bleeding. Healthcare providers should monitor patients closely for signs of bleeding and consider alternative pain management strategies if necessary.

Additionally, ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. It is advisable for patients to consult their healthcare provider regarding the timing and use of these medications to ensure optimal therapeutic outcomes.

Pharmacokinetic Interactions

The use of ibuprofen alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and over-the-counter options such as aspirin and naproxen, can significantly increase the risk of gastrointestinal bleeding. Patients should be counseled to avoid the concurrent use of multiple NSAIDs and to seek medical advice if pain relief is inadequate.

Patients taking diuretics should consult their healthcare provider prior to initiating ibuprofen therapy, as there may be implications for fluid balance and renal function. Furthermore, individuals under medical supervision for serious health conditions are advised to discuss the use of ibuprofen with their healthcare provider to ensure safety and efficacy in their treatment regimen.

Packaging & NDC

Below are the non-prescription pack sizes of Advil (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 capsule every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to 1 capsule, 2 capsules may be administered. It is important not to exceed 6 capsules within a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, should consult a healthcare provider prior to use. This population is at an increased risk for adverse effects, including a higher likelihood of stomach bleeding.

Nonsteroidal anti-inflammatory drugs (NSAIDs), with the exception of aspirin, are associated with an elevated risk of serious cardiovascular events such as heart attack, heart failure, and stroke. This risk is further amplified when these medications are used in dosages exceeding the recommended limits or for durations longer than prescribed.

It is essential to utilize the smallest effective dose in geriatric patients to minimize potential risks and ensure safety. Regular monitoring and assessment of the patient's response to treatment are advised to mitigate adverse effects.

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 after 20 weeks of gestation unless explicitly directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should weigh the potential benefits against the risks when considering the use of this medication in pregnant patients.

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 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 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 necessary to ensure appropriate management and to mitigate potential risks associated with the use of this medication in individuals with hepatic impairment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to be aware that they can vary based on the substance involved and the individual’s health status.

Management of an overdose typically involves supportive care and symptomatic treatment. The healthcare provider should assess the patient's condition and implement appropriate measures based on the severity of the overdose and the symptoms presented. Continuous monitoring and evaluation are recommended to ensure patient safety and effective management of the situation.

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 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, including hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Severe allergic reactions may occur, particularly in individuals with a known allergy to aspirin.

Additionally, the risk of severe stomach bleeding is increased in patients who are aged 60 years or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulant or steroid medications, are using other NSAIDs (both prescription and nonprescription), or consume three or more alcoholic beverages daily while using this product.

It is important to note that the use of NSAIDs, excluding aspirin, is associated with an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is further heightened if the product is used in excess of the recommended dosage or for an extended duration.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial for patients to understand the importance of prompt action in such situations.

Additionally, healthcare providers should recommend that patients take the medication with food or milk if they experience any stomach upset. This guidance can help mitigate gastrointestinal discomfort and enhance the overall tolerability of the treatment.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 20-25°C (68-77°F). Care must be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). Proper storage conditions are essential to maintain the integrity of the product.

Additional Clinical Information

Adults and children aged 12 years and over are advised to take 1 capsule every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 capsule, 2 capsules may be administered. However, the total dosage should not exceed 6 capsules in a 24-hour period unless directed by a healthcare professional. For children under 12 years, consultation with a doctor is recommended.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding, particularly noting that ibuprofen should not be used after 20 weeks of pregnancy unless specifically directed by a doctor due to potential risks to the unborn child or complications during delivery. Patients are also advised to take the medication with food or milk if gastrointestinal upset occurs and to read all warnings and directions before use, ensuring the carton is retained for reference.

Drug Information (PDF)