Ibuprofen

Description

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. It is formulated as coated tablets, each containing 200 mg of ibuprofen. The product is manufactured by Avema Pharma Solutions, located at 10400 NW 29th Terrace, Miami, FL 33172.

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

The medication should be administered orally. For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed while symptoms persist. If the initial dose of 1 tablet does not adequately relieve pain or fever, a dose of 2 tablets may be taken. However, the total daily dosage must 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 advised to consult a physician for appropriate dosing recommendations. It is important to use the smallest effective dose necessary to manage symptoms and to adhere strictly to the prescribed dosage guidelines.

Contraindications

Use of this product is contraindicated in patients with a history of allergic reactions to any other pain reliever or fever reducer. Additionally, it should not be used immediately before or after heart surgery due to potential complications associated with surgical recovery.

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, rash, blisters, and skin reddening. 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 carries a risk of severe stomach bleeding. The likelihood of this adverse effect is increased in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), exceed the recommended dosage or duration of use, or consume three or more alcoholic beverages daily while using this product.

Healthcare professionals should advise patients to consult a physician prior to use if any of the following conditions apply: a history of stomach bleeding, previous adverse reactions to pain relievers or fever reducers, a history of gastrointestinal issues such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, patients taking diuretics or those under medical supervision for serious conditions should seek medical advice before using ibuprofen. It is also crucial to inform patients that taking aspirin for cardiovascular protection may be compromised by ibuprofen use.

In the event of an overdose, immediate medical attention should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Patients should be instructed to discontinue use and contact their healthcare provider if they experience any signs of stomach bleeding, including feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. 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, medical consultation is advised.

Side Effects

Patients may experience a range of adverse reactions associated with the use of ibuprofen, which can be categorized by 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, rash, blisters, and skin reddening. Patients should be vigilant for these signs and seek immediate medical attention if they occur.

The use of ibuprofen carries a warning for potential 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 thinners (anticoagulants) or steroid medications. The risk is also heightened in those who take other non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin and naproxen, or who exceed the recommended dosage or duration of use. Additionally, patients consuming three or more alcoholic drinks daily while using ibuprofen may face an increased risk of stomach bleeding.

Patients are advised to discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding, which may manifest as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Other concerning symptoms that warrant medical consultation include worsening pain lasting more than 10 days, fever that worsens or persists beyond three days, redness or swelling in the painful area, or the emergence of any new symptoms.

Before using ibuprofen, patients should seek medical advice if they have a history of stomach problems, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Individuals with asthma or those taking diuretics should also consult a healthcare provider prior to use. Furthermore, patients under a doctor's care for any serious condition or those taking aspirin for heart attack or stroke should be aware that ibuprofen may diminish the cardioprotective effects of aspirin and should discuss this with their healthcare provider.

Drug Interactions

Taking aspirin for the prevention of heart attack or stroke may diminish the therapeutic effects of aspirin when administered concurrently with ibuprofen. This interaction is particularly relevant for patients relying on aspirin for cardiovascular protection.

Ibuprofen has the potential to induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Clinicians should exercise caution when prescribing ibuprofen to such patients.

The risk of cardiovascular events, including heart attack or stroke, may be elevated if ibuprofen is used in dosages exceeding the recommended limits or for durations longer than advised. It is essential for healthcare providers to monitor patients closely in these situations.

Additionally, the concomitant use of ibuprofen with anticoagulants or steroid medications significantly increases the risk of gastrointestinal bleeding. Therefore, it is imperative to assess the patient's medication regimen thoroughly.

Patients are advised to consult with a healthcare professional, such as a doctor or pharmacist, prior to initiating ibuprofen therapy if they are currently taking any other medications. This precaution helps to mitigate potential drug interactions and ensures safe use.

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, a dose of 2 tablets may be administered. It is important not to exceed 6 tablets 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. It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients, especially in the presence of risk factors such as high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Before initiating treatment, healthcare providers should inquire about the presence of these conditions and consider consulting with a physician if the stomach bleeding warning is applicable. Close monitoring of elderly patients is recommended to ensure safety and to mitigate potential adverse effects associated with the use of 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. The use of ibuprofen during the last trimester is contraindicated 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 evaluate the potential benefits and risks when considering the use of this medication in pregnant patients.

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 individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of renal impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have conditions such as liver cirrhosis. It is essential for these patients to receive appropriate evaluation and monitoring of their liver function to ensure safe and effective use of the medication. Adjustments to dosage may be necessary based on the severity of hepatic impairment, and ongoing assessment of liver function is recommended throughout the treatment period.

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 are advised to call the Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial in mitigating potential adverse effects associated with an overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms as they arise.

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 to address any complications that may develop as a result of the overdose.

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 the following adverse reactions reported voluntarily or through surveillance programs.

Allergic reactions have been observed, including hives, facial swelling, asthma (wheezing), shock, rash, blisters, and skin reddening. Additionally, cases of stomach bleeding have been reported, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, and patients taking blood-thinning (anticoagulant) or steroid medications. The risk may also be heightened in individuals using other drugs containing prescription or non-prescription NSAIDs, exceeding the recommended dosage, or consuming three or more alcoholic drinks daily while using this product.

Furthermore, there is an increased risk of heart attack or stroke associated with the use of ibuprofen beyond the recommended duration or dosage.

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 stomach upset, taking the medication with food or milk may help alleviate discomfort.

It is important to communicate that the risk of heart attack or stroke may increase if the medication is used in higher doses or for a longer duration than recommended. Patients should be instructed to discontinue use and consult a doctor if they notice any signs of stomach bleeding, which include feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain.

Patients should also be counseled to seek medical advice if their pain worsens or lasts longer than 10 days, if their fever intensifies or persists beyond 3 days, if there is redness or swelling in the painful area, or if any new symptoms arise.

Before initiating treatment, healthcare providers should ask patients if they have a history of stomach problems, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Patients should be advised to consult a doctor before use if they are currently taking a diuretic or if they are under medical care for any serious condition.

Additionally, patients should be informed that taking aspirin for heart attack or stroke may be less effective when used concurrently with ibuprofen. It is essential for patients to disclose any other medications they are taking to their healthcare provider or pharmacist prior to use.

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 room temperature, specifically between 20ºC and 25ºC (68ºF and 77ºF). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

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)