Ibuprofen

Description

Ibuprofen Tablets USP are formulated as coated caplets, each containing 200 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) indicated for pain relief and fever reduction. The tablets are capsule-shaped and should not be used if the tamper-evident seal under the bottle cap, imprinted with "SEALED FOR YOUR PROTECTION," is broken or missing. These tablets are 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 in the form of caplets. For adults and children aged 12 years and older, the recommended dosage is 1 caplet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 caplet, a dosage of 2 caplets may be taken. 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 advised to consult a doctor prior to administration. The smallest effective dose should always be utilized, and patients should not exceed the recommended dosage.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to 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 may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative 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 heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are concurrently using blood-thinning medications (anticoagulants) or steroids, are taking other NSAIDs (including aspirin, ibuprofen, naproxen, or similar agents), 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 discontinue use and consult a physician if any signs of stomach bleeding occur. These signs include feeling faint, experiencing bloody or black stools, vomiting blood, having persistent stomach pain that does not improve, worsening pain lasting more than 10 days, a fever that worsens or persists beyond three days, redness or swelling in the affected area, or the emergence of any new symptoms.

In the event of an overdose, immediate medical attention is required. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay.

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 experiencing any of these symptoms should seek immediate medical attention.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a warning for the potential 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 blood-thinning medications or steroids, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), exceed the recommended dosage or duration of use, or consume three or more alcoholic drinks daily while using this product.

Patients should discontinue use and consult a healthcare professional if they experience signs of stomach bleeding, which may include feeling faint, having bloody or black stools, vomiting blood, experiencing persistent stomach pain, or if pain worsens or lasts longer than 10 days. Additionally, if fever worsens or lasts more than three days, or if redness or swelling occurs in the painful area, medical advice should be sought. The appearance of any new symptoms should also prompt a consultation with a healthcare provider.

Before using ibuprofen, patients should consult a doctor if they have a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease, or if they have asthma. It is also advisable to seek medical advice if they are under a doctor's care for any serious condition, are taking aspirin for heart attack or stroke (as ibuprofen may diminish the cardioprotective effects of aspirin), or are using any other medications.

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 underscores the importance of careful consideration when co-administering these medications.

Patients with a known allergy to aspirin may experience severe allergic reactions when taking ibuprofen. Therefore, it is crucial for healthcare providers to assess patient history for aspirin allergies prior to prescribing ibuprofen.

The risk of gastrointestinal bleeding is significantly elevated in patients who are concurrently using ibuprofen with anticoagulants or steroid medications. Monitoring for signs of gastrointestinal distress is advised in these patients to mitigate potential complications.

Additionally, prolonged use of ibuprofen beyond the recommended dosage may increase the risk of cardiovascular events, including heart attack or stroke. It is essential for healthcare professionals to counsel patients on adhering to prescribed dosages and durations of ibuprofen therapy.

Before initiating ibuprofen therapy, it is recommended that patients consult their healthcare provider if they are taking any other medications. This precaution helps to ensure safe and effective use of ibuprofen in the context of their overall medication regimen.

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 and children aged 12 years and older, the recommended dosage is 1 caplet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 caplet, 2 caplets may be administered. It is important not to exceed 6 caplets in a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. Therefore, caution is advised when prescribing this medication to this population.

It is essential for healthcare providers to assess the overall health status of geriatric patients prior to initiating treatment. Patients with pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease should consult with their healthcare provider before use. Monitoring for potential adverse effects is recommended to ensure patient safety and to make any necessary dosage adjustments.

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 explicitly 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 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 specifically directed by a healthcare professional, as it may lead to complications for the unborn child or during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings 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 allergic reactions such as hives, facial swelling, asthma (wheezing), shock, rash, blisters, and skin reddening. Additionally, severe stomach bleeding has been noted, particularly in individuals over 60 years of age, those with a history of stomach ulcers or bleeding problems, and those concurrently using blood thinning medications or other nonsteroidal anti-inflammatory drugs (NSAIDs).

There is an observed potential increase in the risk of heart attack or stroke associated with prolonged use or higher than directed doses. Reports of gastrointestinal adverse events have also been documented, including abdominal pain, nausea, and vomiting. Other adverse reactions reported include dizziness, headache, and rash.

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. It is crucial to inform patients that they should not use this medication if they have ever experienced an allergic reaction to any other pain reliever or fever reducer. Additionally, patients should be cautioned against using this product right before or after undergoing heart surgery.

Patients must be instructed to stop using the medication and consult a doctor if they experience any signs of stomach bleeding, which include feeling faint, having bloody or black stools, vomiting blood, experiencing stomach pain that does not improve, or if pain persists for more than 10 days. They should also seek medical advice if fever worsens or lasts more than 3 days, if redness or swelling occurs 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 to communicate that the risk of heart attack or stroke may increase if the medication is used in excess of the recommended dosage or for a duration longer than directed.

Patients should be encouraged to consult a doctor before use if the warning regarding stomach bleeding applies to them, or if they have a history of serious side effects from pain relievers or fever reducers. Those with a history of stomach problems, such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease should also seek medical advice prior to use. Furthermore, patients with asthma or those taking a diuretic should consult a doctor before using this medication.

Healthcare providers should remind patients to discuss their current medications with a doctor or pharmacist, especially if they are under care for any serious condition or if they are taking aspirin for heart attack or stroke, as ibuprofen may diminish the effectiveness of aspirin.

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°C to 25°C (68°F to 77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent exposure to extreme temperatures.

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)