Ibuprofen

Description

Ibuprofen Capsules contain 200 mg of ibuprofen per capsule and are packaged in a count of 20 capsules. The product is identified by the National Drug Code (NDC) number 53345-014-02. These capsules are manufactured in China. It is recommended to store the product at a temperature range of 20-25°C (68-77°F).

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with 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 that the total dosage does not 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. 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 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 carries a risk of stomach bleeding. The likelihood of experiencing this adverse effect is increased 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, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use.

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, gastrointestinal issues such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if they are currently taking a diuretic. Additionally, patients should seek guidance from a doctor or pharmacist if they are under medical care for any serious condition, are using aspirin for cardiovascular protection, or are taking any other medications.

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 are advised to discontinue use and consult a healthcare provider if they experience any signs of stomach bleeding, including feeling faint, vomiting blood, passing bloody or black stools, 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 advice should be sought promptly.

Side Effects

Patients may experience a range of adverse reactions while using this product, which contains ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID).

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.

Additionally, the use of this NSAID carries a risk of stomach bleeding, which 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, consume three or more alcoholic drinks daily, or use other NSAIDs concurrently. Patients should be vigilant for signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. If any of these symptoms occur, patients are advised to discontinue use and consult a healthcare professional.

Other adverse reactions may include worsening pain that lasts longer than 10 days, fever that persists beyond three days, redness or swelling in the painful area, or the emergence of any new symptoms.

Patients with a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should seek medical advice before using this product. It is also recommended that patients under a doctor's care for any serious condition or those taking aspirin for cardiovascular protection consult with a healthcare provider, as ibuprofen may diminish the cardioprotective effects of aspirin.

In clinical trials and postmarketing experiences, these adverse reactions have been noted, underscoring the importance of monitoring for any signs of serious side effects during treatment.

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 suggests that patients should be cautious when using these medications together, as the intended cardiovascular benefits of aspirin may be compromised.

Ibuprofen has the potential to interact with anticoagulants and steroid medications. The clinical implications of this interaction may necessitate careful monitoring of patients who are prescribed these drug classes concurrently, as the risk of adverse effects could be heightened.

Additionally, the concomitant use of ibuprofen with other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin and naproxen, increases the risk of gastrointestinal bleeding. Therefore, it is advisable for patients to consult with a healthcare professional, such as a doctor or pharmacist, prior to initiating ibuprofen if they are currently taking any other medications. This precaution is essential to ensure safe and effective use of these drugs and to mitigate potential risks associated with their interactions.

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 capsule every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 capsule, 2 capsules may be administered. It is important to note that the maximum dosage should not exceed 6 capsules in a 24-hour period, unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, defined as those aged 65 and older, may have an increased risk of adverse effects when using this medication. Specifically, the likelihood of stomach bleeding is heightened in individuals aged 60 and older. Therefore, it is crucial for healthcare providers to assess the appropriateness of this medication in geriatric patients, particularly those with pre-existing conditions.

Before initiating treatment, healthcare providers should inquire about the presence of risk factors for stomach bleeding, such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. These conditions may necessitate additional caution or alternative therapeutic strategies.

Furthermore, elderly patients may face an elevated risk of heart attack or stroke if the medication is used in excess of the recommended dosage or for an extended duration. It is essential for healthcare providers to monitor these patients closely and consider dose adjustments as necessary to mitigate these risks. Regular evaluation of the patient's response to therapy and ongoing assessment of their overall health status are recommended to ensure safe and effective use of the medication in this population.

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 during the last trimester of pregnancy 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 benefits and risks of ibuprofen use in pregnant patients, especially in the later stages of pregnancy.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of 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. 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 underlying conditions such as kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of renal impairment. Caution is advised in patients with reduced kidney function, as they may be at increased risk for adverse effects.

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 to assess liver function and consider potential risks associated with the use of this medication in individuals with compromised liver function. Monitoring of liver parameters may be warranted to ensure safety and efficacy in this population. Adjustments to dosage or treatment regimens may be necessary based on the severity of hepatic impairment and the patient's overall health status.

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.

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 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 associated with the use of the medication. Reports have included gastrointestinal bleeding, renal impairment, and hypersensitivity reactions, which encompass anaphylaxis and angioedema. Additionally, skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been documented.

Cardiovascular events, including myocardial infarction and stroke, have also been reported in association with the use of ibuprofen. Furthermore, liver enzyme elevations have been observed in some patients during postmarketing surveillance. Severe skin reactions, including exfoliative dermatitis, have been noted, along with instances of gastrointestinal perforation, particularly in patients with a prior history of gastrointestinal issues.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial for patients to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222 for guidance. This information is essential for ensuring patient safety and effective management of potential overdose situations.

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° to 25°C (68° to 77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). Proper storage conditions are crucial to maintain the integrity and efficacy 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 trimester 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)