Ibuprofen

Description

Ibuprofen Tablets are formulated as 200 mg coated caplets, serving as a nonsteroidal anti-inflammatory drug (NSAID) indicated for pain relief and fever reduction. These capsule-shaped tablets are designed for oral administration and are comparable to the active ingredient found in ADVIL®. Each bottle contains 50 coated caplets, ensuring a convenient supply for therapeutic use.

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

Adults and children aged 12 years and older are advised to take 1 caplet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 caplet, a dosage of 2 caplets may be administered. 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 recommended to consult a doctor for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in patients with a history of allergic reactions to ibuprofen or 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 its use in this context.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response may 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 experiencing 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 anticoagulants or steroid medications, are taking 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.

Furthermore, NSAIDs, excluding 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 the medication in excess of the recommended dosage or for extended periods.

In cases of overdose, immediate medical attention is required. Healthcare professionals should advise patients to contact a Poison Control Center or seek emergency medical help without delay (1-800-222-1222).

Patients should be instructed to discontinue use and consult a healthcare provider if they experience any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, such as chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling, warrant immediate medical evaluation. Patients should also 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 affected area, or if any new symptoms arise.

Side Effects

Patients using ibuprofen should be aware of potential adverse reactions, which can range from serious to common.

Severe allergic reactions may occur, 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.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a 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 guidelines.

Patients should discontinue use and consult a healthcare provider if they experience 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, if pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, redness or swelling occurs in the painful area, or any new symptoms arise, patients should seek medical advice.

Before using ibuprofen, patients should consult a healthcare professional if they have experienced serious side effects from pain relievers or fever reducers, if the stomach bleeding warning applies to them, or if they have a history of stomach issues such as heartburn. Those with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also seek medical guidance prior to use. It is advisable for patients taking aspirin for heart attack or stroke to consult a doctor, as ibuprofen may diminish the cardioprotective effects of aspirin. Additionally, patients under a physician's care for any serious condition or those taking other medications should discuss their use of ibuprofen with a healthcare provider or pharmacist.

Drug Interactions

Ibuprofen may interact with several classes of drugs, leading to significant clinical effects.

Pharmacodynamic Interactions

• The concomitant use of ibuprofen and aspirin, particularly when aspirin is utilized for cardiovascular protection in the context of heart attack or stroke, may diminish the cardioprotective effects of aspirin. It is advisable to avoid the simultaneous use of these medications to ensure optimal therapeutic outcomes.

• The administration of ibuprofen alongside anticoagulants or steroid medications can elevate the risk of gastrointestinal bleeding. Clinicians should monitor patients closely for signs of bleeding and consider alternative pain management strategies if necessary.

• The use of ibuprofen in combination with other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin, naproxen, or others, may further increase the risk of gastrointestinal bleeding. It is recommended to avoid the concurrent use of multiple NSAIDs.

Pharmacokinetic Interactions

• Co-administration of ibuprofen with diuretics may heighten the risk of renal impairment. Regular monitoring of renal function is advised for patients receiving this combination, particularly in those with pre-existing kidney conditions.

• The intake of alcohol while using ibuprofen can significantly increase the risk of gastrointestinal bleeding. Patients should be counseled to limit or avoid alcohol consumption during ibuprofen therapy to mitigate this risk.

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 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. However, the total dosage must not exceed 6 caplets in a 24-hour period unless otherwise directed by a physician. It is advised to use the smallest effective dose to manage symptoms.

Parents and caregivers should ensure that the medication is kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor these patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit ratio is essential in this population to ensure safe and effective treatment.

Pregnancy

Pregnant patients and women of childbearing potential should consult a healthcare professional before using this medication. It is particularly important to avoid the use of ibuprofen after 20 weeks 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 potential benefits and risks when considering the use of ibuprofen in this population.

Lactation

Lactating mothers are advised to consult a health professional before 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 available 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 during lactation.

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 may experience altered pharmacokinetics of the medication. It is essential to assess liver function prior to initiating treatment and to monitor liver function periodically throughout the course of therapy.

In patients with significant liver impairment, particularly those with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity. The prescribing physician should consider the severity of liver dysfunction when determining the appropriate dosage and frequency of administration.

Additionally, patients with hepatic impairment may have an increased risk of adverse effects due to altered drug metabolism. Therefore, close monitoring for signs of toxicity and therapeutic efficacy is recommended.

It is advised that healthcare providers evaluate the overall health status of patients, including the presence of comorbid conditions such as high blood pressure, heart disease, kidney disease, asthma, or a history of stroke, as these factors may further influence treatment decisions and patient management.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. It is recommended that healthcare providers remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

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 have been identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. These events have been documented in the context of postmarketing surveillance and are included for informational purposes.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is recommended that patients take the medication with food or milk if they experience stomach upset.

Healthcare providers should encourage patients to consult a doctor before using this medication if they have experienced problems or serious side effects from pain relievers or fever reducers in the past. Additionally, patients should be informed to ask a doctor before use if they have a history of stomach issues, such as heartburn, or if the stomach bleeding warning applies to them.

Patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also be advised to consult a doctor prior to use. Furthermore, it is important for patients to discuss their use of diuretics with their healthcare provider before starting this medication.

Patients taking aspirin for heart attack or stroke should be cautioned to speak with a doctor or pharmacist, as ibuprofen may reduce the effectiveness of aspirin in these situations. Lastly, patients under a doctor’s care for any serious condition or those taking any other medications should be encouraged to consult their healthcare provider or pharmacist before using this medication.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It is essential to store the product at a temperature range of 20-25°C (68-77°F). Care should be taken to avoid exposure to high humidity and excessive heat, particularly temperatures exceeding 40°C (104°F). For quality assurance, the lot number and expiration date are located on the end panel of the packaging.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with a recommended dosage of one caplet every 4 to 6 hours as needed for symptom relief. If symptoms persist and one caplet is insufficient, two caplets may be taken. However, the total daily dosage should not exceed six caplets unless directed by a healthcare professional.

Clinicians should counsel patients who are pregnant or breastfeeding to consult a health professional prior to use, particularly emphasizing the risks associated with ibuprofen use after 20 weeks of pregnancy, which may pose risks to the unborn child or complicate delivery. Additionally, patients should be advised to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose.

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)