Ibuprofen Softgels

Description

Ibuprofen is presented in a softgel dosage form, with each softgel containing 200 mg of the active ingredient. The product is packaged in a container containing 20 softgels.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscular aches, the common cold, headache, toothache, backache, menstrual cramps, 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

Adults and children aged 12 years and over are advised to take 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, a dosage of 2 capsules may be administered. It is imperative that the total daily 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 recommended to consult a doctor prior to administration.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any other pain reliever or fever reducer. Additionally, administration is contraindicated immediately before or after heart surgery due to potential complications associated with surgical recovery.

Caution is advised as exceeding the recommended dosage or duration of use may increase the risk of heart attack or stroke.

Warnings and Precautions

Ibuprofen may elicit severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of such reactions can include blisters, rash, hives, wheezing, shock, skin reddening, and facial swelling. 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 certain populations, including those who:

• Are taking anticoagulants or steroid medications

• Are aged 60 years or older

• Have a history of stomach ulcers or bleeding disorders

• Are concurrently using other NSAIDs, whether prescription or over-the-counter (e.g., aspirin, ibuprofen, naproxen)

• Consume three or more alcoholic beverages daily while using this product

• Exceed the recommended dosage or duration of use

Healthcare professionals should advise patients to discontinue use and consult a physician if any signs of stomach bleeding occur. These signs include feeling faint, persistent stomach pain, bloody or black stools, vomiting blood, worsening pain lasting more than 10 days, 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 using ibuprofen should be aware of the potential for serious adverse reactions, including severe allergic reactions and gastrointestinal complications.

Allergic Reactions Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions can include blisters, rash, hives, wheezing, shock, skin reddening, and facial swelling. In the event of an allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

Gastrointestinal Risks As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries a risk of severe stomach bleeding. This risk is heightened in patients who are taking anticoagulants or steroid medications, are aged 60 or older, have a history of stomach ulcers or bleeding problems, consume three or more alcoholic drinks daily while using the product, or take other NSAIDs concurrently. Patients should be vigilant for signs of stomach bleeding, which may manifest as feeling faint, persistent stomach pain, bloody or black stools, or vomiting blood. If any of these symptoms occur, patients should stop use and consult a healthcare provider.

Cardiovascular Concerns There is an increased risk of heart attack or stroke associated with the use of ibuprofen, particularly if the medication is taken in higher doses or for extended periods.

Contraindications and Precautions Ibuprofen should not be used by individuals who have previously experienced an allergic reaction to any pain reliever or fever reducer, or by those who are undergoing heart surgery. Patients are advised to consult a healthcare professional before using ibuprofen if they have a history of stomach problems, are taking diuretics, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma.

Monitoring for Adverse Effects Patients should monitor for any new symptoms or worsening of existing conditions while using ibuprofen. If pain persists beyond 10 days or fever lasts more than 3 days, or if redness or swelling occurs in the painful area, medical advice should be sought.

Drug Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. Therefore, it is advisable to avoid concurrent use of ibuprofen and aspirin for these indications.

The concomitant use of ibuprofen with anticoagulants or steroid medications significantly elevates the risk of gastrointestinal bleeding. Clinicians should exercise caution and consider monitoring patients closely for signs of bleeding when these medications are prescribed together.

Patients taking diuretics should consult a healthcare professional prior to using ibuprofen, as potential interactions may necessitate dosage adjustments or increased monitoring.

Additionally, the risk of gastrointestinal bleeding is further heightened when ibuprofen is used in conjunction with other nonsteroidal anti-inflammatory drugs (NSAIDs), whether prescription or over-the-counter, such as aspirin, naproxen, or other similar agents. It is recommended that patients avoid the simultaneous use of multiple NSAIDs to mitigate this risk.

Packaging & NDC

Below are the non-prescription pack sizes of Ibuprofen Softgels (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 within a 24-hour period unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. This heightened risk necessitates careful monitoring for signs of stomach bleeding in this population, especially for those with a history of stomach ulcers or bleeding disorders.

Healthcare providers are advised to recommend precautions for geriatric patients, including vigilant observation for any symptoms indicative of gastrointestinal bleeding. Prior to initiating treatment, it is essential for elderly patients to consult with their healthcare provider if they fall within the age group affected by the stomach bleeding warning. This consultation is particularly critical for those with pre-existing conditions that may exacerbate the risk of bleeding.

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. It is crucial for women of childbearing potential to be aware of these considerations to ensure the safety of both themselves and their unborn child.

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 ibuprofen in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication in lactating individuals.

Renal Impairment

Patients with renal impairment may require careful consideration regarding dosing adjustments and monitoring. It is important to assess renal function prior to initiating treatment, particularly in patients who are taking a diuretic or have comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. These factors can influence the pharmacokinetics of the medication and may necessitate modifications to the standard dosing regimen to ensure safety and efficacy. Regular monitoring of renal function is recommended to detect any changes that may arise during treatment.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication. It is essential to assess liver function prior to initiating treatment. In patients with significant liver disease, particularly those with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity.

Monitoring of liver function tests is recommended throughout the treatment period to ensure safety and efficacy. Clinicians should be vigilant for any signs of worsening liver function, and adjustments to the treatment regimen should be made accordingly.

Patients with hepatic impairment should be closely monitored for adverse effects, particularly if they have concurrent conditions such as high blood pressure, heart disease, kidney disease, or asthma, as these may complicate the management of their 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 should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical attention can significantly influence outcomes. 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, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should 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 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 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 a range of adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as anaphylaxis, angioedema, and skin reactions, notably Stevens-Johnson syndrome and toxic epidermal necrolysis. Cardiovascular events have been reported, including myocardial infarction and stroke.

Gastrointestinal events such as gastrointestinal bleeding, ulceration, and perforation have also been documented. Hepatic reactions, including liver failure and hepatitis, were noted, alongside renal reactions such as acute renal failure and interstitial nephritis. Hematologic reactions, including thrombocytopenia and aplastic anemia, have been observed.

Central nervous system events, specifically aseptic meningitis, were reported, as well as respiratory events, including exacerbation of asthma. Additionally, various skin reactions, including rash and pruritus, have been recorded.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical help 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.

Providers should inform patients about the potential increased risk of heart attack or stroke associated with using more than the directed dosage or using the medication for longer than recommended. Patients should be encouraged to consult with their healthcare provider before use if they have a history of stomach problems, such as heartburn, or if they are under a stomach bleeding warning.

Additionally, patients should be advised to discuss their medical history with their healthcare provider, particularly if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It is also important for patients to inform their healthcare provider if they are taking a diuretic or have experienced problems or serious side effects from pain relievers or fever reducers in the past.

Healthcare providers should recommend that patients consult with a doctor or pharmacist before using this medication if they are taking any other drugs or if they are under a doctor's care for any serious condition. Furthermore, patients should be made aware that if they are taking aspirin for heart attack or stroke prevention, ibuprofen may diminish the effectiveness of aspirin, and they should discuss this with their healthcare provider.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature 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 essential 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 Softgels, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)