Ibuprofen, Caseys 4good

Description

Ibuprofen Tablets USP contain 200 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. These tablets are designed for oral administration and are available in a package containing 50 coated tablets. The formulation is comparable to the active ingredient found in Advil Tablets.

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 according to the following guidelines to ensure safety and efficacy.

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 pain or fever does not adequately respond to 1 tablet, a dose of 2 tablets may be taken. However, it is imperative not to exceed a total of 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 doctor for appropriate dosing recommendations.

Healthcare professionals should emphasize the importance of using the smallest effective dose and adhering strictly to the prescribed dosage to avoid potential adverse effects.

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 is associated with several significant warnings and precautions that healthcare professionals must consider to ensure patient safety.

Allergy Alert Ibuprofen may induce 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.

Stomach Bleeding Warning As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen carries a risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in patients who meet any of the following criteria: those aged 60 years or older, individuals with a history of stomach ulcers or bleeding disorders, patients concurrently using anticoagulants or steroid medications, those taking other NSAIDs (including aspirin, ibuprofen, or naproxen), individuals consuming three or more alcoholic beverages daily while using this product, or those who exceed the recommended dosage or duration of use.

Heart Attack and Stroke Warning The use of NSAIDs, excluding aspirin, is 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 ibuprofen in excess of the recommended dosage or for extended periods.

Emergency Medical Help In cases of suspected 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).

Monitoring and Consultation Patients should be instructed to discontinue ibuprofen and consult a healthcare provider if they experience any of the following symptoms indicative of stomach bleeding: bloody or black stools, faintness, vomiting blood, or persistent stomach pain. Additionally, symptoms suggestive of heart problems or stroke, such as chest pain, slurred speech, leg swelling, difficulty breathing, or unilateral weakness, warrant immediate medical evaluation. Patients should also seek medical advice if pain persists beyond 10 days, fever worsens or lasts more than 3 days, redness or swelling occurs in the affected area, or any new symptoms arise.

These precautions are essential for the safe administration of ibuprofen and should be communicated clearly to patients.

Side Effects

Patients may experience a range of adverse reactions associated with the use of ibuprofen. Serious adverse reactions include severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, or blisters, particularly in individuals with a known allergy to aspirin.

The use of ibuprofen, as a nonsteroidal anti-inflammatory drug (NSAID), carries a significant risk of severe stomach bleeding. This risk is heightened in patients who are aged 60 years or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily, or exceed the recommended dosage or duration of use. Patients should be vigilant for signs of stomach bleeding, which include bloody or black stools, faintness, vomiting blood, or persistent stomach pain.

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 ibuprofen in excess of the recommended dosage or for prolonged periods. Patients should discontinue use and seek medical attention if they experience symptoms indicative of heart problems or stroke, such as chest pain, slurred speech, leg swelling, difficulty breathing, or weakness on one side of the body.

Common adverse reactions may include worsening pain lasting more than 10 days, fever persisting beyond three days, or the presence of redness or swelling in the affected area. Patients are advised to consult a healthcare professional prior to use if they have a history of serious side effects from pain relievers or fever reducers, if the stomach bleeding warning applies to them, or if they have pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke.

Furthermore, patients taking aspirin for cardiovascular protection should consult a doctor or pharmacist, as ibuprofen may diminish the cardioprotective effects of aspirin. It is also recommended that patients under a physician's care for serious conditions or those taking other medications seek medical advice before using ibuprofen.

Drug Interactions

Ibuprofen has the potential to diminish the cardioprotective effects of aspirin when both medications are administered concurrently for the prevention of heart attack or stroke. It is advisable to monitor patients closely for any signs of reduced efficacy of aspirin in such scenarios. Consideration should be given to the timing of administration, as taking ibuprofen at least 30 minutes after or 8 hours before aspirin may help mitigate this interaction.

Packaging & NDC

Below are the non-prescription pack sizes of Ibuprofen, Caseys 4good (ibuprofen tablets). 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 tablet every 4 to 6 hours as needed while symptoms persist. 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 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 when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). Due to this heightened risk, it is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients.

Before initiating treatment, healthcare providers should inquire about the presence of any comorbid conditions in elderly patients, including high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. These factors may necessitate careful monitoring and potential dose adjustments to ensure the safety and efficacy of the treatment 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 after 20 weeks of gestation 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 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 provided regarding the excretion of ibuprofen in breast milk or its effects on breastfed infants. Therefore, healthcare providers should weigh the potential benefits against the risks when considering this medication for lactating mothers.

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 should consult a healthcare professional prior to use, particularly if they have a history of liver cirrhosis. It is essential for these patients to discuss their liver function status, as compromised liver function may influence the safety and efficacy of the treatment. Monitoring of liver function may be warranted in this population to ensure appropriate management and to mitigate potential risks associated with the use of the medication.

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 symptoms may vary depending on the substance involved. It is essential for healthcare providers to assess the patient's condition thoroughly and initiate appropriate management procedures based on the specific circumstances of the overdose.

Monitoring and supportive care may be necessary, and healthcare professionals should be prepared to provide symptomatic treatment as required.

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 non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding animal pharmacology and toxicology.

Postmarketing Experience

During postmarketing use of ibuprofen, the following adverse reactions have been reported voluntarily or through surveillance programs:

Allergic reactions have been noted, including cases of anaphylaxis and serious skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Cardiovascular events, including heart attack and stroke, have also been documented. Gastrointestinal complications, such as bleeding, ulceration, and perforation, have been reported.

Liver injury, characterized by elevated liver enzymes and hepatitis, has been observed, along with renal injury, which includes acute renal failure and interstitial nephritis. Hematologic reactions, such as thrombocytopenia and aplastic anemia, have been identified. Central nervous system effects, including aseptic meningitis, have been reported, as well as respiratory reactions, notably asthma exacerbation. Additional reactions include dizziness, tinnitus, and visual disturbances.

Patient Counseling

Patients should be advised to keep this medication out of reach of children. In the event of an overdose, they should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients must be informed to stop using the medication and consult a doctor if they experience any signs of stomach bleeding, which may include bloody or black stools, feeling faint, vomiting blood, or persistent stomach pain. Additionally, they should seek medical attention if they exhibit symptoms indicative of heart problems or stroke, such as chest pain, slurred speech, leg swelling, difficulty breathing, or weakness on one side of the body.

It is important to instruct patients to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days, if their fever intensifies or lasts longer than 3 days, or if they notice redness or swelling in the affected area. They should also be advised to seek medical advice if any new symptoms arise.

When using this product, patients should take it with food or milk if they experience stomach upset. They should be encouraged to consult a doctor before use if they have a history of serious side effects from pain relievers or fever reducers, or if the stomach bleeding warning is applicable to them.

Patients with a history of stomach problems, such as heartburn, or those with conditions like 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, patients taking diuretics or aspirin for heart attack or stroke should seek guidance from a doctor or pharmacist, as ibuprofen may diminish the benefits of aspirin.

Lastly, patients under a doctor's care for any serious condition or those taking any other medications should be encouraged to discuss their use of this product with a healthcare professional.

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 temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines. Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F), to maintain product integrity. Proper storage conditions are crucial for ensuring the efficacy and safety 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 after 20 weeks 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, Caseys 4good, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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