Redicare Ibuprofen 200mg

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "I" on one side and "100" on the other. Each tablet contains 100 mg of Ibuprofen as the active ingredient. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide yellow.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including 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

Adults and children aged 12 years and older are advised to take 1 tablet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 tablet, a dosage of 2 tablets may be administered. It is imperative that the total daily dosage does not exceed 6 tablets 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 is contraindicated in individuals with a history of allergic reactions to any other pain reliever or fever reducer, due to the potential for severe hypersensitivity reactions. Additionally, the product should not be administered immediately before or after heart surgery, as it may pose risks related to surgical recovery and cardiovascular stability.

Warnings and Precautions

The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, carries significant risks that healthcare professionals must consider when prescribing or recommending these medications.

Cardiovascular Risks NSAIDs, with the exception of aspirin, are associated with an increased risk of serious cardiovascular events, including heart attack, heart failure, and stroke, which can be fatal. This risk is amplified when the medication is used in higher doses or for extended periods beyond the recommended guidelines.

Allergic Reactions Ibuprofen may provoke 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, immediate cessation of the medication and prompt medical attention are imperative.

Gastrointestinal Risks This product contains an NSAID that may lead to severe gastrointestinal bleeding. The likelihood of this adverse effect increases in patients who meet any of the following criteria:

• Age 60 years or older

• History of stomach ulcers or bleeding disorders

• Concurrent use of anticoagulants or steroid medications

• Use of other NSAIDs, whether prescription or over-the-counter (e.g., aspirin, ibuprofen, naproxen)

• Consumption of three or more alcoholic beverages daily while using this product

• Exceeding the recommended dosage or duration of use

General Precautions The use of ibuprofen is contraindicated in individuals with a history of allergic reactions to any pain reliever or fever reducer. It should not be administered immediately before or after cardiac surgery. 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

• Existing gastrointestinal issues, such as heartburn

• Diagnosed high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke

• Concurrent use of diuretics

Additionally, patients should be cautioned to seek advice from a healthcare provider or pharmacist if they are under treatment for any serious medical condition, are taking aspirin for cardiovascular protection (as ibuprofen may diminish the efficacy of aspirin), or are using any other medications.

Emergency Medical Assistance In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted.

Monitoring and Discontinuation Patients should be instructed to discontinue use and consult a physician if they experience any signs indicative of gastrointestinal bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Additionally, they should seek medical attention if they exhibit symptoms of cardiovascular issues or stroke, including chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling. Persistent pain lasting more than 10 days, fever lasting more than 3 days, redness or swelling in the affected area, or the emergence of new symptoms also warrant immediate medical evaluation.

Side Effects

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The risk of stomach bleeding is increased in patients who are age 60 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 this product, or take other NSAIDs, including prescription or nonprescription medications such as aspirin, ibuprofen, or naproxen. Patients should be advised to take this product only as directed and for the shortest duration necessary to minimize the risk of adverse reactions.

Patients may also experience severe allergic reactions to ibuprofen, particularly those with a known allergy to aspirin. Symptoms of an allergic reaction may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. In the event of an allergic reaction, patients should discontinue use and seek immediate medical attention.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is heightened when the medication is used in excess of the recommended dosage or for prolonged periods.

Patients should be instructed to stop using the product and consult a healthcare professional if they experience any 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, weakness on one side of the body, slurred speech, or leg swelling, also warrant immediate medical consultation. Furthermore, patients should seek medical advice if their pain worsens or persists beyond 10 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

Before using this product, patients should consult a healthcare provider if they have a history of stomach problems, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also advisable for patients taking diuretics or those under a physician's care for any serious condition to seek medical advice prior to use. Patients taking aspirin for heart attack or stroke should be aware that ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

Ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. Therefore, concurrent use of ibuprofen and aspirin is not recommended in patients who are taking aspirin for these indications.

The concomitant use of ibuprofen with anticoagulants or steroid medications increases the risk of severe gastrointestinal bleeding. It is advisable for healthcare providers to closely monitor patients who are prescribed ibuprofen alongside these agents.

Patients are encouraged 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 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 Redicare Ibuprofen 200mg (ibuprofen 200mg). 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 tablet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 tablet, 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, are at an increased risk of severe stomach bleeding. It is essential for healthcare providers to advise these patients to consult a physician before using this medication if they have concerns related to the stomach bleeding warning.

Additionally, the risk of heart attack and stroke is heightened in geriatric patients who exceed the recommended dosage or duration of use. Therefore, careful monitoring and adherence to prescribed guidelines are crucial in this population to mitigate potential adverse effects. Healthcare providers should consider these factors when prescribing this medication to elderly patients and ensure appropriate dose modifications and safety precautions are communicated.

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 at 20 weeks of gestation or later unless explicitly directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. The potential fetal impacts and associated risks necessitate careful consideration and professional guidance in managing pain or inflammation during 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 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 this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use 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 should consult a healthcare professional prior to use, particularly if they have a history of liver cirrhosis. It is essential for patients with compromised liver function to discuss their medical history, including any conditions such as high blood pressure, heart disease, kidney disease, asthma, or previous strokes, with their healthcare provider to ensure safe and effective use of the medication. Monitoring of liver function may be warranted in these patients to assess any potential impact on drug metabolism and overall safety.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center at 1-800-222-1222 without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with overdose situations.

Symptoms of overdose may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential. Management procedures should be initiated based on the clinical presentation and the substance ingested. It is recommended that healthcare providers remain vigilant and prepared to implement appropriate supportive care and symptomatic treatment as necessary.

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 current information.

Postmarketing Experience

Postmarketing experience includes reports of various adverse reactions. Allergic reactions have been documented, which encompass hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, there have been reports of severe stomach bleeding, particularly in individuals over 60 years of age, those with a history of stomach ulcers or bleeding problems, and those concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs). Furthermore, an increased risk of heart attack, heart failure, and stroke has been associated with NSAID use, especially when utilized in higher doses or for extended durations beyond the recommended guidelines.

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 for patients to understand the importance of prompt action in such situations.

Additionally, healthcare providers should recommend that patients take the medication with food or milk if they experience any stomach upset. This can help mitigate gastrointestinal discomfort and enhance the overall tolerability of the treatment.

Storage and Handling

The product is supplied in a configuration that includes specific packaging details, which are essential for proper handling and storage. It is crucial to store the product at a temperature range of 20-25 °C (68-77 °F) to maintain its efficacy and safety.

Healthcare professionals should ensure that the product is not used if the packet is damaged or opened, as this may compromise the integrity of the contents. Proper adherence to these storage and handling guidelines is vital for optimal product performance.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Redicare Ibuprofen 200mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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