Redicare Ibuprofen

Description

The drug is Ibuprofen, identified by the SPL code 34089-3. Its chemical name is (RS)-2-(4-(2-methylpropyl)phenyl)propanoic acid, with a molecular formula of C13H18O2 and a molecular weight of 206.28. Ibuprofen appears as a white to off-white crystalline powder. It is characterized by its practical insolubility in water, while being soluble in alcohol and various organic solvents.

The formulation includes several inactive ingredients: corn starch, croscarmellose sodium, D&C Red No. 30, dextrose, FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, talc, and titanium dioxide.

Uses and Indications

This drug has no specific indications or usage information provided. There are no noted teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals are advised to consult additional resources or clinical guidelines for further information regarding the appropriate use of this medication.

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. If pain or fever does not adequately respond to the initial dose, a second tablet may be taken. It is imperative that the total dosage does not exceed 6 tablets within a 24-hour period unless specifically directed by a healthcare professional.

For children under 12 years of age, the use of this medication is not recommended unless directed by a physician.

Contraindications

Use is contraindicated in patients 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 to surgical outcomes and patient safety.

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, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains a non-steroidal anti-inflammatory drug (NSAID), which carries a risk of 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 (such as 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 discontinue use and consult a physician if any of the following occur: feeling faint, vomiting blood, or experiencing bloody or black stools, as these may be signs of stomach bleeding; worsening pain or pain persisting beyond 10 days; fever that worsens or lasts more than 3 days; exacerbation of stomach pain or upset; presence of redness or swelling in the affected area; or the emergence of any new symptoms.

In the event of an overdose, it is crucial to seek immediate medical attention or contact a Poison Control Center without delay.

Side Effects

Patients may experience a range of adverse reactions associated with the use of ibuprofen, which is classified as a non-steroidal anti-inflammatory drug (NSAID).

Serious adverse reactions include the potential for severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, or blisters. Additionally, ibuprofen carries a warning regarding the 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 anticoagulants or steroid medications, consume three or more alcoholic drinks daily, or use other NSAIDs concurrently.

Patients are advised to discontinue use and consult a healthcare professional if they experience symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, or passing bloody or black stools. Other concerning symptoms that warrant medical attention include worsening pain lasting more than 10 days, fever persisting beyond 3 days, exacerbation of stomach pain or upset, redness or swelling in the painful area, or the emergence of any new symptoms.

It is recommended that patients with a history of serious side effects from pain relievers or fever reducers, chronic stomach issues (such as heartburn or stomach pain), ulcers, bleeding disorders, high blood pressure, heart disease, liver cirrhosis, or kidney disease consult a healthcare provider prior to use. Furthermore, individuals who are taking diuretics or are 60 years of age or older should seek medical advice before using ibuprofen.

Patients should also inform their healthcare provider or pharmacist if they are currently taking any other NSAIDs, anticoagulants, or steroid medications, or if they are under treatment for any serious medical condition. To mitigate gastrointestinal discomfort, it is advisable to take ibuprofen with food or milk. Long-term continuous use of ibuprofen may increase the risk of heart attack or stroke, necessitating careful consideration of its prolonged use.

Drug Interactions

The concomitant use of ibuprofen with anticoagulants or steroid medications may elevate the risk of gastrointestinal bleeding. Healthcare professionals should exercise caution when prescribing ibuprofen to patients who are on these medications, and consider monitoring for signs of bleeding.

Additionally, the use of ibuprofen alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin or naproxen, may further increase the risk of gastrointestinal bleeding. It is advisable to avoid the concurrent use of multiple NSAIDs to mitigate this risk.

No specific interactions with laboratory tests have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Redicare Ibuprofen (ibuprofen 200mg). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children under 12 years of age should not use this medication unless directed by a doctor. For adults and children aged 12 years and older, the smallest effective dose should be utilized, with a recommended dosage of 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, a second tablet may be taken; however, the total dosage must not exceed 6 tablets in a 24-hour period unless otherwise directed by a healthcare professional.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of stomach bleeding associated with the use of this medication. It is advised that healthcare providers exercise caution when prescribing this medication to geriatric patients.

Before initiating treatment, it is essential for elderly patients to consult with a healthcare professional, such as a doctor or pharmacist, to assess the appropriateness of the medication based on their individual health status and any concurrent medications. This precaution is particularly important for patients who have reached the age of 60 or older, as they may require closer monitoring and potential dose adjustments to mitigate risks.

Healthcare providers should remain vigilant in monitoring for signs of gastrointestinal bleeding in this population and consider alternative therapies if necessary.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. It is especially important to avoid the use of ibuprofen during the last trimester unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should weigh the potential benefits against the 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 during the last three months of pregnancy unless specifically directed by a doctor, 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, healthcare providers should weigh the potential benefits against any 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 for patients under a physician's care for any serious condition, including those with reduced kidney function, to seek advice from a doctor or pharmacist before initiating treatment. Monitoring and appropriate dosing adjustments may be necessary based on the patient's renal status.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential to evaluate liver function and consider potential dosage adjustments or monitoring requirements based on the severity of hepatic impairment. Careful assessment of the patient's overall health status and liver function is necessary to ensure safe and effective use of the medication in this population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to be aware that they can vary based on the substance involved and the individual’s health status.

Management of an overdose typically involves supportive care and symptomatic treatment. The healthcare provider should assess the patient's condition and implement appropriate measures based on the severity of the overdose and the symptoms presented. Continuous monitoring and evaluation are recommended to ensure patient safety and effective management of the situation.

Nonclinical Toxicology

It is especially important not to use ibuprofen during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or 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 has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, and blisters. Additionally, cases of stomach bleeding have been noted, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, patients taking blood thinning or steroid medications, individuals consuming three or more alcoholic drinks daily, or those exceeding the recommended dosage. Furthermore, long-term continuous use of the product may be associated with an increased risk of heart attack or stroke.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. Patients should be informed that taking the medication with food or milk may help alleviate any stomach upset that occurs.

It is important to discuss the potential risks associated with long-term continuous use of the medication, as it may increase the risk of heart attack or stroke. Patients should be instructed to stop using the medication and consult a doctor if they experience symptoms such as feeling faint, vomiting blood, or noticing bloody or black stools, as these may indicate stomach bleeding.

Healthcare providers should also counsel patients to discontinue use and seek medical advice if pain worsens or persists for more than 10 days, if fever intensifies or lasts longer than 3 days, or if stomach pain or upset becomes more severe or lasts. Additionally, patients should be advised to stop use and consult a doctor if there is any redness or swelling in the painful area or if any new symptoms arise.

Before initiating treatment, healthcare providers should encourage patients to consult a doctor if they have a history of problems or serious side effects from pain relievers or fever reducers. Patients with ongoing or recurrent stomach issues, such as heartburn, upset stomach, or stomach pain, should also be advised to seek medical advice prior to use.

Furthermore, it is essential to recommend that patients consult a doctor before use if they have a history of ulcers, bleeding problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients who have taken a diuretic, are aged 60 or older, or are currently under a doctor’s care for any serious condition should also be encouraged to seek medical advice before using the medication.

Lastly, healthcare providers should remind patients to consult a doctor or pharmacist before use if they are taking any other drug containing NSAIDs, blood thinners (anticoagulants), or steroid medications. It is crucial for patients to disclose all medications they are currently taking to ensure safe and effective use of the medication.

Storage and Handling

The product is supplied in a tamper-evident package. It is essential to inspect the packaging prior to use; do not utilize the product if the packet is torn, cut, or opened.

For optimal storage, the product should be maintained at a controlled room temperature between 15˚ to 30˚C (59˚ to 86˚F). It is crucial to avoid exposure to excessive heat and humidity to ensure 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 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.

Drug Information (PDF)

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

View product document (PDF)