Topcare Ibuprofen

Description

Ibuprofen Tablets contain 200 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. These tablets are formulated to provide effective analgesic and antipyretic properties.

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

Patients should adhere strictly to the recommended dosage and not exceed the directed amount. The smallest effective dose should be utilized to manage symptoms effectively.

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 administered. However, the total daily dosage must 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 advised to consult a doctor for appropriate dosing recommendations.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to ibuprofen or 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.

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.

The use of ibuprofen, an NSAID, carries a significant risk of severe stomach bleeding. This risk is notably elevated 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.

Additionally, NSAIDs, excluding aspirin, are associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. The likelihood of these serious cardiovascular events is heightened with the use of higher than recommended doses or prolonged use.

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 physician if they experience any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, passing 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 may experience a range of adverse reactions associated with the use of this product, which contains ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID).

Severe allergic reactions have been reported, particularly in individuals with a known allergy to aspirin. Symptoms of such reactions may include hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters.

The use of this NSAID is also associated with an increased 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, have been linked to an elevated risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly significant for patients who use the medication in excess of the recommended dosage or for prolonged periods.

Patients are advised to discontinue use 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, unilateral weakness, slurred speech, or leg swelling, also warrant immediate medical attention. Furthermore, patients should 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.

It is recommended that patients consult a healthcare provider 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 conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. Patients should also inform their healthcare provider if they are taking a diuretic or if they are under medical care for any serious condition. Additionally, those taking aspirin for the prevention of heart attack or stroke should be aware that ibuprofen may diminish the cardioprotective effects of aspirin.

Drug Interactions

The concomitant use of anticoagulants or steroid medications may elevate the risk of bleeding. Clinicians should exercise caution when prescribing these agents together and consider monitoring for signs of hemorrhage.

Nonsteroidal anti-inflammatory drugs (NSAIDs), whether prescription or over-the-counter, such as aspirin, ibuprofen, and naproxen, may increase the likelihood of adverse effects when used concurrently. It is advisable to evaluate the necessity of NSAID therapy in patients already receiving anticoagulants or steroids.

Additionally, the administration of ibuprofen may diminish the cardioprotective effects of aspirin when used for the prevention of heart attack or stroke. Therefore, it is recommended that healthcare providers assess the appropriateness of ibuprofen in patients who are taking aspirin for cardiovascular protection.

Packaging & NDC

Below are the non-prescription pack sizes of Topcare Ibuprofen (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 tablet every 4 to 6 hours as needed for symptom relief. 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 within 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 when using this medication. It is essential for healthcare providers to consider this heightened risk when prescribing and monitoring treatment in this population.

Additionally, nonsteroidal anti-inflammatory drugs (NSAIDs), with the exception of aspirin, are associated with an elevated risk of cardiovascular events, including heart attack, heart failure, and stroke. This risk is further amplified in elderly patients who exceed the recommended dosage or duration of use. Therefore, careful assessment of the benefits and risks, along with appropriate dosage adjustments and close monitoring, is crucial when treating geriatric patients with NSAIDs.

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 specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. The potential fetal impacts associated with ibuprofen use during late pregnancy warrant careful consideration and professional guidance.

Lactation

Lactating mothers are advised to 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 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 may require careful consideration regarding dosing adjustments and monitoring. In individuals with reduced kidney function, particularly those with comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke, it is essential to evaluate renal function prior to initiating treatment. Regular monitoring of renal parameters is recommended to ensure safe and effective use of the medication. Adjustments to the dosing regimen may be necessary based on the severity of renal impairment to mitigate the risk of adverse effects and optimize therapeutic outcomes.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the drug, necessitating careful consideration of dosage adjustments and monitoring. It is recommended that patients with compromised liver function undergo regular assessment of liver parameters to ensure safe and effective use of the medication.

In patients with liver cirrhosis, the potential for increased drug exposure may require a reduction in dosage or an adjustment in the dosing frequency. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is advised to evaluate the patient's response to therapy and to identify any potential adverse effects related to hepatic impairment.

Additionally, patients with a history of liver disease, such as cirrhosis, should be evaluated for the presence of other comorbid conditions, including high blood pressure, heart disease, kidney disease, asthma, or a history of stroke, as these factors may further complicate treatment and necessitate additional monitoring or adjustments in therapy.

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 are advised to call the Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial in mitigating potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms as they arise.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may develop during the course of treatment.

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 relevant information is available regarding non-teratogenic effects. Additionally, there is no relevant information provided concerning nonclinical toxicology or animal pharmacology and toxicology.

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 routine pharmacovigilance activities.

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 prior to use if they have experienced problems or serious side effects from pain relievers or fever reducers. 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 before using this medication. Furthermore, it is important for patients to discuss their use of diuretics with their healthcare provider prior to use.

Patients taking aspirin for heart attack or stroke should be cautioned to speak with a doctor or pharmacist before using this medication, 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 use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for reference. It should be stored at a controlled room temperature of 20-25°C (68-77°F). Care must be taken to avoid exposure to high humidity and excessive heat, which should not exceed 40°C (104°F). For proper tracking and quality assurance, the lot number and expiration date can be found on the end panel of the packaging.

Additional Clinical Information

Adults and children aged 12 years and older are advised to take 1 tablet every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to 1 tablet, 2 tablets may be administered. However, the total dosage should not exceed 6 tablets within a 24-hour period unless directed by a healthcare professional. For children under 12 years, consultation with a doctor is recommended.

Clinicians should counsel patients who are pregnant or breastfeeding to seek advice from a health professional prior to use. It is particularly crucial to avoid ibuprofen use after 20 weeks of pregnancy unless specifically instructed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery. Additionally, patients should ensure that the medication is kept out of reach of children and be aware that in the event of an overdose, immediate medical assistance or contact with a Poison Control Center (1-800-222-1222) is necessary.

Drug Information (PDF)

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

View product document (PDF)