Topcare Ibuprofen

Description

Ibuprofen Tablets are formulated as capsule-shaped tablets, each containing 200 mg of ibuprofen. This nonsteroidal anti-inflammatory drug (NSAID) serves as a pain reliever and fever reducer. The product is supplied in a package containing 24 caplets.

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 as follows: take 1 caplet every 4 to 6 hours while symptoms persist. If pain or fever does not adequately respond to 1 caplet, a dose of 2 caplets may be administered. However, it is imperative not to exceed a total of 6 caplets within a 24-hour period unless specifically 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 individuals with a history of allergic reactions to any other pain reliever or fever reducer, due to the potential for cross-reactivity. Additionally, the product should not be administered immediately before or after heart surgery, as it may pose risks associated with surgical recovery and cardiovascular stability.

Warnings and Precautions

Ibuprofen may cause severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic reaction 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 taking anticoagulants or steroid medications, are using 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 when the medication is used in excess of the recommended dosage or for prolonged periods.

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 healthcare provider 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 an NSAID. 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.

Additionally, the use of this NSAID carries a warning for severe stomach bleeding, with an increased risk in patients aged 60 years or older, those with a history of stomach ulcers or bleeding problems, individuals taking anticoagulants or steroid medications, and those consuming three or more alcoholic drinks daily while using this product. Symptoms indicative of stomach bleeding include feeling faint, vomiting blood, having bloody or black stools, and experiencing persistent stomach pain.

The risk of cardiovascular events, such as heart attack, heart failure, and stroke, is also heightened with the use of NSAIDs, excluding aspirin. This risk escalates with prolonged use or exceeding the recommended dosage. Patients should be vigilant for symptoms of heart problems or stroke, which may include chest pain, difficulty breathing, unilateral weakness, slurred speech, or leg swelling.

Common adverse reactions may include gastrointestinal discomfort, and patients are advised to discontinue use and consult a healthcare professional if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than three days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

Patients should seek medical advice prior to using this product if they have a history of serious side effects from pain relievers or fever reducers, if the stomach bleeding warning is applicable, or if they have pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke. It is also recommended to consult a healthcare provider if taking aspirin for cardiovascular protection, as ibuprofen may diminish the efficacy of aspirin in this context.

Drug Interactions

Co-administration of aspirin and ibuprofen may result in a diminished therapeutic effect of aspirin, particularly in the context of cardiovascular protection during treatment for heart attack or stroke. It is advisable for patients to consult with a healthcare professional, such as a doctor or pharmacist, prior to using these medications concurrently, especially if they are taking any other drugs. Monitoring for efficacy and potential adverse effects is recommended in such cases.

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 aged 12 years and older may take 1 caplet every 4 to 6 hours as needed while symptoms persist. If pain or fever does not adequately respond to 1 caplet, 2 caplets may be administered. It is important not to exceed 6 caplets in a 24-hour period unless directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a doctor before use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of stomach bleeding when using this medication. Therefore, it is crucial to exercise caution and monitor for any signs of gastrointestinal bleeding in this population.

Additionally, the risk of heart attack and stroke is heightened in geriatric patients who use the medication in excess of the recommended dosage or for an extended duration. To mitigate these risks, healthcare providers should ensure that the smallest effective dose is utilized for elderly patients, and they should regularly assess the necessity of continued treatment.

Close monitoring and appropriate dose adjustments are essential to ensure the safety and efficacy of the medication in this vulnerable population.

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 after 20 weeks of pregnancy 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 ibuprofen in pregnant patients.

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 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 should consult a healthcare professional prior to use, particularly if they have underlying conditions such as high blood pressure, heart disease, liver cirrhosis, or a history of stroke. Special caution is advised for those with kidney disease, as reduced kidney function may necessitate careful monitoring and potential dosing adjustments.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication. It is essential to assess liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary, and careful consideration should be given to the severity of hepatic impairment. Regular monitoring of liver function tests is recommended to ensure safety and efficacy.

Additionally, patients with a history of liver disease, including cirrhosis, should be evaluated for potential contraindications and the need for alternative therapeutic options. It is crucial to tailor treatment plans based on individual liver function status to mitigate risks associated with compromised hepatic function.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved, and it is essential to monitor the patient closely for any signs of adverse reactions.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should assess the patient's condition and provide appropriate interventions based on the severity of symptoms and the specific substance involved.

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

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

Allergic reactions have been noted, including instances 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. Additionally, renal injury, including acute renal failure and interstitial nephritis, has been noted.

Hematologic reactions, such as thrombocytopenia and aplastic anemia, have been identified. Respiratory reactions, including exacerbations of asthma, have also been reported. Other reactions include dizziness, headache, and tinnitus.

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 recommended that patients take the medication with food or milk if they experience stomach upset.

Patients should be encouraged to consult with their healthcare provider before using this medication if they have experienced problems or serious side effects from pain relievers or fever reducers in the past. Additionally, it is important for patients to discuss their medical history with their healthcare provider, particularly if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them.

Healthcare providers should also inquire about the patient's medical conditions, including high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke, as these may influence the safety of the medication. Patients taking diuretics should be advised to consult their healthcare provider prior to use.

Furthermore, patients should be informed that if they are taking aspirin for heart attack or stroke prevention, they should speak with their doctor or pharmacist, as ibuprofen may reduce the effectiveness of aspirin. It is also essential for patients under a doctor's care for any serious condition to seek guidance before using this medication. Lastly, patients should be encouraged to discuss any other medications they are taking with their healthcare provider or pharmacist to ensure safe use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for reference. It is essential to store the product at a temperature range of 20-25°C (68-77°F). Care should be taken to avoid exposure to high humidity and excessive heat, particularly temperatures exceeding 40°C (104°F). For tracking purposes, the lot number and expiration date can be found on the end panel of the packaging.

Additional Clinical Information

Patients aged 12 years and older are advised to take one caplet every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to one caplet, two caplets may be taken; however, the total should not exceed six caplets in 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 to take the medication with food or milk if gastrointestinal upset occurs and to carefully read all warnings and directions prior to use. It is important to use the smallest effective dose and to store the medication in a cool, dry place, avoiding high humidity and temperatures exceeding 40°C (104°F).

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)