Cardiaspirin Protect

Description

CARDIASPIRIN PROTECT is a safety-coated formulation of aspirin, containing 81 mg of aspirin per tablet. It is classified as a nonsteroidal anti-inflammatory drug (NSAID) and is indicated for use in adult low-dose regimens. Each bottle contains 120 tablets, providing a convenient supply for ongoing treatment. The product is identified by the National Drug Code (NDC) 69729-104-12.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains as recommended by a healthcare professional. Due to its delayed release formulation, this product is not intended for the rapid alleviation of headaches or other symptoms requiring immediate relief.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should take each dose with a full glass of water to ensure proper hydration and absorption.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours as needed for symptom relief. It is important not to exceed 48 tablets 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 physician for appropriate dosing recommendations.

Contraindications

Use is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Due to the potential for severe allergic reactions, administration in these patients is not recommended.

Warnings and Precautions

Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a physician, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

Aspirin may induce severe allergic reactions, which can manifest as hives, shock, facial swelling, or asthma (wheezing). This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries the risk of severe stomach bleeding. The likelihood of such an event is increased in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are 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.

Healthcare professionals should advise patients to consult a doctor or pharmacist prior to use if they have asthma, if the warning regarding stomach bleeding applies to them, if they have a history of gastrointestinal issues such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients taking diuretics, prescription medications for diabetes, gout, or arthritis, or those under medical supervision for any serious condition should seek professional guidance before using this product.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should discontinue use and contact a healthcare provider if they experience any signs of stomach bleeding, such as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Immediate medical attention is also warranted in the case of an allergic reaction, the occurrence of ringing in the ears or hearing loss, worsening pain lasting more than 10 days, a fever that worsens or persists beyond three days, the presence of redness or swelling, or the emergence of new symptoms.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can range from serious to common.

Reye's syndrome is a rare but serious illness that may occur in children and teenagers who have or are recovering from chicken pox or flu-like symptoms. It is crucial for these individuals to avoid using this product. If patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these symptoms could indicate the onset of Reye's syndrome.

Aspirin, the active ingredient in this product, may cause severe allergic reactions in some patients. Symptoms of such reactions can include hives, shock, facial swelling, and asthma (wheezing). Patients should discontinue use and seek medical attention if any signs of an allergic reaction occur.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a warning for the potential of severe stomach bleeding. The risk of this adverse reaction 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 take other medications containing NSAIDs (such as aspirin, ibuprofen, or naproxen). Patients should stop using the product and consult a doctor if they experience symptoms indicative of stomach bleeding, such as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain.

Patients are advised not to use this product if they are allergic to aspirin or any other pain reliever or fever reducer. Additionally, it is recommended that patients consult a doctor or pharmacist before use if they have asthma, a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, or kidney disease, or if they are taking a diuretic.

Furthermore, patients should seek medical advice before using this product if they are taking prescription medications for diabetes, gout, or arthritis, are under a doctor's care for any serious condition, or are taking any other drugs.

Common adverse reactions may include ringing in the ears or loss of hearing, worsening pain lasting more than 10 days, fever lasting more than 3 days, redness or swelling, or the emergence of new symptoms. In such cases, patients should stop using the product and consult a healthcare professional.

Drug Interactions

Aspirin has the potential to cause severe gastrointestinal bleeding, particularly when co-administered with anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen. This interaction is primarily pharmacodynamic in nature, as both classes of drugs can exacerbate the risk of bleeding.

Patients who are prescribed medications for diabetes, gout, or arthritis should consult their healthcare provider prior to using aspirin. This is crucial to ensure safe and effective use, as these conditions may influence the risk of adverse effects.

The risk of gastrointestinal bleeding is notably increased in individuals aged 60 years or older, those with a history of stomach ulcers or bleeding disorders, and individuals who consume three or more alcoholic beverages daily while using aspirin. Monitoring for signs of gastrointestinal bleeding is advised in these populations, and dosage adjustments may be necessary based on individual risk factors.

Packaging & NDC

Below are the non-prescription pack sizes of Cardiaspirin Protect (aspirin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients, particularly children and teenagers, should not use this product if they have or are recovering from chicken pox or flu-like symptoms due to the risk of Reye's syndrome. Healthcare professionals are advised to consult a doctor if any changes in behavior accompanied by nausea and vomiting occur, as these may be early indicators of Reye's syndrome.

For dosing recommendations, adults and children aged 12 years and older may take 4 to 8 tablets every 4 hours while symptoms persist, with a maximum of 48 tablets in a 24-hour period unless otherwise directed by a physician. For children under 12 years of age, it is essential to seek medical advice before use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. Therefore, it is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients.

Before initiating treatment, it is advisable for healthcare providers to assess the patient's medical history, especially for those with pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Consultation with a doctor or pharmacist is recommended to ensure the safe use of this medication in elderly patients, taking into account their overall health status and any potential drug interactions.

Monitoring for adverse effects, particularly gastrointestinal complications, is crucial in this population to mitigate risks associated with treatment.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on fetal outcomes or complications during delivery. Therefore, it is essential that pregnant patients only use aspirin in this period if explicitly directed by a healthcare provider.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless explicitly 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 this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use in lactating individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, caution is advised for those who are taking a diuretic, as this may further impact renal function. Monitoring of renal function may be necessary to ensure safe and effective use in this population.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional, such as a doctor or pharmacist, prior to use, particularly if they have underlying conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential to assess liver function and consider potential dosage adjustments or monitoring requirements based on the severity of hepatic impairment. Careful evaluation of the patient's overall health status is recommended 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 at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide supportive care as necessary.

Management of an overdose may involve symptomatic treatment and monitoring of vital signs, as well as specific interventions based on the substance involved. It is recommended that healthcare providers follow established protocols for overdose management to ensure optimal patient outcomes.

Nonclinical Toxicology

It is especially important not to use aspirin 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 provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs.

Allergic reactions have been noted, including manifestations such as hives, shock, facial swelling, and asthma (wheezing). Additionally, cases of stomach bleeding have been reported, particularly in patients aged 60 years or older, those with a history of stomach ulcers or bleeding problems, individuals taking anticoagulant or steroid medications, patients using other drugs containing prescription or nonprescription NSAIDs, and those consuming three or more alcoholic drinks daily while using this product. Furthermore, it has been observed that changes in behavior accompanied by nausea and vomiting may represent an early indication of Reye's syndrome, a rare but serious condition.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use the medication if they have a known allergy to aspirin or any other pain reliever or fever reducer. It is important for healthcare providers to instruct patients to discontinue use and consult a doctor if they experience any signs of stomach bleeding, such as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain.

Patients should also be counseled to stop using the medication and seek medical advice if they notice any allergic reactions, including symptoms that may require immediate medical attention. Additionally, they should be made aware that if they experience ringing in the ears or a loss of hearing, they should stop use and consult a doctor.

Healthcare providers should emphasize the importance of discontinuing use and seeking medical advice if pain worsens or persists for more than 10 days, if fever worsens or lasts more than 3 days, or if there is any redness or swelling. Patients should be encouraged to report any new symptoms, as these may indicate a serious condition.

Before initiating treatment, healthcare providers should recommend that patients consult with a doctor or pharmacist if they have asthma, a history of stomach problems such as heartburn, or if the stomach bleeding warning applies to them. It is also essential to discuss any existing conditions, including high blood pressure, heart disease, liver cirrhosis, or kidney disease, as well as the use of diuretics or prescription medications for diabetes, gout, or arthritis. Patients under a doctor's care for any serious condition should also be advised to seek guidance before use. Lastly, patients should be reminded to consult a healthcare professional if they are taking any other medications.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at room temperature, specifically within the range of 15-30 °C (59-86 °F).

It is essential to ensure that the product is tamper evident; therefore, it must not be used if the safety seal under the cap is broken or missing. Proper handling and storage conditions are crucial to maintain the integrity and safety of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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