Ecotrin

Description

Ecotrin® is a safety-coated aspirin formulation, classified as a nonsteroidal anti-inflammatory drug (NSAID) used for pain relief. Each tablet contains 81 mg of low-strength aspirin, making it suitable for various therapeutic applications. The product is packaged in a bottle containing 150 tablets. It is the most recommended aspirin by cardiologists, reflecting its established role in cardiovascular health management.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache, minor arthritis pain, toothache, menstrual pain, and colds. It may also be used as recommended by a healthcare professional.

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

Dosage and Administration

Adults and children 12 years of age and over are instructed to take 4 to 8 tablets every 4 hours as needed, while symptoms persist. Each dose should be accompanied by a full glass of water to ensure proper administration.

It is imperative that patients do not exceed a total of 48 tablets within a 24-hour period unless specifically directed by a healthcare professional.

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

Contraindications

Use is contraindicated in individuals with a history of allergic reactions to aspirin or any other pain reliever or fever reducer. Due to the potential for severe allergic responses, such patients should avoid this product.

Warnings and Precautions

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

Aspirin may provoke severe allergic reactions, which can manifest as hives, shock, facial swelling, or asthma symptoms such as wheezing. Healthcare professionals should be vigilant for these signs and advise patients to seek immediate medical attention if they occur.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect 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, or exceed the recommended dosage or duration of use.

Healthcare providers should advise patients to consult a physician prior to using this product if they have a history of stomach 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 or those with asthma should seek medical advice before use. It is also recommended that patients on prescription medications for diabetes, gout, or arthritis consult with their doctor or pharmacist prior to using this product.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should discontinue use and contact their healthcare provider if they experience any signs of an allergic reaction, such as difficulty breathing or swelling, or if they notice symptoms indicative of stomach bleeding, including feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Furthermore, if pain worsens or lasts longer than 10 days, if redness or swelling occurs, if new symptoms arise, or if there is ringing in the ears or hearing loss, patients should seek medical attention promptly.

Side Effects

Patients using this product should be aware of several serious adverse reactions and warnings associated with its use.

Reye’s syndrome is a rare but serious illness that may occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. 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, a component of this product, may cause severe allergic reactions in some individuals. Symptoms of such reactions can include hives, shock, facial swelling, and asthma (wheezing). Patients should seek immediate medical attention if they experience any signs of an allergic reaction.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse reaction is increased 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 this product, or take other medications containing NSAIDs (such as aspirin, ibuprofen, or naproxen). Patients should be advised to stop use and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Patients are also cautioned to seek medical advice before using this product if they have a history of stomach problems, such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, those taking diuretics or prescription medications for diabetes, gout, or arthritis should consult a healthcare professional prior to use.

Common adverse reactions that warrant medical consultation include worsening pain that lasts more than 10 days, the presence of redness or swelling, the appearance of any new symptoms, and symptoms such as ringing in the ears or loss of hearing, which could indicate a serious condition.

Drug Interactions

Aspirin has the potential to cause severe gastrointestinal bleeding, particularly when co-administered with anticoagulant medications or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen. This interaction necessitates careful consideration of the concomitant use of these agents.

Additionally, it is advised that patients consult a healthcare professional prior to using aspirin if they are currently prescribed medications for diabetes, gout, or arthritis. This precaution is essential to ensure safe and effective management of their conditions while minimizing the risk of adverse interactions.

Packaging & NDC

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

Pediatric Use

Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product due to the risk of Reye’s syndrome, a rare but serious illness. If changes in behavior accompanied by nausea and vomiting occur while using this product, it is important to consult a doctor, as these may be early signs of Reye’s syndrome.

For dosing, adults and children aged 12 years and older are directed to take 4 to 8 tablets every 4 hours as needed, with a full glass of water for each dose, not exceeding 48 tablets in a 24-hour period unless otherwise directed by a physician. For children under 12 years of age, a doctor should be consulted for appropriate dosing recommendations.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor elderly patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit profile is essential in this population to ensure safe and effective use of the medication.

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 concerning, as it may lead to adverse effects on fetal outcomes or complications during delivery. Therefore, it is crucial 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 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 this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication while breastfeeding.

Renal Impairment

Patients with renal 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 assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of renal impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have conditions such as liver cirrhosis. It is essential for these patients to receive appropriate evaluation and monitoring of their liver function to ensure safe and effective use of the medication. Adjustments to dosage may be necessary based on the severity of hepatic impairment, and ongoing assessment of liver function is recommended throughout the treatment period.

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 for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain informed about the appropriate protocols for managing overdose situations, ensuring that patients receive timely and effective care.

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 regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial to inform patients that they should not use this medication if they have a history of allergic reactions to aspirin or any other pain reliever or fever reducer.

Patients should be instructed to stop using the medication and consult a doctor if they experience any signs of an allergic reaction, which requires immediate medical attention. Additionally, they should be made aware of the signs of potential stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Patients should also be cautioned to seek medical advice if their pain worsens or lasts longer than 10 days, if they notice redness or swelling, if any new symptoms arise, or if they experience ringing in the ears or a loss of hearing.

Before initiating treatment, healthcare providers should encourage patients to consult with a doctor if any of the following conditions apply: a history of stomach bleeding, previous stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients taking diuretics or those with asthma should also be advised to seek medical guidance prior to use.

Furthermore, it is important for patients to discuss with their healthcare provider or pharmacist if they are currently taking prescription medications for diabetes, gout, or arthritis, as these may interact with the treatment.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It must be stored at temperatures below 25ºC (77ºF) to maintain its integrity and efficacy. Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the printed inner seal beneath the cap is missing or broken, as this may indicate compromised safety or quality. Proper handling and storage conditions are essential to ensure the product remains effective and safe for patient use.

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 aspirin 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 Ecotrin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)