Ecotrin

Description

Ecotrin® is a safety-coated formulation of aspirin, classified as a nonsteroidal anti-inflammatory drug (NSAID) used for pain relief. Each tablet contains 81 mg of low-strength aspirin. The product is packaged in a bottle containing 45 tablets.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, minor arthritis pain, toothache, muscle pain, menstrual pain, and discomfort due to 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

Patients should take the medication with a full glass of water for optimal efficacy.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours. The total daily dosage must not exceed 48 tablets within a 24-hour period unless otherwise directed by a healthcare professional.

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

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, a rare but serious illness. 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 may be early indicators of Reye’s syndrome.

Aspirin may provoke severe allergic reactions, which can manifest as hives, facial swelling, shock, 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 increases in patients who are aged 60 or older, take higher doses or use the product for an extended duration, have a history of stomach ulcers or bleeding disorders, are on anticoagulant or steroid medications, consume other NSAIDs (including aspirin, ibuprofen, or naproxen), or regularly consume three or more alcoholic beverages daily while using this product.

Healthcare professionals should advise patients to consult a doctor prior to use if any of the following conditions apply: a history of stomach problems such as heartburn, asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease, or if they are taking diuretics. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently prescribed medications for gout, diabetes, or arthritis.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Patients should be instructed to discontinue use and contact their healthcare provider if they experience any signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Immediate medical attention is also warranted for any allergic reactions, the emergence of new symptoms, ringing in the ears, loss of hearing, worsening pain lasting more than 10 days, or the presence of redness or swelling, as these may indicate serious underlying conditions.

Side Effects

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

Reye’s syndrome is a rare but serious illness that can occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. Patients should not use this product in such cases, and if any changes in behavior accompanied by nausea and vomiting occur, it is crucial to consult a healthcare professional immediately.

Aspirin may also cause severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma (wheezing). Patients experiencing any signs of an allergic reaction should seek medical help right away.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The risk of this adverse reaction is heightened in patients who are 60 years of age or older, those who take more than the recommended dosage or for an extended period, individuals with a history of stomach ulcers or bleeding problems, and those concurrently using blood thinners, steroids, or other NSAIDs. Additionally, patients consuming three or more alcoholic drinks daily while using this product are at increased risk.

Patients are advised to stop using the product and consult a doctor if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Any new symptoms, ringing in the ears, loss of hearing, worsening pain, or the presence of redness or swelling should also prompt a consultation with a healthcare provider.

Before using this product, patients should seek medical advice if they have a history of stomach problems, such as heartburn, asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease, or if they are taking a diuretic.

It is important for pregnant or breastfeeding patients to consult a healthcare professional before use. Aspirin should be avoided after 20 weeks of pregnancy unless specifically directed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Interactions

The presence of a nonsteroidal anti-inflammatory drug (NSAID) in this product may increase the risk of severe gastrointestinal bleeding, particularly in patients concurrently using anticoagulants or steroid medications. Caution is advised when this product is used alongside other NSAIDs, whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen, as this may further elevate the risk of adverse effects.

In terms of laboratory test interactions, it is recommended that patients consult with a healthcare professional prior to using this product if they are currently prescribed medications for gout, diabetes, or arthritis. Monitoring and dosage adjustments may be necessary based on individual patient circumstances and concurrent medication use.

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 chicken pox 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 may take 4 to 8 tablets every 4 hours, with a maximum of 48 tablets in 24 hours unless otherwise directed by a doctor. The use of this product in children under 12 years is not recommended unless directed by a healthcare professional.

Geriatric Use

Elderly patients, particularly those aged 60 years 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 ratio 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 is particularly cautioned against after 20 weeks of pregnancy, as it may pose risks to the unborn child and lead to complications during delivery. It is essential for healthcare providers to evaluate the potential benefits and risks before prescribing this medication to pregnant women.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of aspirin 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 this medication 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 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 at 1-800-222-1222. Prompt action is crucial to mitigate potential adverse effects associated with overdosage.

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 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 text.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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. 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 discontinue 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 stomach pain that does not improve. Additionally, patients should be made aware that they must stop using the medication and seek medical help if they experience any allergic reactions or if new symptoms arise.

Healthcare providers should emphasize the importance of stopping use and consulting a doctor if patients notice ringing in the ears or a loss of hearing. Patients should also be advised to seek medical advice if their pain worsens or persists for more than 10 days, or if they observe any redness or swelling, as these may indicate a serious condition.

It is recommended that healthcare providers ask patients if the stomach bleeding warning applies to them, particularly if they have a history of stomach problems such as heartburn. Patients with asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease should be encouraged to consult a doctor before using this medication. Furthermore, patients taking diuretics or prescription medications for gout, diabetes, or arthritis should be advised to speak with a doctor or pharmacist prior to 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 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F and 86°F).

To ensure optimal product integrity, it is essential to avoid exposure to excessive heat and humidity. The expiration date and lot number can be found on the end flap of the packaging. Proper handling and storage conditions are crucial for maintaining the quality and efficacy of the product.

Additional Clinical Information

No further data are available.

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)