Aspirin 325 mg Ec

Description

Aspirin USP is an enteric-coated tablet formulation containing 325 mg of aspirin, a nonsteroidal anti-inflammatory drug (NSAID). This product is indicated for the relief of pain and reduction of fever. Each bottle contains 100 tablets, designed for oral administration. The formulation is comparable to the active ingredients found in Ecotrin®. The National Drug Code (NDC) for this product is 69618-015-01.

Uses and Indications

This drug is indicated for the temporary relief of various types of pain and discomfort, including headache, menstrual pain, minor pain associated with arthritis, muscle pain, toothache, and pain and fever related to colds.

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

Dosage and Administration

Adults and children aged 12 years and over are advised to take 1 to 2 tablets every 4 hours as needed for symptom relief, with a maximum dosage of 12 tablets within a 24-hour period. For children under 12 years of age, it is recommended to consult a physician for appropriate dosing guidance.

Each dose should be taken with a full glass of water to ensure proper administration and absorption.

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 severe allergic responses, administration in these patients is not recommended.

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 Reye's syndrome, a rare but serious condition.

Individuals with a history of allergic reactions to any other pain reliever or fever reducer should refrain from using this product.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any of the following symptoms arise, as they may indicate serious complications: feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, if pain worsens or lasts longer than 10 days, if fever intensifies or persists beyond 3 days, if redness or swelling occurs in the affected area, or if any new symptoms develop, medical consultation is warranted. Patients should also be alerted to the potential for ringing in the ears or loss of hearing, as these may signal a serious condition.

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

Side Effects

Patients should be aware of the potential for serious adverse reactions associated with this product. Notably, 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. 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.

In addition to the serious risks, patients should discontinue use and seek medical advice 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. Other concerning symptoms warranting medical consultation include worsening pain lasting more than 10 days, a fever that persists or worsens beyond 3 days, redness or swelling in the painful area, the appearance of any new symptoms, or the occurrence of ringing in the ears or loss of hearing. These symptoms could signify a serious underlying condition that requires prompt medical attention.

Drug Interactions

Aspirin has the potential to cause severe gastrointestinal bleeding, particularly when used concurrently with anticoagulants or steroid medications. This interaction is primarily pharmacodynamic in nature, as both aspirin and these agents can increase the risk of bleeding.

The concomitant use of other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as ibuprofen and naproxen, may further elevate the risk of stomach bleeding. This interaction underscores the importance of careful monitoring and consideration of alternative pain management strategies when multiple NSAIDs are involved.

Additionally, patients who are prescribed medications for diabetes, gout, or arthritis should consult their healthcare provider prior to initiating aspirin therapy. These drugs may interact with aspirin, necessitating dosage adjustments or enhanced monitoring to mitigate potential adverse effects.

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin 325 mg Ec (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 1-2 tablets every 4 hours while symptoms persist, with a maximum of 12 tablets in a 24-hour period. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing recommendations.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, are at an increased risk for severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients, especially if they have a history of gastrointestinal issues, such as heartburn, or if they have comorbid conditions including high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Before initiating treatment, healthcare providers should inquire about the presence of any of these risk factors in elderly patients. Close monitoring for signs of gastrointestinal bleeding is recommended in this population to ensure patient safety and to mitigate potential adverse effects.

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 the unborn child 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 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 in lactating mothers.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there is no information available regarding dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population.

Overdosage

In the absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be implemented as necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the pharmacological profile of the medication.

Management Procedures In the absence of detailed overdosage information, standard management protocols should be followed. This may include gastric decontamination, such as activated charcoal, if the patient presents shortly after ingestion. Additionally, healthcare professionals should consider consulting a poison control center for further guidance tailored to the specific circumstances of the overdosage event.

It is imperative that healthcare professionals remain informed about the potential risks associated with overdosage and are prepared to act swiftly to mitigate any adverse effects.

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

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

Allergic reactions have been noted, including manifestations such as hives, facial swelling, asthma (wheezing), and shock. Additionally, cases of stomach bleeding have been reported, particularly among individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, patients taking blood thinners or steroid medications, individuals using other nonsteroidal anti-inflammatory drugs (NSAIDs), those consuming three or more alcoholic drinks daily, or those using the product for longer than directed.

Patient Counseling

Patients should be advised to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Patients must be informed not to use this medication if they have a history of allergic reactions to any other pain reliever or fever reducer. They should be instructed to stop use and consult a healthcare provider 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.

Healthcare providers should emphasize that if pain worsens or persists for more than 10 days, or if fever worsens or lasts more than 3 days, patients should seek medical advice. Additionally, the presence of redness or swelling in the painful area, the appearance of any new symptoms, or symptoms such as ringing in the ears or loss of hearing should prompt patients to contact their healthcare provider, as these may indicate a serious condition.

Patients should be encouraged to ask a doctor before use if they have a history of stomach problems, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is also important to advise patients to consult a healthcare provider if they are taking a diuretic, have asthma, or are under a doctor's care for any serious condition.

Furthermore, patients should be reminded to seek guidance from a doctor or pharmacist before using this medication if they are taking prescription drugs for diabetes, gout, or arthritis, or if they are taking any other medications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at room temperature, within the range of 15° to 30°C (59° to 86°F). Care should be taken to ensure that the product is kept in a suitable container to maintain its integrity. Special handling requirements should be observed to prevent exposure to extreme temperatures or conditions that may compromise the product's quality.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Aspirin 325 mg Ec, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)