Aspirin 81mg Enteric Coated

Description

Aspirin is a nonsteroidal anti-inflammatory drug (NSAID) with a dosage strength of 81 mg. It is commonly used for its analgesic, antipyretic, and anti-inflammatory properties. Aspirin is characterized by its chemical formula C9H8O4 and has a molecular weight of 180.16 g/mol. The formulation is typically presented in a tablet dosage form, which is white to off-white in appearance.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, as well as for use as recommended by a healthcare professional. Due to its delayed action, this product is not intended for the fast relief of headaches or other symptoms that require immediate alleviation.

Limitations of Use: 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 of this product is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, it should not be used in patients who have a history of allergic reactions to this product or any of its components.

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 illness.

Aspirin may provoke severe allergic reactions in some individuals. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing). Immediate medical attention should be sought if any of these symptoms 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, those taking other medications that contain NSAIDs (including aspirin, ibuprofen, or naproxen), individuals with a history of stomach ulcers or bleeding problems, those consuming three or more alcoholic drinks daily while using this product, and patients who exceed the recommended dosage or duration of use. Additionally, individuals taking blood-thinning (anticoagulant) or steroid medications should exercise caution.

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, current use of diuretics, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Furthermore, patients should seek guidance from a doctor or pharmacist if they are currently taking prescription 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 discontinue use and contact a healthcare provider if they experience any signs of an allergic reaction or any of the following symptoms indicative of stomach bleeding: vomiting blood, passing bloody or black stools, feeling faint, experiencing persistent stomach pain, noticing ringing in the ears or loss of hearing, having pain that worsens or lasts longer than 10 days, observing redness or swelling, or developing new symptoms, as these may signal a serious condition.

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 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 may also cause severe allergic reactions in some patients. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing). Patients experiencing any signs of an allergic reaction should stop using the product and seek medical assistance right away.

Additionally, 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, those taking other NSAIDs (either prescription or nonprescription), individuals with a history of stomach ulcers or bleeding problems, patients consuming three or more alcoholic drinks daily while using the product, and those who take the medication for longer than directed or in higher doses. Patients on blood thinners (anticoagulants) or steroid drugs are also at an elevated risk.

Patients should be advised to stop using the product and consult a doctor if they experience any signs of stomach bleeding, which may include vomiting blood, having bloody or black stools, feeling faint, experiencing persistent stomach pain, or noticing ringing in the ears or a loss of hearing. Additionally, if pain worsens or lasts more than 10 days, or if redness or swelling occurs, medical advice should be sought. New symptoms that arise during treatment could also indicate a serious condition and warrant immediate consultation.

Before using this product, patients should consult a doctor if they have a history of stomach problems, such as heartburn, or if they are taking diuretics, have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients with asthma should also seek medical advice prior to use. Furthermore, it is advisable for patients to consult a doctor or pharmacist if they are taking prescription medications for gout, diabetes, or arthritis.

Drug Interactions

Aspirin may interact with various medications, leading to significant clinical effects that require careful consideration.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Aspirin can interact with other drugs containing either prescription or nonprescription NSAIDs, such as ibuprofen and naproxen. Co-administration of these agents may increase the risk of adverse effects, particularly gastrointestinal complications.

Anticoagulants and Steroids The concomitant use of aspirin with blood-thinning agents (anticoagulants) or steroid medications may elevate the risk of stomach bleeding. It is advisable to monitor patients closely for signs of gastrointestinal bleeding and consider dosage adjustments as necessary.

Other Prescription Medications Patients taking prescription medications for conditions such as gout, diabetes, or arthritis should consult their healthcare provider prior to initiating aspirin therapy. These drugs may interact with aspirin, potentially altering its efficacy or increasing the risk of adverse effects. Regular monitoring and dosage adjustments may be warranted based on the specific medications involved.

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin 81mg Enteric Coated (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. If pediatric patients experience changes in behavior accompanied by nausea and vomiting while using this product, a healthcare professional should be consulted, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

For children under 12 years of age, the use of this product is not recommended unless directed by a healthcare provider. In contrast, for adolescents and adults aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours, with a maximum of 48 tablets in a 24-hour period, unless otherwise directed by a healthcare professional.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, are at an increased risk for severe stomach bleeding. This heightened risk necessitates careful consideration and monitoring when prescribing this medication to geriatric patients.

Healthcare providers should advise elderly patients to consult a physician if they have a history of stomach issues, such as heartburn, or if they have comorbid conditions including high blood pressure, heart disease, liver cirrhosis, or kidney disease. These factors may further elevate the risk of gastrointestinal complications and warrant a thorough evaluation before initiating treatment.

Close monitoring and appropriate dose adjustments may be necessary to ensure the safety and efficacy of the medication in this population.

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 development and 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 its use in lactating individuals.

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 a history of liver cirrhosis. It is essential for these patients to discuss their liver function status, as compromised liver function may influence the safety and efficacy of the treatment. Monitoring of liver function tests may be warranted to ensure appropriate management and to mitigate potential risks associated with the use of this medication in individuals with hepatic impairment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial, as the symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment and appropriate management strategies should be implemented based on the specific clinical scenario presented.

Healthcare providers should ensure that they are prepared to provide supportive care and monitor the patient closely for any adverse effects that may arise from the overdose.

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 detailed findings 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. These include allergic reactions such as hives, facial swelling, shock, and asthma (wheezing). Additionally, cases of stomach bleeding have been noted, particularly in patients who are older, those taking other nonsteroidal anti-inflammatory drugs (NSAIDs), individuals with a history of stomach ulcers or bleeding problems, and those who consume alcohol regularly or are on blood thinners or steroids.

Serious conditions associated with aspirin use have also been reported. These include vomiting blood, the presence of bloody or black stools, fainting, persistent stomach pain, ringing in the ears or loss of hearing, worsening pain or symptoms lasting more than 10 days, as well as redness or swelling. New symptoms occurring during treatment have also been documented.

Patient Counseling

Patients should be advised 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 product if they have a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, patients must be cautioned against using the product if they have previously experienced an allergic reaction to it or any of its ingredients.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience any signs of an allergic reaction, emphasizing the importance of seeking medical help promptly. Patients should also be made aware of the signs of potential stomach bleeding, which include vomiting blood, having bloody or black stools, feeling faint, experiencing persistent stomach pain, noticing ringing in the ears or a loss of hearing, or if pain worsens or lasts longer than 10 days. They should be advised to stop use and consult a doctor if redness or swelling occurs or if new symptoms arise, as these may indicate a serious condition.

It is recommended that patients ask their doctor before using this product if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Patients should also be encouraged to consult a doctor before use if they are taking a diuretic, have high blood pressure, heart disease, liver cirrhosis, or kidney disease, or if they have asthma. Furthermore, patients should be advised to speak with their doctor or pharmacist before using this product if they are currently taking a prescription medication for gout, diabetes, or arthritis.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. 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). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

The medication is administered orally. 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 trimester 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 Aspirin 81mg Enteric Coated, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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