Low Dose Aspirin

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

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 suitable for the immediate relief of headaches or other symptoms requiring prompt alleviation. Healthcare providers may consider discussing additional uses for enteric-coated 81 mg Aspirin with patients.

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 to ensure proper administration and absorption.

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, it is advised to consult a physician for appropriate dosing recommendations.

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

Patients should be advised of the following warnings and precautions associated with the use of this product.

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

Allergy Alert Aspirin has the potential to cause severe allergic reactions. Healthcare professionals should be vigilant for signs of an allergic response, which may include hives, facial swelling, asthma (wheezing), or shock. Immediate medical attention is warranted if any of these symptoms occur.

Stomach Bleeding Warning This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in patients who meet any of the following criteria:

• Are aged 60 years or older

• Have a history of stomach ulcers or bleeding disorders

• Are concurrently taking anticoagulants or steroid medications

• Are using other NSAIDs, whether prescription or over-the-counter (e.g., aspirin, ibuprofen, naproxen)

• Consume three or more alcoholic beverages daily while using this product

• Exceed the recommended dosage or duration of use

Monitoring Parameters Patients should be closely monitored for signs of stomach bleeding, which may include feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additional symptoms that warrant immediate medical consultation include worsening pain lasting more than 10 days, fever that persists beyond three days, the presence of redness or swelling, the emergence of new symptoms, or any ringing in the ears or loss of hearing.

Emergency Medical Help In the event of an overdose, it is crucial to seek emergency medical assistance or contact a Poison Control Center (1-800-222-1222) without delay.

Side Effects

Patients using this product should be aware of several serious adverse reactions 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, they should consult a doctor immediately, as these symptoms could indicate the onset of Reye's syndrome.

Additionally, there is a significant risk of severe allergic reactions to aspirin, which may manifest as hives, facial swelling, asthma (wheezing), or shock. Patients should seek immediate medical attention if any signs of an allergic reaction occur.

This 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, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily, or exceed the recommended dosage or duration of use. Patients should 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 persistent stomach pain that worsens or lasts more than 10 days.

Patients are advised to seek medical advice before using this product if they have asthma, a history of stomach problems such as heartburn, or if the stomach bleeding warning applies to them. Additionally, those taking diuretics or who have high blood pressure, heart disease, liver cirrhosis, or kidney disease should consult a doctor prior to use.

It is also recommended that patients inform their healthcare provider or pharmacist if they are taking prescription medications for gout, diabetes, or arthritis, as these may interact with the product.

Drug Interactions

Taking this product may increase the risk of gastrointestinal bleeding when used concurrently with anticoagulants or steroid medications. The risk of stomach bleeding is further elevated in patients who are also taking other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen.

Patients who are on prescription medications for gout, diabetes, or arthritis should consult with a healthcare professional prior to using this product to ensure safe and effective use. Monitoring for potential adverse effects is advised in these cases.

Packaging & NDC

Below are the non-prescription pack sizes of Low Dose Aspirin (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 over may take 4 to 8 tablets every 4 hours, not exceeding 48 tablets in a 24-hour period unless directed by a doctor. For children under 12 years, consultation with a doctor is advised before use.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients, especially those with a history of stomach problems, such as heartburn.

Before initiating treatment, healthcare providers should inquire about the presence of any stomach bleeding warnings applicable to the patient. Additionally, it is advisable to assess the patient's medical history for conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease, as these factors may further elevate the risk of adverse effects.

Patients who are taking diuretics should also be closely monitored, as the combination of these medications may necessitate dosage adjustments or additional precautions. Regular evaluation of the patient's response to therapy and any potential side effects is recommended to ensure safe and effective use of the NSAID in the geriatric 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 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

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established 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. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the lack of detailed overdosage data necessitates a vigilant approach. Symptoms may vary depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement standard supportive care measures, which may include the following:

1. Assessment: Conduct a thorough evaluation of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide symptomatic treatment as necessary, which may involve intravenous fluids, oxygen supplementation, or other interventions based on the patient's needs.

3. Consultation: Engage with a poison control center or toxicology expert for guidance on specific management strategies tailored to the situation.

Given the lack of specific overdosage information, it is crucial for healthcare professionals to remain vigilant and prepared to manage any potential complications that may arise from an overdose scenario.

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, asthma (wheezing), and shock. Additionally, severe stomach bleeding has been reported, particularly in individuals aged 60 years or older, those with a history of stomach ulcers or bleeding problems, patients taking blood-thinning (anticoagulant) or steroid medications, individuals consuming three or more alcoholic drinks daily while using this product, or those exceeding the recommended dosage or duration of use.

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 immediately or contact a Poison Control Center at 1-800-222-1222.

Patients must be informed not to use this product if they have a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, they should avoid use if they have previously experienced an allergic reaction to this product or any of its ingredients. In the case of an allergic reaction, patients should stop using the medication and seek medical help right away.

Healthcare providers should instruct patients 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. Patients should also be advised to stop use and seek medical advice if their pain worsens or persists for more than 10 days, if their fever worsens or lasts more than 3 days, if they notice any redness or swelling, if new symptoms arise, or if they experience ringing in the ears or a loss of hearing.

It is important for patients to consult a doctor before using this medication if they have asthma or if the warning regarding stomach bleeding applies to them. Patients with a history of stomach problems, such as heartburn, should also seek medical advice prior to use. Furthermore, patients taking diuretics, or those with high blood pressure, heart disease, liver cirrhosis, or kidney disease, should consult a doctor before using this product.

Lastly, patients should be encouraged to speak with their doctor or pharmacist if they are taking prescription medications for gout, diabetes, or arthritis to ensure safe and effective use of this medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. 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). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

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 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 Low Dose Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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