Aspirin

Description

The product is a combination of aspirin, with the active ingredient being acetylsalicylic acid. It is available in tablet form in various strengths: 100 mg, 300 mg, and 500 mg. Inactive ingredients include corn starch, microcrystalline cellulose, and magnesium stearate. The SPL Code for this product is 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, colds, menstrual pain, muscle pain, toothache, and minor pain of arthritis. It may also be used as directed 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 to ensure proper administration and absorption.

For adults and children aged 12 years and older, the recommended dosage is 1 to 2 tablets every 4 hours as needed for symptom relief. It is important not to exceed 12 tablets within a 24-hour period unless specifically 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 is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Due to the potential for severe allergic reactions, 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 this rare but serious condition.

Aspirin may provoke severe allergic reactions in some individuals. Symptoms of such reactions can include hives, facial swelling, shock, and asthma-related wheezing. Healthcare professionals should be vigilant for these signs when prescribing or recommending this product.

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 patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are concurrently using anticoagulants or steroid medications, consume three or more alcoholic beverages daily, exceed the recommended dosage or duration of use, or are taking other medications that contain NSAIDs, such as aspirin, ibuprofen, or naproxen.

Healthcare providers should advise patients to seek medical advice prior to using this product if any of the following conditions apply: a history of stomach problems, such as heartburn; asthma; high blood pressure; heart disease; liver cirrhosis; kidney disease; use of diuretics; inadequate fluid intake; or significant fluid loss due to vomiting or diarrhea.

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 consult a healthcare professional if they experience any of the following symptoms indicative of potential stomach bleeding: feeling faint, presence of bloody or black stools, vomiting blood, or persistent stomach pain. Additionally, if pain worsens or lasts longer than 10 days, fever intensifies or persists beyond three days, redness or swelling occurs in the affected area, new symptoms arise, or there is ringing in the ears or hearing loss, medical advice should be sought promptly.

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 can 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 may be early signs of Reye's syndrome.

Aspirin, the active ingredient in this product, may also cause severe allergic reactions. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing). Patients with a known allergy to aspirin should avoid using this product.

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, 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, exceed the recommended dosage, or use other medications containing NSAIDs such as aspirin, ibuprofen, or naproxen.

Patients are advised to stop using the product and seek medical attention if they experience any signs of stomach bleeding, which may include feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Furthermore, if pain worsens or lasts longer than 10 days, if fever worsens or lasts more than three days, if redness or swelling occurs in the painful area, if any new symptoms appear, or if there is ringing in the ears or loss of hearing, patients should consult a healthcare professional.

Before using this product, patients should consult a doctor if they have a history of stomach problems such as heartburn, asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is also important for patients taking diuretics, those who have not been adequately hydrating, or those who have lost significant fluid due to vomiting or diarrhea to seek medical advice prior to use.

Patients taking prescription medications for diabetes, gout, or arthritis, or any other drugs, should also consult a doctor or pharmacist before using this product, especially if they are under medical care for any serious condition.

Drug Interactions

Aspirin has the potential to interact with various drug classes, particularly those that may increase the risk of gastrointestinal bleeding.

Anticoagulants and Antiplatelet Agents The concomitant use of aspirin with anticoagulants or antiplatelet agents may significantly elevate the risk of severe gastrointestinal bleeding. It is advisable for patients to consult a healthcare professional prior to initiating aspirin therapy if they are currently prescribed any blood-thinning medications.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) The risk of stomach bleeding is further heightened when aspirin is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen and naproxen. Patients should be cautioned against the concurrent use of multiple NSAIDs and should seek medical advice if they are considering such combinations.

Diabetes, Gout, and Arthritis Medications Patients who are on prescription medications for diabetes, gout, or arthritis should consult their healthcare provider before using aspirin. This is to ensure that any potential interactions are appropriately managed and monitored.

In summary, careful consideration and consultation with a healthcare provider are essential when aspirin is used in conjunction with anticoagulants, other NSAIDs, or medications for chronic conditions such as diabetes, gout, or arthritis.

Packaging & NDC

Below are the non-prescription pack sizes of 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 are directed to take 1 to 2 tablets every 4 hours while symptoms persist, with a maximum of 12 tablets in 24 hours unless otherwise directed by a healthcare professional. For children under 12 years of age, consultation with a doctor is advised prior to use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). This risk is further heightened in individuals with a history of stomach ulcers or bleeding problems, those who are concurrently using blood-thinning medications (anticoagulants) or steroid drugs, and patients who consume three or more alcoholic drinks daily while using this product.

It is essential for healthcare providers to closely monitor geriatric patients for signs of gastrointestinal bleeding, especially if they are taking this NSAID in conjunction with other medications that may increase the risk, such as prescription or nonprescription NSAIDs (e.g., aspirin, ibuprofen, naproxen). Additionally, dosage adjustments may be necessary for elderly patients to mitigate potential adverse effects. Careful consideration should be given to the duration of therapy and the total daily dose, ensuring that it does not exceed recommended limits.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on fetal outcomes or complications during delivery. Therefore, it is essential that pregnant patients only use aspirin in this period if explicitly directed by a physician.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless explicitly 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

There is no specific information 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 are no established dosage adjustments, special monitoring requirements, or precautions outlined 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 from excessive dosing. Symptoms of overdosage can vary widely 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 supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Documentation of the incident, including the amount ingested and the time of ingestion, is crucial for effective management and follow-up 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 non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of aspirin. These include gastrointestinal bleeding, allergic reactions (including anaphylaxis), Reye's syndrome in children and teenagers, asthma exacerbation, renal impairment, hepatic impairment, skin reactions (such as Stevens-Johnson syndrome and toxic epidermal necrolysis), and cardiovascular events (including myocardial infarction and stroke).

Gastrointestinal bleeding has been reported, particularly in patients with a history of ulcers or those concurrently using anticoagulants. There have also been rare instances of severe allergic reactions, including anaphylaxis, in patients taking aspirin. Cases of Reye's syndrome have been documented in children and teenagers who received aspirin during viral infections.

Postmarketing surveillance has indicated that aspirin may exacerbate asthma in certain patients. Additionally, renal and hepatic impairment has been reported, especially in individuals with pre-existing conditions. Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been noted. Furthermore, cardiovascular events, such as myocardial infarction and stroke, have been associated with aspirin use, particularly in patients with existing cardiovascular risk factors.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients must be informed not to use this medication if they have a known allergy to aspirin or any other pain reliever or fever reducer. It is essential to counsel patients to stop using the medication and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, having bloody or black stools, vomiting blood, or experiencing stomach pain that does not improve.

Healthcare providers should emphasize that patients should 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 there is redness or swelling in the painful area, or if any new symptoms arise. Additionally, patients should be made aware that they should report any occurrence of ringing in the ears or loss of hearing.

Patients should be encouraged to consult a doctor before using this medication if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. It is also important to advise patients to seek medical advice if they have asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Healthcare providers should recommend that patients ask a doctor before use if they are taking a diuretic, have not been drinking fluids, or have lost a significant amount of fluid due to vomiting or diarrhea. Furthermore, patients should be counseled to consult 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. Lastly, patients under a doctor's care for any serious condition should also be advised to seek guidance before using this medication.

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). Temporary excursions are permitted between 15°C and 30°C (59°F to 86°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)