Aspirin

Description

Aspirin is a nonsteroidal anti-inflammatory drug (NSAID) with the chemical name acetylsalicylic acid. Its molecular formula is C9H8O4, and it has a molecular weight of 180.16 g/mol. Aspirin is typically presented in a tablet dosage form, characterized by its white to off-white appearance. The drug exhibits analgesic, antipyretic, and anti-inflammatory properties, making it widely used for the management of pain, fever, and inflammation.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, as recommended by a healthcare professional.

Limitations of Use: There are no known 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, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in patients with a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, the product should not be administered for at least 7 days following a tonsillectomy or oral surgery, unless specifically directed by a healthcare professional.

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, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Healthcare professionals should be vigilant for these signs and advise patients to seek immediate medical attention if an allergic reaction occurs.

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 meet any of the following criteria: individuals aged 60 years or older, those with a history of stomach ulcers or bleeding disorders, patients taking anticoagulants or steroid medications, individuals using other NSAIDs (including aspirin, ibuprofen, or naproxen), those consuming three or more alcoholic beverages daily while using this product, or patients who exceed the recommended dosage or duration of use.

Patients should be instructed to discontinue use and consult a healthcare provider if they experience any signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain), worsening pain that lasts longer than 10 days, the presence of redness or swelling, the emergence of new symptoms, or any ringing in the ears or loss of hearing.

In the event of an accidental overdose, it is crucial to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

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

The 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 blood thinners or steroid medications, consume three or more alcoholic drinks daily while using the product, or exceed the recommended dosage or duration of use. Patients should stop using the product and consult a doctor if they experience symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain.

Common adverse reactions may include worsening pain that lasts more than 10 days, redness or swelling, new symptoms, or auditory disturbances such as ringing in the ears or loss of hearing. Patients are advised to seek medical advice if any of these symptoms occur.

Before using this product, patients should consult a doctor if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease, or if they are taking diuretics. Additionally, patients taking prescription medications for gout, diabetes, or arthritis should seek guidance from a healthcare professional prior to use.

Pregnant or breastfeeding patients should also consult a health professional before using this product, particularly during the last three months of pregnancy, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Interactions

The concomitant use of aspirin with anticoagulant medications may elevate the risk of significant gastrointestinal bleeding. Healthcare professionals should exercise caution when prescribing these agents together and consider monitoring for signs of bleeding.

Additionally, the co-administration of aspirin with other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as ibuprofen and naproxen, may similarly heighten the risk of severe stomach bleeding. It is advisable to avoid this combination or to closely monitor patients for gastrointestinal complications.

Furthermore, caution is warranted when prescribing aspirin to patients who are on diuretics, as the interaction may necessitate careful consideration of the patient's overall treatment plan and potential for adverse effects.

No specific interactions with laboratory tests have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 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. If any changes in behavior accompanied by nausea and vomiting occur while using this product, a healthcare professional should be consulted, as these may be early signs of Reye’s syndrome, a rare but serious condition.

For children under 12 years of age, it is advised to consult a doctor before use. 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 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 stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Before initiating treatment, healthcare providers should inquire about any relevant medical history that may heighten the risk of gastrointestinal complications. Close monitoring of these patients is advised to ensure safety and to mitigate potential adverse effects associated with the use of this medication.

Pregnancy

Pregnant patients 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 fetal outcomes or complications during delivery. Therefore, it is essential that pregnant women only use aspirin in this period if specifically directed by a physician. Additionally, breastfeeding patients are advised to seek medical guidance prior to use.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication if they are pregnant or breastfeeding. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless specifically directed by a doctor, 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.

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, including those with liver cirrhosis, may require careful consideration when being prescribed this medication. Due to the potential impact of compromised liver function on drug metabolism and clearance, dosage adjustments may be necessary.

It is recommended that healthcare providers closely monitor patients with hepatic impairment for any adverse effects or changes in therapeutic response. Regular assessment of liver function tests should be conducted to ensure the safety and efficacy of the treatment regimen.

Patients with a history of high blood pressure, heart disease, or kidney disease should also be evaluated for potential interactions and contraindications related to their hepatic condition. Adjustments to the treatment plan may be warranted based on the severity of liver impairment and the presence of comorbidities.

Overdosage

In the event of an accidental 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 to mitigate potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may arise during the course of treatment.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless specifically 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 current information.

Postmarketing Experience

Postmarketing experience has identified reports of severe allergic reactions, including hives, facial swelling, asthma (wheezing), and shock. Additionally, there have been reports of stomach bleeding associated with the use of aspirin, particularly in patients who are older, have a history of stomach ulcers or bleeding problems, or are taking other medications that increase the risk of bleeding. Furthermore, cases of Reye’s syndrome have been reported in children and teenagers who have used aspirin during or after recovery from chickenpox or flu-like symptoms.

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 accidental overdose.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience any signs of an allergic reaction, which requires prompt medical attention. Patients should also be informed to stop use and seek medical advice if they notice symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, patients should be cautioned to consult a healthcare professional if their pain worsens or lasts longer than 10 days, if they observe any redness or swelling, if new symptoms arise, or if they experience ringing in the ears or loss of hearing.

It is important for healthcare providers to recommend that patients consult a doctor before use if the warning regarding stomach bleeding applies to them, or if they have a history of stomach issues, such as heartburn. Patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also be advised to seek medical guidance prior to use. Furthermore, patients taking diuretics or those with asthma should be encouraged to discuss their situation with a healthcare professional.

Lastly, patients should be advised to consult a doctor or pharmacist before using the product if they are currently taking prescription medications for gout, diabetes, or arthritis.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are necessary beyond standard storage practices.

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. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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)