Adult Low Dose Aspirin

Description

The product is identified by SPL Code 34089-3 and is presented as a white, round, enteric-coated tablet. It is imprinted with "EC 81" on one side and is plain on the reverse side. Each tablet contains 81 mg of aspirin. The formulation includes inactive ingredients such as corn starch, hypromellose, microcrystalline cellulose, polyethylene glycol, and talc.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, as well as for other uses as recommended by a healthcare professional. Due to its delayed action, this product may not provide immediate relief for headaches or other symptoms requiring prompt alleviation.

Healthcare professionals are encouraged to consult with patients regarding additional potential uses for this product. There are no teratogenic or nonteratogenic effects mentioned in the available data.

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 as needed while symptoms persist. It is imperative not to exceed a total of 48 tablets within a 24-hour period unless otherwise directed by a physician.

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 history of allergic reactions to aspirin or any other pain reliever or fever reducer. Due to the potential for severe allergic responses, such patients should avoid this product.

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.

Aspirin may provoke severe allergic reactions in some individuals. Symptoms of such reactions can include hives, asthma (wheezing), facial swelling, and shock. Healthcare professionals should be vigilant for these signs and advise patients to seek immediate medical attention if they 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 patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily, or 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 stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, they should seek medical advice if an allergic reaction occurs, if pain worsens or persists beyond 10 days, if redness or swelling develops, if any new symptoms arise, or if they experience ringing in the ears or loss of hearing, as these may indicate serious underlying conditions.

In the event of an accidental overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can range from serious to common.

Serious adverse reactions include Reye's syndrome, which 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 while using this product, they should consult a doctor immediately, as these symptoms could indicate the onset of Reye's syndrome.

Additionally, patients may experience severe allergic reactions to aspirin, which can manifest as hives, asthma (wheezing), facial swelling, or shock. It is crucial for patients to seek medical attention if any signs of an allergic reaction occur.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a warning for the potential of severe stomach bleeding. The risk of this serious 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 blood-thinning medications or steroids, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily while using this product, 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, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Other reasons to stop use and seek medical advice include the occurrence of an allergic reaction, worsening pain that lasts more than 10 days, presence of redness or swelling, emergence of new symptoms, or symptoms such as ringing in the ears or loss of hearing, as these may indicate a serious condition.

Drug Interactions

Aspirin has the potential to cause severe gastrointestinal bleeding, particularly when used concomitantly with anticoagulants or steroid medications. The risk of bleeding is also heightened when aspirin is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as ibuprofen and naproxen.

Patients who are prescribed medications for gout, diabetes, or arthritis should consult their healthcare provider prior to initiating aspirin therapy, as these drugs may interact with aspirin and necessitate careful monitoring or dosage adjustments.

Packaging & NDC

Below are the non-prescription pack sizes of Adult 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 pediatric patients experience changes in behavior accompanied by nausea and vomiting while using this product, it is essential to consult a physician, as these symptoms may indicate the onset of Reye's syndrome.

For dosing, adults and children aged 12 years and older are directed to take 4 to 8 tablets every 4 hours while symptoms persist, with a maximum of 48 tablets in 24 hours unless otherwise directed by a physician. For children under 12 years of age, consultation with a physician is required before use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor these patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit ratio is essential in this population to ensure safe and effective treatment.

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 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. Therefore, caution is recommended when considering the use of this medication while breastfeeding.

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 conditions such as liver cirrhosis. It is essential for these patients to receive appropriate evaluation and monitoring of their liver function to ensure safe use of the medication. Adjustments to dosage may be necessary based on the severity of hepatic impairment, and ongoing assessment of liver function is recommended throughout the treatment period.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt action is crucial to mitigate potential adverse effects associated with overdosage.

Healthcare professionals should be aware that symptoms of overdose may vary depending on the specific substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should monitor the patient closely for any signs of toxicity and initiate interventions as necessary. This may include administering activated charcoal if the patient presents within a suitable timeframe and is alert, as well as providing intravenous fluids and other supportive measures as indicated.

In summary, immediate medical intervention is critical in cases of overdose, and healthcare professionals should be prepared to implement appropriate management strategies based on the clinical presentation and specific circumstances of the overdose event.

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 additional non-teratogenic effects or specific nonclinical toxicology details have been identified in the available data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports indicate occurrences of allergic reactions, which may include hives, asthma (wheezing), facial swelling, and shock. Additionally, severe stomach bleeding has been noted, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, patients taking blood thinners or steroid medications, individuals consuming three or more alcoholic drinks daily, or those exceeding the recommended dosage.

Serious conditions reported in association with the use of aspirin include signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, and experiencing stomach pain that does not improve. Other reported allergic reactions may also occur. Patients have reported worsening pain or pain persisting for more than 10 days, as well as the presence of redness or swelling. New symptoms have been documented, along with reports of ringing in the ears or loss of hearing.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an accidental overdose. It is crucial to inform patients that they should not use this medication if they have a history of allergic reactions to aspirin or any other pain reliever or fever reducer.

Patients should be instructed 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 persistent stomach pain. Additionally, they should stop use and seek medical advice if any allergic reactions occur, if pain worsens or lasts longer than 10 days, if redness or swelling is observed, or if any new symptoms arise. Patients should also be made aware that they need to consult a doctor if they experience ringing in the ears or loss of hearing.

It is important for healthcare providers to encourage patients to ask 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. Patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also be advised to consult a doctor prior to use. Furthermore, patients with asthma, those taking diuretics, or those on prescription medications for gout, diabetes, or arthritis should seek guidance from a doctor or pharmacist before using this medication.

Storage and Handling

The product is supplied in a tamper-evident container. It should not be used if the safety seal under the cap is broken or missing.

For optimal storage, the product must be kept at room temperature, specifically between 15° and 30°C. It is essential to avoid exposure to excess heat and moisture to maintain the integrity of the product.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours as needed, with a maximum of 48 tablets in a 24-hour period unless otherwise directed by a physician. For children under 12 years, consultation with a physician is advised prior to use.

Clinicians should counsel patients regarding the use of this medication during pregnancy and breastfeeding. It is particularly important to avoid aspirin in the last trimester of pregnancy unless specifically instructed by a healthcare provider, 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 Adult Low Dose Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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