Aspirin Low Dose 81mg Tab

Manufacturer AKRON PHARMA Active Ingredient Aspirin Enteric-Coated and Buffered Tablets(AS pir in) Pronunciation AS-pih-rin
It is used to treat rheumatic fever.It is used to ease pain and fever.It is used to treat some types of arthritis.It is used to protect bypass grafts and stents in the heart.It is used to lower the chance of heart attack, stroke, and death in some people.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antiplatelet agent
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Pharmacologic Class
Cyclooxygenase (COX) inhibitor; Platelet aggregation inhibitor
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Pregnancy Category
Category D
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Aspirin 81 mg is a low-dose medication often called 'baby aspirin.' It works by making your blood less sticky, which helps prevent blood clots that can cause heart attacks and strokes. It's commonly used for people who have had or are at high risk of these conditions.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, but if it causes stomach upset, take it with food. Always take it with a full glass of water and swallow the tablet whole - do not chew, break, or crush it.

Storing and Disposing of Your Medication

Keep your medication at room temperature in a dry place, away from the bathroom. Protect it from heat and store it in a safe location where children and pets cannot access it. When you no longer need your medication or it has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, as there may be drug take-back programs available in your area.

What to Do If You Miss a Dose

If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Take exactly as directed by your doctor, usually once a day.
  • Swallow enteric-coated tablets whole; do not crush, chew, or break them, as this can cause stomach upset or affect how the medicine works.
  • If you miss a dose, take it as soon as you remember, unless it's almost time for your next dose. Do not double doses.
  • Inform your doctor or dentist that you are taking aspirin before any surgery or dental procedures, as it can increase bleeding risk.
  • Avoid or limit alcohol consumption, as it can increase the risk of stomach bleeding.
  • Be cautious with activities that could cause injury or bleeding (e.g., contact sports, sharp objects).
  • Do not take other NSAIDs (like ibuprofen or naproxen) without consulting your doctor, as they can interfere with aspirin's effects or increase side effects.

Dosing & Administration

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Adult Dosing

Standard Dose: 81 mg orally once daily
Dose Range: 81 - 325 mg

Condition-Specific Dosing:

cardiovascular_prophylaxis: 81 mg orally once daily (preferred for long-term use)
acute_myocardial_infarction: 162-325 mg chewable aspirin immediately, then 81 mg daily
ischemic_stroke_TIA_prophylaxis: 50-325 mg orally once daily (81 mg commonly used)
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (generally contraindicated due to Reye's syndrome risk)
Child: Not established (generally contraindicated due to Reye's syndrome risk, unless for specific conditions like Kawasaki disease under medical supervision)
Adolescent: Not established (generally contraindicated due to Reye's syndrome risk, unless for specific conditions under medical supervision)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment for low dose, use with caution.
Moderate: Use with caution; monitor for adverse effects. Avoid if GFR < 30 mL/min.
Severe: Avoid use (GFR < 10 mL/min) due to increased risk of adverse effects and accumulation.
Dialysis: Avoid use. Aspirin is dialyzable, but risks outweigh benefits for chronic use.

Hepatic Impairment:

Mild: Use with caution.
Moderate: Use with caution; consider dose reduction or avoidance in severe hepatic dysfunction due to increased risk of bleeding and salicylate toxicity.
Severe: Avoid use due to increased risk of bleeding and salicylate toxicity.

Pharmacology

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Mechanism of Action

Aspirin irreversibly acetylates and inactivates cyclooxygenase (COX-1 and COX-2) enzymes. At low doses (e.g., 81 mg), it selectively inhibits COX-1 in platelets, preventing the synthesis of thromboxane A2 (TXA2), a potent inducer of platelet aggregation and vasoconstriction. This antiplatelet effect is sustained for the lifetime of the platelet (7-10 days).
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Pharmacokinetics

Absorption:

Bioavailability: 80-100% (for non-enteric coated aspirin; enteric coating delays absorption)
Tmax: 3-4 hours (for enteric-coated aspirin; 0.5-2 hours for non-enteric coated)
FoodEffect: Food can further delay absorption of enteric-coated formulations but may reduce GI upset.

Distribution:

Vd: 0.1-0.2 L/kg (aspirin); 0.15-0.2 L/kg (salicylate)
ProteinBinding: 90-95% (aspirin); 50-90% (salicylate, concentration-dependent)
CnssPenetration: Limited (aspirin); Yes (salicylate, crosses blood-brain barrier)

Elimination:

HalfLife: 15-20 minutes (aspirin); 2-3 hours (salicylate at low doses, becomes dose-dependent and longer at higher doses)
Clearance: Highly variable, depends on dose and urine pH.
ExcretionRoute: Renal (primarily as metabolites, small amount as unchanged salicylate)
Unchanged: <10% (salicylate, highly dependent on urine pH)
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Pharmacodynamics

OnsetOfAction: Within 1 hour (antiplatelet effect, though enteric coating delays absorption)
PeakEffect: Antiplatelet effect is maximal after 1-2 days of daily dosing as new platelets are inhibited.
DurationOfAction: 7-10 days (for antiplatelet effect, due to irreversible inhibition of platelet COX-1)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of bleeding: vomiting or coughing up blood, vomit that resembles coffee grounds, blood in the urine, black, red, or tarry stools, bleeding from the gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrollable bleeding.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach upset or pain, light-colored stools, vomiting, or yellowing of the skin or eyes.
Signs of high potassium levels: irregular heartbeat, confusion, weakness, lightheadedness, dizziness, feeling faint, numbness or tingling, or shortness of breath.
Signs of acidosis (too much acid in the blood): confusion, rapid breathing, rapid heartbeat, irregular heartbeat, severe stomach pain, upset stomach, vomiting, excessive sleepiness, shortness of breath, or extreme fatigue or weakness.
Weakness on one side of the body, difficulty speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
Severe dizziness or fainting.
Severe headache.
Ringing in the ears, hearing loss, or other changes in hearing.
Agitation.
Seizures.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people experience no side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:

Stomach pain or heartburn.
Upset stomach or vomiting.

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Unusual bleeding or bruising (e.g., nosebleeds, bleeding gums, petechiae)
  • Black, tarry stools or blood in stools
  • Vomiting blood or material that looks like coffee grounds
  • Severe stomach pain or persistent heartburn
  • Signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
  • Ringing in the ears or hearing loss (especially with higher doses or toxicity)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reactions you have experienced.
Certain health conditions, including:
+ Asthma
+ Bleeding problems
+ Nose polyps or nose irritation
+ Kidney disease or liver disease
+ Gastrointestinal (GI) bleeding or ulcer disease
If you are taking another medication that contains the same active ingredient as this drug.
If you are taking any other nonsteroidal anti-inflammatory drugs (NSAIDs).
If you are pregnant, plan to become pregnant, or become pregnant while taking this medication. This drug may harm an unborn baby if taken after 20 weeks of pregnancy. Only take this medication after 20 weeks of pregnancy if your doctor has instructed you to do so.
If you are breastfeeding or plan to breastfeed.

Special Considerations for Children:

If the patient is a child, as this medication may not be suitable for all age groups.
If your child or teenager has or is recovering from flu symptoms, chickenpox, or other viral infections. The risk of Reye's syndrome, a severe condition, may be increased. Do not give this medication to a child or teenager with a viral infection or who is recovering from one.

Interactions with Other Medications and Health Conditions:

This is not an exhaustive list of all potential interactions. Inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health conditions you have. Verify that it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are taking this drug for an extended period, your doctor may recommend regular blood tests to monitor your condition.

To minimize the risk of severe side effects, it is crucial to adhere to the prescribed dosage and not exceed the recommended amount. Additionally, do not take this medication for longer than the duration specified by your doctor.

If you are taking this drug on a regular basis, do not discontinue use without consulting the doctor who prescribed it for you. This medication may increase your risk of bleeding, so it is essential to be cautious and avoid injuries. To reduce the risk of bleeding, use a soft toothbrush and an electric razor.

Before consuming alcohol, discuss the potential risks with your doctor. If you smoke, you should also talk to your doctor about the potential interactions between smoking and this medication.

This drug may increase the risk of severe and potentially life-threatening stomach or bowel problems, such as ulcers or bleeding. This risk is higher in older adults and individuals with a history of stomach or bowel ulcers or bleeding. These complications can occur without warning signs, so it is essential to be aware of the potential risks.

If you are over 60 years old, use this medication with caution, as you may be more susceptible to side effects. Your doctor will closely monitor your condition to minimize the risk of adverse reactions.
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Overdose Information

Overdose Symptoms:

  • Ringing in the ears (tinnitus)
  • Hearing loss
  • Dizziness
  • Nausea, vomiting
  • Rapid breathing (hyperventilation)
  • Confusion
  • Fever
  • Sweating
  • Dehydration
  • In severe cases: seizures, coma, respiratory depression, metabolic acidosis.

What to Do:

Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment may involve activated charcoal, gastric lavage, IV fluids, correction of electrolyte imbalances, and potentially hemodialysis for severe toxicity.

Drug Interactions

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Contraindicated Interactions

  • Ketorolac (increased risk of GI bleeding)
  • Methotrexate (high dose, >15 mg/week, increased methotrexate toxicity)
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Major Interactions

  • Anticoagulants (e.g., warfarin, heparin, direct oral anticoagulants): Increased risk of bleeding.
  • Other NSAIDs (e.g., ibuprofen, naproxen): Increased risk of GI bleeding and ulceration; ibuprofen may interfere with aspirin's antiplatelet effect.
  • SSRIs/SNRIs (e.g., fluoxetine, sertraline): Increased risk of GI bleeding.
  • Corticosteroids (systemic): Increased risk of GI ulceration and bleeding.
  • Alcohol: Increased risk of GI bleeding.
  • Sulfonylureas (e.g., glipizide): Enhanced hypoglycemic effect.
  • Valproic acid: Increased valproic acid levels.
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Moderate Interactions

  • ACE inhibitors/ARBs (e.g., lisinopril, valsartan): Reduced antihypertensive effect, potential for renal impairment.
  • Diuretics (e.g., furosemide, hydrochlorothiazide): Reduced diuretic and antihypertensive effect.
  • Probenecid/Sulfinpyrazone: Reduced uricosuric effect.
  • Spironolactone: Reduced diuretic effect.
  • Phenytoin: Increased phenytoin levels.
  • Metoclopramide: Increased aspirin absorption.
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Minor Interactions

  • Antacids: May decrease aspirin absorption (for non-enteric coated) or increase salicylate excretion (by increasing urine pH).

Monitoring

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Baseline Monitoring

Bleeding risk assessment (e.g., HAS-BLED score)

Rationale: To identify patients at higher risk of bleeding complications before initiating therapy.

Timing: Prior to initiation of therapy

Baseline renal function (SCr, eGFR)

Rationale: To assess baseline kidney function, especially in elderly or those with pre-existing renal impairment, as aspirin can affect renal hemodynamics.

Timing: Prior to initiation of therapy

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Routine Monitoring

Signs and symptoms of bleeding (e.g., bruising, petechiae, melena, hematemesis)

Frequency: Regularly, especially during initial therapy and with concomitant medications

Target: Absence of abnormal bleeding

Action Threshold: Any new or worsening signs of bleeding should prompt medical evaluation.

Signs and symptoms of GI upset/ulceration (e.g., dyspepsia, abdominal pain, heartburn)

Frequency: Regularly

Target: Absence of severe GI symptoms

Action Threshold: Persistent or severe symptoms warrant investigation and potential discontinuation.

Renal function (SCr, eGFR)

Frequency: Periodically, especially in patients with risk factors for renal impairment or on concomitant nephrotoxic drugs.

Target: Stable renal function

Action Threshold: Significant decline in eGFR should prompt re-evaluation of aspirin therapy.

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Symptom Monitoring

  • Unusual bleeding or bruising
  • Black, tarry stools
  • Vomiting blood or coffee-ground like material
  • Severe stomach pain
  • Persistent heartburn or indigestion
  • Ringing in the ears (tinnitus - more common with higher doses)
  • Hearing loss (more common with higher doses)
  • Dizziness
  • Confusion

Special Patient Groups

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Pregnancy

Generally avoided in pregnancy, especially in the third trimester, due to risks to the fetus. Low-dose aspirin may be used in specific high-risk conditions (e.g., preeclampsia prophylaxis) under strict medical supervision, but the overall category is D.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for increased risk of miscarriage or congenital malformations (though evidence is mixed and not conclusive for low-dose).
Second Trimester: Generally considered safer than first or third trimester if medically necessary, but still used with caution.
Third Trimester: Contraindicated due to risk of premature closure of the fetal ductus arteriosus, persistent pulmonary hypertension of the newborn, and increased maternal and fetal bleeding risk during labor and delivery.
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Lactation

Aspirin and its metabolite, salicylate, are excreted into breast milk. While low-dose aspirin is generally considered compatible with breastfeeding by some experts due to low levels in milk, there is a theoretical risk of Reye's syndrome in infants, especially if the infant has a viral infection. Use with caution; monitor infant for adverse effects.

Infant Risk: L3 (Moderate concern). Potential for Reye's syndrome in infants with viral illness; theoretical risk of bleeding or metabolic acidosis in the infant, though unlikely with low maternal doses.
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Pediatric Use

Generally contraindicated in children and teenagers with viral infections (e.g., flu, chickenpox) due to the risk of Reye's syndrome, a rare but serious condition affecting the brain and liver. Use in pediatric populations is limited to specific conditions (e.g., Kawasaki disease, rheumatic fever) under strict medical supervision.

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Geriatric Use

Increased risk of gastrointestinal bleeding and renal impairment. Use with caution and monitor closely for adverse effects. Lower doses may be preferred if effective.

Clinical Information

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Clinical Pearls

  • Enteric-coated aspirin is designed to reduce GI upset but may delay absorption and onset of antiplatelet effect. Do not crush or chew.
  • Low-dose aspirin's primary role is antiplatelet therapy for cardiovascular and cerebrovascular disease prevention, not pain relief.
  • Patients should be advised to avoid concomitant use of other NSAIDs (especially ibuprofen) if taking aspirin for antiplatelet effect, as ibuprofen can interfere with aspirin's irreversible platelet inhibition.
  • Always inquire about other medications, including OTCs and herbal supplements, due to significant interaction potential, especially with anticoagulants and other antiplatelet agents.
  • Educate patients on signs of bleeding and GI upset, and when to seek immediate medical attention.
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Alternative Therapies

  • Clopidogrel (Plavix) - another antiplatelet agent, often used when aspirin is contraindicated or not tolerated.
  • Prasugrel (Effient) - stronger antiplatelet, used in specific acute coronary syndromes.
  • Ticagrelor (Brilinta) - another stronger antiplatelet.
  • Dipyridamole (Persantine) - sometimes used in combination with aspirin (Aggrenox) for stroke prevention.
  • Statins (e.g., atorvastatin, rosuvastatin) - for lipid lowering and cardiovascular risk reduction.
  • Antihypertensives (e.g., ACE inhibitors, ARBs) - for blood pressure control and cardiovascular risk reduction.
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Cost & Coverage

Average Cost: $5 - $20 per 30-100 tablets (OTC)
Generic Available: Yes
Insurance Coverage: Often available over-the-counter (OTC) and may be covered by Flexible Spending Accounts (FSA) or Health Savings Accounts (HSA). Some prescription plans may cover it if prescribed.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.