Aspirin 81mg EC Low Dosetablets

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, Nonsteroidal anti-inflammatory drug (NSAID), Analgesic, Antipyretic
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Pharmacologic Class
Cyclooxygenase (COX) inhibitor, Platelet aggregation inhibitor
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Pregnancy Category
Category C (1st/2nd trimester), Category D (3rd trimester)
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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 81mg EC is a low-dose medication that helps prevent blood clots. It works by making your platelets (tiny blood cells that help stop bleeding) less sticky, which reduces the risk of heart attacks and strokes. The 'EC' means it's enteric-coated, so it has a special coating to help protect your stomach.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. 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

Store your medication at room temperature in a dry place, avoiding the bathroom. Protect it from heat and keep it out of reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on proper disposal or explore local drug take-back programs.

Missing a Dose

If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your normal schedule. Do not take two doses at the same time or extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
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Lifestyle & Tips

  • Take with food or milk to help reduce stomach upset.
  • Do not crush, chew, or break enteric-coated tablets; swallow them whole.
  • Avoid or limit alcohol consumption, as it can increase the risk of stomach bleeding.
  • Inform your doctor or dentist that you are taking aspirin before any surgery or dental procedures, as you may need to stop it temporarily.
  • Report any signs of unusual bleeding or bruising immediately to your doctor.

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
acute_myocardial_infarction: Initial loading dose of 162-325 mg (chewable, non-EC preferred for rapid absorption), then 81 mg daily
acute_ichemic_stroke_TIA: Initial loading dose of 162-325 mg (chewable, non-EC preferred for rapid absorption), then 81 mg daily
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Pediatric Dosing

Neonatal: Not established (contraindicated for fever/pain due to Reye's syndrome risk)
Infant: Not established (contraindicated for fever/pain due to Reye's syndrome risk); specific indications (e.g., Kawasaki disease) under specialist supervision
Child: Not established (contraindicated for fever/pain due to Reye's syndrome risk); specific indications (e.g., Kawasaki disease, post-cardiac surgery) under specialist supervision
Adolescent: Not established (contraindicated for fever/pain due to Reye's syndrome risk); specific indications under specialist supervision
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor for adverse effects
Moderate: Use with caution; consider dose reduction or extended dosing interval; monitor for adverse effects (e.g., bleeding, renal function)
Severe: Avoid use (CrCl < 10 mL/min) due to increased risk of adverse effects and accumulation of active metabolites
Dialysis: Avoid use; aspirin is dialyzable, but risk of bleeding outweighs benefits in most cases

Hepatic Impairment:

Mild: Use with caution; monitor for adverse effects
Moderate: Use with caution; consider dose reduction; monitor for adverse effects (e.g., bleeding, liver function)
Severe: Avoid use due to increased risk of bleeding and hepatic encephalopathy

Pharmacology

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Mechanism of Action

Aspirin irreversibly inhibits cyclooxygenase (COX-1 and COX-2) enzymes by acetylation. In platelets, this prevents 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). At higher doses, it also exerts analgesic, antipyretic, and anti-inflammatory effects by inhibiting prostaglandin synthesis.
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Pharmacokinetics

Absorption:

Bioavailability: 80-100%
Tmax: 3-12 hours (for enteric-coated formulation, due to delayed absorption in the small intestine)
FoodEffect: Food may further delay absorption of enteric-coated aspirin but can reduce gastrointestinal irritation.

Distribution:

Vd: 0.1-0.2 L/kg (for salicylic acid)
ProteinBinding: 90-95% (salicylic acid, concentration-dependent)
CnssPenetration: Yes (crosses blood-brain barrier)

Elimination:

HalfLife: 0.25-0.33 hours (aspirin); 2-3 hours (salicylic acid at low doses, dose-dependent, can extend to 15-30 hours at high doses)
Clearance: Highly variable, dose-dependent
ExcretionRoute: Renal (salicylic acid and its metabolites)
Unchanged: Less than 10% (aspirin); 10-85% (salicylic acid, depending on urine pH and dose)
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Pharmacodynamics

OnsetOfAction: Antiplatelet effect: 1 hour (non-EC, chewable); delayed for EC formulation (onset corresponds to absorption)
PeakEffect: Antiplatelet effect: Within hours of absorption, sustained for platelet lifespan
DurationOfAction: Antiplatelet effect: 7-10 days (lifetime of platelet)

Safety & Warnings

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BLACK BOX WARNING

Reye's Syndrome: Aspirin should not be used in children or teenagers for viral infections, with or without fever, because of the risk of Reye's syndrome, a rare but serious illness.
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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, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or 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, including:
+ 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
+ Uncontrollable bleeding
Signs of kidney problems, such as:
+ Inability to urinate
+ Changes in urine output
+ Blood in the urine
+ Sudden significant weight gain
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes (jaundice)
Signs of high potassium levels, such as:
+ Abnormal heartbeat
+ Confusion
+ Weakness, lightheadedness, or dizziness
+ Feeling faint
+ Numbness or tingling
+ Shortness of breath
Signs of acidosis (too much acid in the blood), including:
+ Confusion
+ Rapid breathing
+ Rapid heartbeat
+ Abnormal heartbeat
+ Severe stomach pain, upset stomach, or vomiting
+ Excessive sleepiness
+ Shortness of breath
+ Feeling extremely tired or weak
Weakness on one side of the body
Difficulty speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred vision
Severe dizziness or fainting
Severe headache
Ringing in the ears, hearing loss, or other changes in hearing
Feeling agitated
Seizures

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor 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:

  • Black, tarry stools or blood in vomit (looks like coffee grounds)
  • Severe stomach pain or heartburn that doesn't go away
  • Unusual bleeding or bruising (e.g., nosebleeds, bleeding gums, excessive bruising)
  • Signs of allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
  • Ringing in the ears (tinnitus) or hearing loss (more common with higher doses, but report any new symptoms)
  • Sudden weakness or numbness on one side of the body, sudden severe headache, or vision changes (signs of stroke, though aspirin is preventative, these are emergency symptoms)
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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 reaction you experienced, including the symptoms.
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, planning 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 advises 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 ages.
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 all 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 its use without first 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, it is also important to 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
  • Seizures (severe overdose)
  • Coma (severe overdose)

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment may involve activated charcoal, gastric lavage, IV fluids, correction of acid-base imbalances, and potentially hemodialysis for severe cases.

Drug Interactions

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Contraindicated Interactions

  • Ketorolac (and other NSAIDs in patients with active peptic ulcer disease or bleeding disorders)
  • Methotrexate (high-dose, >15 mg/week, due to increased methotrexate toxicity)
  • Live attenuated influenza vaccine (intranasal) in children/adolescents (due to Reye's syndrome risk)
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Major Interactions

  • Anticoagulants (e.g., Warfarin, Dabigatran, Rivaroxaban, Apixaban, Edoxaban) - increased risk of bleeding
  • Other NSAIDs (e.g., Ibuprofen, Naproxen) - increased risk of GI bleeding and ulceration, may interfere with aspirin's antiplatelet effect
  • Corticosteroids (systemic) - increased risk of GI bleeding and ulceration
  • SSRIs/SNRIs (e.g., Fluoxetine, Sertraline, Venlafaxine) - increased risk of GI bleeding
  • Alcohol - increased risk of GI bleeding
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Moderate Interactions

  • ACE inhibitors (e.g., Lisinopril, Enalapril) - reduced antihypertensive effect, increased risk of renal impairment
  • Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan, Losartan) - reduced antihypertensive effect, increased risk of renal impairment
  • Diuretics (e.g., Furosemide, Hydrochlorothiazide) - reduced diuretic and antihypertensive effect, increased risk of renal impairment
  • Sulfonylureas (e.g., Glipizide, Glyburide) - increased hypoglycemic effect
  • Valproic acid - increased valproic acid levels
  • Uricosurics (e.g., Probenecid) - reduced uricosuric effect
  • Spironolactone - reduced diuretic effect
  • Phenytoin - increased phenytoin levels
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Minor Interactions

  • Antacids - may reduce aspirin absorption (separate administration)
  • Herbal supplements (e.g., Ginkgo biloba, Garlic, Ginger) - potential increased bleeding risk

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC) with platelets

Rationale: To assess baseline hemoglobin, hematocrit, and platelet count, which are important for monitoring potential bleeding complications.

Timing: Prior to initiation

Renal function (Serum Creatinine, BUN)

Rationale: To assess baseline kidney function, as aspirin can impair renal function, especially in susceptible individuals.

Timing: Prior to initiation

Liver function tests (ALT, AST)

Rationale: To assess baseline liver function, as aspirin can cause hepatotoxicity, though rare at low doses.

Timing: Prior to initiation (if clinically indicated)

Gastrointestinal history (e.g., peptic ulcer disease, GI bleeding)

Rationale: To identify pre-existing risk factors for GI complications.

Timing: Prior to initiation

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Routine Monitoring

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

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

Target: Absence of abnormal bleeding

Action Threshold: Any new or worsening signs of bleeding warrant immediate medical evaluation.

Gastrointestinal symptoms (e.g., dyspepsia, abdominal pain)

Frequency: Regularly

Target: Absence of severe or persistent GI discomfort

Action Threshold: Persistent or severe symptoms may indicate GI irritation or ulceration and require evaluation.

Renal function (Serum Creatinine, BUN)

Frequency: Periodically, especially in patients with pre-existing renal impairment, heart failure, or on concomitant nephrotoxic drugs

Target: Stable renal function

Action Threshold: Significant increase in creatinine or BUN may indicate renal impairment and require dose adjustment or discontinuation.

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Symptom Monitoring

  • Unusual bleeding or bruising (e.g., nosebleeds, bleeding gums, petechiae, purpura)
  • Black, tarry stools (melena)
  • Vomiting blood or material that looks like coffee grounds (hematemesis)
  • Severe or persistent stomach pain
  • Signs of allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
  • Tinnitus (ringing in the ears) or hearing loss (signs of salicylism, more common at higher doses)
  • Dizziness or confusion

Special Patient Groups

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Pregnancy

Avoid in the third trimester due to potential for premature closure of the fetal ductus arteriosus, prolonged labor, and increased maternal/fetal bleeding. Use in the first and second trimesters only if clearly needed and the potential benefit outweighs the risk, typically for specific indications like preeclampsia prophylaxis under medical supervision.

Trimester-Specific Risks:

First Trimester: Potential increased risk of miscarriage and congenital malformations (e.g., gastroschisis), though data are conflicting for low-dose aspirin.
Second Trimester: Generally considered safer than first or third trimester, but still use with caution and only if clearly indicated.
Third Trimester: Contraindicated due to risk of premature closure of the fetal ductus arteriosus, persistent pulmonary hypertension of the newborn, oligohydramnios, renal dysfunction, and increased maternal/fetal bleeding.
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Lactation

Aspirin and its metabolite, salicylic acid, are excreted into breast milk. Low-dose aspirin is generally considered compatible with breastfeeding, but caution is advised. Monitor the infant for signs of bleeding (e.g., bruising, petechiae) or other adverse effects.

Infant Risk: Low risk at low doses, but theoretical risk of Reye's syndrome (extremely rare) or bleeding in the infant. Avoid if infant has viral illness or bleeding disorder.
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Pediatric Use

Generally contraindicated for fever or pain in children and adolescents due to the risk of Reye's syndrome, a rare but serious condition. Specific indications (e.g., Kawasaki disease, post-cardiac surgery, certain rheumatologic conditions) may warrant low-dose aspirin use under strict specialist supervision, where the benefits outweigh the risks.

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Geriatric Use

Increased risk of gastrointestinal bleeding, renal impairment, and other adverse effects compared to younger adults. Use with caution, monitor for adverse effects, and consider lower doses or alternative therapies if appropriate. Concomitant use of other medications that increase bleeding risk is common in this population.

Clinical Information

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Clinical Pearls

  • Enteric-coated (EC) aspirin is designed to reduce gastrointestinal irritation but does not eliminate the risk of GI bleeding or ulcers. The antiplatelet effect is delayed compared to chewable or plain aspirin.
  • The antiplatelet effect of aspirin is irreversible and lasts for the lifetime of the platelet (7-10 days). Patients should typically discontinue aspirin 5-7 days prior to elective surgery to minimize bleeding risk, as advised by their surgeon.
  • Aspirin resistance, where patients do not achieve adequate platelet inhibition, can occur. This may be due to non-adherence, drug interactions (e.g., ibuprofen), or genetic factors.
  • Low-dose aspirin is primarily used for its antiplatelet effect in cardiovascular disease prevention, not for pain or fever.
  • Patients should be educated on the signs of bleeding and the importance of not taking other NSAIDs concurrently without consulting a healthcare professional.
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Alternative Therapies

  • P2Y12 inhibitors (e.g., Clopidogrel, Ticagrelor, Prasugrel) - alternative antiplatelet agents, often used in combination with aspirin or as monotherapy if aspirin is contraindicated/not tolerated.
  • Other NSAIDs (e.g., Ibuprofen, Naproxen) - for pain/inflammation, but do not have the same irreversible antiplatelet effect and may interfere with aspirin's antiplatelet action if taken concurrently.
  • Anticoagulants (e.g., Warfarin, DOACs) - for prevention of thromboembolic events in specific conditions (e.g., atrial fibrillation), but have a different mechanism of action and higher bleeding risk than low-dose aspirin.
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Cost & Coverage

Average Cost: Typically <$10 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.