Aspirin 325mg EC Tablets

Manufacturer RELIABLE 1 Active Ingredient Aspirin Enteric-Coated and Buffered Tablets(AS pir in) Pronunciation AS-pi-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, Salicylate
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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 is a common medicine used to relieve pain, reduce fever, and lower inflammation. It also helps prevent blood clots, which is why it's often used to prevent heart attacks and strokes. The 'EC' means 'enteric-coated,' which is a special coating that helps protect your stomach from irritation, but it also means the medicine takes longer to start working.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most benefit from your medication, follow these steps:

Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food. If it causes stomach upset, take it with food to help minimize this side effect.
Drink a full glass of water with your medication.
Swallow the medication whole; do not chew, break, or crush it.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication:

Store it at room temperature in a dry place, avoiding the bathroom.
Protect it from heat sources.
Keep all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider. Check with your pharmacist for guidance on the best disposal method, as there may be drug take-back programs available in your area.

What to Do If You Miss a Dose

If you take your medication on a regular schedule:

Take the missed dose as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses.

If you take your medication as needed:

* Do not take it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Take with food or milk to further reduce stomach upset, even with the enteric coating.
  • Do not crush, chew, or break enteric-coated tablets; swallow them whole.
  • Avoid alcohol, as it can increase the risk of stomach bleeding.
  • Inform your doctor or dentist you are taking aspirin before any surgery or dental procedures due to increased bleeding risk.
  • Stay hydrated, especially if you experience fever or vomiting.

Dosing & Administration

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Adult Dosing

Standard Dose: For pain/fever: 325-650 mg orally every 4-6 hours as needed. For cardiovascular prevention (secondary): 325 mg orally once daily (often 81 mg is preferred for primary prevention).
Dose Range: 325 - 650 mg

Condition-Specific Dosing:

Pain/Fever: 325-650 mg every 4-6 hours, not to exceed 4000 mg/day.
Cardiovascular Prevention (secondary): 325 mg once daily.
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Pediatric Dosing

Neonatal: Not established (contraindicated due to Reye's Syndrome risk)
Infant: Not established (contraindicated due to Reye's Syndrome risk)
Child: Not established (contraindicated in children/adolescents with viral infections due to Reye's Syndrome risk)
Adolescent: Not established (contraindicated in children/adolescents with viral infections due to Reye's Syndrome risk)
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Dose Adjustments

Renal Impairment:

Mild: Use with caution; monitor renal function.
Moderate: Use with caution; consider dose reduction or avoidance in chronic use. Monitor renal function.
Severe: Contraindicated or avoid use due to risk of accumulation and toxicity. Monitor renal function closely.
Dialysis: Salicylates are dialyzable. Avoid use or use with extreme caution and monitor levels.

Hepatic Impairment:

Mild: Use with caution; monitor for signs of toxicity.
Moderate: Use with caution; consider dose reduction. Monitor for signs of toxicity (e.g., tinnitus, bleeding).
Severe: Contraindicated or avoid use due to risk of accumulation and toxicity, and increased bleeding risk. Monitor closely.

Pharmacology

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Mechanism of Action

Aspirin irreversibly inhibits cyclooxygenase (COX-1 and COX-2) enzymes by acetylation, leading to decreased synthesis of prostaglandins, prostacyclin, and thromboxane A2 (TXA2). This results in anti-inflammatory, analgesic, antipyretic, and antiplatelet effects. The antiplatelet effect is due to irreversible inhibition of COX-1 in platelets, preventing TXA2 synthesis, which is crucial for platelet aggregation.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 68% (for salicylic acid, after hydrolysis of aspirin); enteric coating delays absorption.
Tmax: For enteric-coated aspirin: 3-12 hours (for salicylic acid).
FoodEffect: Food may further delay absorption of enteric-coated formulations but can reduce GI upset.

Distribution:

Vd: 0.1-0.2 L/kg (for salicylic acid)
ProteinBinding: 80-90% (salicylic acid, concentration-dependent)
CnssPenetration: Limited, but can cross blood-brain barrier, especially at higher concentrations.

Elimination:

HalfLife: Aspirin: 15-20 minutes (due to rapid hydrolysis). Salicylic acid: 2-3 hours (low dose), 15-30 hours (high dose, due to saturation of metabolic pathways).
Clearance: Dose-dependent; decreases with increasing dose due to saturation of metabolic pathways.
ExcretionRoute: Renal (as salicylic acid and its metabolites).
Unchanged: Approximately 5-10% (salicylic acid, dose-dependent)
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Pharmacodynamics

OnsetOfAction: Analgesic/Antipyretic: 30-60 minutes. Antiplatelet: Within 1 hour (for irreversible platelet inhibition).
PeakEffect: Analgesic/Antipyretic: 1-2 hours. Antiplatelet: 2-4 hours.
DurationOfAction: Analgesic/Antipyretic: 4-6 hours. Antiplatelet: Life of the platelet (7-10 days).

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 medical attention immediately:

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, trouble 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 uncontrolled 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 yellow skin and 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, nausea, 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 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 for guidance:

Stomach pain or heartburn.
Nausea 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:

  • Any signs of bleeding (e.g., unusual bruising, nosebleeds, black/tarry stools, vomiting blood).
  • Severe stomach pain or persistent heartburn.
  • Ringing in the ears (tinnitus) or hearing changes.
  • Signs of allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing).
  • Unexplained fatigue or weakness (could indicate anemia from bleeding).
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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 use of this medication:

Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. 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, 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 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 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.

Additional Important Information:

This list is not exhaustive, and it is crucial to 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 problems you have. This will help ensure your safety while taking this medication. Never 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 take precautions to avoid injury. Use a soft toothbrush and an electric razor to reduce the risk of bleeding.

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, particularly those 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
  • Nausea, vomiting, stomach pain
  • Rapid breathing (hyperventilation)
  • Dizziness, confusion, agitation
  • Fever
  • Sweating
  • Dehydration
  • Seizures (severe cases)
  • Coma (severe cases)

What to Do:

If you suspect an overdose, seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Do not wait for symptoms to worsen.

Drug Interactions

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Contraindicated Interactions

  • Methotrexate (high-dose): Increased methotrexate toxicity.
  • Ketorolac (and other NSAIDs with high bleeding risk): Increased risk of GI bleeding/ulceration.
  • Live attenuated influenza vaccine (intranasal): Risk of Reye's Syndrome in children/adolescents.
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Major Interactions

  • Anticoagulants (e.g., Warfarin, Heparin, DOACs): Increased risk of bleeding.
  • Other NSAIDs (e.g., Ibuprofen, Naproxen): Increased risk of GI bleeding/ulceration, may reduce aspirin's antiplatelet effect.
  • Corticosteroids: Increased risk of GI ulceration and bleeding.
  • SSRIs/SNRIs: Increased risk of GI bleeding.
  • Antiplatelet agents (e.g., Clopidogrel, Ticagrelor): Increased risk of bleeding.
  • Sulfonylureas (e.g., Glipizide, Glyburide): Enhanced hypoglycemic effect.
  • Valproic acid: Increased valproic acid levels and toxicity.
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Moderate Interactions

  • ACE inhibitors/ARBs: Reduced antihypertensive effect, increased risk of renal impairment.
  • Diuretics (e.g., Furosemide, Hydrochlorothiazide): Reduced diuretic and antihypertensive effect.
  • Beta-blockers: Reduced antihypertensive effect.
  • Probenecid/Sulfinpyrazone: Reduced uricosuric effect.
  • Phenytoin: Increased phenytoin levels.
  • Spironolactone: Reduced diuretic effect.
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Minor Interactions

  • Antacids: May decrease aspirin absorption (for non-EC forms) or increase urinary excretion of salicylates.
  • Activated charcoal: Reduces aspirin absorption if given shortly after overdose.

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC)

Rationale: To assess baseline hemoglobin and platelet count, especially before long-term or high-dose therapy, due to bleeding risk.

Timing: Prior to initiation of chronic therapy.

Renal Function (BUN, Creatinine)

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

Timing: Prior to initiation of chronic therapy or in patients with pre-existing renal impairment.

Liver Function Tests (LFTs)

Rationale: To assess baseline hepatic function, especially in patients with pre-existing liver disease.

Timing: Prior to initiation of chronic therapy or in patients with pre-existing hepatic impairment.

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Routine Monitoring

Signs of Bleeding (e.g., melena, hematemesis, petechiae, bruising)

Frequency: Regularly, especially during initial therapy and with dose changes.

Target: Absence of bleeding.

Action Threshold: Any signs of significant bleeding warrant immediate medical evaluation and potential discontinuation.

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

Frequency: Regularly.

Target: Absence or minimal symptoms.

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

Renal Function (BUN, Creatinine)

Frequency: Periodically for chronic high-dose therapy or in patients with risk factors for renal impairment.

Target: Within normal limits or stable baseline.

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

Salicylate Levels (if toxicity suspected)

Frequency: As needed, if signs of salicylism (e.g., tinnitus, hyperventilation, confusion) occur.

Target: Therapeutic range for anti-inflammatory effect: 150-300 mcg/mL. Toxic levels: >300 mcg/mL.

Action Threshold: Levels >300 mcg/mL indicate toxicity and require immediate intervention.

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Symptom Monitoring

  • Unusual bleeding or bruising
  • Black, tarry stools or blood in vomit (signs of GI bleeding)
  • Severe stomach pain or heartburn
  • Ringing in the ears (tinnitus)
  • Hearing loss
  • Dizziness or confusion
  • Rapid breathing
  • Nausea or vomiting
  • Rash or hives
  • Swelling of the face, lips, tongue, or throat (signs of allergic reaction)

Special Patient Groups

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Pregnancy

Generally avoided, especially in the third trimester. Category C in 1st and 2nd trimesters (animal studies show adverse effects, no adequate human studies). Category D in 3rd trimester (positive evidence of human fetal risk). May cause premature closure of the ductus arteriosus, fetal renal dysfunction, and increased maternal/fetal bleeding.

Trimester-Specific Risks:

First Trimester: Category C. Potential for increased risk of miscarriage and congenital malformations (e.g., gastroschisis, cardiovascular defects) with high doses, though data are conflicting for low doses.
Second Trimester: Category C. Risk of fetal renal dysfunction and oligohydramnios, especially with prolonged use.
Third Trimester: Category D. Risk of premature closure of the fetal ductus arteriosus, persistent pulmonary hypertension of the newborn, fetal renal dysfunction, oligohydramnios, and increased maternal/fetal bleeding.
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Lactation

Aspirin and its metabolite, salicylic acid, are excreted into breast milk. Low doses (e.g., 81 mg daily) are generally considered compatible with breastfeeding, but higher doses or chronic use should be avoided due to potential for adverse effects in the infant (e.g., metabolic acidosis, bleeding, Reye's Syndrome risk). Monitor infant for unusual bruising or bleeding.

Infant Risk: L3 (Moderately Safe - use with caution, monitor infant for adverse effects, especially with higher doses).
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Pediatric Use

Contraindicated in children and adolescents (under 16-18 years old, depending on guidelines) with viral infections (e.g., influenza, chickenpox) due to the risk of Reye's Syndrome, a rare but severe and potentially fatal condition affecting the brain and liver. Use in children for specific conditions (e.g., Kawasaki disease, rheumatic fever) should only be under strict medical supervision.

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Geriatric Use

Increased risk of adverse effects, particularly gastrointestinal bleeding and renal impairment, due to age-related physiological changes (e.g., decreased renal function, increased comorbidity, polypharmacy). Use lowest effective dose and monitor closely.

Clinical Information

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Clinical Pearls

  • Enteric-coated aspirin is designed to reduce GI irritation but has a delayed onset of action compared to plain aspirin. It should not be used for acute pain relief where rapid onset is needed (e.g., acute myocardial infarction).
  • Patients should be advised to swallow enteric-coated tablets whole and not to crush, chew, or break them, as this would destroy the enteric coating and increase GI irritation.
  • The antiplatelet effect of aspirin is irreversible and lasts for the lifetime of the platelet (7-10 days). Therefore, aspirin should typically be discontinued 5-7 days prior to elective surgery to minimize bleeding risk.
  • Educate patients on the signs of bleeding (e.g., black, tarry stools; coffee-ground vomit; unusual bruising) and to seek immediate medical attention if they occur.
  • Aspirin should be avoided in children and adolescents with suspected viral infections due to the risk of Reye's Syndrome.
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Alternative Therapies

  • Other NSAIDs (e.g., Ibuprofen, Naproxen) for pain/inflammation (note: may interact with aspirin's antiplatelet effect).
  • Acetaminophen (Tylenol) for pain/fever (no anti-inflammatory or antiplatelet effects).
  • Other antiplatelet agents (e.g., Clopidogrel, Ticagrelor) for cardiovascular prevention (different mechanisms).
  • Proton pump inhibitors (PPIs) or H2 blockers may be co-prescribed with aspirin in high-risk patients to reduce GI bleeding risk.
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Cost & Coverage

Average Cost: $5 - $20 per 30 tablets (generic)
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.