Ezacard 75 (Low-Dose Aspirin): Uses, Secondary Prevention, Dosage & Safety

EZACARD 75

1- Disclaimer:

This commentary is provided for general educational and informational purposes only and is not intended as a substitute for professional medical advice, diagnosis, or treatment. Aspirin (acetylsalicylic acid) is a potent antiplatelet and NSAID drug that can cause serious bleeding, gastrointestinal, renal, and hypersensitivity reactions; the decision to start, continue, adjust, or stop it must be made by a qualified physician who has assessed the individual patient's cardiovascular risk, bleeding risk, comorbidities, and concomitant medications.

We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. Readers are responsible for independently verifying the information before relying on it.

2- Summary:

Ezacard 75 is an enteric-coated, low-dose acetylsalicylic acid (aspirin) tablet manufactured in Egypt by Apex Pharma (Multi-Apex for Pharmaceutical Industries – S.A.E., Badr City). It is a cornerstone antiplatelet agent used mainly for the secondary prevention of atherothrombotic cardiovascular and cerebrovascular events (myocardial infarction, ischemic stroke, TIA, unstable and chronic stable angina) and after revascularization procedures (CABG, PCI, carotid endarterectomy). It works by irreversibly acetylating platelet cyclo-oxygenase-1 (COX-1), thereby blocking thromboxane A₂ synthesis for the whole 7–10-day lifespan of the platelet. Current international guidance (ACC/AHA 2019; USPSTF 2022; ESC 2024) has narrowed the role of low-dose aspirin in primary prevention because the bleeding risk often outweighs the vascular benefit, especially in patients ≥60 years old.

3- Brand Name:

Ezacard® 75.
Other locally marketed strength from the same manufacturer: Ezacard® 100 mg enteric-coated tablets.

4- Category:

• Pharmacological class: Non-steroidal anti-inflammatory drug (NSAID) — salicylate subclass.
• Therapeutic class: Antiplatelet agent (irreversible COX-1 inhibitor) used at low, cardioprotective doses.
• ATC code: B01AC06 (platelet aggregation inhibitor, low-dose aspirin).

5- Active Ingredient:

Acetylsalicylic acid (Aspirin) 75 mg per enteric-coated tablet.

6- Pharmaceutical Form & Strength:

• Form: Enteric-coated oral tablet designed to bypass gastric dissolution and release the drug in the proximal small intestine.
• Strength: 75 mg per tablet.
• Locally available strengths of the same brand: 75 mg and 100 mg enteric-coated tablets.

7- Manufacturer & Marketing Authorization Holder:

Manufactured by Apex Pharma – S.A.E. (Multi-Apex for Pharmaceutical Industries), Badr City, Egypt. The product is registered with and regulated by the Egyptian Drug Authority (EDA).

8- Mechanism of Action:

Aspirin selectively and irreversibly acetylates the serine-529 residue in the active site of platelet cyclo-oxygenase-1 (COX-1). This permanently blocks the conversion of arachidonic acid into prostaglandin H₂, and hence the synthesis of thromboxane A₂ (TXA₂) — a potent platelet aggregator and vasoconstrictor. Because mature platelets are anucleate and cannot re-synthesize the enzyme, a single low daily dose produces cumulative, near-complete (>95%) suppression of platelet TXA₂ for the platelet's lifespan (~7–10 days). Low doses (75–100 mg once daily) largely spare vascular endothelial COX-2 and prostacyclin (PGI₂), preserving the antithrombotic balance of the vessel wall.

9- Spectrum of Activity:

Not applicable in the antimicrobial sense. Ezacard's "spectrum" is its antiplatelet-antithrombotic effect on the arterial side of the circulation, where thrombi are platelet-rich (coronary, cerebral, and peripheral arteries). It has minimal effect on venous thrombosis, where fibrin-rich clots are better controlled by anticoagulants. At antiplatelet doses it does not exert clinically meaningful analgesic, antipyretic, or anti-inflammatory activity.

10- Pharmacokinetics:

• Absorption: Aspirin is a weak acid, rapidly absorbed from the stomach and upper small intestine. Enteric coating delays absorption; peak antiplatelet effect with enteric-coated formulations is typically reached in 4–5 hours vs 30–40 minutes with plain aspirin. Oral bioavailability of acetylsalicylic acid is ~50% due to pre-systemic hydrolysis.
• Distribution: Widely distributed; highly bound to plasma albumin (salicylate metabolite).
• Metabolism: Rapidly hydrolyzed by esterases in the gut wall, liver, and blood to salicylic acid, which is then conjugated (glycine → salicyluric acid; glucuronidation) and partly hydroxylated in the liver.
• Half-life: Acetylsalicylic acid 15–20 minutes; salicylate 2–3 hours at low doses (dose-dependent, prolonged at toxic doses).
• Excretion: Renal; excretion of salicylate is increased in alkaline urine.
• Note: Recent evidence suggests that enteric-coated low-dose aspirin may result in inadequate platelet inhibition in patients with body weight >120 kg or BMI >35 kg/m²; plain (uncoated) formulations may be preferred in such patients.

11- Indications:

Approved / evidence-based uses at low antiplatelet doses:

• Vascular indications — ischemic stroke, transient ischemic attack (TIA), acute myocardial infarction (MI), secondary prevention of recurrent MI, unstable angina, and chronic stable angina.
• Reduction of the combined risk of death and non-fatal stroke in patients with prior ischemic stroke or TIA due to fibrin-platelet emboli.
• Reduction of vascular mortality in chronic stable angina.
• Following revascularization procedures — coronary artery bypass graft (CABG), percutaneous coronary intervention/angioplasty (PCI/PTCA), and carotid endarterectomy — when there is a pre-existing indication for aspirin.
• Primary prevention of cardiovascular disease: No longer routinely recommended. Current USPSTF (2022) and ESC (2024) guidance restrict it to selected patients aged 40–59 years with a 10-year ASCVD risk ≥10% and low bleeding risk, after individualized discussion; it is not recommended to initiate in adults ≥60 years.

12- Administration:

• Route: Oral.
• The tablet must be swallowed whole with water; never crushed, chewed, or split, as this destroys the enteric coating and increases gastric irritation.
• Preferably taken with or after food to further reduce gastric complaints (although the enteric coating already limits gastric exposure).
• Standard dosing:
  • Secondary prevention of thrombotic cerebrovascular or cardiovascular disease: 75–300 mg once daily (75–100 mg once daily is the most widely used regimen).
  • Angina: 75–150 mg once daily.
  • Acute MI / suspected ACS (loading dose, on physician's order): 150–300 mg of a plain, chewable, non-enteric-coated aspirin, followed by a low daily maintenance dose. Ezacard's enteric-coated form is not suitable for the acute loading dose because of delayed absorption.

13- Method of Preparation:

No preparation, reconstitution, or dilution is required. Ezacard 75 is a ready-to-use, film-coated, enteric-coated solid oral tablet supplied in blister strips. It must be kept in its original packaging until use to protect the enteric coating from moisture.

14- Contraindications:

• Hypersensitivity to acetylsalicylic acid, salicylates, or any NSAID (including aspirin-induced asthma / NSAID-exacerbated respiratory disease).
• Active peptic ulceration or history of recurrent GI ulceration/bleeding.
• Haemophilia and other bleeding or clotting disorders (e.g., thrombocytopenia, severe coagulopathy).
• Children and adolescents under 16 years of age with febrile viral illness — risk of Reye's syndrome (many international references now use <16 cut-off="" li="" older="" rather="" than="" the="">
• Severe hepatic impairment.
• Severe renal impairment (creatinine clearance <30 li="" min="" ml="">
• Severe uncontrolled heart failure.
• Third trimester of pregnancy.
• Breastfeeding (see Section 18).
• Concomitant use with methotrexate at doses ≥15 mg/week.

15- Warnings & Precautions:

• Gastrointestinal risk: NSAIDs, including aspirin, increase the risk of serious GI adverse events — inflammation, bleeding, ulceration, and perforation of the stomach or intestines — which can be fatal and may occur at any time without warning symptoms. Elderly patients and those on concomitant antiplatelets, anticoagulants, corticosteroids, or SSRIs are at greatest risk. Consider co-prescribing a proton-pump inhibitor in high-risk patients.
• Bleeding risk: Increased risk of intracranial and other major haemorrhage, especially with uncontrolled hypertension, advanced age, low body weight, or combined antithrombotic therapy.
• Asthma: Use with caution; may precipitate bronchospasm in aspirin-sensitive asthmatics.
• Uncontrolled hypertension: Control blood pressure before starting long-term aspirin.
• Hepatic / renal impairment: Use with caution; avoid in severe impairment.
• Elective surgery: Continuation vs interruption should be individualized based on cardiovascular vs bleeding risk.
• G6PD deficiency: Rarely, aspirin may precipitate haemolysis at high doses.
• Perform periodic monitoring of blood pressure, renal function, haemoglobin, and signs of occult GI bleeding in long-term users.

16- Drug Interactions:

• Anticoagulants (warfarin, DOACs, heparins): Additive bleeding risk.
• Other antiplatelets (clopidogrel, prasugrel, ticagrelor): Increased bleeding risk (used together only when a dual antiplatelet regimen is clinically indicated).
• Other NSAIDs: Avoid concomitant use — additive GI toxicity; ibuprofen in particular may block aspirin's access to platelet COX-1 (via arginine-120 docking site) and attenuate its cardioprotective effect. If both are needed, ibuprofen should be taken at least 30 minutes after or 8 hours before aspirin.
• Corticosteroids: Increased risk of GI bleeding/ulceration; corticosteroids may reduce plasma salicylate concentration.
• SSRIs/SNRIs: Additive bleeding risk.
• Antacids and adsorbents: Alkaline urine increases salicylate excretion; kaolin reduces absorption.
• Phenytoin and valproate: Effect enhanced (displacement from albumin).
• Methotrexate: Reduced renal excretion — increased toxicity (contraindicated with high-dose methotrexate).
• Spironolactone: Aspirin may antagonize the diuretic effect.
• Acetazolamide: Reduced excretion — risk of salicylate toxicity.
• Zafirlukast: Aspirin increases its plasma concentration.
• Metoclopramide: Increased rate of aspirin absorption.
• Mifepristone: Avoid aspirin for 8–12 days after mifepristone.
• Probenecid and sulfinpyrazone: Uricosuric effect antagonized.
• ACE inhibitors / ARBs: May blunt antihypertensive effect and, in dehydrated or elderly patients, increase risk of acute kidney injury (the "triple whammy" when combined with a diuretic).
• Alcohol: Increased risk of GI bleeding.

17- Side Effects:

Because Ezacard is enteric-coated, direct gastric irritation is reduced but not eliminated. Reported adverse effects include:

• Common: Dyspepsia, nausea, epigastric discomfort, mild bruising.
• Uncommon / rare but serious: Gastrointestinal haemorrhage (occasionally major), peptic ulceration and perforation, subconjunctival and other mucocutaneous bleeding, epistaxis, intracranial haemorrhage, bronchospasm, urticaria, angioedema, and anaphylactoid reactions in hypersensitive individuals.
• Long-term / high-dose: Iron-deficiency anaemia from occult blood loss, tinnitus, hearing loss, renal impairment, salicylate toxicity in overdose (metabolic acidosis, hyperventilation, hyperthermia, CNS disturbance).

18- Use in Special Populations:

• Pregnancy: Low-dose aspirin (75–150 mg) is used during pregnancy in selected obstetric indications (e.g., prevention of pre-eclampsia in high-risk women, typically from ~12 weeks). However, aspirin should generally be avoided during the third trimester (last 3 months): risks include premature closure of the fetal ductus arteriosus, persistent pulmonary hypertension of the newborn, impaired platelet function with maternal and neonatal bleeding, delayed onset and prolonged labour, and kernicterus in jaundiced neonates. Use only under specialist supervision.
• Breastfeeding: Small amounts pass into breast milk; regular use is generally not recommended because of theoretical Reye's syndrome and bleeding risk in the infant.
• Pediatrics: Contraindicated in children and adolescents under 16 years with febrile viral illness due to the risk of Reye's syndrome. Use in children only under specialist care (e.g., Kawasaki disease, certain cardiac conditions).
• Elderly (>65 years): Higher risk of GI and intracranial bleeding; use the lowest effective dose and consider gastroprotection.
• Renal impairment: Avoid in severe impairment (CrCl <30 li="" min="" ml="">
• Hepatic impairment: Avoid in severe hepatic disease.
• Obesity (body weight >120 kg or BMI >35 kg/m²): Enteric-coated low-dose aspirin may provide suboptimal platelet inhibition; a plain aspirin formulation or an alternative regimen may be preferred.

19- Storage Conditions:

Store in a cool, dry place at a temperature not exceeding 30 °C. Keep in the original blister to protect the enteric coating from moisture and light. Keep out of the reach and sight of children. Do not use after the expiry date printed on the pack.

20- Additional Sections:

• Packaging (Egyptian market): Box of 3 blister strips × 10 enteric-coated tablets (30 tablets per pack).
• Missed dose: If a dose is missed, take it as soon as remembered on the same day; if it is almost time for the next dose, skip the missed one — do not double up.
• Overdose: Symptoms include tinnitus, deafness, hyperventilation, sweating, vomiting, dehydration, and mixed respiratory alkalosis / metabolic acidosis. Serious overdose is a medical emergency requiring hospital care (activated charcoal if recent, urinary alkalinization, IV fluids, correction of electrolyte/glucose disturbances, and haemodialysis in severe cases).
• Peri-operative use: In secondary prevention, aspirin is often continued around low- to moderate-bleeding-risk surgery; decisions on interruption must be individualized.
• Aspirin and cancer prevention: Emerging evidence supports a chemopreventive effect of long-term low-dose aspirin against colorectal (and other digestive tract) adenocarcinomas; this remains an off-label use and is not a licensed indication.

21- Frequently Asked Questions (FAQ):

Q1. Can I break, crush, or chew Ezacard 75?
No. The tablet must be swallowed whole. Crushing or chewing destroys the enteric coating, releases the drug in the stomach, and increases gastric irritation. In a suspected heart attack, chewing is only appropriate for plain, non-enteric-coated aspirin under medical instruction.

Q2. Should Ezacard be taken in the morning or at night?
Either time is acceptable as long as it is taken consistently once daily. Some studies suggest a slight cardiovascular benefit with bedtime dosing, but the evidence is not conclusive.

Q3. Can I take Ezacard for headache or fever?
No. At 75 mg the dose is too low for meaningful analgesic or antipyretic effect and is intended for antiplatelet cardiovascular protection.

Q4. What should I do if I forget a dose?
Take it as soon as remembered on the same day. If it is nearly time for the next dose, skip the missed one — never double the dose.

Q5. Can I stop Ezacard suddenly?
Do not stop long-term aspirin without medical advice. Abrupt discontinuation in patients with established cardiovascular disease has been associated with a rebound increase in thrombotic events.

Q6. Is Ezacard safe in pregnancy?
Low-dose aspirin is prescribed in specific obstetric indications (e.g., prevention of pre-eclampsia) but only under specialist supervision, and it should be avoided during the last trimester unless clearly indicated.

Q7. Can I combine Ezacard with ibuprofen or other painkillers?
Avoid regular use of ibuprofen, as it can block aspirin's cardioprotective effect and add to GI risk. Paracetamol is generally the preferred analgesic/antipyretic in patients on low-dose aspirin.

Q8. What are the warning signs I should watch for?
Seek medical attention for black or tarry stools, vomiting of blood or coffee-ground material, unexplained bruising, prolonged nosebleeds, severe abdominal pain, ringing in the ears, wheezing, or signs of an allergic reaction (rash, swelling of the face/lips, difficulty breathing).

Q9. Does Ezacard interact with food or alcohol?
Food does not significantly reduce efficacy but may improve tolerability. Alcohol increases the risk of gastrointestinal bleeding and should be minimized.

Q10. What is the difference between Ezacard 75 and Ezacard 100?
Both are enteric-coated low-dose aspirin products from the same manufacturer; the only difference is the amount of acetylsalicylic acid per tablet (75 mg vs 100 mg). The choice depends on the physician's prescription and local practice.

22- References:

1. Manufacturer's approved leaflet – Ezacard 75 mg, Apex Pharma / Multi-Apex for Pharmaceutical Industries – S.A.E., Badr City, Egypt.
2. Egyptian Drug Authority (EDA) – product registration database.
3. Patrono C. Low-dose aspirin for the prevention of atherosclerotic cardiovascular disease. European Heart Journal 2024; 45(27): 2362–2376.
4. Arnett DK, Blumenthal RS, Albert MA, et al. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease. Circulation 2019; 140: e596–e646.
5. US Preventive Services Task Force. Aspirin Use to Prevent Cardiovascular Disease: USPSTF Recommendation Statement. JAMA 2022; 327(16): 1577–1584.
6. European Society of Cardiology (ESC) Guidelines on the management of chronic coronary syndromes, 2024.
7. British National Formulary (BNF), current edition – Aspirin monograph.
8. Martindale: The Complete Drug Reference – Acetylsalicylic Acid monograph.
9. WHO Model List of Essential Medicines – Acetylsalicylic acid.
10. Awtry EH, Loscalzo J. Aspirin. Circulation 2000; 101: 1206–1218 (foundational pharmacology reference).