AZERA 100/MG EC TAB 90/TAB

Indications

Approved Uses

Antiplatelet therapy for secondary prevention of atherothrombotic events (e.g., myocardial infarction, ischemic stroke/TIA) and related cardiovascular risk reduction where low‑dose aspirin is indicated; not intended for analgesia/fever at this 100 mg EC strength.

Dosage & Administration

Dosing by Condition

Antiplatelet/secondary prevention: 75-100 mg once daily (this product: 100 mg once daily). Acute MI/ACS or acute ischemic stroke/TIA: a loading dose of immediate‑release aspirin 150-300 mg (chewed) may be used, then 75-100 mg daily; the enteric‑coated tablet is not preferred for loading. Analgesia/fever requires higher doses (e.g., 300-1000 mg per dose) and is not appropriate with this 100 mg EC product.

Initial Dose

75-100mg once daily for cardiovascular protection.

Maintenance Dose

75-100mg once daily for cardiovascular protection.

Maximum Dose

4g/day for analgesic/antipyretic use; 100-325mg/day is typical for cardiovascular protection.

Children's Dosage

Contraindicated in children and adolescents with viral infections due to the risk of Reye's syndrome.

Dose Adjustment Notes

No routine dose adjustment for low‑dose antiplatelet therapy, but use caution in renal or hepatic impairment and avoid in severe renal failure or severe hepatic disease; use the lowest effective dose and monitor closely in older adults/high bleeding risk.

How to Take

Swallow the 100 mg enteric‑coated tablet whole with a full glass of water; do not crush, chew, or split. May be taken with food if gastric upset occurs.

Side Effects

Common Side Effects

Dyspepsia/heartburn, nausea, abdominal discomfort; increased bleeding tendency (e.g., easy bruising, epistaxis) and GI bleeding risk.

Safety & Warnings

Contraindications

Hypersensitivity to acetylsalicylic acid/salicylates or other NSAIDs (including aspirin-induced asthma/AERD); active peptic ulcer or active GI bleeding; hemorrhagic diathesis/bleeding disorders; severe hepatic impairment; severe renal impairment; third trimester of pregnancy; concomitant methotrexate at high doses (commonly >15 mg/week).

Warnings & Precautions

GI bleeding/ulcer risk (consider PPI in high-risk patients); avoid/use extreme caution in AERD/asthma with NSAID sensitivity; increased bleeding risk (monitor, avoid excess alcohol, caution with concomitant anticoagulants/antiplatelets); perioperative management-do not stop for procedures without clinician direction (often held ~5-7 days before elective high-bleeding-risk surgery if clinically appropriate); caution in renal/hepatic impairment; enteric coating reduces dyspepsia but does not eliminate serious GI bleeding risk; avoid in 3rd trimester and avoid in <16 with viral illness/fever.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Major interactions: anticoagulants/antiplatelets/thrombolytics (↑ bleeding); other NSAIDs (↑ GI bleeding and ibuprofen can reduce aspirin antiplatelet effect if taken concomitantly); methotrexate (↑ toxicity, especially at higher doses); SSRIs/SNRIs and systemic corticosteroids (↑ GI bleeding); ACE inhibitors/ARBs and diuretics (possible ↓ antihypertensive/renal effects, more relevant at higher aspirin doses or in at-risk patients); uricosurics such as probenecid (↓ uricosuric effect).

Interaction Severity

MAJOR: anticoagulants/other antithrombotics (e.g., warfarin, DOACs, heparins, clopidogrel) due to bleeding; methotrexate (especially higher doses, e.g., >15 mg/week) due to reduced clearance/toxicity. MODERATE: other NSAIDs (e.g., ibuprofen/naproxen) increasing GI bleeding and potentially reducing aspirin antiplatelet effect if timed improperly; SSRIs/SNRIs and systemic corticosteroids increasing GI bleeding; ACEi/ARBs/diuretics-renal function and BP effects are more relevant at higher NSAID doses but caution is reasonable. MINOR/variable: antacids may affect absorption; valproate may increase bleeding risk/protein-binding effects.

Food Interaction

May take with food or milk to reduce GI upset; food can delay absorption/onset, so in acute settings immediate‑release (not EC) aspirin is preferred.

Alcohol Interaction

Avoid

Special Populations

Children

Contraindicated in children and adolescents with viral infections due to the risk of Reye's syndrome.

Elderly

Use standard antiplatelet dose (75-100mg once daily); increased risk of GI bleeding - consider co-prescribing a proton pump inhibitor; monitor renal function

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered the same day; if it is close to the next scheduled dose, skip the missed dose and resume the regular schedule-do not double doses.

Stopping the Medicine

Do not stop abruptly when used for cardiovascular protection (secondary prevention, post-stent, recent ACS) without clinician advice; otherwise discontinuation is generally safe but should consider bleeding vs thrombosis risk.

Patient Counseling

Swallow enteric-coated tablet whole (do not crush/chew); take once daily at the same time with water (with food if GI upset); do not stop without clinician advice if used for secondary prevention; watch for bleeding (black/tarry stools, vomiting blood, unusual bruising/prolonged bleeding) and seek care; avoid/limit alcohol; tell doctors/dentists before procedures; avoid routine use of other NSAIDs (especially ibuprofen) unless advised; avoid in children/adolescents with viral illness (Reye’s risk) and in aspirin allergy/asthma sensitive to NSAIDs.

Monitoring Requirements

No routine laboratory monitoring is required for low‑dose aspirin, but monitor clinically for bleeding (e.g., melena, hematemesis, easy bruising) and anemia symptoms; consider periodic CBC/renal function in higher‑risk patients (elderly, prior GI bleed, concomitant anticoagulants/NSAIDs, renal impairment).

Pharmacology

Mechanism of Action

Irreversibly inhibits COX‑1 (and to a lesser extent COX‑2), decreasing thromboxane A2 synthesis in platelets and thereby inhibiting platelet aggregation for the platelet lifespan; at low doses (75-100 mg) the antiplatelet effect predominates.

Onset of Action

Antiplatelet effect begins within ~1 hour (often 30-60 minutes); platelet inhibition is irreversible and persists for the platelet lifespan (~7-10 days).

Duration of Effect

Irreversible platelet inhibition persists for the lifespan of affected platelets, about 7-10 days after discontinuation.

Half-Life

Aspirin: 15-20 minutes; active metabolite salicylate: 2-3 hours at low doses, up to 15-30 hours at high doses

Bioavailability

Aspirin has variable systemic bioavailability due to presystemic hydrolysis/first-pass; typical estimates are ~40-50% for aspirin (with salicylate exposure higher), and enteric-coated formulations can delay and reduce/variabilize absorption (rate and sometimes extent).

Metabolism

Rapid hydrolysis to salicylic acid in the gut wall, blood/plasma, and liver; salicylate is then hepatically metabolized mainly by glycine conjugation (salicyluric acid) and glucuronidation (phenolic/acyl glucuronides).

Excretion

Primarily renal excretion as salicylate metabolites (and some free salicylate); urinary excretion is pH-dependent and increases with alkaline urine.

Product Information

Available Dosage Forms

For this SFDA-registered product: enteric‑coated tablet (oral).

Composition per Dose

Each enteric-coated tablet: 100mg acetylsalicylic acid

Generic Availability

Yes

OTC Alternatives

OTC alternatives with the same antiplatelet indication: other low-dose acetylsalicylic acid products (e.g., 75-100 mg, preferably enteric-coated). Paracetamol/ibuprofen are OTC analgesic alternatives but are NOT therapeutic alternatives for antiplatelet/cardiovascular protection.

Cv Drug Class

Antiplatelet

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