PLAVIX 75/MG FC TAB 28/FC TAB

Indications

Approved Uses

Acute coronary syndrome (NSTEMI, STEMI), recent myocardial infarction, recent ischemic stroke, established peripheral arterial disease, prevention of atherothrombotic events

Dosage & Administration

Dosing by Condition

ACS (UA/NSTEMI): loading dose 300-600 mg once, then 75 mg once daily with aspirin; STEMI: if PCI planned, 600 mg load then 75 mg daily; if fibrinolysis/medical therapy, 300 mg load if age ≤75 years then 75 mg daily, and if age >75 years start 75 mg daily without a loading dose; Secondary prevention (recent MI, recent ischemic stroke, or PAD): 75 mg once daily; PCI (elective/ACS): typically 600 mg loading dose then 75 mg daily as part of DAPT per stent/ACS strategy.

Initial Dose

75 mg once daily (maintenance); 300-600 mg loading dose for ACS/PCI

Maintenance Dose

75 mg once daily

Maximum Dose

Maintenance: 75 mg orally once daily; Loading (when indicated, e.g., ACS/PCI): 300-600 mg once (commonly 600 mg for PCI/ACS strategies).

How to Take

Swallow the film-coated tablet whole with water; may be taken with or without food; take once daily at the same time each day.

Side Effects

Common Side Effects

Bleeding/bruising (including epistaxis and GI bleeding), diarrhea, abdominal pain/dyspepsia, nausea, rash/pruritus; headache and dizziness can also occur.

Safety & Warnings

Contraindications

Hypersensitivity to clopidogrel or any component of the product.

Warnings & Precautions

Warnings/precautions: bleeding risk (including perioperative-stop ~5 days before elective surgery if advised), reduced effectiveness in CYP2C19 poor metabolizers and with CYP2C19 inhibitors (avoid omeprazole/esomeprazole), monitor for TTP, and hypersensitivity/cross-reactivity with other thienopyridines.

Age Restriction

Not established/Not recommended for routine use in patients <18 years (pediatric safety and efficacy not established).

Drug Interactions

Interaction Severity

MAJOR/AVOID: strong CYP2C19 inhibitors (especially omeprazole, esomeprazole) can reduce activation/antiplatelet effect; MAJOR: concomitant anticoagulants/other antiplatelets/NSAIDs increase bleeding risk; MODERATE: SSRIs/SNRIs increase bleeding risk; MODERATE: repaglinide exposure may increase (CYP2C8 inhibition) requiring monitoring/adjustment; Pantoprazole is generally preferred if a PPI is needed.

Food Interaction

No clinically significant food restriction; may be taken with or without food.

Special Populations

Elderly

Standard adult dosing. For STEMI patients over 75 years, a loading dose is not recommended.

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly without medical supervision; premature discontinuation increases risk of MI/stroke and (if post-stent) stent thrombosis-stop ~5 days before elective surgery if directed.

Monitoring Requirements

Monitor clinically for bleeding/bruising and signs of GI or intracranial bleeding; obtain CBC/hemoglobin/platelets if bleeding is suspected or if symptoms suggest hematologic toxicity (e.g., TTP); CYP2C19 genotype or platelet function testing may be considered in selected high-risk situations where results would change therapy.

Pharmacology

Mechanism of Action

Prodrug converted to an active metabolite that irreversibly inhibits the platelet P2Y12 (ADP) receptor, preventing ADP-mediated activation of GPIIb/IIIa and thereby reducing platelet aggregation for the platelet lifespan.

Onset of Action

With a loading dose (300-600 mg), meaningful platelet inhibition begins within ~2 hours; without a loading dose (75 mg daily), maximal/steady-state inhibition is reached in about 3-7 days.

Duration of Effect

Antiplatelet effect is irreversible for exposed platelets; platelet function typically recovers as new platelets are produced, usually about 5 days after stopping (may take up to ~7-10 days for full turnover).

Half-Life

Approximately 6 hours for the parent drug; 30 minutes for the active metabolite.

Bioavailability

Approximately 50% absorbed after oral administration; clopidogrel is a prodrug with limited systemic availability of the active thiol metabolite due to extensive first-pass hydrolysis (most converted to an inactive carboxylic acid metabolite).

Metabolism

Extensive hepatic metabolism: prodrug activation via a two-step CYP450 oxidation (primarily CYP2C19; also CYP3A4, CYP1A2, CYP2B6) to an active thiol metabolite; ~85% is hydrolyzed by esterases to an inactive carboxylic acid derivative.

Protein Binding

Clopidogrel ~98% protein bound; inactive carboxylic acid metabolite ~94% protein bound.

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: 75 mg clopidogrel as clopidogrel bisulfate (equivalent to 97.875 mg clopidogrel bisulfate)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Cv Drug Class

Antiplatelet

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