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Clopidogrel Uses, Dosage, Side Effects & Warnings | DrugsAtlas

Authoritative Clinical Reference

Therapeutic Class

Antiplatelet agent

Subclass

P2Y12 ADP receptor inhibitor (Thienopyridine)

Speciality

Cardiology

Schedule (India)

Schedule H

Routes

Oral

Formulations

Formulations Available in India:

Tablets: 75 mg, 150 mg, 300 mg
Fixed-dose combinations (FDCs): Clopidogrel 75 mg + Aspirin 75 mg; Clopidogrel 75 mg + Aspirin 150 mg

Adult indications

NDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Acute Coronary Syndrome (ACS) — NSTEMI / Unstable Angina

Parameter	Recommendation
Starting dose (Loading)	300 mg orally as single dose
Titration	Not applicable
Usual maintenance dose	75 mg once daily
Maximum dose	75 mg once daily

Clinical Notes:

Administer with aspirin (75–100 mg/day) unless contraindicated
Duration: Minimum 12 months (DAPT — dual antiplatelet therapy)
Continue aspirin indefinitely; clopidogrel may be stopped after 12 months in stable patients
Consider higher loading dose (600 mg) if planned for early invasive strategy/PCI

2. ST-Elevation Myocardial Infarction (STEMI) — Treated with Thrombolytics

Parameter	Age <75 years	Age ≥75 years
Starting dose (Loading)	300 mg orally	No loading dose (omit)
Titration	Not applicable	Not applicable
Usual maintenance dose	75 mg once daily	75 mg once daily
Maximum dose	75 mg once daily	75 mg once daily

Clinical Notes:

Administer with aspirin (loading 325 mg, then 75–100 mg daily)
Duration: Minimum 14 days; up to 12 months recommended
Based on CLARITY-TIMI 28 and Indian STEMI guidelines
Loading dose omitted in elderly (≥75 years) due to increased bleeding risk per Indian cardiology practice

3. Percutaneous Coronary Intervention (PCI) with Stent Placement

Parameter	Elective PCI	Primary PCI (STEMI)
Starting dose (Loading)	300–600 mg orally	600 mg orally (preferred)
Titration	Not applicable	Not applicable
Usual maintenance dose	75 mg once daily	75 mg once daily
Maximum dose	75 mg once daily	75 mg once daily

Duration of DAPT (with Aspirin):

Stent Type	Minimum Duration	Recommended Duration
Bare-metal stent (BMS)	1 month	1–3 months
Drug-eluting stent (DES)	6 months	6–12 months
High bleeding risk patients	May shorten to 1–3 months	Specialist decision
High ischaemic risk patients	May extend beyond 12 months	Specialist decision

Clinical Notes:

600 mg loading achieves faster platelet inhibition than 300 mg
Co-administer with aspirin (75–100 mg daily)
Pre-treatment with clopidogrel preferred if PCI planned within 24–48 hours

4. Secondary Prevention of Atherothrombotic Events (Post-MI, Ischaemic Stroke, PAD)

Parameter	Recommendation
Starting dose	75 mg once daily (no loading dose required)
Titration	Not applicable
Usual maintenance dose	75 mg once daily
Maximum dose	75 mg once daily

Clinical Notes:

May be used as monotherapy or with aspirin in selected high-risk cases
Duration: Long-term (often indefinite) based on cardiovascular risk
Alternative to aspirin in patients with aspirin intolerance
In PAD: reduces risk of MI, stroke, and vascular death

Secondary Indications — Adults Only (Off-label)

Indication	Loading Dose	Maintenance Dose	Duration	Notes
Minor Ischaemic Stroke / High-risk TIA (DAPT) — OFF-LABEL	300 mg clopidogrel + aspirin 75–100 mg	75 mg clopidogrel + aspirin 75–100 mg daily	21–30 days, then switch to single antiplatelet	Specialist (Neurology) only. Initiate within 24 hours of symptom onset. Based on CHANCE and POINT trials. AIIMS Neurology protocol. Reduces recurrent stroke risk by ~25%.
Atrial Fibrillation (unable to take oral anticoagulants) — OFF-LABEL	Not applicable	75 mg daily with aspirin 75–100 mg	Long-term	Specialist only. Inferior to OAC but reduces stroke risk vs aspirin alone. Based on ACTIVE-A trial. Reserve for patients unsuitable for anticoagulation.
Coronary Artery Bypass Graft (CABG) — Post-operative — OFF-LABEL	Not applicable	75 mg once daily	12 months typically	Specialist only. Used in saphenous vein graft protection. Limited evidence; based on institutional practice.

Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

No approved routine indication in children in India.

Secondary Indications — Paediatric (Off-label)

Indication	Age/Weight	Dose	Duration	Notes
Paediatric Arterial Ischaemic Stroke — OFF-LABEL	>1 month; any weight	0.2–1 mg/kg/dose once daily (maximum 75 mg/day)	Variable; often long-term in selected cases	Paediatric neurologist or haematologist only. Based on limited observational data and IAP neurological protocols. Individualise based on stroke aetiology.
Kawasaki Disease with Giant Coronary Aneurysms — OFF-LABEL	>6 months	1 mg/kg/day (max 75 mg)	Long-term; often combined with aspirin	Paediatric cardiologist only. Added to aspirin in high-risk coronary involvement. Based on AHA guidelines adapted to Indian practice.
Systemic-to-Pulmonary Artery Shunts (e.g., BT shunt) — OFF-LABEL	Neonates onwards	0.2 mg/kg/day	Until shunt takedown	Paediatric cardiac surgery/cardiology only. Limited data; institutional protocols.

Dosing Structure (General Paediatric Off-label Use):

Parameter	Recommendation
Starting dose	0.2 mg/kg/day orally
Titration	Increase to 1 mg/kg/day based on indication and response
Usual maintenance dose	0.5–1 mg/kg/day
Maximum dose	75 mg/day

Age Restrictions:

Not recommended below 1 month of age except under specialist supervision in cardiac surgical cases
Tablets may need to be crushed/dispersed for administration in young children — confirm stability

Safety Monitoring in Children:

Monitor for bleeding manifestations (bruising, petechiae, gum bleeding, haematuria)
Periodic CBC if long-term use (baseline, 2 weeks, then every 3–6 months)
Assess for signs of TTP (thrombocytopenia, neurological symptoms, renal impairment)
Drug compliance — liquid formulations not readily available in India

Renal Adjustments

eGFR (mL/min/1.73m²)	Recommendation
>60	No dose adjustment required
30–60	No dose adjustment required
15–30	Use with caution; no specific dose reduction but increased bleeding risk
<15 / Dialysis	Limited data; use with caution. Not significantly removed by haemodialysis. Monitor for bleeding.

Note: Active metabolite exposure may be increased in severe renal impairment. No formal dose adjustment recommended, but enhanced bleeding surveillance is advised.

Hepatic adjustment

Contraindications

Active pathological bleeding (intracranial haemorrhage, active GI bleeding, haemorrhagic stroke)
Known hypersensitivity to clopidogrel or any formulation component
Severe hepatic impairment (Child-Pugh C)
History of thrombotic thrombocytopenic purpura (TTP) associated with clopidogrel or other thienopyridines (ticlopidine)

Cautions

Recent major surgery or trauma (within 7 days) — increased bleeding risk
History of gastrointestinal bleeding or peptic ulcer disease
Concurrent use of anticoagulants (warfarin, DOACs, heparin)
Concurrent NSAID use — increased GI bleeding risk
Patients with bleeding diathesis or thrombocytopenia
CYP2C19 poor metaboliser status — reduced drug efficacy (genetic polymorphism common in Indian population)
Planned elective surgery — discontinue 5–7 days prior
Elderly patients (increased bleeding risk)
Concurrent use of CYP2C19 inhibitors (e.g., omeprazole, esomeprazole)
Moderate hepatic impairment
Renal impairment (enhanced surveillance needed)

Pregnancy

Parameter	Information
Overall safety	Limited human data; animal studies show no teratogenicity
Risk assessment	Use only if potential benefit clearly outweighs risk
Preferred alternatives	Low-dose aspirin (75–150 mg) is preferred antiplatelet in pregnancy when indicated
When may be used	Compelling indications (e.g., recent coronary stent, mechanical heart valve with aspirin intolerance) — specialist decision only
Monitoring	Maternal bleeding risk; fetal growth; discontinue 7 days before expected delivery to reduce peripartum haemorrhage

Lactation

Parameter	Information
Compatibility	Likely compatible with breastfeeding; limited human data
Milk levels	Expected to be low (based on pharmacokinetic profile — highly protein-bound)
Preferred alternatives	Low-dose aspirin if antiplatelet therapy required
Infant monitoring	Observe for unusual bruising, bleeding, petechiae; monitor feeding and weight gain

Elderly

Parameter	Recommendation
Starting dose	75 mg once daily for maintenance
Loading dose	Use 300 mg with caution; avoid loading dose in patients ≥75 years with STEMI treated with thrombolytics
Titration	Not applicable
Special considerations	Higher bleeding risk; increased fall risk (bruising, haematoma); reduced renal reserve
Polypharmacy	Review concurrent medications for interactions (PPIs, anticoagulants, NSAIDs)
Monitoring	More frequent assessment for bleeding; periodic CBC and renal function

Major drug interactions

Drug/Class	Interaction	Mechanism	Management
Omeprazole, Esomeprazole	Reduced clopidogrel efficacy; increased cardiovascular events risk	CYP2C19 inhibition reduces conversion to active metabolite	Avoid combination. Use pantoprazole or rabeprazole (minimal CYP2C19 inhibition) instead.
Warfarin	Significantly increased bleeding risk	Additive anticoagulant/antiplatelet effects	Avoid unless strongly indicated (e.g., mechanical valve + recent ACS). Triple therapy should be time-limited. INR monitoring essential.
DOACs (rivaroxaban, apixaban, dabigatran)	Increased bleeding risk	Additive effects	Avoid routine combination. If required (AF + recent stent), use lowest DOAC dose and limit duration. Specialist supervision.
Rifampicin	May paradoxically increase active metabolite levels acutely but reduce overall efficacy with chronic use	CYP inducer affecting prodrug activation	Monitor for both increased bleeding (short-term) and reduced efficacy (long-term). Consider alternative antiplatelet if prolonged rifampicin course.
Strong CYP2C19 inhibitors (fluconazole, fluoxetine, fluvoxamine)	Reduced clopidogrel efficacy	Inhibit metabolic activation	Avoid if possible. Consider alternative antifungal/antidepressant or alternative antiplatelet (prasugrel, ticagrelor — not CYP2C19 dependent).

Moderate drug interactions

Drug/Class	Interaction	Management
Aspirin	Increased bleeding risk (especially GI)	Routine combination in ACS/post-PCI. Co-prescribe PPI (pantoprazole preferred) for gastroprotection.
NSAIDs (ibuprofen, diclofenac, naproxen)	Increased GI bleeding risk	Avoid if possible. If needed, use short-term with PPI cover.
SSRIs (sertraline, paroxetine, citalopram)	Additive bleeding risk	Monitor for bleeding. Consider gastroprotection. Paroxetine may also inhibit CYP2D6.
Atorvastatin	Theoretical CYP3A4 competition	Clinical impact minimal. No dose adjustment needed.
Diltiazem, Verapamil	Mild CYP3A4 inhibition	Usually no dose change required. Monitor clinical response.
Phenytoin, Carbamazepine, Phenobarbital	May reduce clopidogrel efficacy	CYP induction. Monitor for recurrent ischaemic events. Consider platelet function testing if available.
Morphine (in ACS setting)	Delayed clopidogrel absorption; reduced antiplatelet effect	Consider crushed tablets or alternative P2Y12 inhibitors (ticagrelor, cangrelor) in primary PCI if morphine required.

Common Adverse effects

Bleeding (minor) — bruising, epistaxis, gum bleeding
Dyspepsia, abdominal pain
Diarrhoea
Rash, pruritus
Headache

Serious Adverse effects

Effect	Notes
Major bleeding	GI haemorrhage, retroperitoneal bleeding — requires discontinuation and supportive care. No specific antidote; platelet transfusion may be considered.
Intracranial haemorrhage	Rare but life-threatening. Discontinue immediately. Emergency neurosurgical assessment.
Thrombotic Thrombocytopenic Purpura (TTP)	Rare (1 in 250,000); usually within first 2 weeks. Presents with thrombocytopenia, microangiopathic haemolytic anaemia, neurological symptoms, renal impairment, fever. Discontinue immediately. Urgent haematology referral. Plasma exchange required.
Severe neutropenia / Agranulocytosis	Rare. Monitor if unexplained fever or infection. Discontinue if confirmed.
Stevens-Johnson Syndrome / TEN	Very rare. Discontinue immediately if mucocutaneous reaction develops.
Hepatotoxicity	Rare; cholestatic or hepatocellular. Monitor LFTs if symptomatic.

Monitoring requirements

Timing	Parameters
Baseline	CBC (haemoglobin, platelets), renal function, LFTs (if hepatic impairment suspected), bleeding history assessment
After initiation	Clinical assessment for bleeding at each visit; CBC if bleeding suspected
Long-term (>6–12 months)	Periodic CBC (every 6–12 months); renal and hepatic function annually or as indicated
Special situations	CYP2C19 genotyping: Not routine, but consider in treatment failure, recurrent thrombotic events despite compliance, or family history of clopidogrel resistance. Platelet function testing (e.g., VerifyNow) may be available at tertiary centres.

Pre-operative:

Discontinue 5–7 days before elective surgery
Urgent surgery: Proceed with awareness of bleeding risk; platelet transfusion if severe bleeding

Brands in India

Single Ingredient:

Clopivas (Cipla)
Deplatt (Torrent)
Clopilet (Sun Pharma)
Plavix (Sanofi)
Clopitab (Lupin)
Clopid (Zydus)
Plagril (USV)

Fixed-Dose Combinations (with Aspirin):

Clopivas-A, Clopivas-AP (Cipla)
Deplatt-A, Deplatt-CV (Torrent)
Clopilet-A (Sun Pharma)
Ecosprin-AV (USV) — aspirin + atorvastatin + clopidogrel

Note: 150 mg and 300 mg tablets available for loading doses from select manufacturers.

Price range (INR)

Formulation	Price Range
Tablet 75 mg	₹2–7 per tablet
Tablet 150 mg	₹4–12 per tablet
Tablet 300 mg	₹8–20 per tablet
FDC (Clopidogrel 75 mg + Aspirin 75 mg)	₹3–8 per tablet
FDC (Clopidogrel 75 mg + Aspirin 150 mg)	₹4–10 per tablet

Note: Clopidogrel 75 mg is included in NLEM 2022 and under NPPA price control. Available in government supply and Jan Aushadhi outlets at reduced cost.

Clinical pearls

PPI selection matters: Always avoid omeprazole and esomeprazole with clopidogrel due to CYP2C19 interaction. Prefer pantoprazole or rabeprazole — they have minimal interaction and provide adequate gastroprotection during DAPT.
Loading dose in elderly STEMI: Omit the 300 mg loading dose in patients ≥75 years receiving thrombolytics — bleeding risk outweighs benefit. Maintenance dose of 75 mg remains appropriate.
CYP2C19 polymorphism: Approximately 25–30% of the Indian population are poor metabolisers (CYP2C19*2/*3 carriers) with reduced clopidogrel response. Consider prasugrel or ticagrelor in high-risk ACS patients, particularly post-PCI, if available and affordable.
DAPT duration flexibility: Standard DAPT duration post-DES is 6–12 months, but can be shortened (1–3 months) in high bleeding risk or extended (>12 months) in high ischaemic risk patients based on individualised assessment.
Pre-operative planning: Discontinue clopidogrel 5–7 days before elective surgery. For semi-urgent surgery, balance bleeding vs thrombotic risk — may proceed after 3–5 days in consultation with cardiology.
Morphine interaction in primary PCI: Morphine delays clopidogrel absorption. Consider crushed tablets via NG tube or alternative P2Y12 inhibitors (ticagrelor, cangrelor) in STEMI undergoing primary PCI.

Version

RxIndia v1.0 — 05 Jan 2025

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Clinical Responsibility

This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.

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