Clopidogrel Uses, Dosage, Side Effects & Warnings | DrugsAtlas
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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 ā FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
1. Acute Coronary Syndrome (ACS) ā 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 (75ā100 mg/day) unless contraindicated
- Duration: Minimum 12 months (DAPT ā 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) ā 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 75ā100 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)
|
300ā600 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 | 1ā3 months |
| Drug-eluting stent (DES) | 6 months | 6ā12 months |
| High bleeding risk patients | May shorten to 1ā3 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 (75ā100 mg daily)
- Pre-treatment with clopidogrel preferred if PCI planned within 24ā48 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 ā Adults Only (Off-label)
| Indication | Loading Dose | Maintenance Dose | Duration | Notes |
|---|---|---|---|---|
|
Minor Ischaemic Stroke / High-risk TIA (DAPT) ā OFF-LABEL
|
300 mg clopidogrel + aspirin 75ā100 mg | 75 mg clopidogrel + aspirin 75ā100 mg daily | 21ā30 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) ā OFF-LABEL
|
Not applicable | 75 mg daily with aspirin 75ā100 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) ā Post-operative ā 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 ā Paediatric (Off-label)
| Indication | Age/Weight | Dose | Duration | Notes |
|---|---|---|---|---|
|
Paediatric Arterial Ischaemic Stroke ā OFF-LABEL
|
>1 month; any weight | 0.2ā1 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 ā 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) ā 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
|
0.5ā1 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 ā 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 3ā6 months)
- Assess for signs of TTP (thrombocytopenia, neurological symptoms, renal impairment)
- Drug compliance ā liquid formulations not readily available in India
Renal Adjustments
| eGFR (mL/min/1.73m²) | Recommendation |
|---|---|
| >60 | No dose adjustment required |
| 30ā60 | No dose adjustment required |
| 15ā30 | 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) ā increased bleeding risk
- History of gastrointestinal bleeding or peptic ulcer disease
- Concurrent use of anticoagulants (warfarin, DOACs, heparin)
- Concurrent NSAID use ā increased GI bleeding risk
- Patients with bleeding diathesis or thrombocytopenia
- CYP2C19 poor metaboliser status ā reduced drug efficacy (genetic polymorphism common in Indian population)
- Planned elective surgery ā discontinue 5ā7 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 (75ā150 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) ā 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 ā 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 ā 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) ā bruising, epistaxis, gum bleeding
- Dyspepsia, abdominal pain
- Diarrhoea
- Rash, pruritus
- Headache
Serious Adverse effects
| Effect | Notes |
|---|---|
|
Major bleeding
|
GI haemorrhage, retroperitoneal bleeding ā 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 (>6ā12 months)
|
Periodic CBC (every 6ā12 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 5ā7 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) ā 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 | ā¹2ā7 per tablet |
| Tablet 150 mg | ā¹4ā12 per tablet |
| Tablet 300 mg | ā¹8ā20 per tablet |
| FDC (Clopidogrel 75 mg + Aspirin 75 mg) | ā¹3ā8 per tablet |
| FDC (Clopidogrel 75 mg + Aspirin 150 mg) | ā¹4ā10 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 ā 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 ā bleeding risk outweighs benefit. Maintenance dose of 75 mg remains appropriate.
- CYP2C19 polymorphism: Approximately 25ā30% 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 6ā12 months, but can be shortened (1ā3 months) in high bleeding risk or extended (>12 months) in high ischaemic risk patients based on individualised assessment.
- Pre-operative planning: Discontinue clopidogrel 5ā7 days before elective surgery. For semi-urgent surgery, balance bleeding vs thrombotic risk ā may proceed after 3ā5 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 ā 05 Jan 2025
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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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