Ticagrelor Uses, Dosage, Side Effects & Warnings | DrugsAtlas
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Therapeutic Class
Antiplatelet Agent
Subclass
P2Y12 Receptor Antagonist (Reversible, Direct-acting)
Speciality
Cardiology
Schedule (India)
Schedule H
Routes
Oral
Formulations
- Tablets: 60 mg, 90 mg
Adult indications
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
1. Acute Coronary Syndrome (ACS) — Unstable Angina, NSTEMI, STEMI (with or without PCI)
Adults — In Combination with Low-Dose Aspirin:
| Parameter | Recommendation |
|---|---|
| Starting dose | 180 mg loading dose (two 90 mg tablets) as single dose |
| Titration | Not applicable |
| Usual maintenance dose | 90 mg orally twice daily |
| Maximum dose | 180 mg/day (90 mg twice daily) |
| Duration | Up to 12 months from index event |
Clinical Notes:
- Always administer with low-dose aspirin (75–100 mg once daily)
- Do NOT use aspirin doses >100 mg/day — may reduce ticagrelor efficacy
- Loading dose given as early as possible at presentation
- No need for CYP2C19 genotyping (unlike clopidogrel)
- Contraindicated in patients with history of intracranial haemorrhage
2. Secondary Prevention of Atherothrombotic Events — High-Risk Patients with History of MI (≥12 Months Post-MI)
Adults — Long-Term Secondary Prevention:
| Parameter | Recommendation |
|---|---|
| Starting dose | 60 mg orally twice daily |
| Titration | Not applicable |
| Usual maintenance dose | 60 mg twice daily |
| Maximum dose | 120 mg/day (60 mg twice daily) |
| Duration | Up to 3 years from index MI |
Clinical Notes:
- Initiate after completion of initial 12-month therapy with 90 mg twice daily
- Continue low-dose aspirin (75–100 mg once daily) concomitantly
- Indicated for patients with high-risk features (diabetes, multivessel CAD, recurrent MI, age ≥65, CKD)
- Reassess bleeding risk periodically during extended therapy
Pre-Operative Management
| Clinical Scenario | Recommendation |
|---|---|
| Elective surgery requiring discontinuation | Stop ticagrelor at least 5 days before surgery |
| Urgent CABG | Avoid ticagrelor initiation if urgent CABG planned; discontinue at least 3–5 days prior if already on therapy |
| Minor procedures (dental, skin) | May continue with caution; assess bleeding risk |
Secondary Indications – Adults Only (Off-label)
| Indication | Dose | Duration | Supervision | Evidence Basis |
|---|---|---|---|---|
|
Minor Ischaemic Stroke or High-Risk TIA (in CYP2C19 loss-of-function carriers) — OFF-LABEL
|
Loading: 180 mg; Maintenance: 90 mg BD | 21–30 days in combination with aspirin | Specialist only (Neurology) | CHANCE-2 trial; not standard practice in India; requires genotyping |
|
Post-Transcatheter Aortic Valve Implantation (TAVI) — OFF-LABEL
|
90 mg BD with low-dose aspirin | 3–6 months | Specialist only (Interventional Cardiology) | Limited RCT data; not superior to clopidogrel in some trials |
Paediatric indications
PAEDIATRIC DOSING (Specialist Only)
Primary Indications
Regulatory Status: NOT approved for paediatric use in India.
Age Restriction: Not recommended below 18 years of age.
Secondary Indications – Paediatric (Off-label)
- NOT AVAILABLE in India — no paediatric dosing established in Indian guidelines
- International studies in congenital heart disease exist but not adopted in Indian practice
- LMWH or aspirin remain preferred antiplatelet/anticoagulant options in paediatric cardiac conditions
- Use only in exceptional circumstances under specialist paediatric cardiology/haematology supervision
Minimum Age Statement:
Not recommended below 18 years of age except in highly specialised settings with paediatric cardiology supervision.
Not recommended below 18 years of age except in highly specialised settings with paediatric cardiology supervision.
Renal Adjustments
No dose adjustment required based on renal function:
| Renal Function | Recommendation |
|---|---|
| Mild impairment (eGFR 60–89 mL/min) | No adjustment |
| Moderate impairment (eGFR 30–59 mL/min) | No adjustment |
| Severe impairment (eGFR 15–29 mL/min) | No adjustment; use with caution due to increased bleeding risk |
| ESRD (eGFR <15 mL/min) not on dialysis | Limited data; use with caution |
| Haemodialysis | Limited data; ticagrelor unlikely to be dialysed significantly; use with caution |
Note: Ticagrelor may transiently increase serum creatinine (reversible, not indicative of nephrotoxicity).
Hepatic adjustment
Contraindications
- Active pathological bleeding (e.g., GI haemorrhage, intracranial bleeding)
- History of intracranial haemorrhage (ICH) — regardless of cause or timing
- Severe hepatic impairment (Child-Pugh C)
- Known hypersensitivity to ticagrelor or any excipient
- Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin)
- Concomitant use with strong CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital)
Cautions
- Bradyarrhythmias — sinus node dysfunction, second or third degree AV block (without permanent pacemaker); risk of ventricular pauses
- Asthma or COPD — dyspnoea is common adverse effect; may exacerbate respiratory symptoms
- History of hyperuricaemia or gout — ticagrelor increases uric acid levels
- Moderate hepatic impairment (Child-Pugh B) — increased drug exposure
- Bleeding diathesis or recent significant bleeding
- Concomitant use with anticoagulants — markedly increased bleeding risk
- Recent major surgery or trauma
- Planned surgery or invasive procedure — discontinue at least 5 days prior
- Elderly (>75 years) — increased bleeding risk
- Low body weight (<60 kg) — potentially increased exposure
- Concomitant use with moderate CYP3A4 inhibitors (diltiazem, verapamil)
- Concomitant use with drugs that increase bleeding risk (NSAIDs, SSRIs)
Pregnancy
| Parameter | Details |
|---|---|
| Risk category | Not formally assigned in India; animal studies show embryo-fetal toxicity at supratherapeutic doses |
| Preferred alternatives | Low-dose aspirin (if antiplatelet indicated); clopidogrel has more established (though limited) safety data |
| When may be used | Only if no suitable alternative and potential benefit clearly justifies risk; specialist decision (cardiology + obstetrics) |
| Monitoring | Maternal bleeding risk; fetal growth monitoring; plan delivery with haematology/cardiology input |
Lactation
| Parameter | Details |
|---|---|
| Compatibility | Not recommended — unknown if excreted in human breast milk; excreted in animal milk |
| Drug levels in milk | Unknown in humans; expected to be low based on protein binding |
| Preferred alternatives | Clopidogrel (more established safety) or low-dose aspirin if antiplatelet required |
| Infant monitoring | If exposure occurs: monitor for bleeding, bruising, feeding difficulties |
Elderly
| Parameter | Recommendation |
|---|---|
| Starting dose | Same as younger adults — 180 mg loading, then 90 mg twice daily for ACS |
| Titration | Not applicable |
| Special risks | Increased bleeding risk (particularly GI and intracranial); falls risk; polypharmacy with interacting drugs; assess renal and hepatic function |
| Monitoring | Close monitoring for bleeding; regular haemoglobin checks; assess for dyspnoea and bradycardia |
Note: Age alone is not a contraindication; benefit in reducing cardiovascular events generally outweighs bleeding risk in appropriately selected elderly patients.
Major drug interactions
| Drug/Class | Mechanism/Effect | Recommendation |
|---|---|---|
| Strong CYP3A4 inhibitors (ketoconazole, itraconazole, voriconazole, ritonavir, nelfinavir, clarithromycin) | Marked increase in ticagrelor exposure → high bleeding risk |
Contraindicated — avoid concomitant use
|
| Strong CYP3A4 inducers (rifampicin, phenytoin, carbamazepine, phenobarbital, St. John's Wort) | Significant reduction (~60%) in ticagrelor levels → loss of efficacy |
Contraindicated — avoid concomitant use
|
| Anticoagulants (warfarin, rivaroxaban, apixaban, dabigatran, LMWH) | Additive bleeding risk |
Avoid unless specifically indicated (e.g., AF with ACS) — specialist supervision mandatory
|
| Digoxin | Ticagrelor inhibits P-glycoprotein → increased digoxin levels (up to 75%) | Monitor digoxin levels; consider dose reduction; watch for toxicity |
| Aspirin doses >100 mg/day | Reduced ticagrelor efficacy demonstrated in PLATO trial |
Avoid — use only low-dose aspirin (75–100 mg/day)
|
Moderate drug interactions
| Drug/Class | Effect | Recommendation |
|---|---|---|
| Moderate CYP3A4 inhibitors (diltiazem, verapamil, fluconazole, erythromycin) | Modest increase in ticagrelor levels | Use with caution; monitor for bleeding and dyspnoea |
| Simvastatin, lovastatin | Ticagrelor increases statin levels via CYP3A4 inhibition | Limit simvastatin to ≤40 mg/day; consider atorvastatin or rosuvastatin (less interaction) |
| Cyclosporine | Increased ticagrelor exposure via P-gp and CYP3A4 inhibition | Monitor closely; avoid if possible |
| NSAIDs (diclofenac, ibuprofen, naproxen) | Additive GI bleeding risk | Avoid chronic use; use short courses with gastroprotection |
| SSRIs/SNRIs (fluoxetine, sertraline, venlafaxine) | Increased bleeding tendency | Monitor for bleeding; counsel patient |
| Proton pump inhibitors | No significant interaction (unlike clopidogrel) | Can be used together for gastroprotection |
| Other P2Y12 inhibitors (clopidogrel, prasugrel) | Overlapping mechanism; no additive benefit; bleeding risk |
Avoid combination
|
Common Adverse effects
- Dyspnoea (up to 14%) — usually mild, transient; rarely requires discontinuation
- Bleeding — minor (bruising, epistaxis, gingival bleeding, haematuria)
- Elevated serum creatinine (reversible; not true nephrotoxicity)
- Hyperuricaemia (usually asymptomatic)
- Headache
- Dizziness
- Nausea
- Diarrhoea
- Back pain
Serious Adverse effects
| Adverse Effect | Clinical Action |
|---|---|
| Major bleeding (GI haemorrhage, intracranial haemorrhage, retroperitoneal bleeding) |
Immediate discontinuation; supportive care; platelet transfusion may have limited efficacy (reversible inhibitor); hospitalisation
|
| Ventricular pauses (>3 seconds) | Usually occur in first week; typically asymptomatic; monitor ECG in high-risk patients (elderly, sinus node dysfunction); generally resolve with continued therapy |
| Bradyarrhythmias (symptomatic — syncope, presyncope) | Evaluate for pacemaker requirement; consider alternative antiplatelet |
| Severe hypersensitivity / Angioedema | Discontinue immediately; emergency management |
| Gout flare | Treat acute gout; consider alternative antiplatelet if recurrent |
| Thrombotic Thrombocytopenic Purpura (TTP) | Very rare; discontinue immediately; urgent haematology referral |
Note: Unlike thienopyridines (clopidogrel, prasugrel), ticagrelor is a reversible inhibitor — platelet function recovers within 3–5 days of discontinuation.
Monitoring requirements
Baseline:
- Complete blood count (haemoglobin, platelet count)
- Renal function (serum creatinine, eGFR)
- Liver function tests
- Serum uric acid
- ECG (assess baseline rhythm, PR interval)
- Bleeding risk assessment
After Initiation:
- Clinical assessment for dyspnoea and bradycardia in first week
- Monitor for bleeding at 2–4 weeks
- Repeat haemoglobin if bleeding symptoms or unexplained fatigue
- Serum creatinine at 1 month (expect mild increase; usually not clinically significant)
Long-term Monitoring:
- Complete blood count every 3–6 months
- Renal function every 6 months
- Serum uric acid if history of gout or symptoms
- Clinical assessment for bleeding at each visit
- Reassess indication and bleeding risk annually
Pre-Operative:
- Document when last dose taken
- Ensure ≥5 days discontinuation before elective major surgery
- Liaise with surgical team regarding timing of resumption
Brands in India
Originator:
- Brilinta (AstraZeneca)
Generic/Licensed Brands:
- Ticavag (Intas)
- Ticabid (Zydus Cadila)
- Ticari (Lupin)
- Tigrelor (Torrent)
- Ticamet (Sun Pharma)
- Axcer (Mankind)
- Brilor (Cipla)
Fixed-Dose Combinations:
- Ticagrelor 90 mg + Aspirin 75 mg (available from select manufacturers)
Price range (INR)
| Formulation | Approximate Price per Tablet |
|---|---|
| Tablet 60 mg | ₹30–₹65 |
| Tablet 90 mg | ₹40–₹80 |
- Not currently under NPPA price control
- Not included in NLEM 2022
- Significant price variation between originator and generic brands
- Generic options substantially more affordable
- May be available through government hospital procurement for ACS management in tertiary centres
Clinical pearls
- Superior to clopidogrel in ACS — PLATO trial demonstrated significant reduction in cardiovascular death, MI, and stroke compared to clopidogrel; preferred P2Y12 inhibitor for most ACS patients in Indian cardiology practice
- Aspirin dose matters — use ONLY low-dose aspirin (75–100 mg/day); higher doses reduce ticagrelor efficacy (post-hoc PLATO analysis); common prescribing error to avoid
- Dyspnoea is expected and usually manageable — occurs in ~14% of patients; typically mild, transient, and self-limiting; does not require discontinuation in most cases; counsel patients proactively
- No CYP2C19 dependency — unlike clopidogrel, ticagrelor does not require hepatic activation; more predictable antiplatelet effect; useful when clopidogrel resistance suspected or confirmed
- Reversible inhibition — platelet function recovers faster (3–5 days) compared to thienopyridines; advantageous if urgent surgery needed, but daily compliance critical due to shorter duration of effect
- Switching protocols — when switching FROM clopidogrel to ticagrelor: give ticagrelor loading dose without clopidogrel loading; when switching FROM ticagrelor to clopidogrel: give clopidogrel 600 mg loading dose 24 hours after last ticagrelor dose
- Ventricular pauses — usually occur in first week; generally asymptomatic and benign; avoid in patients with sick sinus syndrome or high-grade AV block without pacemaker
Version
RxIndia v1.0 — 05 Jun 2025
Reference
-
- CDSCO approved product inserts
- Indian Pharmacopoeia
- API Textbook of Medicine
- AIIMS Cardiology Treatment Protocols
- Cardiological Society of India — ACS Management Guidelines
- ICMR Guidelines on STEMI and ACS Management
- Goodman & Gilman's The Pharmacological Basis of Therapeutics (supportive)
- Harrison's Principles of Internal Medicine (supportive)
- PLATO trial (primary efficacy data)
- PEGASUS-TIMI 54 trial (extended secondary prevention)
- CHANCE-2 trial (for stroke off-label context only)
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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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