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Ticagrelor Uses, Dosage, Side Effects & Warnings | DrugsAtlas

Authoritative Clinical Reference

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.

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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