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Acora 90mg

Tablet
Ticagrelor
ACI Pharmaceuticals

Other Strength:

Alternative:
- Tigel 90mg
- Ticarel 90mg
- Ticalog 90mg
- Ticacard 90mg
- Gleron 90mg



Acora
Description
Acora®is a preparation of Ticagrelor. It is a cyclopentyltriazolopyrimidinewhich is a reversible platelet aggregation inhibitor.Ticagrelorreversibly binds with the platelet P2Y12adenosine diphosphate (ADP) receptors and thereby inhibits signal transduction and platelet aggregation. In contrast to the other antiplatelet drugs,Ticagrelor has a binding site different from ADP, making it anallostericantagonist, and the blockage is reversible. Moreover, the drug does not needhepaticactivation, which might work better for patients with genetic variants regarding the enzymeCYP2C19.

Indication
Ticagreloris indicated to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (unstable angina, non-ST elevation myocardial infarction, or ST elevation myocardial infarction). Ticagrelor has beenshown to reduce the rate of a combined endpoint of cardiovascular death, myocardial infarction, or stroke compared to clopidogrel. The difference between treatments was driven by CV death and MI with no difference in stroke. In patients treated with PCI, it also reduces the rate of stent thrombosis.

Dosage and administration
Treatment should be initiated with Ticagrelor 180 mg (two 90 mg tablets) withaninitial dose of Aspirin (325 mg) as a loading dose. Then treatment should be continued with Ticagrelor 90 mg twice daily with Aspirin (75-100 mg) as a maintenance dose. A patient who misses a dose of Ticagrelorshould take one 90 mg tablet (their next dose) at its scheduled time.

Use is pregnancy & lactation
Ticagrelor isa Pregnancy CategoryC. There are no adequate and well-controlled studies of Ticagrelor usein pregnant women. Ticagrelor should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Ticagreloror its active metabolites are excreted in human milk.Therefore,Ticagrelor is not recommended for use in lactating mother.

Side effects
The most common side effects are bleeding and dyspnea. Other side effects are headache, back pain, nausea, dizziness, cough, hypotension, fatigue, and atrial fibrillation.

Contraindications
Ticagrelor iscontraindicated in patients with hypersensitivity (e.g. angioedema) to Ticagreloror any component of the product. It is also contraindicated in patients with a history of intracranial hemorrhage (ICH) because of a high risk of recurrent ICH in this populationand patients with active bleeding disorders (e.g., peptic ulcer and intracranial hemorrhage). Ticagrelor is contraindicated in patients with severe hepatic impairment because of a probable increase in exposure, andit has not been studied in these patients. Severe hepatic impairment increases the risk of bleeding because of reduced synthesis of coagulation proteins.

Precautions
Caution should be exercised in patientswith bleeding disorder as because likeother antiplatelet agents, Ticagrelor increases the risk of bleeding. Consider the risks and benefits of treatment, noting the probable increase in exposure to ticagrelor in case of moderate hepatic impairment. Premature discontinuation increases the risk of myocardial infarction, stent thrombosis, and death.

Drug interaction
Ticagreloris predominantly metabolized by CYP3A4 and to a lesser extent by CYP3A5. Ticagrelor is also a p-glycoprotein (P-gp) substrate. Patients receiving more than 40 mg per day of simvastatin or lovastatinmay be at increased risk of statin-related adverse effects. Monitor digoxin levels with initiation of or any change in Ticagrelor. Use of Ticagrelorwith aspirin maintenance doses above 100 mg reduced the effectiveness of Ticagrelor.

Overdose
There is currently no known treatment toreverse the effects of Ticagrelor, and Ticagrelor is not expected to be dialyzable. Treatment of overdose should followthelocal standard medical practice. Bleeding is the expected pharmacologic effect of overdosing. If bleeding occurs, appropriate supportive measures should be taken. Other effects ofanoverdose may include gastrointestinal effects (nausea, vomiting, and diarrhea) or ventricular pauses. Monitor the ECG.

Pharmaceutical precautions
Store in a cool and dry place.Protect from light.

Presentation
Acora®tablet:Eachcoated tablet containsTicagrelorINN90mg.

Package quantities
Acora®tablet: Carton of 10tablets in blisterpack.

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