Tablet, Generic Name: Ticagrelor INN, Manufacturer: Incepta Pharmaceuticals Ltd.
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Indications
Ticagrelor is indicated for the prevention of thrombotic events in adult patients with acute coronary syndromes (unstable angina, non-ST segment elevation myocardial infarction [NSTEMI] or ST-segment elevation myocardial infarction). [STEMI]); included patients who were medically managed and those managed by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CAP).
Pharmacology
Ticagrelor is a selective adenosine diphosphate (ADP) receptor antagonist that inhibits ADP-mediated platelet activation and aggregation. It works by blocking the P2Y12 ADP-receptor. Ticagrelor interacts with the platelet P2Y12 ADP-receptor in a reversible manner. Ticagrelor inhibits signal transduction by interacting with the platelet P2Y12 ADP-receptor rather than the ADP binding site. As a result, platelet activation and aggregation are prevented.
Dosage & Administration
Initiate Ticagrelor treatment with a 180 mg (two 90 mg tablets) loading dose and continue treatment with 90 mg twice daily. After the initial loading dose of aspirin (usually 325 mg), use Ticagrelor with a daily maintenance dose of aspirin of 75-100 mg.
Interaction
CYP3A inhibitors: Avoid the use of strong CYP3A inhibitors (eg, ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromycin).
CYP3A inducers: Avoid use with strong CYP3A inducers (eg, rifampin, dexamethasone, phenytoin, carbamazepine, and phenobarbital).
Aspirin: Administration of Ticagrelor with a maintenance dose of aspirin greater than 100 mg reduces the effectiveness of Ticagrelor.
Simvastatin, Lovastatin: Ticagrelor will cause higher serum concentrations of simvastatin and lovastatin because these drugs are metabolized by CYP3A4. Avoid doses of simvastatin and lovastatin greater than 40 mg.
Digoxin: Due to inhibition of the P-glycoprotein transporter, monitor digoxin levels early or any changes in ticagrelor therapy.
Other Concomitant Therapy: Ticagrelor can be used with unfractionated or low molecular weight heparin, GPIIb / IIIa inhibitors, proton pump inhibitors, beta blockers, ACE inhibitors. angiotensin and angiotensin receptor blockers.
Contraindications
Hypersensitivity to Ticagrelor or any of the excipients is a contraindication to taking Ticagrelor.
Pathological bleeding that is active (peptic ulcer)
Intracranial haemorrhage history
Hepatic impairment ranging from moderate to severe
Ticagrelor in combination with powerful CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir)
Side Effects
Dyspnea, bleeding, headache, cough, dizziness, nausea, atrial fibrillation, hypertension, non-cardiac chest pain, diarrhea, back pain, hypotension, fatigue, chest pain.
Pregnancy & Lactation
Pregnancy: Pregnancy category C. There are no or limited amount of data from the use of Ticagrelor in pregnant women. Ticagrelor is not recommended during pregnancy. Nursing mothers: Available pharmacodynamic/toxicological data in animals have shown excretion of Ticagrelor and its active metabolites in milk. A risk to newborns/infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from ticagrelor therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the women.
Precautions & Warnings
Drugs that limit platelet activity, such as Ticagrelor, increase the risk of bleeding in general.
Ticagrelor's efficacy was reduced when it was used with aspirin maintenance doses more than 100 mg. As a result, after the initial loading dose of aspirin (typically 325 mg), take Ticagrelor with a 75-100 mg aspirin maintenance dose.
Patients with significant hepatic impairment have not been investigated with ticagrelor.
Ticagrelor withdrawal: Withdrawing from Ticagrelor increases the risk of myocardial infarction, stent thrombosis, and mortality.
Storage Conditions
Protect from light & moisture. Store below 25° C. Keep out of reach of children.
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