Tiginor 10mg

PRESENTATION

Ticarel 90: Each tablet contains Ticagrelor INN 90 mg.

DESCRIPTION

Ticagrelor, a cyclopentyltriazolopyrimidine which is a reversible platelet aggregation inhibitor. Ticagrelor reversibly binds with

the platelet P2Y12 adenosine diphosphate (ADP) receptor and thereby inhibits signal transduction and platelet aggregation.

INDICATIONS

Acute Coronary Syndromes

Ticagrelor is a P2Y12 platelet inhibitor indicated to reduce the rate of thrombotic cardiovascular events in patients with acute

coronary syndrome (ACS) (unstable angina, non-ST elevation myocardial infarction, or ST elevation myocardial infarction).

Ticagrelor has been shown to reduce the rate of a combined endpoint of cardiovascular death, myocardial infarction or stroke in

ACS patients. In patients treated with percutaneous coronary intervention (PCI), it also reduces the rate of stent thrombosis.

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.

SIDE EFFECTS

• Bleeding

• Dyspnea

• Other side effects (Headache, Back pain, Nausea, Dizziness, Cough, Hypotension, Fatigue, Atrial fibrillation)

PRECAUTIONS

• General Risk of Bleeding

Drugs that inhibit platelet function including Ticagrelor increase the risk of bleeding.

• Concomitant Aspirin Maintenance Dose

Use of Ticagrelor with maintenance doses of aspirin above 100 mg decreased the effectiveness of Ticagrelor. Therefore, after the

initial loading dose of aspirin (usually 325 mg), use Ticagrelor with a maintenance dose of aspirin of 75-100 mg.

• Moderate Hepatic Impairment

Ticagrelor has not been studied in patients with moderate hepatic impairment.

• Discontinuation of Ticagrelor

Discontinuation of Ticagrelor will increase the risk of myocardial infarction, stent thrombosis, and death.

USE IN PREGNANCY & LACTATION

Pregnancy Category C, There are no adequate and well-controlled studies of Ticagrelor used in pregnant women. It is not known

whether ticagrelor or its active metabolites are excreted in human milk.

Pediatric Use

The safety and effectiveness of Ticagrelor in pediatric patients have not been established.

Geriatric Use

No overall differences in safety or effectiveness were observed in patients of

Hepatic Impairment

Ticagrelor has not been studied in the patients with moderate or severe hepatic impairment. Ticagrelor is metabolized by the liver

and impaired hepatic function can increase risks for bleeding and other adverse events. Hence,

Renal Impairment

No dosage adjustment is needed in patients with renal impairment. Patients receiving dialysis have not been studied.

DRUG INTERACTION

Avoid use of strong inhibitors of CYP3A (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir,

saquinavir, nelfinavir, indinavir, atazanavir and telithromycin). Use of Ticagrelor with aspirin maintenance doses above 100 mg

reduced the effectiveness of Ticagrelor. Ticagrelor will result in higher serum concentrations of simvastatin or rosuvastatin

because these drugs are metabolized by CYP3A.

OVER DOSE

Other effects of overdose may include gastrointestinal effets (e.g- nausea, diarrhea) or ventricular pauses. Proper management

should be taken through ECG monitoring in severe bleeding.

COMMERCIAL PACK

Ticarel 90: Each box contains 2 blister strips of 10 tablets.