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Ticaflow

Tablet

60 mg

GENERIC NAMETicagrelor

MANUFACTURED BYThe ACME Laboratories Ltd

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Available Pack Sizes:2 Sizes

Purchase Option:Full Pack

Maximum Retail Price (MRP):

Quantity

৳ 318.15/ 1 x 10

(Unit: ৳ 35.00 / 1 Tablet)

16263

Composition

Ticaflow 60: Each film-coated tablet contains Ticagrelor INN 60 mg.

Ticaflow 90: Each film-coated tablet contains Ticagrelor INN 90 mg.

Description

Ticagrelor is a selective adenosine diphosphate (ADP) receptor antagonist acting on the P2Y12 ADP-receptor that can prevent ADP mediated platelet activation and aggregation. Ticagrelor reversibly interacts with the platelet P2Y12 ADP-receptor. Ticagrelor does not interact with the ADP binding site itself, but interacts with platelet P2Y12 ADP receptor to prevent signal transduction. Thus it prevents platelet activation & aggregation.

Pharmacokinetics:

Absorption: Absorption of Ticagrelor occurs with a median Tmax of 1.5 hour (range 1.0-4.0). The formation of major circulating metabolite of Ticagrelor occurs with a median Tmax of 2.5 hours (range 1.5-5.0). * Distribution: Ticagrelor and the active metabolite are extensively bound to human plasma proteins (>99%). * Metabolism: CYP3A4 is the major enzyme responsible for Ticagrelor metabolism & the formation of its major active metabolite. Ticagrelor & its major active metabolite are weak P-glycoprotein substrates & inhibitors. * Excretion: The primary route of Ticagrelor elimination is hepatic metabolism. When radiolabeled Ticagrelor is administered, the mean recovery of radioactivity is approximately 84% (58% in feces & 26% in urine). The primary route of elimination for the major metabolite of Ticagrelor is most likely to be biliary secretion. The mean $t_{1/2}$ is approximately 7 hours for Ticagrelor & 9 hours for the active metabolite.

Indications

Ticaflow is a P2Y12 platelet inhibitor indicated to reduce the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction (MI).

For at least the first 12 months following ACS, it is superior to Clopidogrel.

Ticaflow also reduces the rate of stent thrombosis in patients who have been stented for treatment of ACS.

Dosage & Administration

Route of administration: Oral.

Initiate treatment with 180 mg (Ticaflow 90 mg + Ticaflow 90 mg) oral loading dose following an ACS event. Continue treatment with Ticaflow 90 mg tablet twice daily during the first year after an ACS event. After one year, administer Ticaflow 60 mg tablet twice daily.

Use Ticaflow with a daily maintenance dose of Aspirin of 75-100 mg.

Interaction

CYP3A inhibitors: Avoid use or strong inhibitors of CYP3A (e.g., Ketoconazole, Itraconazole, Voriconazole, Clarithromycin, Nefazodone, Ritonair, Saquinavir, Nelfinavir, Indinavir, Atazanavi and Telithromycin). * CYP3A Inducers: Avoid use with potent Inducers of CYP3A (e.g., Rifampin, Dexamethasone, Phenytoin, Carbamazepine and Phenobarbital). * Aspirin: Use of the Ticagrelor with Aspirin maintenance doses above 100 mg reduced the effectiveness of Ticagrelor. * Simvastatin/Lovastatin: Ticagrelor will result in higher serum concentrations of Simvastatin and Lovastatin because these drugs are metabolized by CYP3A4. Avoid Simvastatin and Lovastatin doses greater than 40 mg. * Digoxin: Because of inhibition of the P-glycoprotein transporter, monitor Digoxin levels with initiation of or any change in Ticagrelor therapy.

Overdose:

There is currently no known antidote to reverse the effects of Ticagrelor and it is not expected to be dialyzable. Treatment of overdose should follow local standard medical practice. The expected effect of excessive ticagrelor dosing is prolonged duration of bleeding risk associated with platelet inhibition. If bleeding occurs appropriate supportive measures should be taken.

Contraindications

Ticagrelor is contraindicated in case of.

hypersensitivity to Ticagrelor or to any of the excipients.

active pathological bleeding (peptic ulcer).

history of intracranial hemorrhage.

Side Effects

Dyspnea, Bleeding.

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. * Lactation: Available pharmacodynamics/toxicological data in animals have shown excretion of Ticagrelor and its active metabolites in milk. 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.

Use in Children & Adolescent:**

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

Precautions & Warnings

Dyspnea was reported more frequently with Ticagrelor than with control agents in clinical trials.

Severe Hepatic Impairment: Avoid use of Ticagrelor in patients with severe hepatic impairment. Likely increase in exposure to Ticagrelor.

Storage Conditions

Store below 30Â°C temperature & dry place, protected from light Keep all medicines out of reach of children.

Ticaflow • 1 x 10

৳ 318.15