Skip to main content
x

OUR PRODUCTS

ticagrelor
Commercial name
VIZOGOL
Category
CardIOVASCULAR DRUGS
Chemical composition

Each film coated tablet contains 60 mg ticagrelor

Each film coated tablet contains 90 mg ticagrelor

Dosage Form
film - coated tablets
Pharmaceutical group
Cardiovascular drugs / anticoagulant drugs
Contraindications

Hypersensitivity to the active substance or to any of the excipients

- Active pathological bleeding.

- History of intracranial bleeding

- Severe hepatic failure

- Co-administration of ticagrelor with potent CYP3A4 inhibitors (eg, ketoconazole, clarithromycin, nefazodone, ritonavir and atazanavir), as co-administration may lead to a significant increase in exposure to ticagrelor.

Drug interactions

- CYP3A4 Inhibitors:

• Potent CYP3A4 Inhibitors: Co-administration of ketoconazole with ticagrelor increased ticagrelor Cmax and AUC by 2.4-fold and 7.3-fold, respectively. The Cmax and AUC of the active metabolite were reduced by 89% and 56%, respectively. Other strong CYP3A4 inhibitors (clarithromycin, nefazodone, ritonavir, atazanavir) are expected to have similar effects and therefore concomitant use of strong CYP3A4 inhibitors with ticagrelor is of no effect.

Moderate CYP3A4 Inhibitors: Co-administration of diltiazem with ticagrelor increased ticagrelor Cmax by 69% and AUC to 2.7-fold and decreased the active metabolite Cmax by 38% and did not change the area under the curve. There was no effect of ticagrelor on plasma diltiazem levels. Other mild CYP3A4 inhibitors (such as amprenavir, aprepitant, erythromycin, and fluconazole) are expected to have a similar effect and can also be taken with ticagrelor.

A twofold increase in exposure to ticagrelor was observed after daily consumption of large quantities of grapefruit juice (3 x 200 ml). This scale of increased exposure is not expected to be clinically relevant for most patients.

- CYP3A inducers:

Co-administration of rifampicin with ticagrelor reduced ticagrelor Cmax and AUC by 73% and 86%, respectively. The Cmax of the active metabolite was unchanged and the AUC decreased by 46%, respectively. Other CYP3A inducers (eg, phenytoin, carbamazepine, and phenobarbital) are expected to reduce exposure to ticagrelor as well. Co-administration of ticagrelor with strong CYP3A inducers may reduce exposure and efficacy of ticagrelor, so concomitant use with ticagrelor is not recommended.

- Cyclosporine (a P-gp and CYP3A inhibitor):

Co-administration of cyclosporine (600 mg) with ticagrelor increased ticagrelor Cmax and AUC by 2.3-fold and 2.8-fold, respectively. The AUC of the active metabolite was increased by 32% and Cmax was decreased by 15% in the presence of cyclosporine.

- Oral contraceptives:

Co-administration of ticagrelor, levonorgestrel, and ethinyl estradiol increased exposure to ethinyl estradiol by approximately 20% but did not alter the pharmacokinetics of levonorgestrel..

Dosage and usage

 

Visogol, taken in combination with acetylsalicylic acid (ASA), is used to prevent arterial thrombotic events in adult patients with:

- Acute coronary syndromes (ACS)

- A history of myocardial infarction (MI) and a high risk of developing an atherosclerotic thrombotic event

Dosage: Patients taking Visogol should take a low daily maintenance dose of aspirin (75-150 mg) if there are no contraindications.

- Acute coronary syndromes

Vizogol treatment should begin with a single loading dose of 180 mg (two 90 mg tablets) and then continue at 90 mg twice daily.

Treatment with Vizogol 90 mg twice daily for 12 months is recommended in patients with ACS unless clinical discontinuation is advised.

- a history of myocardial infarction

Visogol 60 mg twice daily is the recommended dose when extended treatment is required for patients with a history of MI of at least 1 year and at risk of arterial thrombosis. Uninterrupted therapy can be started as continuous therapy after the initial treatment for 1 year with Visogol 90 mg or treatment with adenosine receptor inhibitors. Diphosphate (ADP) in ACS patients at risk for atherosclerosis. Treatment may also be started for up to 2 years of MI, or within 1 year after previous ADP receptor inhibitor therapy has been discontinued. There are limited data on the efficacy and safety of ticagrelor after 3 years of extended therapy.

If a switch is required, the first dose of Vizogol should be given 24 hours after the last dose of other antiplatelet drugs.

Side Effect

Back pain, bleeding gums, blurred vision, chest pain or tightness, cough, shortness of breath, dizziness and lightheadedness, irregular heartbeat, headache, loss of consciousness, vaginal bleeding, nausea, vomiting, ringing in the ears, red or black stools Dark urine, excessive sweating, unusual bruising

Marketing authorization number(s)

vizogol 60 mg f.c.tablets ............(355/2021)

vizogol 90 mg f.c.tablets ............(356/2021)

 

The nature and content of the packaging

A carton box containing 3 blisters ,each one contain 10 f.c.tablets.