قرص ونوتیکا 90 میلی گرم

VENOTICA 90 MG Tablet

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اطلاعات دارویی قرص ونوتیکا 90 میلی گرم
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Drug Information For VENOTICA 90 MG Tablet

What is Venotica?
The antiplatelet medicine Ticagrelor, sold under the brand name Venotica, is manufactured by Arvand Pharmed Company. Venotica is used in people with a history of heart attack, coronary artery disease and certain types of stroke. The use of this drug in patients can reduce the risk of cardiovascular events as well as mortality.

Product Information
Ticagrelor, under the brand name Venotica, is an oral antiplatelet drug that reversibly inhibits platelet aggregation. Venotica is produced in two doses of 60 mg and 90 mg by Arvand Pharmed Company. This medicine should be taken according to the doctor's prescription, and its arbitrary use should be avoided. Venotica is used in people with a history of heart attack, coronary artery disease and certain types of stroke and it can reduce the risk of death.

What is Venotica's mechanism of action?
It can be simply stated that Venotica (ticagrelor) reduces platelet accumulation.
Venotica Reversibly and noncompetitively binds the Adenosine Diphosphate (ADP) P2Y12 receptor on the platelet surface, which prevents ADP-mediated activation of the GPIIb/IIIa receptor complex thereby reducing platelet aggregation.

What are the indications of Venotica?
1)    Acute coronary syndrome
To reduce the risk of cardiovascular death, myocardial infarction (MI), and stroke in patients with Acute Coronary Syndrome (ACS) or a history of MI. Ticagrelor also reduces the risk of stent thrombosis in patients who have been stented for the treatment of ACS.

2)    Coronary artery disease (stable) and high risk for ischemic cardiovascular events, primary prevention
To reduce the risk of first MI or stroke in patients with coronary artery disease at high risk for such events. 

3)    Minor ischemic stroke (based on the National Institutes of Health Stroke Scale score) or high-risk transient ischemic attack (based on ABCD2 score)
To reduce the risk of stroke in patients who meet these criteria.

What are the dosage forms of Venotica?
Oral tablets 60 mg & 90 mg

How is the administration of Venotica?
•    Administer with or without food.
•    Missed doses should be taken at their next regularly scheduled time. 
•    For patients unable to swallow whole, tablets may be crushed and mixed with water to create a suspension for oral or NG.

Does Venotica need to adjust the dose in renal failure?
Altered kidney function
No dosage adjustment is necessary for any degree of kidney dysfunction.
Hemodialysis, intermittent (thrice weekly): Not dialyzed
No dosage adjustment is necessary. Patients with End-Stage Kidney Disease (ESKD) are at increased risk for bleeding, with or without antiplatelet therapy; monitor closely.
Peritoneal dialysis
No dosage adjustment is necessary. Patients with ESKD are at increased risk for bleeding, with or without antiplatelet therapy; monitor closely.

Does Venotica need to adjust the dose in liver failure?
Mild impairment: No dosage adjustment is necessary.
Moderate impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, undergoes hepatic metabolism; use caution.
Severe impairment: Avoid use.

Who should not use Venotica (Ticagrelor)? (Contraindications)
Hypersensitivity (e.g., angioedema) to Ticagrelor or any component of the formulation; active pathological bleeding (e.g., peptic ulcer, intracranial hemorrhage); history of intracranial hemorrhage

Is it safe to use Venotica during pregnancy or breastfeeding?
Use in pregnancy or breastfeeding is not recommended.

What drugs does Venotica interact with?
Avoid use of Venotica with the following medicines (category X):
•    Antiplatelet Agents (P2Y12 Inhibitors): May enhance the antiplatelet effect of Ticagrelor. 

•    Strong CYP3A Inhibitors: Strong CYP3A inhibitors substantially increase ticagrelor exposure and so increase the risk of adverse events. Avoid use of strong inhibitors of CYP3A (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir and telithromycin) 

•    Strong CYP3A Inducers: Strong CYP3A inducers substantially reduce ticagrelor exposure and so decrease the efficacy of ticagrelor. Avoid use with strong inducers of CYP3A (e.g., rifampin, phenytoin, carbamazepine and phenobarbital)

•    Urokinase: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Urokinase.

Combination use of Venotica with the following medicine requires therapy modification (category D):
•    Aspirin: Avoid maintenance aspirin doses greater than 150 mg/day in patients receiving Ticagrelor. After any initial dose, only low-dose aspirin (75 to 100 mg/day) is recommended.

What precautions and warnings does Venotica (Ticagrelor) have when using it?

Risk of Bleeding
•    Drugs that inhibit platelet function, including Venotica, increase the risk of bleeding.
Discontinuation of Venotica in Patients Treated for Coronary Artery Disease
•    Discontinuation of Venotica will increase the risk of myocardial infarction, stroke, and death in patients being treated for coronary artery disease.
Dyspnea
•    If a patient develops new, prolonged, or worsened dyspnea that is determined to be related to Venotica, no specific treatment is required; In most cases, dyspnea is self-limiting and resolves within 1 week of treatment.
continue Venotica without interruption if possible. In the case of intolerable dyspnea requiring discontinuation of Venotica, consider prescribing another antiplatelet agent.
Severe Hepatic Impairment
•    Avoid use of Venotica in patients with severe hepatic impairment.
Laboratory Test Interferences
•    Venotica has been reported to cause false negative results in platelet functional tests (including the Heparin-Induced Platelet Aggregation (HIPA) assay) for patients with Heparin Induced Thrombocytopenia (HIT).


Frequently Asked Questions (FAQs)
How long do I have to take Venotica after a stent or heart attack?

•    Venotica is typically used for 6 to 12 months or longer after a stent or heart attack. Follow your doctor’s orders when taking Venotica. It is given with low-dose aspirin to help prevent blood clots. If you stop taking Venotica too soon, it can increase your risk of heart attack, stroke, or death.

What foods should I eat or avoid when taking Venotica?
•    Do not drink grapefruit juice while taking Venotica (ticagrelor). Grapefruit juice can inhibit (block) one of the enzymes (3A4) needed to break down Venotica for excretion from the body. Drinking grapefruit juice with Venotica may increase the antiplatelet effect of your medicine and increase the risk of bleeding.

What analgesic can I take with Venotica?
•    If you take Venotica, do not take extra aspirin or NSAIDs like ibuprofen, naproxen, or celecoxib for pain relief unless directed by your doctor. This may increase your risk for serious bleeding. If you need a pain reliever, it is usually safe to take acetaminophen with Venotica.

How long should Venotica be held/stopped before surgery?
•    If you are having surgery, your doctor may instruct you to stop taking Venotica (ticagrelor) 3-5 days before your procedure. This will help to lower the chance of bleeding. Always follow your doctor’s directions about when to stop or start taking Venotica again.

Is ticagrelor better than clopidogrel?
•    Ticagrelor is recommended over clopidogrel by current guidelines for people with ACS or following a myocardial infarction (heart attack).
•    Trials have found that ticagrelor is more effective than clopidogrel in reducing cardiovascular events in people taking low dose aspirin.

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