VIXAM 75MG POLFARMEX AYTHOTH ROOM ROOMS (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Clopidogrel
Ingredient
| Composition information | Content |
| Clopidogrel | 75mg |
Uses
Indications
75 mg VIXAM drug is indicated in the precaution of arterial thrombosis in the following cases:
ATC code: B01AC-04.
Clopidogrel is a precursor, one of the metabolites that inhibit platelet aggregation.
Clopidogrel must be metabolized by CYP450 enzyme to produce metabolites that inhibit platelet aggregation. Clopidogrel's active metabolites inhibit the ability of Adenosine Diphosphate (ADP) and P2Y12 platelet and active substance through ADP intermediaries of GPILB / IIIA Glycoprotein complexes, thus inhibiting platelets.
Due to the irreversible cohesion, platelet activity is affected by their life (about 7-10 days) and restoring normal platelet function occurs at a speed in accordance with platelet changes.
Platelet gathering caused by non -ADP agreeders is also inhibited by preventing ADP's platelet activation amplifier.
Because the metabolites are formed by CYP450 enzyme, some red in red is polymorphic or inhibited by other drugs, not all patients respond to platelet inhibitors.
The dose of 75 mg per day significantly produces ADP due to platelet aggregation from the first day, this effect increases and reaches a stable state from the 3rd and 7th day. In a stable state, the average inhibition level is observed with a dose of 75 mg daily from 40% to 60%.
Platelet gathering and bleeding time gradually return to the basic value, usually within 5 days after the stop treatment.
pharmacokinetic
absorption
After using the single oral dose and repeated 75 mg daily, Clopidogrel is quickly absorbed.
Clopidogrel's peak concentration does not change (about 2.2 - 2.5 mg/ml after taking a single dose of 75 mg oral) occurs about 45 minutes after taking the drug. Absorb at least 50%, based on the metabolites of clopidogrel excretion of urine.
distribution
Clopidogrel and main metabolites (inactive) are associated with plasma proteins that are constrained in reversible metabolites with the corresponding ratio of 98% and 94% in in vitro tests. Conducting non-saturated plasma-protein in Vitro tests on a wide range of concentrations.
transformation
Clopidogrel is widely metabolized in the liver. In vitro and in vivo, clopidogrel are metabolized in two main paths: one intermediate by the esterization and leads to hydrolyzed into carboxylic acid without active arising (85% of metabolites), and an intermediary by a lot of cytochrome P450.
The first clopidogrel transforms into 2-Tlopidogrel intermediate conversion. After that, the metabolism of the intermediate results of 2-oxo-clopidogrel metabolites formed the metabolites, a derivative of clopidogrel.In vitro, this path transformed intermediate by CYP3A4, CYP2C19, CYP1A2 and CYP2B6. Active thiol metabolites have been isolated in vitro, quickly and indispensable with platelet recovery, thus inhibiting platelet aggregation.
Elimination
After a dose of Clopidogrel, there is a 14C isotope in men, about 50% of the drug is excreted in the urine and about 46% of the drug is excreted in the feces for about 120 hours after taking the drug.
After taking a single dose of 75 mg, Clopidogrel has a sale time of about 6 hours. The sale time of the metabolites is 8 hours after the only dose and repeated.
Special patient group
The pharmacokinetics of clopidogrel metabolites are not known in these special populations.Patients with renal failure
After repeating the daily clopidogrel of Clopidogrel 75mg in patients with severe renal disease (clearing 5 - 15 ml/minute creatinin), ADP's platelet aggregation inhibits (25%) compared to observations found in healthy people, however, the prolonged bleeding time is similar to that in healthy people using 75 mg Clopidogrel every day.
In addition, good clinical response to all patients.
Patients with liver failure
After repeating the dose of Clopidogrel 75 mg daily for 10 days in patients with severe hepatic failure, inhibiting platelet aggregation due to ADP observed is similar to healthy people.
Average bleeding is similar in two groups.
Before taking VIXAM 75MG POLFARMEX AYTHOTH ROOM ROOMS (3 blisters x 10 tablets)
How to use
75 mg VIXAM drugs are taken orally.
Dosage
Adults and the elderly
Clopidogrel should be used 1 single dose of 75 mg/day in or away from meals.
In patients with acute coronary syndrome
Acute coronary heart syndrome does not have a difference of ST segment (unstable angina or q -wave myocardial infarction): Treatment should start with a single dose of Clopidogrel 300 mg and then continue to maintain 75 mg daily with acetylsalicylic acid (ASA) 75 - 325 mg daily). When using a higher dose of Asa, the risk of high bleeding is also higher, so the ASA dose is not higher than 100 mg.
Acute myocardial infarction with a difference of ST segment: Clopidogrel should be used a single daily dose of 75 mg starting to use a loading dose of 300 mg of ASA for patients with or without thrombosis. For patients over 75 years old, Clopidogrel has the starting dose without a load dose. Combining treatment should be started as soon as possible after symptoms appear and continue for at least four weeks.
kidney failure
Experience in limited treatment in patients with renal impairment.
Hepatic failure
Experience in limited treatment in patients with liver disease may have organs.
Children
The safety and effectiveness of clopidogrel in children and adolescents have not been established.
Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.
What to do when overdose? Appropriate treatment should be considered if bleeding is observed. There is no detoxification of clopidogrel. Should promptly adjust the prolonged bleeding time, platelet transmission can oppose the effect of clopidogrel.
In an emergency, call the 115 emergency center immediately or go to the nearest local health station.
What to do when forgetting a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.
Side Effects
When using 75 mg VIXAM, you may experience unwanted effects (ADR).
The adverse reaction occurred one of the reported clinical studies presented in the table below. The frequency of the adverse adverse reactions is determined by the following convention: Very popular (1/100 to
In each system of organs, the side effects of the drug are presented seriously in the order of gradual decrease.
Popular
Rare
When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
VIXAM 75 mg contraindicated drug in the following cases:
Precautions when using
bleeding and hematological disorders
Due to the risk of bleeding and unwanted effects on hematology, other appropriate measures to determine calculation and/or testing must be promptly considered whenever the symptoms of bleeding process have.
Like other anti-platelets, clopidogrel should be cautious in patients at risk of increased bleeding from trauma, surgery or other pathology and in patients treated with Asa, heparin, Glycoprotein ilb/IIIA inhibitors or nonsteroidal anti-inflammatory drugs including COX-2 inhibitors.
Patients should be carefully monitored for any signs of bleeding including hidden bleeding, especially in the first weeks of treatment and/or after heart or surgical procedure. Clopidogrel's simultaneous treatment with oral anticoagulant is not recommended as it can increase bleeding.
If the patient is about to undergo surgery and the function of temporary platelets is not as usual, it is necessary to stop using Clopidogrel 7 days before surgery. Patients should notify the doctor and dentist about the use of clopidogrel before the surgery and before taking any other medicine.
Clopidogrel extends the bleeding time and should be used carefully in patients with lesions that tend to bleed (especially digestion and intraocularity).
Patients should be indicated that it may take more time than usual to prevent bleeding when using clopidogrel (single or combined with ASA), and should report to the doctor if any abnormal bleeding (position or time).
Object of thrombocytopenia (TTP)
Blood thrombocytopenia (TTP) has been reported in cases that rarely use clopidogrel, sometimes after short contact time.
Symptoms are characterized by thrombocytopenia and related capillary hemolysis or identifying nerves, renal or fever dysfunction.
TTP is a symptom of death that needs timely treatment including plasma red blood cell separation.
Just undergoing ischemic stroke
Due to lack of data, Clopidogrel may not be recommended in the first 7 days after acute ischemic stroke.
Cytochrome P450 2C19 (CYP2C19)
For patients with normal CYP2C19 function. When Clopidogrel is partially metabolized into metabolites operating by CYP2C19, the use of enzyme inhibitors inhibitors will lead to a decrease in the concentration of the metabolic metabolites of Clopidogrel.
Clinically related to this interaction is uncertain. Simultaneously using CYP2C19 inhibitors should not be used (see a list of CYP2C19 inhibitors).
kidney failure
Experience treatment with clopidogrel is limited to patients with renal failure. Therefore, Clopidogrel should be used carefully in these patients.
Hepatic failure
Experience is limited to patients with liver disease that can have organs. Clopidogrel therefore should be used carefully in these patients.
excipients
Vixam contains lactose. Patients with rare genetic problems of galactose tolerance, Lapp Lactase deficiency or malposure-galactose should not be used.
Medicines containing hydrogenated castor oil can cause abdominal pain and diarrhea.
The ability to drive and operate machinery
Clopidogrel does not affect the ability to operate machinery and trains.
Pregnancy
When there is no clinical data on the use of clopidogrel during pregnancy, so Clopidogrel should not be used during pregnancy. Animal studies do not indicate directly or indirect effects on pregnancy, embryo/fetal development, birth or development after birth.
Breastfeeding period
There is still no evidence of clopidogrel excreted into breast milk. Animal studies have shown Clopidogrel's excretion in breast milk. Therefore, during breastfeeding should not be treated with Vixam.
Medicinal interaction
Anticoagulant drugs
Concomitance Clopidogrel use with oral anticoagulant is not recommended because it can enhance bleeding.
Glycoprotein IIB/IIIA inhibitors
Clopidogrel should be used cautiously in patients when using Glycoprotein ILB/IIIA inhibitors.
acetylsalicylic acid (ASA)
ASA does not change the effect of inhibiting platelet gathering through the intermediary ADP of Clopidogrel, but ASA is at risk of changing the inhibitory effect of the plateloon collection of clopidogrel through collagen. However, simultaneously indicated ASA 500 mg twice a day in a day does not significantly increase the prolonged bleeding time of clopidogrel.
A pharmacological interaction between clopidogrel and acetylsalicylic acid is possible, leading to an increased risk of bleeding. Therefore, simultaneous use must be conducted carefully. However, Clopidogrel and ASA have been indicated simultaneously until one year.
heparin
In a clinical study conducted in healthy people, clopidogrel did not require changes, supplementing heparin or changing heparin's blood clotting effects.
Concomitant use of chodopigrel with heparin does not have the effect of inhibiting platelet aggregation. A pharmacological interaction between clopidogrel and heparin is possible, leading to an increased risk of bleeding.
Therefore, use simultaneously must be conducted cautious.
Blood solubility
Safety of clopidogrel indications, fibrin or fibrin -free medications and heparins have been observed in acute myocardial infarction patients.
The clinical bleeding rate is similar to observations found in patients using thrombolytic and heparin medications simultaneously with ASA.
Non -steroid anti -inflammatory drugs (NSAIDs)
In a clinical study conducted in healthy volunteers, simultaneously indicated Clopidogrel and Naproxen increased hidden blood loss of gastrointestinal tract.
However, due to the lack of interactive studies with other NSAID drugs, it is unclear whether there is an increase in the risk of gastrointestinal bleeding with all NSAIDs.
Therefore, it is careful to simultaneously indicate NSAIDs including COX-2 and clopidogrel inhibitors.
Other treatment coordination
Clopidogrel is partially metabolized into active metabolites by CYP2C19, using enzyme inhibitors that will lead to a decrease in the concentration of the active metabolites of clopidogrel.
Clinically related to this interaction is uncertain.
Therefore should not use CYP2C19 inhibitors. CYP2C19 inhibitors include Omeprazole and Esomeprazole, Fluvoxamine, Fluoxetine, Moclobemide, Voriconazole, Fluconle, Ticlopidine, Ciprofloxacin, Cimetidine, Carbamazepine, Oxcarbazepine and Chloramphenicol.
Other drugs
Some clinical studies have been conducted with clopidogrel and other drugs prescribed simultaneously to investigate pharmacokinetic and pharmacokinetic interaction capabilities. Clinically significant pharmacological interaction when indicating clopidogrel simultaneously with Atenolol, Nifedipine or both Atenolol and Nifedipine. Moreover, Clopidogrel's pharmacological effects do not affect significantly when indicated with phenobarbital or estrogen.
Digorative pharmacokinetics of Digoxin or Theophylline is not changed when coordinated with clopidogrel. The antacids do not change the level of clopidogrel absorption.
Data from studies on human liver microsome shows that clopidogrel's carboxylic acid metabolites can inhibit the activity of Cytochrome P450 2C9. This can lead to increased plasma concentrations of drugs such as phenytoin, tolbutamide and NSAIDs, metabolized by Cytochrome P450 2C9.
Storage
Store less than 30 ° C, avoid moisture and light.
Expiry date: 24 months from the date of manufacture. Do not use overdue drugs stated on the packaging.
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