Pidocar 75mg pymepharco tablets prevent arterial thrombosis (2 blisters x 14 tablets)
Dosage form Box of 2 blisters x 14 tablets
Specifications Clopidogrel
Ingredient
| Composition information | Content |
| Clopidogrel | 75mg |
Uses
indications
pidocar medicine is indicated in the following cases:
Preventive events caused by clopldogrel arterial thrombosis
is indicated in: patients myocardial infarction (from a few days to less than 35 days), stroke caused by ischemic (from 7 days to less than 6 months) or peripheral artery disease was established.
Patients with acute coronary syndrome
In patients with adults with atrial fibrillation, there is at least one risk factor for vascular events, not suitable for treatment with vitamin K (VKA) and those who are less at risk of bleeding. Clopidogrel is indicated in combination with ASA for the part of the thrombosis and blood thrombosis, including a stroke.
Pharmacokinus
Clopidogrel is a precursor, one of its metabolites is the inhibitor of platelet aggregation. Clopidogrel must be metabolized by CYP450 enzymes to form metabolites that inhibit platelets. Clopidogrel's active metabolites selectively inhibit the attachment of adenosin diphosphate (ADP) with platelet's P2YI2 receptor, and thereby inhibit the activity of Glycoprotein GPIIB/LLA complex via ADP intermediaries, thus inhibiting platelet aggregation.
Due to the irreversible cohesion, these platelets are affected for the rest of their lifetime (about 7-10 days) and normal platelet function recovery that occurs at a speed in accordance with platelet movement. The platelet collection caused by non -ADP -owned subjects is also inhibited by the blocking effect of platelet activation from ADP release.
Due to the active metabolic substance formed by CYP450 enzymes, some of which have been shaped or the object is inhibited by other drugs, so not all patients achieve adequate platelet inhibition.
Pharmacological effectiveness
Dosage of 75 mg per day significantly inhibits platelet aggregation due to ADP from the first day; This inhibition is increasing and achieving a stable state between 3 to 7. In a stable state, the average inhibitor level is 75 mg daily in about 40% and 60%. Platelet's collection and bleeding time gradually return to the basic value, usually within 5 days after stopping treatment.
Pharmacokinetics
absorption
After taking the only dose or repeating 75 mg/day, Clopidogrel is quickly absorbed. The average peak concentration in the plasma of Clopidogrel does not change (about 2.2 - 2.5 ng/ml after taking a single dose of 75 mg) reached about 45 minutes after drinking. The absorption rate is at least 50%, based on the excretion of the metabolites of clopidogrel in the urine.
Distribution
Clopldogrel and the main metabolite (inactive) in vitro reversible with human plasma proteins (in order of 98% and 94%). In Vito unsaturated cohesion occurs with a wide range of concentrations.
Metabolism
Clopidogrel is widely metabolized in the liver. In vitro and in vivo, clopidogrel are metabolized in two main metabolic paths: one through the intermediary of the esterase and leads to the hydrophobia into the carboxyllc acid that is not active (85% of the amount of metabolites in the blood), and an intermediary with many cytochrom P450.
Clopidogrel is first metabolized into 2-oxo-clopidogrel metabolites. The next metabolism of intermediate metabolites 2-olo-clopidogrel leads to the formation of activated metabolites, a clopidogrel. In vitro, this transformation line is through intermediaries CYP3A4, CYP2C19, CYP1A2 and CYP2B6. The thiol metabolites are active, have been isolated in vitro, quickly united with platelets, thereby inhibiting platelets.
CMAX of metabolites is 2 times higher after using Clopidogrel a single dose of 300 mg as well as after 4 days of maintenance dose of 75 mg. CMAX reached about 30 to 60 minutes after taking the drug.
Elimination
In humans, after taking a dose of Clopidogrel is marked with 14C, about 50% is excreted in the urine and about 46% is excreted in the stool for 120 hours after drinking. After taking a single dose of 75 mg, Clopidogrel has a half -life of approximately 6 hours. The sale time of the main metabolite (inactive) during the circulation is 8 hours after the single dose and the dose repeated.
genetic pharmacy
Clopidogrel is activated by multiple polymorphic CYP450 enzymes. CYP2C19 is involved in the formation of active metabolites and intermediate metabolites 2-olo-clopidogrel. The pharmacokinetics of metabolites are active of clopidogrel and anti -platelet effects, measured by EX Vivo platelet trial, different depending on the CYP2C19 genotype.
Allen CYP2C19*1 corresponds to the complete metabolic function while the Allen CYP2C19*2 and CYP2C19*3 corresponds to a decrease in metabolism. Allen CYP2C19*2 and CYP2C19*3 accounts for 85% of the number of Allen reduced functions in poorly metabolized white people and 99% in poor Asian metabolic. Other Allenes associated with the lack or reduction include CYP2C19 *4, *5, *6, *7 and *8, but these Allenes are less common in the common population.
A patient with poor metabolic condition will have 2 functions reducing function as defined above. The frequency of published for poor metabolic CYP2C19 genotypes is about 2% for white people, 4% for Den people and 14% for Chinese people. Examining tests to determine the patient's CYP2C19 genotype.
Special subjects
The pharmacokinetics of clopidogrel metabolites are not well known in these special objects.
kidney failure
After the doses of chloroography repeat 75 mg/day on severe renal failure objects (clearing creatinine from 5 to 15 ml/minute), inhibiting platelet aggregation caused by ADP lower (25%) compared to healthy objects. However, the extension of the bleeding time is similar to being seen on healthy people using Clopidogrel 75mg/day. In addition, clinical tolerance in patients is good.
Hepatic failure
After the repeated doses of Clopidogrel 75 mg/day for 10 days in patients with severe hepatic impairment, the inhibitory effect of platelet aggregation caused by ADP is similar to that of healthy objects. The effect of prolonging the average bleeding time is similar between the two groups.
Race
The current ratio of Allen CYP2C19 causes the intermediate and poor metabolism of different CYP2C19 depending on the race. In literature, there are only limited figures on Asian populations to assess the clinical significance of determining the genotype of this CYP on the clinical consequences of events.
Before taking Pidocar 75mg pymepharco tablets prevent arterial thrombosis (2 blisters x 14 tablets)
How to use
use oral, maybe with food or not.
Do not chew, break or crush the pill but have to swallow the whole tablet.
Dosage
Adults and the elderly
Clopidogrel is recommended at a single dose of 75 mg/day.
In patients with acute coronary syndrome
Acute coronary syndrome does not have a difference of ST segment (unstable angina or myocardial infarction without Q wave), it is advisable to start clopidogrel treatment with a single dose of 300 mg used only and then continue at a dose of 75 mg once a day (combined with ASA 75 - 325 mg daily).
The higher the dose of ASA, the higher the risk of bleeding, therefore, do not use ASA at a dose exceeding 100 mg. Optimal treatment time has not been officially defined. Clinical test data supports the use of up to 12 months, and the maximum benefit is recorded from the 3rd month.acute myocardial infarction has a difference of ST segment
start treatment with Clopidogrel at a single dose of 75 mg used only after the beginning of the treatment with a 300 mg loaded dose combined with ASA and with or without fiber pepper. In patients over 75 years old, do not use the dose at the beginning of treatment. Combined therapy should be started as soon as possible after the beginning of symptoms and continue to maintain for at least 4 weeks. Benefits of the combination of clopidogrel and ASA after 4 weeks have not been studied.
Patients with atrial fibrillation
Should start treatment with clopidogrel at a single dose of 75 mg used single. ASA (75 - 100 mg per day) should be started and continue in the form of a therapy combined with clopidogrel.
Children
Clopidogrel should not be used in children because of the unknown effectiveness.
kidney failure
Experience is limited in patients with renal failure.
Hepatic failure
Experience is limited in patients with average liver disease - who may bleed.
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 using overdose? There is no specific treatment and the patient recovers without leaving sequelae. In healthy people when using a single dose of 800 mg of clopidogrel, bleeding time increases by 1.7 times compared to the only dose of 75 mg/day.
There is no specific antidote, platelet transmission may limit the effect of clopidogrel.
What to do when you forget 1 dose? If you forget to take medicine for more than 12 hours, just take the next dose at the usual time. Do not double the dose to compensate for the forgotten dose.
Side Effects
When using pidocar medicine , you may experience unwanted effects (ADR).
Blood disorders and lymphatic systems
Very rare, unknown: Platelet hemorrhage committee (TTP), anemia is anemia, reduces all bloody blood, granulocytosis, severe thrombocytopenia, type of bleeding disease is category A, decreased granulocytes, anemia.
Heart rebel basket
immune system disorders
Mental disorders
Nervous system disorders
Uncommon: Bleeding in the skull (some cases reported as death), headache, paresthesia, dizziness.
Eye disorders
Vascular disorders
Respiratory, chest and mediastinum disorders
Gastrointestinal disorders
Rare: post -abdominal bleeding. Very rare, unknown: Stomach bleeding and post -abdominal peritoneal, pancreatitis, colitis, stomatitis. Liver disorder Skin and subcutaneous skin disorders Uncommon: rash, itching, skin bleeding (bleeding). Very rare, unknown: blistering dermatitis (poisoned epidermal necrosis, Stevens Johnson syndrome, diverse roses), angioedema, medication syndrome, medication syndrome with acid -preferred leukemia and many systemic symptoms (dress), redness or peeling, urticaria, eczema, flat lichen. musculoskeletal disorders, connective tissue and bone Kidney and urinary disorders General disorders Other research Instructions on how to handle ADR Periodically monitor the parameters of signs of anemia, hemoglobin, hematocrit during clopidogrel treatment. Replacement of emergency plasma in case of thrombocytopenia. 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
Pidocar medicine contraindicated in the following cases:
Patient severe liver failure .
Pregnant or lactating women.
Caution when using
bleeding disorders and hematology
Due to the risk of bleeding and adverse hematological reactions, the determination of the number of blood cells and/or other tests should be considered for conducting whenever clinical symptoms occur during treatment. Like other platelet anti-platelets, Clopidogrel should be used carefully in patients with increased risk of bleeding due to trauma, surgery or other pathological conditions and in patients treated in combination with aspirin, heparin, Glycoprotein ilb/IIIA or nonsteroidal anti-inflammatory drugs (NSAID) including COX-2 or Serotonin inhibitors (SSRI).
Patients should be carefully monitored with signs of hemorrhage including hidden bleeding, especially in the first weeks of treatment and/or after surgery or cardiac intervention. The simultaneous use of clopidogrel with oral anticoagulant is not recommended because it increases the level of bleeding.
If a patient is preparing for surgery without wanting to have platelet resistance, Clopidogrel should be stopped 7 days before surgery. Patients should notify the doctor and dentist to know that Clopidogrel is using the surgery and before using any new drug. Clopidogrel prolongs bleeding time and should be used cautiously in patients with trauma tend to bleed (especially the stomach and intraocularity).
Patients should know that it may take more time to stop the bleeding when they use clopidogrel (single or combined with aspirin) and should notify abnormal bleeding (position and time) to the doctor.
thrombocytopenic hemorrhage (TTP)
thrombocytopenic hemorrhage (TTP) has been reported very rare after using clopidogrel, sometimes short after contact. Characteristic is platelets and hemolysis of capillary hemolysis or with neurological disorders, kidney dysfunction or fever. TTP has a high risk of death requires timely treatment including plasma separation.
Difficult hematoma
Hard -free hematoma has been reported after using clopidogrel. In case the thromboplastin time is long -lasting, there is or without bleeding, the hemorrhage is difficult to coagulate, so it should be considered. Patients with diagnosis determined that difficulty clotting blood must be managed and treated by experts, and should stop using clopidogrel.
Recent stroke
Clopidogrel is not recommended in the first 7 days after acute stroke.
Cytochrom P450 2C19 (CYP2C19)
In patients with less enzymes to transfer CYP2C19, using clopidogrel at the recommended dose to create less metabolites and have less effect on platelet function. Conduct tests to determine the patient's CYP2C19 genotype.
Because Clopidogrel is converted into metabolites operating through CYP2C19, using enzyme inhibitors is expected to reduce the activity concentration of clopidogrel. Clinically, this interaction is unclear. Do not use CYP2C19 inhibitors simultaneously or fit Clopidogrel.
Cross reactions between thienopyridin
Patients need to be assessed for hypersensitivity to thienopyridin (such as clopidogrel, ticlopidin, prasugrel) because of the cross -reaction between the Thienopyridin has been reported. Thienopyridine can cause mild to severe allergic reactions such as rash, angioedema or hematological reactions such as thrombocytopenia and neutropenia. Patients who have an allergic reaction and/or hematological reaction with a thienopyridine may increase the risk of appearing with or another reaction with other Thienopyricin. Should monitor hypersensitive signs in patients allergic to thienopyridin.
Patients with renal failure
Experience treatment with clopidogrel is limited in patients with renal failure. Therefore, Clopidogrel should be used cautiously in these patients.
Patients with liver failure
Experience is limited in patients with average liver disease that may be bleeding. Therefore, Clopidogrel should be used cautiously in these patients.
excipients
The drug contains lactose. Patients with rare genetic problems are galactose intolerance, lactase lack of lactase or Glucose - Galactose should not use this drug.
The ability to drive and operate machinery
clopidogrel does not affect the ability to drive machinery.
Pregnancy
There is no clinical data on the use of clopidogrel during pregnancy, not using clopidogrel during pregnancy. Animal research does not show direct or indirect harm to pregnancy, embryo/fetal development, birth or postpartum development.
Nursing period
unknown whether clopidogrel is excreted in breast milk or not. Animal studies have shown Clopidogrel's elimination in breast milk. Do not breastfeed during treatment with clopidogrel.
Interactive drug
oral anticoagulant drugs
Concomitance Clopidogrel and oral anticoagulant drugs are not recommended because it can increase the level of bleeding. Although Clopidogrel 75 mg/day does not change the pharmacokinetics of s-warfarin or INR in patients treated with long-term warfarin, simultaneous use of clopidogrel and warfarin increases the risk of bleeding because of the independent effect on blood clots.
Glycoprotein ilb/IIIA inhibitors
Use carefully clopidogrel in patients who are using Glycoprotein inhibitors Ilb/IIIA.
Acetylsalicylic acid (aspirin)
Aspirin does not change the intermediate inhibition of clopidogrel on ADP - platelet collection agent but clopidogrel is likely to affect aspirin on collagen - platelet collection agent. However, simultaneously using clopidogrel with Aspirin 500 mg twice a day for a day does not significantly increase the extension of bleeding time caused by clopidogrel.
There may be pharmacokinetic interactions between clopidogrel and aspirin, resulting in an increased risk of bleeding. Therefore, simultaneous use of clopidogrel and aspirin should be cautious. However, clopidogrel and aspirin have been used together for 1 year.
heparin
In a clinical study conducted in healthy people, the use in combination with clopidogrel does not need to change heparin's doses or change heparin's blood clotting effects. Simultaneous use of heparin does not affect the inhibition of platelet collection of clopidogrel. There may be pharmacokinetic interactions between clopidogrel and heparin, leading to an increased risk of bleeding. Therefore, simultaneous use of heparin and clopidogrel should be cautious.
Hematoma pills
Safety when using clopidogrel with selective or non -selective medications of fibrin and heparin has been evaluated in acute myocardial infarction patients. The clinical bleeding rate is similar when the thrombolytic and heparin drugs are treated simultaneously with aspirin.
nsaids
In a clinical study conducted in healthy volunteers, simultaneously used clopidogrel and Naproxen, increasing hidden gastrointestinal hemorrhage. However, due to the lack of interactive research with other NSAIDs, whether Clopidogrel is unknown, increases the risk of gastrointestinal bleeding with all NSAIDs. Therefore, be careful when using simultaneously NSAIDs including Cox-2 inhibitors with clopidogrel.
Selective absorption inhibitors Serotonin - SSRIs
Because SSRI affects platelet activation and increases the risk of bleeding, simultaneous use of SSRI with clopidogrel should be cautious.
Other treatment coordination
Because clopidogrel metabolizes partially into active metabolites via CYP2C19. The use of these enzyme inhibitors is at risk of reducing the concentration of clopidogrel metabolic metabolites. The clinical involvement of this interaction is unclear. To prevent, the simultaneous use of clopidogrel and the strong or medium CYP2C19 inhibitors should be limited.
Strong or medium CYP2C19 inhibitors include: omeprazol and esomeprazol, fluvoxamin, fluoxetin, moclobemid, voriconazole, fluconazol, ticlopidin, carbamazepine and efavirenz.
Proton pump inhibitors (PPI)
Use omeprazol 80 mg once a day and time clopidogrel or 12 hours apart, reducing the exposure to the active metabolitus of clopidogrel by about 45% (compared to the starting dose) and 40% (compared to the maintenance dose). The inhibition of platelets decreased by about 39% (compared to the starting dose) and 21% (compared to the maintenance dose). Esomeprazol is expected to create similar interactions with clopidogrel.
Data on clinical impact of pharmacokinetics (PK)/Pharmacokinetic (PD) on cardiovascular events are reported from inconsistent observation and clinical research. To be cautious, it is not recommended to simultaneously use clopidogrel with omeprazol or esomeprazol.
Observed pantoprazol or Lansoprazol less in contact with clopidogreled metabolites.
Simultaneously using 80 mg Pantoprazol 1 time/day with clopidogrel reduces the plasma concentration of the activity of clopidogrel 20% (compared to the starting dose) and 14% (compared to the maintenance dose). This is related to the average average platelet aggregation inhibition of 15% and 11%. This result shows that it can be used simultaneously clopidogrel with pantoprazol.
There is no evidence that other drugs reduce stomach acid such as H2 blockers or antacids interacting with platelet resistant activity of clopidogrel.
Other drugs
There have been a number of other clinical studies using Clopidogrel in combination with other drugs to observe the pharmacokinetic and pharmacokinetic interaction. There is no clinical interaction with pharmacological significance when used in combination with clopidogrel with Atenolol and Nifedipine, or both Atenolol and Nifedipln. Moreover, Clopidogrel's pharmaceutical activity is not significantly affected when used in combination with phenobarbital or estrogen.
Digor pharmacokinetics of Digoxin or theophylllin are not changed when combined with clopidogrel. Stomach antacids do not change the level of clopidogrel absorption.
Data from Caprie studies shows that Phenytoin and Tolbutamid are metabolized by CYP2C9 that can be combined safely with clopidogrel.
CYP2C8 substrate
Clopidogrel increases the level of contact with repaglinid in healthy volunteers. In vitro research shows that the increase in contact with repaglinid is due to CYP2C8 inhibitors by Clopidogrel's glucuronid metabolites. Due to the risk of increased plasma concentrations, it is careful to use clopidogrel with the main metabolic drug mainly by CYP2C8 (such as Repaglinid, Paclitaxel).
In addition to the specific drug interaction information described above, studies on interaction between clopidogrel and some drugs often used in patients with thrombosis due to atherosclerosis have not been done. However, patients who are included in clinical trials that use clopidogrel have also been used simultaneously with other drugs including diuretics, beta blockers, angiotensin transfer enzyme inhibitors, calcium channel blockers, cholesterol -reducing drugs, coronary pills, diabetes treatments (including insulin), anti -experience drugs and LLA anti -GPIB/LLA Clinical significance.Storage
Store in a dry place, avoid light, temperature below 30 ° C.
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