Clopidogrel Stada 75mg drug prophylaxis due to arterial thrombosis (2 blisters x 14 tablets)
Dosage form Box of 2 blisters x 14 tablets
Specifications Clopidogrel
Ingredient Myocardial infarction, coronary artery disease, psoriasis
Ingredient
| Composition information | Content |
| Clopidogrel | 75mg |
Uses
indications
Periodic thrombosis prevention
Clopidogrel Stada 75mg is indicated in:
Patients with myocardial infarction (from a few days to less than 35 days), stroke due to ischemia (from 7 days to less than 6 months) or peripheral artery disease was established.
Patients with acute coronary syndrome:
Preventing the events of atherosclerosis and blood thrombosis in the atrial fibrillation
In patients with adults with atrial fibrillation, there is at least one risk of blood vessel events, not suitable for treatment with vitamin K anti -vitamin (VKA) and those who are less at risk of bleeding, clopidogrel is indicated in combination with ASA for prevention of thrombosis and blockage thrombosis, including stroke.
Pharmacology
Clopidogrel is a platelet aggregation inhibitor due to selective inhibition of attaching adenosine diphosphate (ADP) to its receptor in platelets. Clopidogrel also inhibits platelet training due to co -transportation elsewhere in addition to the amplification of platelet activation from ADP release. Clopidogrel is acting by non -recovery of platelet recovery. Platelet's collection and bleeding time gradually returning to the basic value, within 5 days after stopping treatment.
The safety and effectiveness of clopidogrel in preventing ischemic complications in the blood vessels have been identified in some studies in patients with stable angina, peripheral artery diseases have been established. Clopidogrel significantly reduces the incidence of ischemia (myocardial infarction, ischemic stroke and blood vessel deaths).
Dynamic 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 mg/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
Clopidogrel and main metabolites (inactive) in the blood binding in vitro in vitro with human plasma proteins (in order of 98% and 94%). In Vito unsaturated cohesion occurs with a wide range of concentrations.
transformation
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 carboxylic acid derivative inexperienced (85% of the amount of metabolites in the blood) and an intermediary with multiple cytochrome P450. Clopidogrel is first converted into 2-oxo-clopidogrel metabolites. The next metabolism of intermediate metabolites 2-oxo-clopidogrel leads to the formation of active metabolites, a conductor conductor of clopidogrel.
In vitro, this metabolic 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 is reached about 30 - 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 the only 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 platelet resistant effects, measured by Ex vivo platelet set test, varies depending on the CYP2C19 genotype. Allen CYP2C19*1 corresponds to fully metabolic function while the Alien CYP2C19*2 and CYP2C19*3 corresponds to a decrease in metabolism. The Alien CYP2C19*2 and CYP2C19*3 accounts for 85% of the number of Alien reduces the function of poorly metabolized and 99% in poor Asians.
Other Allenes associated with the lack of metabolism include CYP2C19M, *5, *6, *7 and *8, but these Allenes are less common in the common population. A patient with poor metabolism will have 2 alien functions as defined above. The frequency of published for poor metabolic CYP2C19 genotypes is about 2% for white people, 4% for black 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.
Renal failure: After the doses of clopidogrel repeat 75 mg/day on severe renal failure objects (clearing creatinine from 5 - 15 ml/minute), the effect of inhibiting platelet aggregation caused by ADP is lower (25%) compared to healthy subjects, however, the extension of the same bleeding time as seen on healthy people uses Clopidogrel 75 mg/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, inhibiting 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 the Alien 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 Clopidogrel Stada 75mg drug prophylaxis due to arterial thrombosis (2 blisters x 14 tablets)
How to use
use oral, may be 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 for a single dose of 75 mg/day.
In patients with acute coronary syndrome:
In patients with atrial fibrillation, Clopidogrel should be started at 75 mg single -dose. ASA (75 - 100 mg per day) should be started and continue in the form of a therapy combined with clopidogrel.
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?
What to do when you forget 1 dose?
If you forget to take the 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.
Pediatric: Clopidogrel should not be used in children because of the unknown effectiveness.
Renal failure: Experience is limited in patients with renal failure.
Liver failure: Experience is limited in patients with liver disease that can be bleeding.
Side Effects
Safety summary: Clopidogrel's safety has been assessed over 44,000 patients participating in clinical studies, of which more than 12,000 patients treated for 1 year or more. The general intake of Clopidogrel 75 mg/day is similar to Asa 325 mg/day in Caprie studies regardless of age, gender or race. Clinical significant adverse reactions are recorded in Caprie, Cure, Clarity, Commit and Active-A research below. In addition to experience from clinical studies, adverse reactions are also spontaneously reported.
Bleeding is the most common side effect reported mainly in the first month of treatment, both in clinical studies as well as in reports after circulation.
In Caprie study, in patients treated with clopidogrel or ASA, the general bleeding rate for any type of bleeding is 9.3%. The proportion of serious cases is similar to clopidogrel and ASA.
In Cure research, Clopidogrel and ASA combined not causing excessive bleeding within 7 days after coronary coronary surgery in patients who stop treatment for more than 5 days before surgery. In patients still treated within 5 days of bridge surgery, the incident rate is 9.6% of the clopidogrel group in combination with ASA and 6.3% in the placebo group in combination with ASA.
In Clarity study, in general, there is a phenomenon of increasing bleeding rate in the clopidogrel group in collaboration with ASA compared to the placebo group in combination with ASA. This ratio is similar in two groups when grouping the patient according to the initial characteristics, the method of fiber options or whether it is treated with heparin or not.
In the commit study, the rate of severe common bleeding without brain bleeding or brain bleeding is low and the same in both groups.
In Active-A study, the greater bleeding rate in the clopidogrel group in collaboration with Asa compared to the placebo group in collaboration with ASA (6.7% compared to 4.3%). Severe bleeding mainly originates in both groups (5.3% in the clopidogrel group in combination with ASA; 3.5% in the placebo group in collaboration with ASA), mainly through the gastrointestinal tract (3.5% compared to 1.8%). There is excessive intracranial bleeding in the group using clopidogrel in combination with ASA compared to the placebo in collaboration with ASA (equivalent to 1.4% compared to 0.8%). There is no statistically significant difference in the mortality rate due to bleeding (1.1% in the group using clopidogrel in combination with ASA and 0.7% in the placebo group in collaboration with ASA) and bleeding stroke (0.8% and 0.6%) between groups.
The adverse reactions may occur in clinical studies or have been reported spontaneously presented below.
The frequency is determined as follows: Common (1/100 to 1/1000 to 1/10,000 to
Blood disorders and lymphatic systems
Very rare: you hemorrhage reduced thrombocytopenia (TTP), anemia inexplicable, reduced all bloody blood, granulocytosis, severe thrombocytopenia, difficulty blood with type A, granulocytopenia, anemia.
immune system disorders
Mental disorders
Nervous system disorders
Very rare: taste disorders. Less eye disorders: Eye bleeding (conjunctiva, eye, retina).
Disorders of ears and mesmerizing
Blood vessel disorders
Very rare: serious bleeding, surgical wound bleeding, vasculitis, hypotension.
Respiratory disorders, chest and mediastinum
Very rare: respiratory bleeding (coughing blood, pulmonary bleeding), bronchospasm, interstitial pneumonia, Eosin leukemia.
Gastrointestinal disorders
Very rare: gastrointestinal bleeding and post -peritoneal death, pancreatitis, colitis (including colon or colitis increased lymphocytes), stomatitis.
Liver disorders - bile
Skin and subcutaneous skin disorders
Uncommon: rash, itching, bleeding skin (bleeding). Very rare: Water polished dermatitis (toxic epidermal necrosis, Stevens - Johnson syndrome, diverse pink you, acute all -body pustules (AGEP), angioedema, drug -sensitive syndrome, drug syndrome with eosemagic hyperthyroidism and many general symptoms of body (Dress), pink rash or peeling. Reproductive and mammary system disorders musculoskeletal disorders, connective tissue and bone Magic and urinary disorders Very rare: glomerulonephritis, increased blood creatinine. General disorder Very rare: Fever. Biochemical index Notice immediately to the doctor or pharmacist the harmful reactions encountered when using the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
contraindicated
Caution when using
bleeding disorders and hematology
Due to the risk of bleeding and adverse hematological effects, in the course of treatment there are clinical symptoms that suggest bleeding, it must quickly perform blood cell count and/ or other appropriate tests. Like other anti-platelets, should be cautious when using clopidogrel in patients at risk of increased bleeding due to trauma, surgery or other pathological conditions and in patients who are being treated with Asa, heparin, Glycoprotein LLB/LLA or nonsteroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors or SSRIRIN (SSRIS) Other drugs associated with the risk of bleeding like pentoxityllin.
Patients must be carefully monitored any signs of bleeding including hidden bleeding, especially in the first few weeks of treatment and/ or after performing heart invasive or surgical procedures. It is not recommended to use Clopidogrel combination with warfarin due to this combination that can enhance bleeding.
If the patient is on the surgery program and is not careful to the platelet resistance effect, Clopidogrel should stop using Clopidogrel 7 days before surgery. Patients should notify the doctor and dentist to know that Clopidogrel is using the surgery schedule and before taking any new drug. Clopidogrel extends the bleeding time and should be used carefully in patients with damage tend to bleed (especially the stomach and intraocularity).
Patients should know that when using clopidogrel (alone or in combination with ASA), it takes longer longer than usual to stop bleeding, and should notify abnormal bleeding for the doctor.
Object of thrombocytopenia (TTP)
Blood thrombocytopenia (TTP) has been reported but rarely after using clopidogrel, sometimes only after a short time of medication. This phenomenon is manifested by a decrease in the number of platelets and small blood blood cell anemia accompanied by either nervous manifestations, kidney dysfunction or fever. TTP is a life -threatening situation that requires immediate treatment including plasma extraction methods.
Difficult blood clotting
Hard -free hemorrhage has been reported after using clopidogrel. In the case of confirmation that extends the time of thromboplastin each activated part (APTT) with or without bleeding, it is advisable to consider the difficulty of clots. Patients diagnosed with difficulty clotting blood must be monitored and treated by experts and should stop using clopidogrel.
Recent ischemic stroke
Due to lack of data, Clopidogrel is not recommended for the first 7 days after the acute ischemic stroke.
Cytochrome P450 2C19 (CYP2C19)
Geneticallygenetic pharmacy: In patients who are inferior to CYP2C19, clopidogrel at the recommended dose to form less active metabolites of clopidogrel and have less effect on platelet function. Examining tests to determine the patient's CYP2C19 genotype.
Because Clopidogrel is partially metabolized into an active metabolic substance by CYP2C19, using active inhibitors of this enzyme will be able to reduce the concentration of the active metabolites of clopidogrel. The clinical involvement of this interaction is uncertain. In order to be cautious, it is not recommended to simultaneously use clopidogrel with strong or moderate inhibitors CYP2C19.
CYP2C8 substrate
Be careful in patients treated simultaneously clopidogrel and with CYP2C8.
Cross reactions between thienopyridin
Patients need to be assessed for hypersensitivity to Thienopyridin (such as clopidogrel, ticlopidin, prasugrel) due to a report on cross -reactions between Thienopyridin. Thienopyridine can cause mild to severe allergic reactions such as rash, angioedema or hematurian diagonal reactions such as thrombocytopenia and neutropen leukopenia. Patients with allergic reactions before and/ or hematological reactions to a Thienopydin may increase the risk of arising in the same or other reactions to other Thienopyricin. Recommended monitoring of hypersensitive signs in patients with allergies to Thienopyridin.
kidney failure
Experience treatment with clopidogrel is limited in patients with renal failure. So use Clopidogrel cautiously in these patients.
Hepatic failure
Experience is limited in patients with average liver disease - who may be able to bleed. Therefore, Clopidogrel should be used in these patients.
Lactose excipients
This product contains lactose, patients with rare genetic disorders in galactose tolerance, Lapp Lactase deficiency or glucose-Galactose absorption disorders should not use this drug.
The ability to drive and operate machinery
Clopidogrel is not significantly affected by the ability to drive machinery. However, be careful because the drug can cause unwanted effects such as headache, dizziness.
Pregnancy
Clinical data is limited in the use of clopidogrel during pregnancy, should not use clopidogrel during pregnancy. Animal research does not show direct or indirect effects on 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 excreted in breast milk. Do not breastfeed during treatment with clopidogrel.
Interactive drug
oral anticoagulant drugs
It is not recommended to simultaneously use clopidogrel with anticoagulant drugs because it can enhance blood release. Although using Clopidogrel 75 mg/day does not change the pharmacokinetics of s-warfarin or international normalization index (INF) in patients treated long-term with Warfarin, simultaneous use of clopidogrel with warfarin increases the risk of bleeding because of its independent effect on coagulation.
Glycoprotein receptor inhibitor llb/llla
Clopidogrel should be used cautiously in patients using simultaneously inhibitors of Glycoprotein LLB/LLA.
acetylsalicylic acid (ASA)
ASA does not change the ability to inhibit platelets through the intermediary ADP of Clopidogrel, but Clopidogrel increases Asa's efficiency on platelet aggregation through collagen. However, the combination of 500 mg ASA 2 times/day with clopidogrel once a day does not significantly increase the extension of bleeding time caused by clopidogrel. Pharmacological interaction between clopidogrel and acetylsalicylic acid can occur and increase the risk of bleeding. Therefore, be careful when using combination.
heparin
In a clinical study conducted on healthy people, the use in combination with clopidogrel has shown that heparin's dose is not careful or changing the effects of heparin on blood clotting.
The use in combination with heparin does not affect the inhibition of platelet gathering due to clopidogrel. Pharmacological interaction between clopidogrel and heparin is possible and increases the risk of bleeding. Therefore, be careful when using combination.
Hematoma pills
Safety when using clopidogrel with specific fiber fiber pepper or not specific fibrin and heparins have been evaluated in patients with acute myocardial infarction. Clinically significant bleeding rate is similar to observing only when using fiber blood and heparin in combination with ASA.
nsaids
In a clinical study conducted in healthy volunteers, when used simultaneously clopidogrel and Naproxen have the phenomenon of increasing hidden stomach bleeding.
However, currently due to no interaction research between clopidogrel and all other NSAIDs, it is unclear whether this combination increases the risk of stomach bleeding. Therefore, be careful when used in combination with clopidogrel with NSAIDs including COX-2 inhibitors.
Serive reconfacitent inhibitors (SSRIs)
Because SSRI affects platelet activation and increases the risk of bleeding, should be cautious when used simultaneously SSRI with clopidogrel.
Other treatment coordination
Because Clopidogrel is partially metabolized into an active metabolic substance by CYP2C19, using active inhibitors of this enzyme will be able to reduce the concentration of the active metabolites of clopidogrel. The clinical involvement of this interaction is uncertain. In order to be cautious, it is not recommended to simultaneously use clopidogrel with strong or moderate inhibitors CYP2C19.
Medicines are strong or medium or medium CYP2C19 inhibitors including omeprazol and esomeprazol, fluvoxamine, fluoxetin, moclobemid, voriconazol, fluconazol, ticlopidin, carbamazepine and efavirenz.
Proton pump inhibitors (PPI)
Use omeprazol 80 mg 1 time/time and clopidogrel at the same time or 12 hours apart, reducing the exposure to the active metabolites of Clopidogrel by 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. In order to be cautious, it is not recommended to simultaneously use clopidogrel with omeprazol or esomeprazol.
Observed that Pantoprazol or Lansoprazol has lessened contact with the active metabolites of clopidogrel.
Simultaneously use Pantoprazol 80 mg 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 associated with the average average platelet aggregation reduction, equivalent to 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 nifedipine drugs. Moreover, Clopidogrel's pharmaceutical activity is not significantly affected when used in combination with phenobarbital or estrogen.
pharmacokinetics of digoxin or theophylin is not changed when combined with clopidogrel.
Stomach antacids do not change the level of clopidogrel absorption.
Data from Caprie research shows that Phenytoin and Tolbutamid - Metabolized pharmaceutical by CYP2C9 can be safely combined 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 simultaneously with a metabolic drug mainly by CYP2C8 (such as Repaglinid, Paclitaxet).
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 dilatation drugs, diabetes drugs (including insulin), anti -Kinh anti -GPIIB/LLA drugs that do not see any adverse effects that do not see any adverse effects that do not see the effects that do not see any adverse effects on any effects that are unfamiliar effects Clinical significance.Storage
Leave a cool dry place, avoid light, temperature below 30 ° C.
To stay out of reach of children.
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