Copedina Adamed medicine prevent myocardial infarction, peripheral disease (2 blisters x 14 tablets)
Dosage form Box of 2 blisters x 14 tablets
Specifications Clopidogrel
Ingredient Pharmaceutical work adamed pharma
Ingredient
| Composition information | Content |
| Clopidogrel | 75mg |
Uses
Indications
75 mg Copedina drugs are indicated for adults to prevent congestion events in the following cases:
Patients with myocardial infarction (from a few days to less than 35 days), stroke (from 7 days to less than 6 months) or peripheral vascular disease identified.
Patients with acute coronary syndrome:
Code ATC: B 01 AC 04.
Clopidogrel is a medicine.
One of the metabolic forms of clopidgrel is platelet supply inhibitors, Clopidogrel is metabolized by CYP450 enzyme created by platelet aggregation inhibitors.
The activity of clopidogrel conversion selects the process of adenosin diphosphate (ADP) with P2Y12 receptor in platelets and inhibits the Glycoprotein Gpilb/111A complex activation process through ADP intermediaries, thereby inhibiting platelet aggregation.
Because Clopidogrel is not reversible to the ADP receptor, platelets exposed to clopidogrel are influenced by the drug during the existence (about 7-10 days) and the level of normal functional rehabilitation depends on the new platelet production speed.
Clopidogrel also inhibits platelet gathering due to induction by the agonized substances other than the ADP by preventing platelet activity amplifier because ADP is released.
Due to the active metabolic form of clopidogrel, it is created by the catalyst of the CYP450 enzyme, some patients with genetic polymorphic or CYP450 are inhibited by other drugs that may not achieve satisfactory platelet inhibitors.
Using the dose of 75 mg per day can obtain an inhibitory effect on platelet gathering through the ADP intermediaries from the first day, this effect gradually increases and achieved a stable state from Monday to Saturday.
In a stable state, the average level of inhibition when using a dose of 75 mg daily is from 40% to 60%.
The process of platelets and bleeding time gradually returns to normal levels after the drug is about 5 days.
pharmacokinetic
absorption
When using a single dose and a dose of 75 mg per day, Clopidogrel is quickly absorbed. The average peak concentration in the plasma of Clopidogrel (about 2.2 - 2.5 ng/ml after using a single dose of 75 mg) reached about 45 minutes after taken. The minimum ratio of drugs is 50% on the metabolites of Clopidogrel is eliminated in the urine.
distribution
Clopidogrel and main metabolites (without active) inversely associated with In vitro plasma proteins (the associated ratio is 98% and 94% respectively). The level of cohesion of plasma protein is not saturated in vitro in a wide dose.
transformation
Clopidogrel is strongly metabolized in the liver.
When testing in vito and in vivo, clopidogrel is metabolized in two main roads:
1. The first path is done by esterase enzymes and leads to hydrolysis to produce carboxylic acid derivatives that are not active (accounting for 85% of the metabolites in the circulation).
2. The second path is done by the catalyst of the Cytochrom P450 system. The first clopidogrel is transformed into an intermediate form of 2-oxoclopidogrel. Next 2-olo-clopidogrel is transformed into the activity form as the thiol substance of Clopidogrel. In vitro, this metabolic path is made by CYP3A4, CYP2C19, CYP1A2 and CYP2B6. Inactive thiol derivative has been isolated in vitro capable of fast and not reversible with platelet receptors, thus inhibiting platelet aggregation.
Cmax of metabolites is active after taking a single dose of 300 mg Clopidogrel twice as tasted than the concentration after 4 days of taking the maintenance dose of 75 mg. CMAX is approximately 3060 minutes after taking the drug.
Elimination
When testing using Clopidogrel contains an atomic marked 13C in humans, about 50% of the drug is eliminated in the urine and nearly 46% is found in the part within 120 hours after drinking.
When using a single dose of 75 mg by oral, Clopidogrel's sale time is about 6 hours.
The semi -discharged time of the main metabolic form (inactive) is 8 hours when using a single dose and a repeat dose.
The half -life of metabolites is about 30 minutes.
Special patient groups
It is unclear about the pharmacokinetics of the activity of clopidogrel in these patients,
Patients with renal failure
After using the dose of 75 mg clopidogrel every day in patients with severe kidney disease (the rate of creatinine clearance from 5 to 15 ml/minute), inhibiting platelet aggregation through ADP is weaker (25%) than in a healthy person.
However, the extension of the bleeding time is similar to that in healthy people using the dose of 75 mg clopidogrel every day. In addition, clinical drug tolerance is good in all patients.
Patients with liver failure
After using the dose of 75 mg Clopidogrel per day for 10 days in patients with severe liver failure, the effect of inhibiting platelet aggregation through ADP inhibitors is similar to in healthy people.
The extension of the average bleeding time is the same when comparing the group of patients with liver failure and healthy people.
Before taking Copedina Adamed medicine prevent myocardial infarction, peripheral disease (2 blisters x 14 tablets)
How to use
75 mg Copedina drugs are taken orally.
Dosage
adults and elderly patients
Use a single dose of 75 mg daily during or outside meals.
In patients with acute coronary syndrome
Acute coronary syndrome does not have a difference ST segment (unstable angina or myocardial infarction without Q)
Should start treatment with 300 mg of clopidogrel load and continue using the dose of 75 mg once a day (along with acetylsalicylic 75 - 325 mg daily).
Due to high doses of Asa may increase the risk of bleeding, ASA dose should not exceed 100 mg.
It is unclear optimal treatment time. Data obtained from clinical studies recommend the use of drugs for up to 12 months, the maximum efficiency achieved after 3 months of treatment.
Acute myocardial infarction has a difference of ST segment
Should use Clopidogrel dose of 75 mg daily, starting with a 300 mg load dose in combination with ASA with or without drugs that soluble thrombosis. For patients over 75 years old, do not use the starting dose.
Should start the method of coordination as soon as possible after detecting symptoms and continuing the drug for at least 4 weeks.
The effect of clopidogrel combination with Asa when used for more than 4 weeks has not been studied in this patient group.
genetic pharmacy
Patients with weak CYP2C19 activity often decrease in response to clopidogrel. The optimal dose is not clear for poor metabolic patients.
Pediatric patients
The safety and effectiveness of clopidogrel in children and teenagers have not been proven.
Patients with renal failure
There is no enough experience for treatment for patients with renal failure.
Patients with liver failure
Do not have enough experience for treatment for patients with liver disease that has just been hemorrhagic.
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? Applying appropriate treatment if the patient has bleeding.
There is no special antidote in the case of clopidogrel overdose. If it is necessary to handle the condition of prolonged bleeding time, platelet transmission can help reverse 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 Copedina, you may experience unwanted effects (ADR).
The safety of Clopidogrel has been assessed on more than 42,000 patients participating in clinical studies, including 9,000 patients who are treated for a year or longer. The clinical adverse reactions recorded in Caprie, Cure, Clarity and Commit studies presented below. Overall, the safety of Clopidogrel 75mg/day is equivalent to ASA 325 mg/day in Caprie study when compared to age, gender and race. In addition to adverse effects recorded in clinical studies, adverse reactions are also spontaneously reported.Hemorrhage is the most common adverse reaction that has been recorded in both clinical studies and post -commercial reports, in which this condition is most common in the first month of treatment. In Capril study, in patients treated with clopidogrel or ASA, the total hemorrhage rate is 9.3%. The proportion of severe bleeding cases is 1.4% in the clopidogrel use group and is 1.6% in the group using ASA.
In Cure study, the severe hemorrhage rate when using Clopidogrel + ASA does not depend on the dose of ASA ( 200 mg: 4.9%), similar to the placebo use + ASA ( 200 mg: 4.0%).
Hemorrhagic risk (life -threatening, severe, mild, other levels) gradually decreases during testing: (0 - 1 month (clopidogrel: 9.6%; placebo: 6.6%), 1-3 months (clopidogrel: 4.5%; placebo: 2.3%), 3 - 6 months (clopidogrel: 3.8%; pharmaceutical price: 1.6%) Pharmacy: 1.5%); 9 - 12 months (Clopidogrel: 1.9%; placebo: 1.0%).
Severe hemorrhage rate when using clopidogrel + Asa within 7 days after coronary coronary sphere in patients stopped treatment over 5 days before surgery does not increase excessively (4.4% in the group using Clopidogrel + ASA compared to 5.3% in the gia + ASA). In patients, they continued to treat within 5 days after conducting the coronary artery surgery, the hemorrhage rate rate was 9.6% in the group using clopidogrel + ASA and 6.3% in the placebo -use group + ASA.
In Clarity research, the total ratio of hemorrhage increases in the clopidogrel + ASA (17.4%) S4 group with a placebo group + ASA (12.9%). The severe hemorrhage ratio is similar to each other between the two groups (1.3% and 1.1% in the group using clopidogrel + Asa and placebo + ASA). This result is suitable for patient subgroups classified by characteristics, blood pepper or heparin.
In the commit study, the total ratio of severe bleeding in the brain or the bleeding related to the brain is low and similarly between the two research groups (0.6% and 0.5% in the group using clopidogrel + Asa and placebo + ASA).
The adverse reactions recorded in clinical trials or from spontaneous reports presented in the following table.
The frequency of these adverse reactions is conventional as follows: common (> 1/100 to 1/1,000 to 1/10,000 to
In each agency, adverse reactions are arranged in order of severity.
often meet
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
Copedina 75 mg contraindicated drug in the following cases:
Precautions when using
Due to the risk of bleeding and unwanted effects on hematology, need to check the number of blood cells and/or other necessary tests when the patient has clinical manifestations of bleeding during treatment.
Like KLThu anti-platelet drugs, be careful when using clopidogrel for patients at risk of hemorrhage due to trauma, surgery or other pathological conditions and patients being treated with Asa, Heparin, Glycoprotein ILB/UIA inhibitors or non-steroid anti-inflammatory drugs (NSAID) such as COX-2 inhibitors.
Need to closely monitor any signs of bleeding such as closed bleeding, especially in the first weeks of treatment and/or after invasive procedures.
Do not use clopidogrel simultaneously with oral anticoagulants because it can increase the risk of bleeding.
If the patient undergo selective and temporary surgery may not need platelet anti -platelet drugs, Clopidogrel should stop using Clopidogrel 7 days before surgery. Patients need to notify the doctor and dentist about using clopidogrel before any surgery or before using any other medicine.
Clopidogrel prolongs bleeding time and should be cautious when used for damaged patients at risk of bleeding (especially gastrointestinal bleeding and intraocular bleeding).
It is necessary to notify the patient that may need more time than usual to stop bleeding when using clopidogrel (alone or in combination with ASA) and the patient should notify any abnormal bleeding (position and time) to the doctor.
Plateletal hemorrhage has been recorded with a very rare frequency after using clopidogrel, sometimes after exposure of drugs in a short time. This condition manifested by microchemical anemia associated with neurological complications, kidney dysfunction or fever.
Plateletal hemorrhage is a condition that can be fatal for patients, which should be treated promptly, including plasma filtration methods.
Do not have enough data, do not use clopidogrel within 7 days after the stroke due to ischemic.
Genetic pharmacy
According to the literature data, the patient reduces the CYP2C19 function due to genetics with a level of body exposure to a lower -active metabolic form of clopidogrel, weaker platelet resistance and usually has a higher cardiovascular disease rate after patients with normal CYP2C19 functions.
Because Clopidogrel is converted into an activity thanks to CYP2C19, using these enzyme inhibitors can reduce the concentration of the active metabolic form of plasma clopidogrel, thereby reducing the effectiveness of treatment. Unable to encourage the use of CYP2C19 inhibitors with Clopidogrel.
Although CYP2C19 inhibitors are different among drugs in the proton bomb inhibitor group, clinical studies show the risk of interactive between clopidogrel and these drugs. Therefore, it is necessary to avoid using proton pump inhibitors with clopidogrel unless it is really necessary. There is no evidence that drugs that reduce stomach acidity such as H2 blockers or antacids affect the platelet resistance activity of clopidogrel.
Do not have enough experience for treatment for patients with renal failure. Therefore, be cautious when using clopidogrel for these patients.
There is no enough experience for treating patients with liver disease average with internal hemorrhage. Therefore, be careful when using clopidogrel for these patients. Copedina contains lactose. Patients with rare genetic diseases are galactose intolerance, deficiency of lapp lactase enzymes or malposes-galactose should not use this drug.
The drug contains hydrogenated castogenizer oil oil that can cause discomfort in the stomach and diarrhea.
The ability to drive and operate machinery
The drug does not affect the driver and operating machinery, but it is necessary to be cautious when used for driving objects and operating machinery.
Pregnancy
Because there is no data on the use of clopidogrel during pregnancy, Clopidogrel should not be used for pregnant women.
Animal studies do not detect any direct or indirect harmful effects of clopidogrel for pregnancy, embryo development during or after birth.
Breastfeeding period
whether Clopidogrel is unclear whether it is secreted into breast milk or not. Animal studies show that Clopidogrel is secreted into milk. To ensure safety, breastfeeding women should not continue using Copedina.
Medicine interaction
Antaginalism drugs used by oral route
It is not recommended to use clopidogrel with oral anticoagulants because it can increase the level of bleeding.
Glycoprotein ilb/IIIA inhibitors: Be careful when using Clopidogrel for the disease that is at risk of hemorrhage due to trauma, surgery or other pathological conditions using Glycoprotein ILB/Illa inhibitors.
Acetysalicylic acid (ASA)
Asa does not change the inhibitory effect of the ADP intermediate gathering of Clopidogrel but Clopidogrel may affect ASA's Collagen intermediaries. However, simultaneous use of 500 mg ASA twice a day in a day does not significantly increase the bleeding time in patients who are using clopidogrel. Pharmacological interaction between clopidogrel and acetylsalicylic acid may occur, increasing the risk of bleeding. Therefore, it is necessary to be cautious when using this medicine at the same time. In some patients, Clopidogrel and ASA have been used simultaneously for up to 1 year.
heparin
In a healthy clinical study, using clopidogrel does not require changes in heparin and does not affect the effects of heparin on the dynamic process. Simultaneous use of heparin does not affect Clopidogrel's platelet collection effect. Pharmacological interaction between clopidogrel and heparin may occur, increasing the risk of bleeding. Therefore, it is necessary to be cautious when using this drug simultaneously. Hemotoding drugs: Safety of simultaneous use of clopidogrel, specific or non -specific blood pepper drugs with fibrin and heparin have been assessed in patients with acute myocardial infarction. The clinical hemorrhage ratio is the same sugar statue as when using simultaneously causing blood and heparin with ASA.
nsaid
In a clinical study conducted on healthy volunteers, simultaneously using clopidogrel and Naproxen increases blood loss due to Kin gastrointestinal bleeding. However, due to the fact that the interaction between clopidogrel has not conducted NSAID, it is unclear whether there is a risk of interaction between clopidogrel and all NSAIDs. Therefore, it is necessary to be cautious when using NSAIDs such as COX-2 inhibitors along with clopidogrel.
Cases of use other simultaneously
Because Clopidogrel is converted into a partial activity form in part by CYP2C19, the use of these enzyme active inhibitors can reduce the concentration of the activity of clopidogrel and thus reduce the effectiveness of treatment. It is not recommended to simultaneously use Clopidogrel with CYP2C19 inhibitors,
CYP2C19 inhibitors include:
Omeprazol, Esomeprazol, Iluvoxamine, Fluoxetin, Moclobemid, Voriconazole, Fluconazol, Ticlopidin, Ciprofloxacin, Cimetidin, Carbamazepine, Oxcarbazepine and Chloramphenicol.
Proton pump inhibitors
Although CYP2C19 inhibitors are different among drugs in the inhibitor group by proton, clinical studies show the risk of interactive between clopidogrel and these drugs.
Therefore, it is necessary to avoid using the butter inhibitors at the same time with clopidogrel unless it is really necessary. There is no evidence that drugs that reduce stomach acidity such as H2 blockers or antacids affect the platelet resistance activity of clopidogrel.
A number of other clinical studies have been conducted to evaluate pharmacokinetic and pharmacokinetic interaction between clopidogrel and medications used simultaneously. It is not observed that the pharmacological interaction is clinically significant when using clopidogrel simultaneously with Atenolol, Nifedipine or both Atenolol and Nifedipine.
In addition, Clopidogrel's learning activity is not significantly affected when used with phenobarbital, cimetidine or estrogen.
Digital pharmacokinetics of Digoxin or Theophyllin is not changed when using copper with clopidogrel. Antacids do not change Clopidogrel's absorption.
Data from studies on human liver microsom shows that the metabolism of carboxylic acid of clopidogrel can inhibit the activity of cytochrom P450 2C9.
This may increase the concentration of drugs such as Phenytoin, Tolbutamid and NSAIDs are drugs metabolized by Cytochrom P450 249. The data obtained from Caprie studies shows that can be used with phenytoin and tolbutamid along with Clopidogrel safe.
In addition to information about the above drug interactions, there has not been a study of clopidogrel interaction with some drugs that are used for patients with blood vessel obstruction.
However, patients participating in clinical trials with clopidogrel have used many drugs such as diuretics, beta blockers, alugiotensin transferring yeast inhibitors, calcium antagonistic drugs, cholesterol lowering drugs, coronary dilatation drugs, diabetic medications (such as insulin), anti -epileptic drugs, GBIIB/ILA Clinical disadvantages.
Storage
Store at temperatures below 30 ° C. To be out of reach of children.
Expiry date: 24 months from the date of manufacture. Do not use overdue drugs stated on the packaging.
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