Midorel 75mg Korea Drug tablets reduce events caused by atherosclerosis, myocardial infarction (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Clopidogrel

Ingredient

Composition information	Content
Clopidogrel	75mg

Uses

Indications

Midorel 75mg indicated treatment in the following cases:

Preventing events caused by atherosclerosis (myocardial infarction, stroke and stroke) in patients with a history of atherosclerosis manifested by ischemic stroke (from 7 days to less than 6 months), myocardial infarction (from a few days to less than 35 days) or peripheral artery disease has been established.

Treatment for patients with acute coronary syndrome without a difference of ST (unstable angina or heart -free muscle infarction), used in combination with acetylsalicylic acid.

Treatment for patients with acute myocardial infarction has a difference, used in combination with acetylsalicylic acid.

Pharmacokic of

Clopidogrel is a platelet supply inhibitor selecting the attachment of adenosin diphosphate (ADP) on its receptor in platelets and thereby inhibiting the consequence of this mounting is the activation through the ADP intermediate of Glycoprotein GPIIB/IIIA, thus inhibiting the decline of demands. The metabolism of clopidogrel is needed for creating a platelet training inhibition.

Clopidrogel also inhibits platelet training due to the co -movement in addition to blocking the amplification of platelet activation from the ADP release. Clopidogrel has an impact of non -recovery of platelet recovery, platelets attached to clopidogrel will affect the later stage of platelet life and the recovery of normal platelet function that appears at a constant rate.

The repeated dose of 75mg Clopidogrel has significantly inhibit the platelet aggregation due to ADP from the first day, this inhibitor is increasing and reaching stability on the 3rd and 7th day. Stopping sub -sentence and bleeding time gradually returns to the basic value, in about 5 days after the treatment.

Clopidogrel significantly reduces the incidence of ischemic complications when compared to ASA.

The benefits of using clopidogrel in patients over 75 years old are worse than patients under 75 years old.

pharmacokinetics

After taking orally the dose repeated 75mg/day, Clopidogrel was quickly absorbed. However, the plasma concentration of the mother molecule is very low and below the determined limit of quantity (0.00025mg/l) 2 hours after taking the drug. The minimum absorption is 50%, based on the excretion through the urine of clopidogrel metabolism.

Clopidogrel is mainly metabolized in the liver and mainly metabolites, inactive form, is the derivative of carboxylic acid and this derivative accounts for 85% of the drug component circulating in plasma. This metabolic substance reaches a plasma peak concentration (approximately 3mg/l after the dose repeated 75mg by oral) about 1 hour after taking the drug.

Clopidogrel is a precursor. The metabolites are active, conducting thiol substance, formed by clopidogrel's oxidation into 2-olo-clopidogrel and the next hydrolysis. The oxidation step is regulated mainly by Cytochrome P450 Isoenzyme 2B6 and 3A4 and at a smaller range by 1A1, 1A2 and 2C19. Thiol metabolites work, quickly and not recover from platelet receptors, thus prevent platelet aggregation. This metabolite is not detected in plasma.

The pharmacokinetics of administrative metabolites, the linear change in the dosage range from 50 - 150mg clopidogrel (plasma concentration increases proportional to the dose).

Clopidogrel and administrative metabolites associate with human plasma proteins (98% with clopidogrel and 94% with metabolites). The cohesion is not saturated in the laboratory at a large concentration).

When using Clopidogrel with 14C marking in humans, about 50% is excreted in the urine and nearly 46% in the feces for about 120 hours after taking the drug. The half -life of the elimination of administrative metabolites is 8 hours after the single dose and repeated dose.

After the repeated dose of 75mg Clopidogrel every day, the plasma concentration of administrative metabolites lower in patients with severe renal disease (creatinine clearance from 5 - 15ml/min) than patients with mild kidney disease (creatinine clearance from 30 - 60ml/minute) and compared to healthy people in other studies. Although the inhibition of platelets is lowered by ADP (25%) compared to healthy people, the prolongation of bleeding time is equivalent to a healthy person using 75mg Clopidogrel every day. In addition, the tolerance is good in all patients.

Clopidogrel's

pharmacokinetics and pharmacy are evaluated at the single-dose and multiple research in both healthy people and people with cirrhosis (group A or B). The daily dose of 75mg clopidogrel for 10 days is safe and good tolerance.

Clopidogrel's peak (CMAX) concentration for both dosage and stable state in patients with cirrhosis several times higher than normal people. However, the plasma concentration of administrative metabolites as well as the effects of clopidogrel on plateletic training due to ADP and bleeding time are the same between groups.

Before taking Midorel 75mg Korea Drug tablets reduce events caused by atherosclerosis, myocardial infarction (3 blisters x 10 tablets)

How to use

oral drugs. Use as directed by the treating doctor.

Dosage

Adults

The only dose 75mg/day used during or outside meals.

In patients with acute coronary syndrome without stir segment (unstable angina or myocardial infarction without Q)

Should start treatment at a dose of 300mg clopidogrel on the first day, then continue at a dose of 75mg/day (combined with acetylsalicylic acid 75 - 325mg/day) in the following days.

In patients with myocardial infarction with the difference of ST segment

Should start treatment at a dose of 300mg Clopidogrel on the first day, then continue at a dose of 75mg/day in combination with acetylsalicylic acid, which can be combined with thrombolytic drugs. Patients over 75 years of age should not start the starting dose of 300mg.

Elderly or patients with renal failure

No dose adjustment.

children and young people

There is no data on the safety and effectiveness of the drug for patients under 18 years old.

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? Bleeding time increases to 1.7 times equivalent to Clopidogrel dose of 75mg/day.

There is no drug that detoxifies the pharmacological activity of clopidogrel. Platelets can limit 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 you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Midorel 75mg often has unwanted effects (ADR).

Common, ADR> 1/100

Blood vessels: Hematoma.

digestive: gastrointestinal bleeding, diarrhea, abdominal pain, indigestion.

Skin and subcutaneous tissue: bruising. Other: nosebleeds.

Uncommon, 1/1000

Blood and lymphatic system: thrombocytopenia, leukocytes, eosinophilia like eosin.

Neurological: intracranial hemorrhage (some cases have been reported with death results), headache, paresthesia, dizziness. Eye: Eye bleeding (conjunctiva, eyeball, retina).

digest: gastric ulcer - Ta Trang, gastritis, vomiting, nausea, constipation, flatulence.

Skin and subcutaneous tissue: rash, itching, skin bleeding (bleeding).

Kidney and urinary: urinating bleeding.

Other: prolonging bleeding time, neutropenia, reducing the number of platelets.

Rare, 1/10,000

Blood and lymphatic system: neutropenia, including severe neutropenia.

Digesting: Perfume bleeding.

Other: dizziness.

Instructions on how to handle ADR

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

Contraindicated

Midorel 75mg Contraindicated in the following cases:

Hypersensitivity to any ingredients of the drug.

Severe liver failure.

There is pathological bleeding such as digestive ulcers or bleeding in the brain.

Pregnant or breastfeeding women.

Children under the age of 18.

Precautions when using

in patients with acute myocardial infarction, do not start treatment with clopidogrel in the first few days after myocardial infarction.

Like other anti -platelets, Clopidogrel should be used with patients with increased risk of bleeding due to trauma, surgery or other pathological conditions. Clopidogrel should stop using clopidogrel 7 days before surgery to avoid platelet resistance. Clopidogrel prolongs the bleeding time and should be used carefully with patients with the possibility of bleeding (especially the stomach and intraocularity).

Patients should know that when using Clopidogrel longer than usual, it is necessary to stop using when bleeding appears and should notify abnormal bleeding to the doctor. Patients should notify the doctor and dentist who is using clopidogrel before scheduling surgery and before taking any new drug.

Not much experience using clopidogrel in patients with liver disease is both those who may have bleeding organs. Be cautious when using clopidogrel for these patients.

Do not use clopidogrel with warfarin as it can increase the level of bleeding.

Because of the ability to increase the risk of bleeding, caution should be used when combined with clopidogrel with acetylsalicylic acid, nonsteroidal anti -inflammatory drugs, heparin, or thrombolytic drugs.

Object of thrombocytopenia, transient complications, cross allergies between the Thienopyridine.

Excipients containing lactose: Do not use for patients with galactose intolerance, Lapp Lactose deficiency, Glucose absorption disorders - Galactose.

The ability to drive and operate machinery

Clopidogrel has little influence on driving and operating machinery.

Pregnancy

There are no adequate and controlled studies on pregnant women. Therefore, do not use clopidogrel during pregnancy.

Breastfeeding period

Because the drug has not been fully studied in breastfeeding, do not use clopidogrel for breastfeeding women.

Drug interaction

Warfarin: Do not use Clopidogrel with Warfarin because it can increase bleeding level.

Acetylsalicylic acid: does not change the ability to inhibit platelet training due to the ADP of clopidogrel, but clopidogrel increases the efficiency of acetylsalicylic acid on the collagen -based breakdown. However, the combination of 500mg of aspirin twice a day with clopidogrel once a day has not increased the meaning of prolonging the bleeding time due to the use of clopidogrel. Pharmacological interaction between clopidogrel and acetylsalicylic acid is possible, increasing the risk of bleeding. Therefore, be careful when used in combination.

Heparin: In a clinical study in healthy people, the use in combination with clopidogrel has shown no need to change heparin's dose or change heparin's blood clotting effects. The use in combination with heparin does not affect platelet training due to clopidogrel. Pharmacological interaction between clopidogrel and heparin is possible, increasing the risk of bleeding. Therefore, be careful when used in combination.

Blood solubility: Safety when used in combination with Clopidogrel, RT-PA and Heparin has been assessed in new patients with myocardial infarction. The clinically significant bleeding rate is observed when using RT-PA and heparin combined with acetylsalicylic acid. There is no data on the safety of the use of clopidogrel with thrombolytic drugs, so be careful when used in combination.

Non-steroid anti-inflammatory drugs (NSAIDs) include COX-2 inhibitors or selective Serotonin re-inhibitors (SSRIs) and norepinephrin and serotonin re-inhibitors (SNRI): When used in combination with clopidogrel with Naproxen, there is an increase in hidden gastric bleeding. Therefore, be careful when using Clopidogrel with these drugs.

Other treatments: Use clopidogrel in combination with other drugs to observe the interaction of pharmacokinetics and pharmacokinetics. There is no clinical interaction with pharmacological significance when used in combination with clopidogrel with Atenolol, Nifedipine or both Atenolol and Nienedipine drugs. Moreover, Clopidogrel's pharmacological activity is not affected when combined with phenobarbital, cimetidine or estrogen.

pharmacokinetics of Digoxin or theophylin is not changed when combined with clopidogrel. Stomach antacids do not change the absorption time of clopidogrel.

Phenytoin and Tolbutamid can be combined safely with clopidogrel.

Storage

Store drugs under 30 ° C, in a dry place. Avoid light.

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