Tunadimet khapharco medicine for treatment of cardiovascular complications (10 blisters x 10 tablets)

Dosage form Box of 10 blisters x 10 tablets
Specifications Clopidogrel

Ingredient

Composition information	Content
Clopidogrel	75mg

Uses

Indications

Tunadimet 75mg drugs are indicated in the following cases

Secondary prophylaxis reduces the risk of cardiovascular disease after myocardial infarction, stroke and peripheral artery disease. Clopidogrel is chosen to replace aspirin in preventing cardiovascular and brain vessels in patients who need to prevent platelet anti -platelet drugs. The nucleus with chronic stable angina cannot tolerate aspirin. Patients with coronary artery disease with high risk leading to cardiovascular events should combine aspirin with clopidogrel. Aspirin to prevent reinforcement of narrowing vascular intervention after skin and coronary stent. Thienopyridin has the same structure and pharmacological effects Ticlopidin, which is a platelet aggregation inhibitor. Clopidogrel is a precursor (Prodrug) with the effect of inhibiting platelet gathering depending on the metabolism in the liver into active thiol metabolites.

Biological metabolism occurs through 2 steps: Clopidogrel is initially oxidized into intermediate conversion of 2 - Oxo - Clopidogrel, then metabolized into active thiol metabolites. The metabolic path associated with some isenzyme cytochrom P450 (such as CYP3A4, CYP2C19, CYP1A2, CYP2B6).

Clopidogrel is an adenosin diphosphate receptor inhibitor (ADP Receptor), clopidogrel's active metabolites selectively and not competing with low affinity to the P2Y12 position of ADP receptor on platelet surface, thus inhibiting ADP attachment to receptors and leading to Glycoprotein GPIIB/III -III complex inhibitors Needed to attach fibrinogen - platelets to inhibit platelets.

Clopidogrel also inhibits solid particles (containing ADP, calcium and serotonin) platelet) through ADP intermediaries and Alfa beads (containing fibrinogen and thrombospondin), these particles contain substances that enhance platelet training. Platases are in contact with Clopidogrel to maintain the end of the life of platelets (7-10 days). Unlike aspirin, clopidogrel and ticlopidin inhibit non -active platelet training cyclooxygenase to prevent the synthesis of prostaglandin and thromboxan a.

Clopidogrel is more effective than aspirin to reduce the risk of cardiovascular events and have similar safety. However, many clinical houses still choose aspirin priority when long -term treatment of platelet resistance in coronary artery disease because it is cheap and has no contraindications. Because clopidogrel is safer than ticlodipine and can be used once a day (while ticlopidin is used twice a day), many clinical houses prioritize using clopidogrel more than ticlopidin.

When taking daily dose clopidogrel 75mg, the inhibitory effect of plateletic exercise appears on the first day of treatment and reaches 40 - 60% inhibition at a stable level of about 3-7 days. After stopping the drug, platelet training and bleeding time return to the original level within 5 days.

pharmacokinetics

Clopidogrel absorbs quickly and not completely through oral, absorbing at least 50% of oral dose. When taking the dose of 75mg Clopidogrel, the clopidogrel concentration in plasma at 2 hours after drinking is very low, usually under the quantitative limit (0.00025mg/liter).

The highest concentration of the main metabolite in the plasma of clopidogrel (carboxylic acid conductor is not active for platelet aggregation) is 3mg/liter at 1 hour after drinking.

Clopidogrel is a precursor and is metabolized through the liver, most of which into carboxylic acid derivatives are inactive metabolites. Metabolized by liver by isenzyme cytochrome P450 including CYP3A4, CYP2C19, CYP1A2, CYP2B6.

Active metabolites are a thiol derivative, but very unstable if separated from plasma. Clopidogrel and main metabolites associated with high -ratio plasma proteins (98% and 94%).

Clopidogrel and metabolites are eliminated through urine and feces. About 50% of oral doses are eliminated through urine and 46% excreted in feces. The half -life of the metabolite is 8 hours after the single dose and the dose restores.

The pharmacokinetics research of the main metabolite shows that Clopidogrel's bioavailability is not affected by food.

Genetic pharmacology

The polymorphic gene of CYP2C19 may affect the pharmacokinetics and pharmacokinetics response of Clopidogrel.

CYP2C19 is involved in creating both active metabolites and intermediate metabolites 2 - Oxo - Clopidogrel.

pharmacokinetics and platelet resistance effects of metabolites have the activity of clopidogrel when quantified by experimental platelet training of different bodies depending on the genotyps of CYP2C19. The genetic variants of other CYP450 enzymes can also work to create the active metabolites of clopidogrel.

Alen CYP2C19*1 corresponds to the function of sufficient fire transfer, while alleles CYP2C19*2 and CYP2C19*3 have no function. The percentage of people carrying CYP2C19 alenes reduces the function in the general population depends on the race. Most people with poor skin metabolism (85%), Asia (99%) have alleles reducing CYP2C19*2 and CYP2C19*3. Other alleles are less functional and less common.

Research shows that a group of patients with poor metabolic and intermediaries with a high rate of cardiovascular events (heart attack and stroke) or thrombosis due to stent are compared to people with strong metabolism.

Pharmacokinetics in special subjects

Renal failure: Doser daily dose of 75mg in people with severe renal failure (ClCr = 5 - 15ml/minute), the effect of inhibiting the collection with healthy people, but the extension of bleeding time is the same compared to healthy people using the dose of 75mg clopidogrel every day.

Hepatic failure: The daily dose of 75mg per day for 10 days in severe liver failure, the effect of inhibiting platelet aggregation as well as the extension of bleeding time is similar to healthy people.

Race: The polymorphic gene morphology of CYP2C19 leads to different metabolism in each toxic strain.

Before taking Tunadimet khapharco medicine for treatment of cardiovascular complications (10 blisters x 10 tablets)

How to use

Tunadimet 75mg tunadimet medicine.

Dosage

The dose is calculated by clopidogrel, paying attention to genetic pharmacology in poor metabolic people.

Daily oral dose in adults: 75mg/day.

After myocardial infarction, stroke, peripheral artery pathology: 75mg/day, 1 time.

Acute coronary syndrome: Unstable angina, myocardial infarction without ST difference: If the patient is selected to intervene through the skin, the initial loading dose is 300mg before intervention at least 2 hours, then 75mg/day (in combination with 75 - 325mg Aspirin/day). If the patient cannot use aspirin, the first dose of Clopidogrel 300 - 600mg before intervention for at least 24 hours, then 75mg/day, lasts at least 12 months.

Myocardial infarction has ST difference: If the patient is conservative, drink Clopidogrel 75mg/day (in combination with Aspirin 75mg - 162mg/day). Treatment period

Put coronary artery stent in patients who are not at high risk of bleeding or clopidogrel tolerance: The ideal treatment time is 12 months after the stent release slow drug, daily dose of treatment. The minimum treatment period of 1 month if the ceiling stent is placed, 3 months with a stent release syrolimus and 6 months if the stent releases Paclitaxel. If the early treatment is stopped, it can lead to thrombosis in the stent and myocardial infarction (causing myocardial infarction or death).

Adjusting the dose in patients with renal failure, the elderly is not necessary.

Dosage for children: There is no optimal dose information for children, the information about the dose in children is very limited, there should be continued research. Research shows that children 2 years old, no optimal dose is recommended, but not higher doses of adults, 1mg/kg initial dose may be used, then adjustment depending on the response.

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? Overdose of clopidogrel by platelet transmission to antagonistic pharmacological effects of clopidogrel.

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 Tunadimet 75mg, you may experience unwanted effects (ADR).

Bleeding is the most common ADR of clopidogrel, bleeding can occur in any position.

The risk of bleeding depends on many factors, including those that can affect the patient's blood clotting and sensitivity.

Very common, 3/100

Digestive: Gastrointestinal disorders can be up to 27%, may experience abdominal pain, vomiting, anorexia, gastritis, constipation.

Cardiovascular: chest pain (8%), angioedema (4%), hypertension (4%).

Central nervous system: headache (3 - 8%), dizziness (2 - 6%), fatigue (3%), human pain (6%).

Skin: itching (4%), erythema (3%).

Endocrine and metabolism: hypercholesterol (4%).

urinary tract infection (3%).

Hematology: Bleeding (4%large, 5%small), erythema (5%), nosebleeds (3%).

Liver: abnormal liver function (

muscle and bone: joint pain (6%), back pain (6%).

Respiratory: Difficulty (5%), rhinitis (4%), bronchitis (4%), upper respiratory infection (9%).

Fake influenza syndrome (8%).

Common, 1/100

Cardiovascular: Atrial fibrillation, heart failure, tachycardia, fainting.

Neurology: fever, insomnia, dizziness, anxiety.

Skin: indigo.

Endocrine and metabolism: increased blood uric, goute.

Digestive: Constipation, Tien Hoa bleeding, vomiting.

urinary tract: cystitis.

Hematology: Anemia, bleeding.

skeletal muscle: cramps, nerve pain, muscle weakness.

Eyes: cataract, conjunctivitis.

Uncommon, 1/1 000

These ADRs are rare but serious, can be life -threatening:

Acute liver failure, loss of granulocytes, allergies, anaphylaxis, rash, angioedema, anemia, hyperlirubin blood, bronchospasm, pink rash, pleural bleeding, hepatitis, interstitial pneumonia, intracranial bleeding, ischemic necrosis, label bleeding, pancreatitis, stevens - Johnson syndrome, platelets, hemorrhagic hemorrhage, neutral hemorrhage Trong.

Instructions on how to handle ADR

When experiencing side effects of tunadimet, 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

Tunadimet 75mg contraindications in the following cases:

Patients are allergic to clopidogrel or any component of the drug. Manifestations of pathological bleeding (eg stomach - duodenal ulcer, intracranial bleeding).

Lactating women, liver failure and jaundice.

Be cautious when using

Lactose -containing drugs, so patients with rare genetic disorders in galactose tolerance, Lactose Lapp deficiency or Plucose - Galactose absorption disorders should not use this drug.

Because clopidogrel extends the bleeding time, should be cautious when used for patients at risk of bleeding due to trauma, surgery, or pathological bleeding such as peptic ulcer, intraocular bleeding, intracranial bleeding. If the patient needs surgery, the medication must be stopped in advance.

When suspected hemorrhage or hematological disorders during clopidogrel treatment must be tested for red blood cells and other appropriate tests.

Plateletal hemorrhage (within the first 2 weeks of treatment) occurred in some cases leading to death, in the event of a plateletal hemorrhage that needs to be replaced with emergency plasma.

Patients with a history of fleeting brain anemia or stroke, risk of recurrence of ischemic anemia, if combined with prophylaxis with Aspirin in combination with clopidogrel, it increases effectively compared to using clopidogrel but also increases the risk of large bleeding.

The risk of gastrointestinal bleeding increases when using clopidogrel, so be cautious when used for patients with damage in the gastrointestinal tract tends to bleed like ulcers. During Clopidogrel treatment also should be cautious if using other drugs at risk of gastrointestinal ulcers.

Patients with liver failure or renal failure also need to be used cautiously. So far, there are very little information related to the safety of clopidogrel for these objects.

Need to notify patients they are susceptible to bruising and bleeding, prolonged bleeding time during the use of clopidogrel. Patients also need to notify physicians and dentists that they are using clopidogrel before they have surgery or other drugs.

Patients who are taking 2 -drug anti -platelets (clopidogrel and aspirin) after the stent release slowly, there are some evidence that the ratio of late thrombosis in the stent (often leads to myocardial infarction or death) increases after stopping clopidogrel, even in patients who have long -term treatment. The optimal treatment time for 2 anti -platelets is not known, may continue to be indefinite in people at risk of low bleeding. Although it is often recommended to stop clopidogrel before surgery, should consider based on the risk of bleeding of each patient to decide.

The ability to drive and operate machinery

Due to unwanted effects are headaches, dizziness. Patients need to be cautious when participating in activities that require alertness such as driving or operating machinery.

Pregnancy

There is no clinical data on the use of clopidogrel in pregnant women, so it is best not to use for pregnant women.

Breastfeeding period

So far, no information shows whether Clopidogrel has excreted through breast milk or not. Therefore, it is necessary to consider stopping breastfeeding during the use of clopidogrel or stop clopidogrel depending on the degree of need to take the drug in the mother who is breastfeeding.

Medicinal interaction

pharmacokinetic interaction

Medicines that affect or metabolized by Cytochrom P450 can cause pharmacokinetic interaction, due to clopidogrel the metabolic inhibitor of ISOENZYM CYP2C19 increases the concentration of the following drugs: Phenytoin, Tamoxifen, Tolbutamid, Warfarin, Torsemid, Fluvastatin, non -steroid anti -inflammatory drugs.

CYP2C19 inhibitors (e.g. omeprazol, cimetidin, fluconazole, ketoconazole, ether, felbamat, fluoxetin, fluvoxamin) can reduce the concentration of active metabolites in the plasma of clopidogrel and reduce platelet resistance.

Increase effect/toxicity

Clopidogrel may increase the effects/toxicity of the following drugs: anticoagulants, anti -platelets, blood clots, Drotrecogin Alfa, Ibritumomab, Salicylate, Tositumomab, Warfarin.

The effect of clopidogrel increases when used the same drugs: dasatinib, nonsteroidal anti -inflammatory drugs, ethyl ester of omega acid - 3, pentosan sodium polysulfate, prostacyclin, rifamycin conductivity.

Using clopidogrel in combination with cilostazol can add platelet training effects. Therefore, it is necessary to be cautious when using a combination of Cilostazol with clopidogrel, and must monitor the bleeding time if there is a combination.

Reducing effects

Proton pump inhibitors can cause pharmacokinetic interaction with clopidogrel (reduce the concentration of metabolic substances that are active of clopidogrel) and pharmacological interaction (reducing platelet resistance), due to CYP2C19 inhibitors inhibitors reduce the effect of clopidogrel.The effect of clopidogrel may be reduced when used with the following drugs: Calcium channel blockers, macrolide antibiotics, nonsteroidal anti -inflammatory drugs, Proton pump inhibitors, CYP2C19 inhibitors.

Avoid coordination

The manufacturer recommends avoiding the combination of clopidogrel with drugs that are known to inhibit CYP2C19 such as omeprazol, cimetidin, fluconazole, ketoconazole, voriconazole, ellavirin, felbamat, fluoxetin, fluvoxamine, ticlopidin.

Interaction with some herbs

Some herbs increase the platelet resistance of clopidogrel: Grass, anise, blueberries, pineapple, lemon basil, cardamom oil, garlic, turmeric, ginger, ginseng, ginkgo, grape seeds, green tea, chestnuts, licorice, red nails, frequency, clover, willow.

Due to the absence of studies on the dysentery of tunadimet, this drug is not mixed with other drugs.

Storage

In a cool, dry place, avoid light, temperatures below 30 ° C.

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