Cadigrel 75mg Cadila prevents arterial thrombosis (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Clopidogrel
Ingredient Atherosclerosis, stroke, myocardial infarction, peripheral artery disease, angina

Ingredient

Composition information	Content
Clopidogrel	75mg

Uses

indications

Cadigrel drugs are indicated in the following cases:

Treatment of myocardial infarction (from a few days to no more than 35 days after the infarction), anemia stroke (from 7 days to no more than 6 months) or have been determined to have peripheral artery disease. Use in combination with acetylsalicylic acid (ASA). In addition, there is an acute myocardial infarction syndrome, coordinating with ASA in patients who are eligible to apply anti -thrombotic therapy. Clopidogrel must be metabolized by CYP450 enzyme to create metabolites with platelet aggregation inhibitors. The active metabolites of clopidogrel selectively inhibit the cohesion of adenosine diphosphate (ADP) on P2Y, platelet receptor and lead to the activity of Glycoprotein Gpilb/ULA complex and inhibit platelet aggregation. Because the cohesion is not reversible, platelets exposed to the drug will be affected until the end of the platelet's life cycle (about 7-10 days); Platelet function returns to normal after this time. In addition to ADP, platelet collection caused by other agents is also inhibited due to the effect of preventing platelet activation by ADP.

Pharmacokinetics

absorption

After using a single dose or a repeated dose of Clopidogrel 75 mg daily, clopidogrel is quickly absorbed. The average plasma concentration in the form of non -metabolic (about 2.2 - 2.5 ng/ml after taking the single dose of 75 mg) appears about 45 minutes after drinking. About 50% of the drug is absorbed, based on the excretion of metabolites of clopidogrel in urine.

Distribution

Clopidogrel and the main transfer of the blood (inactivated form) are associated with in vitro plasma proteins (equivalent to 98% and 95.4%). The level of attachment in in vitro test is not saturated on a sequence of surveyed wide concentrations.

Metabolism

Clopidogrel is strongly metabolized in the liver. In vitro and in vivo studies show that Clopidogrel is metabolized through two main roads: one through the esterase enzyme that helps hydrolyze clopidogrel into non -active metabolites of carboxylic acid (85% of blood metabolites), and a path through cytochrome P450 enzymes. Clopidogrel is first converted into 2-olo-clopidogrel. The 2-oxo-clopidogrel metabolism will form active metabolites, which is a clopidogrel. In vitro, this metabolic path is made by CYP3A4, CYP2C19, CYP1A2 and CYP2B6. The active metabolites have a thiol group that quickly attaches not reversible with platelet receptors and inhibits platelet aggregation.

Elimination

After using Clopidogrel is marked by 14C in humans, about 50% are eliminated in urine and 46% excreted in feces for 120 hours after drinking. After using Clopidogrel a single -dose of 75 mg, Clopidogrel's sale time is about 6 hours. The sale time of metabolites is about 8 hours after single doses or repeated doses.

Before taking Cadigrel 75mg Cadila prevents arterial thrombosis (3 blisters x 10 tablets)

How to use

Take oral use.

Clopidogrel is used at a dose of 75 mg once a day, with or without food.

Dosage

adults and elderly patients

Clopidogrel's initial starting dose is 300 mg for patients with acute coronary syndrome.

Acute coronary artery syndrome (unstable angina or non -wave myocardial infarction)

Clopidogrel is started with a dose of 300 mg and then continues for patients to use the dose of 75 mg once a day (combined with Acetylsalicylic Acid (ASA) 75 mg - 325 mg daily). High doses can cause bleeding at risk, so ASA should not be used at a dose exceeding 100 mg. The optimal treatment time is not determined, but clinical trials show that it can be used for up to 12 months.

Myocardial infarction has a difference.

Clopidogrel's initial dose is 300 mg, then 75 mg once a day, combined with ASA and may be combined or not combined with anti -thrombotic drugs. For patients over 75 years old, do not use the initial dose for patients. Combined therapy should be started early, immediately after symptoms and continue treatment within a minimum of 4 weeks.

Patients with renal failure

Experience in using drugs for treatment in patients with renal failure is very limited.

Patients with liver failure

Experience used for treatment in patients with average liver failure, may be very limited.

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?

When bleeding, it is necessary to have appropriate therapy. There is no antidote to Clopidogrel's activity. If it is necessary to adjust the extended machine melt time, platelets can be transmitted.

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. Do not use double the prescribed dose.

Side Effects

When using Cadigrel, you may experience unwanted effects (ADR).

The adverse reactions occurred in clinical studies or spontaneous reports presented in the table below. The frequency of appearance is determined as follows: usually occurs (≥1/100 to

Very common, 1/100

Digestive: digestive disorders, may experience abdominal pain, vomiting, anorexia, gastritis, constipation. Blood. Influenza.

Common, 1/100 Cardiovascular: Atrial fibrillation, heart failure, tachycardia, fainting. Learning: Anemia, bleeding.

These ADRs are rare but serious, can be life-threatening: Acute liver failure, grain leukocytes, allergies, anaphylaxis, rash, angioedema, anemia, hyperlirubin blood, bronchial spasms, pneumothorax, pneumothorax, hepatitis, interstitial pneumonia, intracranial bleeding, local anemia necrosis, pancreatitis, pancreatitis, reduction of minor reduction, minor reduction, minor reduction, minor reduction, minor reduction, minor reduction Bridge, toxic skin necrosis, vasculitis, severe neutropenia.

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

Before using the drug you need to read the instructions carefully and refer to the information below.

contraindicated

Cadigrel drug contraindicated in the following cases:

Hypersensitivity to active ingredients or any excipients.

Severe liver failure.

There are hemorrhage diseases such as stomach ulcers, intracranial hemorrhage.

Caution when using

bleeding disorders and hematology

Due to the risk of hemorrhage and adverse effects on hematology, blood formula should be determined and other necessary tests when clinical symptoms suspect bleeding occurs during the treatment process (see item of unwanted effects). Similar to other platelet anti-platelets, it is necessary to be cautious when using clopidogrel in patients at risk of bleeding due to trauma, surgery and other pathological conditions or in patients who are using Asa, heparin, Glycoprotein ILB/LLA inhibitors and NSAID anti-inflammatory drugs including COX-2 inhibitors.

Need to monitor patients closely on any signs of hemorrhage, including hemorrhage that is hidden, especially in the first weeks of therapy or after the process of invasive or surgical heart intervention. It is not recommended to simultaneously use Clopidogrel with oral anticoagulants due to increased risk of bleeding (see drug interaction).

If the patient is indicated for non -urgent surgery and the use of platelet resistant drugs during this time is inappropriate, clopidogrel treatment is needed 7 days before surgery. Patients need to notify the doctor or dentist about using clopidogrel before any surgery and before using any new treatment. Clopidogrel extends the bleeding time, so be careful when used for patients with lesions that tend to cause bleeding (especially in the digestive tract and in the eyeball).

It is necessary to notify patients with bleeding time may be longer than usual when patients use clopidogrel (used alone or in combination with ASA), and note that the patient needs to report to the doctor about abnormal bleeding phenomena (location or time).

The hemorrhage due to thrombocytopenia (TTP) of the hemorrhage due to thrombocytopenia (TTP) has been recorded in some rare cases of using clopidogrel, sometimes only after use a short time. This condition is characterized by thrombocytopenia and hemolytic anemia in small blood vessels accompanied by nervous manifestations, kidney dysfunction or fever. TTP may be fatal; Therefore, it is necessary to treat promptly, including plasma replacement measures.

The ability to drive and operate machinery

clopidogrel does not cause or cause significant impact on the ability to drive and operate machinery.

Pregnancy

Because there is no clinical data on the use of clopidogrel in pregnant women, should not use clopidogrel in pregnant women.

Animal studies do not show that Clopidogrel has a direct or indirect impact on pregnancy, the development of the embryo/fetal embryo, the birth process and the development after birth.

The period of breastfeeding

has not yet determined whether clopidogrel has excreted in breast milk or not. Animal studies show that Clopidogrel is excreted in milk, so it is advisable to stop breastfeeding while being treated with the drug.

Interactive drug

Oral anticoagulant drugs: It is not recommended to simultaneously use clopidogrel with oral anticoagulants due to increased risk of bleeding (see caution and special warnings when used).

Glycoprotein ilb/lla inhibitors: Be cautious when using clopidogrel in patients who are using glycoprotein ilb/Ulla inhibitors (see caution and special warnings when used).

Acetylsalicylic Acid (ASA): ASA does not change the inhibitory activity of clopidogrel on plateletic collection caused by ADP, but clopidogrel increases the effects of Asa on plateletic collection caused by collagen. However, using ASA dose 500 mg, 2 times daily does not significantly increase bleeding time in patients using clopidogrel. The interaction of pharmaceutical force between clopidogrel and acetylsalicylic acid may occur and may increase the risk of bleeding. Therefore, it is necessary to be cautious when using these two drugs at the same time (see caution and special warning when used).

heparin: In a clinical study conducted on healthy objects, the use of heparin simultaneously with clopidogrel is not necessarily forced to adjust the dose of heparin or change the effects of heparin on blood clotting. Heparin also has no impact on the inhibition of platelet collection of clopidogrel. The pharmacological interaction between clopidogrel and heparin may occur and increase the risk of bleeding. So be careful when using these drugs together (see caution and special warning when used).

Anti -thrombotic drugs: Safety when using clopidogrel, fibrin or non -specific anti -thrombotic drugs on fibrin and heparin have been evaluated in acute myocardial infarction patients. The frequency of hemorrhage is clinically significant when using the above combination of drugs similar to the frequency of hemorrhage when using anti -thrombotic and heparin medications simultaneously with ASA (see the item of unwanted effects).

NSAID: In a clinical study conducted on healthy subjects, the use of clopidogrel simultaneously with Naproxen increases hidden digestive blood loss. However, because there is not enough studies on interactive dopidogrel and other NSAIDs, it is unclear whether there is an increase in the risk of gastrointestinal bleeding with all other NSAIDs. In short, it is necessary to be careful when using clopidogrel with NSAID, including COX-2 inhibitors (see caution and special warnings when used).

Other simultaneous therapies: Because Clopidogrel is converted into a partial activity thanks to CYP2C19, the use of other drugs that inhibits this enzyme activity can reduce the concentration of the metabolitus of clopidogrel. The clinical significance of this interaction has not been determined, however, it is recommended that the CYP2C19 inhibitors should not be used simultaneously with Clopidogrel (see caution and special warning when used and pharmacological properties).

CYP2C19 inhibitors include omeprazole, Esomeprazole, Fluvoxamine, Fluoxetine, Moclobemide, Voriconazole, Fluconazole, Ticlopidine, Ciprofloxacin, Cimetidine, Carbamazepine, Oxcarbazepine and Chloramphenicol.

Proton pump inhibitors (PPI): There is a lot of data with inconsistent results of pharmacokinetic/pharmaceutical interaction between omeprazol and clopidogrel on cardiovascular events that have been reported from clinical observation and clinical studies. Therefore, it is not recommended to simultaneously use Omeprazol with clopidogrel (see caution and special warning when used). There is no conclusion about the pharmacokinetic interaction between clopidogrel and other proton pump inhibitors. There is no evidence that drugs that reduce stomach acid such as Histamine H, (except cimetidine has the effect of inhibiting CYP2C19) or antacids that interact with the inhibition of platelograms of clopidogrel.

Other drugs: There is no clinical significant pharmaceutical interaction recorded when using clopidogrel at the same time as Atenolol, Nifedipine, or both Atenolol and Nifedipine. In addition, the pharmacological activity of Clopidogrel is not affected when used at the same time with phenobarbital or estrogen.

Digodic pharmacokinetics of Digoxin or Theophylline is not affected when used at the same time as clopidogrel. Antacids do not change the absorption level of clopidogrel. Data from studies on microsomes from human liver shows that clopidogrel's carboxylic acid metabolites may have the activity of Cytochrome P450 2C9 inhibitors. This can lead to an increase in plasma concentrations of some drugs such as Phenytoin, Tolbutamide and NSAIDs are metabolized through Cytochrome P450 2C19.

Storage

Store at temperatures below 30 ° C, avoid moisture and light.

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