Tegrucil-1 Davi Pharm medicine prophylaxis of clogged thrombosis (10 blisters x 10 tablets)

Dosage form Box of 10 blisters x 10 tablets
Specifications Acenocoumarol

Ingredient

Composition information	Content
Acenocoumarol	1mg

Uses

indications

Tegrucil 1 drug is indicated in the following cases:

Heart disease clogged: Preventing clogged thrombosis due to atrial fibrillation, mitral valve, artificial valve.

Myocardial infarction: Preventing clogged blood clogging in myocardial infarction complications such as thrombosis on the heart, severe left ventricular dysfunction, left ventricular disorder causing clogging when treated instead of heparin; Preventive recurrence of myocardial infarction when aspirin cannot be used.

Venous blood thrombosis, pulmonary embolism in hip surgery.

Blood spurming in the catheter.

Pharmacology

acenocoumarol is a vitamin K-resistant cooumarin conductor. These drugs inhibit vitamin K Epoxid Reductase enzyme, leading to the process of transferring glutamic acid into gamma-carboxglutamic acid of the precursor protein of blood coagulation factors II, VII, IXX. Thus, vitamin K -resistant coumarin conductors have an indirect anticoagulant effect by preventing the synthesis of the activity of the above coagulation factors (II, VII, IX, X).

After taking acenocoumarol, the effect on prolongrombin time is usually maximum within 24 to 48 hours, depending on the dose. After stopping the drug 48 hours, prothrombin time is back before taking the drug. After drinking, generally, vitamin K -resistant cooumarin derivatives cause blood prothrombin within 36 to 72 hours. Balancing treatment with antacids of vitamin K requires many days.

After stopping the drug, anticoagulant effects can last for 2-3 days. The drug can limit the development of the existing thrombosis and prevent secondary symptoms of thrombosis, although there is no direct thrombotic effect because it does not reverse the damage of ischemic tissue.

Compared to warfarin and phenprocoumon, acenocoumarol has the advantage of shorter effect time.

Dynamic pharmacokinetics

acenocoumarol is quickly absorbed through the gastrointestinal tract. Oral bioavailability reaches 60%. The concentration of the drug in plasma changes between individuals should not have the correlation of the dose level, the concentration of the drug in plasma with pharmacological effects shown through prothrombin.

A significant part of isomorphic s ( -) -acenocoumarol through initial metabolism in the liver, while the bioavailability of the isomers R (+) -acenocoumarol is 100%. The drug is strongly attached to plasma proteins (99%). The peak concentration of the drug in plasma is within 1-3 hours. Distribution volume 0.16 - 0.34 liters/kg. Acenocoumarol through the placenta and a small part is detected in breast milk.

Acenocoumarol is metabolized in the liver by the cytochrom P450 enzyme system (isenzyme CYP2C9 isomered S isomer, r isomer is metabolized by some other isenzymes) into non -active amino and acetamid metabolites. Some other metabolites such as diastereoisometric alcohol and hydroxyl metabolites may be active. The waste sale time of acenocoumarol is about 8 - 11 hours. The drug is excreted mainly in the urine (60% in about 1 week) in the form of metabolism and partially through feces (29% in about 1 week).

Before taking Tegrucil-1 Davi Pharm medicine prophylaxis of clogged thrombosis (10 blisters x 10 tablets)

How to use

Drink whole tablets with a cup of water.

Dosage

adults

The dosage must be adjusted to achieve the purpose of preventing blood clotting mechanism that there is no thrombosis but avoiding spontaneous bleeding. Dosage depends on the response of each person.

Take dosage usual

The first day is 4 mg/day, the 2nd day is 4 - 8 mg/day. The maintenance dose is from 1 - 8 mg/day depending on the biological response. The adjustment usually conducts each step of 1 mg. Acenocoumarol is usually taken once at the same time.

Biological monitoring and dose adjustment

The appropriate biological test is to measure prothrombin (PT) time that is indicated by the International standardized ratio of Inr. Prothrombin time allows the exploration of factors II, VII, and X are factors that are reduced by vitamin K anti -vitamin K.

INR is a way to indicate the time for the sensitivity of the reagent (Thromboplastin) used for testing, so it should reduce erratic changes between labo. When not taking anti -vitamin K, Inr in normal people is 1. When using the drug in the following situations, in most cases the target of the INR needs to be 2.5, fluctuating in the range 2 and 3, Inr under 2 reflects the use of anticoagulants is not enough. Inr above 3 is to use excess medicine. Inr above 5 is at risk of bleeding.

Biological inspection rate

The first test was conducted 48 hours + 12 hours after taking the first vitamin K anti -vitamin to detect an individual's sensitivity. If INR above 2, signaling will overdose when balanced, so the dose should be reduced. The following tests are conducted daily or Japan until the INR is stable, then gradually away from the response, the longest is every 12 weeks.

Balance of treatment sometimes only reaches after weeks. After each dose change, check the Inr 1-2 days later and repeat until stable. Overall, Inr from 2 - 3 is recommended for prevention or treatment of venous thrombosis, including pulmonary embolism, atrial fibrillation, heart valve, or biological valve. Inr from 2.5 to 3.5 is recommended after myocardial infarction, patients with mechanical valve, or in some patients with thrombosis or phospholipid resistance syndrome, higher Inr can be recommended for recurrent embolism.

Stop medicine

Normally after stopping the drug, there is no risk of increased blood clotting so there is no need to reduce the dose slowly. However, in some particularly rare cases, some patients are at high risk (for example: after heart attack), should stop the drug slowly.

Dosage in the elderly

The starting dose must be lower than the adult dose. The average balancing dose in treatment is usually only 1/2 to 3/4 of adult doses.

Serial treatment Heparin

Due to the slow anticoagulants of vitamin K anti -vitamin drugs, heparin must be maintained with constant doses during the necessary time, that is, until the INR is in the desired value for 2 consecutive days. In case of heparin platelets, vitamin K should not be given soon after heparin stops because there is a risk of hyper coagulation due to protein S (anticoagulant) early. Only vitamin K resistance after giving thrombin drugs (Danaparoid or Hirudine).

Need to stop anticoagulants 5 days before surgery. If the day before the surgery Inr> 1.5, it is necessary to give vitamin K injected 1 - 5 mg. If the bleeding is good, it is possible to reuse the drug (acenocoumarol) with a normal maintenance dose on the surgical day or the next morning.

Patients taking the drug before surgery are considered to be high risk, so they may need support with a low molecular heparin (used for treatment dose), which should be stopped at least 24 hours of low molecular heparin before surgery. If surgery is at high risk of bleeding, do not reuse low molecular heparin within at least 48 hours after surgery.

Patients taking drugs (acenocoumarol) need urgent surgery that can slow down about 6 - 12 hours, it can be given intravenous 5 mg of vitamin K to reverse anticoagulant effect. If it is not possible to postpone, both vitamin K and dry prothrombin mixture (for example, 25 units/kg) and must be tested for Inr before surgery.

Children

Experience in using anticoagulants for children is limited, do not recommend using drugs for children.

kidney failure

Acenocoumarol control in patients with severe and cautious renal failure when used in patients with mild to moderate renal failure.

liver failure

Acenocoumarol is contraindicated in patients with severe and cautious liver failure when used in patients with mild to moderate liver failure.

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? If you have stopped anticoagulants but do not use vitamin K, need to re -test Inr 2-3 days later to ensure that the INR has decreased.

INR

Inr> 8, no bleeding: stop acenocoumarol, drink 1 - 5 mg of phytomenadiol (vitamin K1) (use injection form instead of oral). After 24 hours, if the INR is still high, repeat treatment with vitamin K. Only use acenocoumarol when Inr

Inr> 8, mild bleeding: stop the drug, use vitamin K from 1 - 3 mg by slow intravenous injection. After 24 hours, if the INR is still high, the dose of vitamin K is high.

In case of signs of severe bleeding or severe overdose (for example, Inr> 20): Stop drug, slow intravenous injection of 5 mg of vitamin K, for dry prothrombin mixture (factor II, VII, IX and X) 25 - 50 units/kg (if there is no dry prothrombin mixture, replaced with frozen plasma 15 ml/kg but the effect will be worse). Do not use the VIIA factor in the case of emergency to reverse anticoagulant effects.

In case of poisoning due to an accident, it must also be evaluated according to INR and manifests bleeding complications. Must measure the INR for many days later (2-5 days), taking into account for half a long life of anticoagulant drugs. Use vitamin K to adjust the effects of anticoagulant drugs.

What to do when forgetting 1 dose? If the patient forgets to take the medication on time, should take the medicine as soon as possible in the same day. Do not double the daily dose to compensate for the forgotten dose, and should contact the doctor for monitoring.

Side Effects

When using Tegrucil 1, you may experience unwanted effects (ADR).

The most common complications of bleeding, which can occur throughout the body: the central nervous system, the limbs, the organs, in the abdomen, in the eyeball manifest such as: bleeding of gums (gums), nose bleeding, blood in urine, blood onion, hematoma ..., fatigue, shortness of breath, headache, uncomfortable uncomfortable ...

Sometimes diarrhea occurs (may be accompanied by fatty fertilizer), individual joint pain.

Rarely occurs: Hair loss, localized skin necrosis, may be due to genetically deficient C protein C or homogeneous factor is S protein; Allergic skin.

Venous vasculitis, liver damage.

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

Tegrucil 1 contraindicated in the following cases:

Hypersensitivity to Coumarin derivatives or any ingredients of the drug.

Define vitamin C, pericarditis caused by bacteria, blood dysplasia or any blood disorders that increase the risk of bleeding.

Hypertension (severe).

Severe liver failure, especially when prothrombin is prolonged.

The risk of bleeding, new surgical intervention of neurological and eye or the possibility of surgery.

Stroke (except in the case of elsewhere).

Severe renal failure (CLCR

Varicose veins.

Gastro -duodenal ulcer is progressing.

Do not combine with high doses of aspirin, nonsteroidal anti -inflammatory drugs pyrazol, miconazole use systemic, vagina; phenylbutazon, chloramphenicol, diflunisal.

Contraindicated for pregnant women. Do not use acenocomarol within 48 hours after birth.

Be cautious when using

Must pay attention to the cognitive ability of the patient during the treatment process (the risk of wrong medication). Careful guidance for them to comply with accurate indications, understanding the risk and attitude of handling, especially for the elderly.

Experience in using anticoagulants for children is limited, it is not recommended to use drugs for children.

Must emphasize the daily medication at the same time.

Testing for international standardized ratio (INR) must be tested and in the same place. In case of surgical intervention, each case must be considered to adjust or suspend anticoagulic drugs, based on the risk of patient thrombosis and the risk of bleeding associated with each type of surgery.

Careful monitor and adjust the dose accordingly in people with liver failure, kidney failure or lower blood protein.

Hemorrhagic complications are prone to the first months of treatment, so it is necessary to closely monitor, especially when the patient goes home to return home. Do not stop the drug suddenly.

Preparations contain lactose monohydrates. Do not use Tegrucil for patients with galactose intolerance due to genetics, deficiency of lapp lactase enzymes or impaired absorption of glucose, galactose.

To be out of reach of children.

The ability to drive and operate machinery

There has been no report on the effect of the drug when driving and operating machinery. However, patients need to be cautious because of the risk of bleeding due to injury when using anticoagulants.

Pregnancy

There was a statistics of about 4% of the fetal deformity when the mother took this medication in the first quarter of pregnancy. In the next quarters, there is still risk (including miscarriage). So contraindicated use of acenocoumarol for pregnant women. It is recommended that women of reproductive age use effective contraception when treating with acenocoumarol.

Breastfeeding period

The drug passes through breast milk. Avoid breastfeeding. If you have to breastfeed, you should offset vitamin K at the daily dose for the child.

Interactive drug

A lot of drugs can interact with vitamin K anti -vitamin drugs, so they need to monitor patients 3-4 days after adding or removing combined drugs.

Contraindications for coordination

Aspirin (especially with high doses> 3 g/day) increases anticoagulant effects and the risk of bleeding due to platelet aggregation inhibits and transferring anticoagulant oral fluids from bonds with plasma proteins.

Miconazole: Unexpected hemorrhage can be severe due to increased blood in the blood and inhibition of metabolism of anti -vitamin K drugs.

phenylbutazon: Increases anticoagulant effects in combination with gastrointestinal mucosa irritation.

Non -steroid anti -inflammatory drugs, pyrazol groups: Increased risk of bleeding due to platelet inhibition and gastrointestinal mucosa irritation.

Do not coordinate

Aspirin at a dose

Chloramphenicol: Increases the effect of anticoagulant oral medications due to reducing this drug metabolism in the liver. If it is not possible to avoid coordination, you must check the Inr more often, adjust the dose in and after 8 days of stopping chloramphenicol.

diflunisal: Increases the effect of anticoagulant oral medications due to competition associated with plasma proteins. Other painkillers should be used, for example paracetamol.

Precautions when coordinating

The drug may increase the anticoagulant effect of acenocoumarol: Allopurinol; benzbromaron; Anabolic steroids; Androgen; anti -arrhyths (such as amiodaron, quinidine, propafenon); Antibiotics (broad -spectrum antibiotics such as amoxicillin, co - amoxiclav; macrolide such as erythromycin, clarithromycin); Cephalosporin generation II and III; Metronidazol; Quinolones (such as ciprofloxacin, norfloxacin, ofloxacin); tetracycline; neomycin.

Imidazol derivatives, including topical drugs (such as Econazol, Fluconazol, Ketoconazol); Sulfonamids (including Co - Trimoxazol); Fibrats (such as clofibric acid), derivative and substances with similar structure fibrat (such as fenofibrat, gemfibrozil); disulfiram; Etacrynic acid; Glucagon; Drugs for oral diabetes (such as glibenclamid); Sulphonylurea (such as tolbutamid and chlorpropamid); H2 antagonists (such as cimetidine); paracetamol.

Thyroid hormones (including dextrothyroxin); Statin (such as Atorvastatin, Fluvastatin, Simvastatin); Selective inhibitors of Serotonin reabsorption (such as citalopram, fluoxetin, sertralin, paroxetin); Tamoxifen; 5 - Fluorouracil and similar substances; tramadol; Proton pump inhibitors (such as omeprazol); Plasminogen activation (such as Urokinase; Streptokinase and Alteplase); Thrombin inhibitors (such as argatroben); pentoxifylin; Orlistat; Perhancer increased drugs (such as Cisaprid); antacids (such as Magnesi Hydroxyd); viloxazin. CYP2C9 inhibitors can increase the anticoagulant effect of acenocoumarol.

The drug can reduce the anticoagulant effect of acenocoumarol: aminoglutethimid; Bosentan; Sucralfate, anti -cancer drugs (such as azathioprin, 6 mercaptopurin, tamoxifen, raloxifen); Barbiturates (such as phenobarbital); Carbamazepin; cholestyramin; Griseofulvin; Oral contraceptive pills; Rifampicin; HIV protease inhibitors (such as ritonavir, nelfinavir); thiazid diuretics; St. John's World/Hypericum Perforatum.

CYP2C9, CYP2C19 or CYP3A4 touch substances may reduce the anticoagulant effect of acenocomarol. Vitamin E and corticosteroids (such as methylprednisolon, Prednison) may reduce the anticoagulant effect of cooumarin derivatives.

drugs have an unpredictable effect (both increase and decrease) on anti -dynamic effects: Protease inhibitors (such as indinavir, nelfinavir, ritonavir, saquinavir, Lopinavir); Nevirapin, Efavirenz.

The effect of acenocoumarol on other drugs

Hytantoin derivatives (such as phenytoin): Increased serum serum levels of Hytantoin.

Sulphonylurea derivatives (such as Glibenclamid, Glimepirir): increase hypoglycemia.

Effect of food

Alcohol can affect the impact of the drug, so it should not be taken alcohol when using the drug.

Avoid using food or drinks made from cranberry fruit due to the risk of increased anticoagulant effect.

Storage

In a dry place, avoid light, the temperature does not exceed 30⁰C.

Other drugs

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