Acenocoumarol 1 SPM treats and prevents congestion (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Acenocoumarol
Ingredient S.P.M Corporation

Ingredient

Composition information	Content
Acenocoumarol	1mg

Uses

indications

Acenocoumarol 1 drug is indicated in the following cases:

Treatment and prevent congestion.

Acenocoumarol is an anti -vitamin K anti -coagulation drug. The disabled Vitamin K acts as a carboxylase to convert glutamic acid into gamma acid - carboxyglutamic acid on blood clotting factors. Therefore reducing coagulation factors such as prothrombin (factor II) factors VII, IX, X and proteins C and S.

After taken, vitamin K resisted to lower prothrombin in the blood for 36 to 72 hours. Treatment with vitamin K anti -vitamin K medication requires days. After stopping the drug, anticoagulants can last for 2-3 days. The drug restricts the development of the existing thrombosis and prevents secondary symptoms of thrombosis, although there is no direct thrombotic effect because it does not reverse the damage of ischemic tissue.

Pharmacokinetics

absorption

acenocoumarol is a mixture of racemic mixture of optical contrast r (+) and s (-).

acenocoumarol quickly absorbed after oral; At least 60% of the dose is present in the circulatory system. The peak concentration of plasma is achieved after 1-3 hours of single -dose 10 mg and AUC value is proportional to the dose of 8 - 16 mg.

There is no correlation between acenocoumarol plasma concentrations and prothrombin levels that can be set, due to the difference in the drug concentration in plasma between patients.

Distribution

more than 98% acenocoumarol binds to protein, mainly with albumin. The distribution volume 0.16 - 0.18 l/kg for the opposite R (+) and 0.22 - 0.34 l/kg for the opposite S ( -).

Metabolism

Acenocoumarol is metabolized widely, the hydroxylation 6- and 7- of both images of acenocoumarol is the main metabolite and the cytochrome P450 2C9 is the main place that converts into these four metabolites. Other enzymes related to metabolic (R) - Acenocoumarol are CYP1A2 and CYP2C19. By reducing the keto group, two carbinol metabolites are formed.

The reduction of nitro groups forms amino metabolites. No metabolites in this group of substances have anticoagulant effects in humans, but they all work in animals. Properties can be related to CYP2C9 related gene explaining 14% of the pharmaceutical response of acenocoumarol.

Elimination

The waste time of acenocoumarol from plasma is from 8 to 11 hours. The amount of plasma clearance reaches 3.65 l/hour after drinking. The total plasma removal of the image R (+) of acenocoumarol, has a significant higher blood coagulation activity, is lower than the image s (-).

29% are eliminated through feces and 60% in urine, with less than 0.2% of the dose excreted through the renal in the form of constant.

Before taking Acenocoumarol 1 SPM treats and prevents congestion (3 blisters x 10 tablets)

How to use

oral medication. The daily dose must always be used at the same time of the day. The pill must be swallowed with water.

Dosage

sensitivity to blood coagulation substances variable from one patient to another and can also change abnormally during treatment. Therefore, it is necessary to regularly check prothrombin (PT)/normal ratio of internationally (INR) and thereby adjust the dose for patients. If it is impossible to do it, do not use acenocoumarol.

acenocoumarol must be taken orally at a single dose.

Initial dose

The dose of acenocoumarol must be personalized. If the value of PT/INR is within the normal range before the beginning of treatment, the following dose schedule is recommended.

Initial doses are useful in the range of 2 mg/day to 4 mg/day, no initial dose is higher. The treatment can also start with a higher initial dose regime, usually 6 mg on the first day and the second day is 4 mg.

If the thromboplastin time is normal, the treatment must be built with caution.

Elderly patients (> 65 years old), patients with severe liver or heart failure with liver congestion or malnourished patients may require lower doses during the initial and maintenance treatment.

Measuring thromboplastin time must be done daily at the hospital starting at the second or third dose until the blood clotting is stable within the target range. The time between tests can be expanded later, depending on the stability of the results. Blood samples to perform tests in the laboratory must always be performed at the same time of the day.

Maintenance treatment and blood clotting tests

The maintenance dose of acenocomarol changes from patients to another and must be checked separately on the basis of PT/INR value. PT/INR must be evaluated at a regular period as at least once a month.

The maintenance dose is generally in the range of 1 to 8 mg daily depending on the individual patient, other diseases in the body, clinical indications and enhance the desire to resist blood coagulation.

Depending on clinical indications, optimize blood coagulation resistance or a targeted treatment range is generally located between Inr 2.0 and 3.5 values. The Inr value is higher than 4.5 may be required for separate cases.

Inr is recommended for oral blood coagulation treatment

indicated

Inr is recommended

2.0 - 3.0

2.0 - 3.5

The response of ThromBoplastin of each individual compared to the international comparative standards of the World Health Organization is reflected by the international sensitive index (ISI).

"International normal ratio" (INR) is given for the purpose of standardizing PT. Inr is the ratio of the patient's blood coagulation PT for normal plasma pt and thromboplastin in the same test system to reach the capacity of the value defined by the international sensitive index.

Continuing treatment

In general, after the acenocoumarol stops, there is usually no danger to increased reaction blood clotting and therefore it is not necessary to give a decreased dose slowly. However, in very rare cases, in some patients at high risk (for example: after myocardial infarction), the suspension must be slowly.

The transformation from heparin treatment

In clinical states that require fast blood coagulation, the initial treatment with heparin is more preferred because the blood coagulation effect of acenocoumarol is slow. The conversion to acenocoumarol can start simultaneously with heparin treatment or may slow down depending on the clinical state. To ensure continued blood coagulation resistance, it is recommended to continue prescribing treatment with heparin enough doses in at least 4 days after starting treatment with acenocoumarol and continuing heparin treatment until the INR is in the target range for at least two consecutive days.

During the conversion phase, closely monitoring anticoagulant effects is necessary.

Dental treatment and surgery

Patients who use acenocoumarol, who undergo surgery or invasion requires strict exploration of their blood clotting status. In defined conditions, such as when the surgery position is limited and accessible, it is allowed to effectively use the local processes for hemostasis, very small dental and surgical processes can be performed during the continued blood coagulation process, without excessive hemorrhage. The decision to stop acenocoumarol, even in a short time, must carefully consider the risks and individual benefits. Based on the northern type of bridge to treat blood coagulation, such as heparin must be based on careful evaluation of the risk of embolism and bleeding.

Special population

kidney failure

Acenocoumarol is not recommended for patients with severe renal impairment due to increased risk of bleeding. Must be clear in patients with mild and medium renal failure.

Hepatic failure

Acenocoumarol is not recommended for patients with severe liver failure due to increased risk of bleeding. Must be cautious in patients with mild and medium liver failure.

The population of children

Experience in oral blood coagulation drugs including acenocoumarol in children are limited. Precautions and monitoring more often than prothrombin and INR are recommended.

Elderly: Lower doses are recommended, adult dose may be sufficient for older patients. Precautions and monitoring more often than prothrombin and INR are recommended.

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 INR is on the treatment area but below 5, and the patient does not show signs of bleeding or does not need to quickly adjust blood clotting before surgery: 1 time to take 1 medication, then continue treatment at lower doses when he has reached the desired INR. If the INR is very close to the desired INR, then reduce the dose without having to quit the medication.

If Inr above 5 and less than 9, the patient does not show signs of bleeding other than bleeding or nosebleeds: remove 1 or 2 times to take anticoagulant drugs, because the Inr more often then when the INR has reached the desired Inr, take the drug again at a lower doses. If the patient has other risks of bleeding, giving up 1 time to take the drug and giving vitamin K from 2.5mg by oral, or 0.5 - 1 mg by intravenous veins slowly for 1 hour.

If Inr is over 9 without bleeding, remove 1 taken medicine and use vitamin K from 3 to 5mg by oral, or 1 - 1.5mg by slow intravenous infusion for 1 hour allows to reduce INR within 24 - 48 hours; Then use acenocomarol in lower doses, monitor the Inr regularly and if needed to be repeated with vitamin K.

If it is necessary to quickly adjust the anticoagulant effect in the absence of severe bleeding or severe overdose (for example, Inr above 20), taking a dose of 10mg of vitamin K slowly intravenously and depending on the requirements of emergency, combined with fresh frozen plasma. Vitamin K may repeat every 12 hours. After high -dose vitamin K treatment, there may be a period of time before the effect of vitamin K anti -vitamin K.

In case of poisoning due to an accident, it must also be evaluated according to INR and manifests bleeding complications. It must be due to Inr for many days later (2-5 days), taking into account half -life of the anticoagulant drug.

In case of overdose, take the patient to the nearest emergency room for supportive treatment.

Symptoms: Bleeding occurs within 1-5 days after drinking, nose bleeding, coughing up blood, gastric bleeding, vaginal bleeding, hematuria, bleeding under the skin, gums, uterus and joints. Moreover, symptoms: tachycardia, hypotension, peripheral circulatory disorders, nausea, diarrhea, abdominal pain.

Treatment: The necessity of treatment by gastrointestinal, adding activated carbon and taking cholestyramine helps increase the elimination of the drug. The benefits of treatments should be balanced with the risk of bleeding of each patient.

Note:

Gastrointestinal lavage may increase the risk of stomach bleeding.

Do not use vitamin K as antagonists, especially patients who require continuous anticoagulant drugs like patients using artificial valve.

What to do when forgetting 1 dose? If the patient forgets the prescribed dose at the schedule, the dose must be used as soon as possible during the same day. Patients should not use the forgotten dose by double the daily dose to compensate for the forgotten doses, but must refer to the treatment doctor.

Side Effects

When using acenocoumarol 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, ...

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

Rarely occurs: Hair loss; localized skin necrosis, possibly due to genetics lacking C protein or homogeneous factor is S protein; allergic skin.

Venous vasculitis, liver damage.

Bleeding in different internal organs due to the dosage of the drug, the age of the patient and the nature of hidden diseases (but not during the treatment period). Bleeding positions can be seen in: stomach, intestines, brain, genital urinary tract, uterus, liver, gallbladder and eyes. If bleeding occurs in a patient with a period of thromboplastin in the scope of treatment, the diagnosis of the patient's condition must be clearly defined for appropriate treatment.

Sometimes symptoms related to COUMARIN and its derivative such as gastric - intestinal disorders (loss of appetite, nausea, vomiting), allergies (rash and rash, dermatitis and fever), Hair loss, skin necrosis (due to protein C and congenital protein S), vasculitis and liver damage.

Rarely the following conditions

Allergic reactions (for example, urticaria, rash).

Vasculitis.

Gastrointestinal disorders, loss of appetite, nausea, vomiting.

Hair loss appears.

Very rare: skin necrosis bleeding (usually combined with congenital protein deficiency or its homogeneous protein s).

Instructions on how to handle ADR

Notify the doctor with unwanted effects when using the drug.

Warnings

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

Contraindicated

Acenocoumarol 1 drug is contraindicated in the following cases:

Hypersensitivity to acenocoumarol, the derivatives of cooumarin or the ingredients in the drug.

Pregnant women.

The elderly, alcoholism, neurological disorders or people without supervision.

All conditions of excessive hemorrhage may have clinical benefits such as hemorrhage and/or hemorrhagic dysplasia.

right before or after surgery on the central nervous system or eye and trauma surgery related to over -exposing the tissues.

Gastrointestinal ulcers or gastroenteriorium hemorrhage, urinary - genital or respiratory system.

Hemorrhage of blood vessels.

Acute pericarditis; Cydra fluid flowing.

Inflammation of the pericardium.

Severe hypertension.

severe or severe liver failure and cases of fibrin decomposition activity increased with activities of lung, prostate or uterus.

Be cautious when using

liver failure

Be cautious in patients with mild and medium liver failure because of the synthesis of coagulation factors may be impaired or may have abnormal activity of platelets.

kidney failure

Due to the ability to accumulate metabolites when impaired renal function, be careful in patients with mild and medium renal impairment.

heart failure

In severe heart failure, the expression of extremely cautious dose must be done, as congestion can reduce the activity of gamma - carboxylation of blood clotting factors. However, with the recovery of liver congestion, it is necessary to increase the dose.

Hematology

Be cautious with patients who have known or suspected (such as: abnormal bleeding after injury) deficiency of protein C or protein S.

Special population

In patients with children and older (> 65 years old), caution and monitoring more often than prothrombin and INR are recommended.

Other forms

Strict medical monitoring must be performed in cases or conditions that can reduce the protein bonds of acenocoumarol (such as hyperthyroidism, tumor, kidney disease, inflammation and infection).

The disorders of the stomach -intestinal absorption may change the anticoagulant effect of acenocoumarol.

During treatment with anti -coagulation drugs, injecting in muscle can cause tumors and must be avoided. Injection subcutaneously and intravenously can be done without causing this complication.

Careful care must be done is necessary to shorten PT/INR (Thromboplastin time) for the diagnosis or treatment process (such as X -rays, spinal removal, very small surgery, tooth extraction ...).

Patients with rare genetic problems in galactose tolerance, Lapp lactase deficiency or malposure - Galactose are not allowed to use this drug.

The ability to drive and operate machinery

No report.

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 only use the drug when it is impossible for heparin.

Breastfeeding period

Avoid breastfeeding. If you have to breastfeed, you should offset vitamin K for the child. Do not take medicine for pregnant and breastfeeding women, because the drug goes through the placenta and breast milk.

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 of over 3 g/day) increases anticoagulant effects and the risk of bleeding due to platelet aggregation inhibits and transferring anticoagulant oral fluids from bonding with plasma proteins.

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

phenylbutazon increases anticoagulant effects combined with the gastrointestinal mucosa irritation.

Pyrazol nonsteroidal anti -inflammatory drugs: Increased risk of platelet bleeding and gastrointestinal mucosa.

Do not coordinate

Aspirin at a dose of less than 3 g/day.

Non -steroid anti -inflammatory drugs, including the type of selective inhibition COX - 2.

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: Increasing the effect of anticoagulant oral medications due to competition associated with plasma proteins.

Should take other painkillers, such as paracetamol.

Precautions when coordinating

Allopurinol, aminoglutethimid, amiodaron, Androgen, anti -depression drugs Serotonin, Benzbromaron, Bosentan, Carbamazepin, Cephalosporin, Cimetidin (over 800 mg/day), Cisaprid, Cholestyramin, Corticoid (except Hydrocortison used in Addisane) Cyclin, cytotoxic drugs, fibrats, fungal Azols, fluoroquinolones, heparin, thyroid hormones, enzyme induction drugs, statins, macrolids (except for spiramycin), neviparin, efavirenz, imidazol group, orlistat, pentoxifylin, phenytoin, propafenon, propafenon, propafenon Ritonavir, Lopinavir, some sulfamids (sulfamethoxazol, sulfafurazol, sulfamethizol), sucralfate, cancer medicine (Tamoxifen, Raloxifen), Tibolon, Vitamin E above 500 mg/day, alcohol, anti -cubic platelets, Blood Pepper, ... also change anti -coagulating effects.

Medications that increase anticoagulant effects of acenocomarol

Allopurinol; Anabolic steroids; Androgen.

Anti -arrhyths (such as amiodarone, quinidine).

Antibiotics, broad -spectrum antibiotics (such as amoxicillin, coamoxiclav), macrolid (such as erythromycin, clarithromycin).

Cephalosporin for the second and third generation.

metronidazole; Quinolone (such as ciprofloxacin, norfloxacin, ofloxacin); Tetracyclines; Neomycin; Chloramphenicol; Fibrates (like clofibric acid).

Fibrates derivatives or similar structures (such as gemfibrozil, fenofibrate).

disulfiram; Etacrynic acid; Glucagon; H2 anti -H2 (ascimetidine).

Imidazole derivatives (Econazole, Fluconazole, Ketoconazole, Miconazole).

paracetamol; Sulfonamides (including co - trimoxazole); Antidiabetic (Glibenclamide).

Dextrothyroxine.

sulfinyrazone; Sulphonylirros (Tolbutamide and Chlopropamide).

Statin (Atorvastatin, Fluvastatin, Simvastatin).

Selective Serotonin reabsorption inhibitors (fluoxetine, paroxetine); Tamoxifen; 5 - Fluorouracil; Tramadol.

corticosteroid (methylprednisolone, prednisone).

Inhibitors of CYP2C9, hemostatic drugs include heparin; Plateloon inhibitors (clopidogrel, dipyridamole), salicylic acid and derivatives such as acetylsalicylic acid, para - aminosalicylic acid; diflunisal, phenylbutazone and pyrazolone derivatives (sulfinpyrazone); Non -steroid anti -inflammatory (NSAIDs) includes COX - 2 inhibitors (Celecoxib) and methylprednisolone. They can increase the risk of bleeding. In case the use is simultaneously inevitable, the blood clotting test should be done regularly.

Medications that reduce the anticoagulant effect of acenocoumarol

aminoglutethimide.

anti-cancer drugs (Azathioprine, 6-Mercaptopurine), barbiturates (phenobarbital); Carbamazepine; Colestyramine; Griseofulvin; birth control pills; Rifampicin.

diuretics; Induction agents: CYP2C19, CYP2C9 or CYP3A4.

Protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir) also affect the anticoagulant effect of the drug and have no reports on the increase or decrease of anticoagulant activity of the drug.

Serum levelin concentration may increase when treated simultaneously with Hytantoin's derivatives (such as phenytoin).

Acenocoumarol may increase hypoglycemia when using sulphonylurea derivatives (such as glibenclamide, Glimepiride).

Patients with liver dysfunction when treated with acenocoumarol should limit drinking.

When treated with acenocoumarol, patients should avoid drinking juice. Strengthen monitoring and monitoring of INR for patients often using kumquat juice.

Do not combine with high doses of aspirin, nonsteroidal anti -inflammatory drugs pyrazol, miconazole use systemic and vaginal sugar; phenylbutazol, chloramphenicol, diflunisal.

Storage

In a dry place, avoid light, the temperature does not exceed 30 ° C.

Other drugs

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.