Warfarex, tablets 5 mg, 100 pcs.

Varfarex belongs to the group of anticoagulants – drugs that prevent blood clotting and is intended for long-term use.

It has an indirect anticoagulant effect, inhibiting in the liver the synthesis of a number of factors involved in the regulation of blood clotting.

Warfarex prevents the formation of new blood clots and prevents the growth of already formed ones.

Indications

Prevention of heart attacks and strokes, myocardial infarction, thrombosis prevention

Prevention and treatment of diseases caused by the formation of blood clots in the blood vessels:

• deep vein thrombosis;
• lung thromboembolism;
• myocardial infarction;
• prosthetic heart valves.

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Active ingredient

Warfarin

Composition

1 tablet contains sodium warfarin (in the form of clathrate) 5 mg;

excipients:

lactose;

MCC;

crospovidone;

magnesium stearate;

indigo carmine dye.

How to take, the dosage

Overly, once a day, preferably at the same time of day.

The dose, regimen and duration of Warfarex is determined for each patient individually by the physician based on the severity of the disease and the results of clotting control (INR). It is not allowed to change the dose or stop treatment with Varfarex without doctor’s permission.

The initial dose is 2.5-5 mg per day for the first 2 days, then it is gradually adjusted according to the patient’s individual clotting reaction (INR). After achieving the desired INR level (2.0-3.0, and in some cases 3.0-4.5) a maintenance dose is prescribed.

Elderly, frail, or at-risk patients are prescribed lower starting doses and are cautious about increasing them.

Warfarex is not usually prescribed in children.

The laboratory INR is monitored every day at the beginning of treatment; during the next 3-4 weeks, INR is monitored 1-2 times per week; later, every 1-4 weeks.

More frequent additional monitoring is necessary when the patient’s health condition changes, before a planned surgery or other procedure, or when any other medication is prescribed or cancelled.

Interaction

High levels of vitamin K in foods (spinach, broccoli, lettuce, and other leafy vegetables) may reduce the effects of Warfarex. However, you should not change your diet too drastically or use vitamins or supplements without consulting your doctor. Smoking may decrease the anticoagulant effect of the drug.

The effect of Warfarex may be changed by a large number of drugs. NSAIDs, dipyridamole, valproic acid, cytochrome P450 inhibitors, cimetidine, chloramphenicol, laxatives – increase the risk of bleeding. Combined use of these drugs and Warfarex should be avoided (cimetidine may be replaced by ranitidine or famotidine).

If treatment with chloramphenicol is necessary, anticoagulant therapy may be temporarily stopped. Diuretics may decrease the effect of anticoagulants (in case of marked hypovolemic action, which may lead to increased concentration of clotting factors). Weakens the effect of: barbiturates, vitamin K, glutethimide, griseofulvin, dicloxacillin, carbamazepine, mianserine, paracetamol, retinoids, rifampicin, sucralfate, phenazone, cholestyramine.

The effects are enhanced by: allopurinol, amiodarone, anabolic steroids (alkylated at position C-17), acetylsalicylic acid and other NSAIDs, heparin, glibenclamide, glucagon, danazol, diazoxide, disopyramide, disulfiram, isoniazid, ketoconazole, clarithromycin, clofibrate, levamisole, metronidazole, miconazole, nalidixic acid nilutamide, omeprazole, paroxetine, proguanil, oral hypoglycemic agents – sulfonamide derivatives, sulfonamides, tamoxifen, thyroxine, quinine, quinidine, fluvoxamine, fluconazole, fluorouracil, quinolones, chloral hydrate, chloramphenicol, cephalosporins, cimetidine, erythromycin, etacrynic acid, ethanol. When using Warfarex in combination with above mentioned drugs it is necessary to perform INR control at the beginning and at the end of treatment and, if possible, 2-3 weeks after the beginning of therapy.

When using drugs that may increase the risk of bleeding due to decreased normal coagulation (inhibition of clotting factors or liver enzymes), the strategy of anticoagulant therapy should be determined by the possibility of laboratory monitoring. If frequent laboratory control is possible, the dose of Warfarex can be reduced by 5-10% if therapy with such agents is necessary.

If laboratory monitoring is difficult, Warfarex treatment should be discontinued if indicated agents are necessary.

Special Instructions

The use of anticoagulants increases the risk of bleeding. To monitor the condition of the blood clotting system, during the treatment with Varfarex, you should regularly visit a doctor and have the prescribed tests.

When visiting doctors, dentists, or pharmacists, you should tell them that you are taking Warfarex. You should see a doctor if digestive disorders appear accompanied by diarrhea (diarrhea), fever.

Pregnancy during treatment with Varfarex is highly undesirable, so it is necessary to use effective methods to prevent it. It is necessary to be careful when handling sharp and traumatic objects, avoid activities associated with the risk of injury and subsequent bleeding. During treatment it is necessary to refrain from drinking ethanol (risk of hypoprothrombinemia).

The safety of the drug in children in clinical trials has not been studied sufficiently.

There are no data on adverse effects of Varfarexan on the ability to drive vehicles and operate other mechanisms.

Patients with lactose intolerance should note that 1 tablet of Varfarex contains 106-112 mg of lactose.

Contraindications

• high sensitivity to Warfarex components;
• bleeding (or risk of bleeding) in some severe diseases;
• bacterial endocarditis;
• bacterial endocarditisSevere liver or kidney failure or disease;
• obturative jaundice;
• diabetes mellitus;
• acute DIC syndrome;
• protein C and S deficiency;
• hemorrhagic diathesis;
• thrombocytopenia;
• gastric and duodenal ulcer in the acute stage;
• cerebral hemorrhage;
• alcoholism;
• severe arterial hypertension;
• complicated surgeries and diagnostic procedures recently performed or suspected;
• insufficient ability to assess the clotting system through laboratory methods;
• childhood.

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Side effects

The most common side effects observed during treatment with anticoagulants are bleeding and hemorrhage in various organs and tissues.

The possible risk of these side effects can be significantly reduced by strict adherence to the physician’s recommendations regarding the administration of Warfarex.

In some cases, treatment with anticoagulants may cause circulatory disorders in the extremities or internal organs.

The circulatory disorder is most often indicated by pain and dark red skin on the toes.

If these symptoms occur, you should see a doctor right away.

Other rare side effects include skin allergic reactions (itching, urticaria, dermatitis), nausea, vomiting, diarrhea, abdominal pain, liver disorders (increased liver enzymes in the blood, jaundice), fever, general weakness, changed blood count, transient alopecia.

Overdose

Symptoms of chronic intoxication: bleeding from gums, nosebleeds, excessive menstrual bleeding, heavy or prolonged bleeding for minor superficial injuries, bleeding in the skin, presence of blood in urine and feces, etc.

Treatment: In case of minor bleeding, it is necessary to reduce the drug dose or stop treatment for a short time. If severe bleeding develops – transfusion of prothrombin complex factor concentrates, or fresh frozen plasma, or whole blood.

Pregnancy use

Warfarex should not be prescribed to pregnant women due to the identified teratogenic effect, development of fetal bleeding and fetal death.

The drug is excreted with mother’s milk in small amount and practically has no effect on blood clotting in a child, therefore the drug can be used during lactation, however it is recommended to refrain from breast-feeding during first 3 days of warfarin therapy.

Similarities

Warfarin