Orion warfarin of the tab. of 5 mg No. 100

tablets "Orion Warfarin" are applied at the following indications:

• treatment and prevention of a deep vein thrombosis and embolism of a pulmonary artery;
• secondary prevention of a myocardial infarction and prevention of tromboembolic episodes (cerebral embolism or a system embolism) after a myocardial infarction;
• prevention of tromboembolic episodes (cerebral embolism or a system embolism) at patients with fibrillation of auricles, damages of heart valves or the fitted a prosthesis heart valves.

Structure

One tablet contains (active ingredient) of warfarin of sodium of 5 mg.

Excipients: lactoses monohydrate, starch corn, gelatin, magnesium stearate, E 132 indigo carmine.

Contraindication

Tendency to bleedings (Villebrandt's disease, hemophilia, thrombocytopenia and disturbance of functions of thrombocytes), acute bleeding, in order to avoid risk of developing heavy bleedings within 72 hours after extensive surgeries, within 48 hours in a puerperal period, pregnancy, a heavy renal failure, a heavy liver failure and cirrhosis, not treated or uncontrollable arterial hypertension, recent intracraneal hemorrhage, the state of health which causes intracraneal hemorrhage for example aneurysm of brain arteries, an aortic aneurysm, a tendency to falling, a lumbar puncture, operations of the central nervous system or eye operations, gastrointestinal or renal bleedings and their complications, a divertuculosis or malignant tumors, a gullet varicosity, an infectious endocarditis or an exudative pericarditis, dementia, psychoses, alcoholism and other situations when the komplayentnost can be insufficient and therapy it is impossible to carry out by anticoagulants rather safely, hypersensitivity to warfarin or to any of excipients.

Route of administration

Target INI (International Normalizing Index) level for oral anticoagulating therapy:

• prevention of tromboembolic episodes at patients with the fitted a prosthesis heart valves - RUMPLE 2.5-3.5;
• other indications - RUMPLE 2.0-3.0.

to Patients with normal body weight and spontaneous RUMPLE

lower than 1.2 to appoint 10 mg of warfarin within three consecutive days. Then to calculate a dose according to the information given below based on measurement THINK for the fourth day.

At out-patient treatment and at patients with hereditary insufficiency of a protein With or S recommended initial dose makes 5 mg of warfarin within three consecutive days. Then to calculate a dose according to the information given below based on measurement THINK for the fourth day.

For patients of advanced age, patients with small body weight, with spontaneous RUMPLE higher than 1.2, or that which have associated diseases or receive any medicines affecting efficiency of anticoagulating therapy, the recommended initial dose makes 5 mg of warfarin within two next days. Then to calculate a dose according to the information given below based on measurement THINK for the third day.

Recommended dosage of the medicament "Varfarin-FS":

• day of 1 - 10 (5.0) mg/days;
• day of 2 - 10 (5.0) mg/days;
• put 3:
  • RUMPLE <2.0 - 10 (5.0) mg/days;
  RUMPLE
  • from 2.0 to 2.4 - 5.0 mg/days;
  RUMPLE
  • from 2.5 to 2.9 - 3.0 mg/days;
  RUMPLE
  • from 3.0 to 3.4 - 2.5 mg/days;
  RUMPLE
  • from 3.5 to 4.0 - 1.5 mg/days;
  RUMPLE
  • > 4.0 - to miss one day of reception;
• put 4-6:
  • RUMPLE <1.4 - 10.0 mg/days;
  RUMPLE
  • from 1.4 to 1.9 - 7.5 mg/days;
  RUMPLE
  • from 2.0 to 2.4 - 5.0 mg/days;
  RUMPLE
  • from 2.5 to 2.9 - 4.5 mg/days;
  RUMPLE
  • from 3.0 to 3.9 - 3.0 mg/days;
  RUMPLE
  • from 4.0 to 4.5 - to miss one day of reception, then - 1.5 mg/days;
  RUMPLE
  • > 4.5 - to miss two days of reception, then - 1.5 mg/days;
put
• 7 (a week dose of the medicament "Varfarin-FS"): RUMPLE
  • from 1.1 to 1.4 - increases by 20%;
  RUMPLE
  • from 1.5 to 1.9 - increases by 10%;
  RUMPLE
  • from 2.0 to 3.0 - the dose remains;
  RUMPLE
  • from 3.1 to 4.5 - decreases by 10%;
  RUMPLE
  • > 4.5 to miss reception while THINK will not become <4.5, then - to continue treatment by the dose reduced by 20%.

Measurement RUMPLE

to carry out daily, the stable target level which usually is established for 5-6 day of treatment will not be reached yet. Then RUMPLE measurements to carry out weekly, reaching a 4 weeks interval. In case of big deviations in the THINK level or patients with diseases of a liver or diseases which influence vitamin K absorption intervals of measurements can have less than 4 weeks. Appointment new or cancellation of medicines which were accepted earlier demands carrying out additional measurements THINK. At long therapy of adjustment it is carried out to a week dose of warfarin according to information given above. If the dose demands correction, then RUMPLE the following measurement it is necessary to carry out in one or two weeks after correction. After this measurement proceed before achievement of 4 weeks intervals.

Planned operations

Pre-, a feather - and postoperatively anticoagulating therapy is carried out by

as it is provided below.

to Define

THINK one week prior to the appointed operation.

to Stop intake of warfarin in 1-5 days prior to operation. In case of high risk of thrombosis the patient for prevention subcutaneously should enter low-molecular heparin.

pause Duration in intake of warfarin depends from THINK. To stop intake of warfarin:

• in 5 days prior to operation if THINK> 4.0;
• in 3 days prior to operation if THINK = from 3.0 to 4.0;
• in 2 days prior to operation if THINK = from 2.0 to 3.0.

to Define

THINK in the evening before operation and to enter 0.5-1.0 mg of K1 vitamin orally or if THINK> 1.8.

to Take into account need of infusion of unfractionated heparin or preventive administration of low-molecular heparin in day of operation.

to Continue by

hypodermic administration of low-molecular heparin within 5-7 days after operation with the accompanying restored intake of warfarin.

to Continue by

intake of warfarin from a usual maintenance dose on the same day in the evening after small operations and in day when the patient begins to receive an enteroalimentation after large operations.

Children

Therapy by anticoagulants at children is carried out by

under observation of the pediatrician. Doses are selected according to the data given below.

Recommended dosage:

• put 1 - if the MNI basic value from 1.0 to 1.3, then the initial dose makes 0.2 mg/kg of body weight;
• days from the 2nd for the 4th, if THINK value (maintenance dose):
  • from 1.1 to 1.3 - to repeat an initial dose;
  • from 1.4 to 1.9 - 50% of an initial dose;
  • from 2.0 to 3.0 - 50% of an initial dose;
  • from 3.1 to 3.5 - 25% of an initial dose;
  • > 3.5 - to stop administration of medicament before achievement THINK <3.5, then to resume treatment by a dose, for 50% smaller from the previous dose;
• maintenance therapy, if THINK value (week dose):
  • from 1.1 to 1.4 - to increase a dose by 20%;
  • from 1.5 to 1.9 - to increase a dose by 10%;
  • from 2.0 to 3.0 - without changes;
  • from 3.1 to 3.5 - to reduce a dose by 10%;
  • > 3.5 - to stop administration of medicament before achievement THINK <3.5, then to resume treatment by a dose 20% less previous.

to

Pregnant

Warfarin is contraindicated to

Feature of use

Warfarin does not get into breast milk therefore feeding by a breast can be continued during therapy by warfarin.

Drivers

Drug does not affect ability to run motor transport or to work with mechanisms.

Overdose

In cases gradual overdoses is usually enough to stop administration of drug.

At acute overdose does not recommend gastric emptying because of danger of bleeding. To repeatedly appoint activated carbon for prevention of absorption and enterogepatichesky circulation of warfarin. When prescribing activated carbon, vitamin K which can be necessary later should be entered parenterally (intravenously). In case of bleeding warfarin it can be terminated by administration of vitamin K, a concentrate of a factor of coagulation or freshly frozen plasma. If oral anticoagulants are shown in the future, it is necessary to avoid high doses of vitamin K which exceed 10 mg as patients become resistant to warfarin within two weeks.

Side effects

Most often arrive messages (from 1% to 10%) about such side reaction as bleeding which develops at about 8% of the patients who are annually accepting warfarin. Moderate bleedings arise annually at 6%, heavy bleedings - 1% and lethal - at 0.25% of patients. The frequent risk factor for emergence of intracraneal hemorrhage is not treated or uncontrollable hypertensia. Probability of bleeding increases if THINK much above target level. If bleeding began at RUMPLE that it is in limits of target level, it means existence of other accompanying conditions which need to be investigated.

to Store

at a temperature not above 25 °C, out of children's reach. To store in densely corked bottle. To keep a bottle in an external pack.

Expiration date - 3 years.