Warfarin Orion tablets are indicated for the treatment and prevention of deep vein thrombosis and pulmonary embolism. Secondary prevention of myocardial infarction and prevention of thromboembolic complications (cerebral embolism or systemic embolism) after myocardial infarction. Prevention of thromboembolic complications (cerebral embolism or systemic embolism) in patients with atrial fibrillation, heart valve disease or prosthetic heart valves.
Composition
Active ingredient: 1 tablet contains warfarin sodium 3 mg or 5 mg;
Excipients: lactose monohydrate, corn starch, gelatin, magnesium stearate, indigo carmine E 132 (3 mg tablets) or erythrosine E 127 (5 mg tablets).
Contraindication
Bleeding tendency (von Willebrand's disease, hemophilia, thrombocytopenia and platelet dysfunction), acute bleeding to avoid the risk of severe bleeding within 72 hours after major surgery, within 48 hours in the postpartum period, pregnancy, severe renal failure, severe hepatic failure and cirrhosis, untreated or uncontrolled arterial hypertension, recent intracranial hemorrhage, medical conditions leading to intracranial hemorrhage, such as cerebral aneurysm, aortic aneurysm, tendency to fall, lumbar puncture, central nervous system or eye surgery, gastrointestinal or renal bleeding and their complications, diverticulosis or malignant tumors, esophageal varices, infective endocarditis or exudative pericarditis, dementia, psychosis, alcoholism and other situations where compliance may be insufficient and anticoagulant therapy cannot be carried out safely enough, hypersensitivity to warfarin or to any of the excipients.
Method of application
Target INR (International Normalized Ratio) level for oral anticoagulant therapy:
Prevention of thromboembolic complications in patients with prosthetic heart valves: INR 2.5-3.5.
Other indications: INR 2.0-3.0.
Application features
Pregnant women
Contraindicated.
Children
Anticoagulant therapy in children is carried out as prescribed and under the supervision of pediatricians.
Drivers
Does not affect.
Overdose
In cases of gradual overdose, it is usually sufficient to stop taking the drug. In acute overdose, gastric emptying is not recommended due to the risk of bleeding. Activated charcoal should be administered again to prevent absorption and enterohepatic circulation of warfarin. If activated charcoal is administered, vitamin K, which may be needed later, should be administered parenterally (intravenously). In the event of bleeding, the effect of warfarin can be stopped by the administration of vitamin K, clotting factor concentrate or fresh frozen plasma. If oral anticoagulants are indicated in the future, large doses of vitamin K exceeding 10 mg should be avoided, as patients become resistant to warfarin within two weeks.
Side effects
The following adverse reactions have been observed in the post-marketing period: fever, subdural hematoma, hemothorax, epistaxis, gastrointestinal bleeding, rectal bleeding, hematemesis, pancreatitis, melena, purpura, erythematous skin edema leading to ecchymosis, skin infarction and necrosis, hematuria, decreased hematocrit.
Interaction
Concomitant use with cranberry juice and other products containing cranberries should be avoided, as they significantly enhance the effect of warfarin.
If temporary pain relief is required, it is recommended that patients receiving warfarin be prescribed paracetamol or opiates.
Warfarin may enhance the effect of oral hypoglycemic agents of sulfonylurea derivatives.
Smoking may increase the elimination of warfarin, so patients who smoke may be given slightly higher doses of warfarin. On the other hand, smoking cessation may increase the effect of warfarin. Therefore, a patient who quits smoking after a long smoking history should have their INR levels monitored closely.
Storage conditions
Store at a temperature not exceeding 25 °C.
Store in a tightly closed bottle.
Keep the bottle in the outer carton.
Keep out of reach of children.
Shelf life - 3 years.
