|Dosage and administration||
Known hypersensitivity to coumarin derivatives or to any component of the drug.
|Warnings and precautions for use||
– Attention should be paid to the patient's awareness during the treatment (risk of error in drug use). Patients should be carefully instructed to adhere to the indications correctly, understand the risk and attitude to treatment, especially the elderly.
|Recommendation for pregnancy and breastfeeding||
|Effects on ability to drive and use machines||
Acenocoumarol has no influence on ability to drive and use machines.
|Interactions, incompatibilities of medicine||
A lot of drugs can interact with vitamin K antagonists, so it is necessary to monitor the patients for 3-4 days after increasing or reducing combined drugs.
|Undesirable effects (ADRs)||
Bleeding manifestations are the most common complications occurring throughout the body: Central nervous system, limbs, viscera, inside of abdomen, eyeballs, etc.
|Overdose and management||
Acenocoumarol is a coumarin derivative and functions as vitamin K antagonist. It inhibits the vitamin K epoxide reductase enzyme, resulting in preventing the conversion of glutamic acid to gamma-carboxyglutamic acid in vitamin K dependent proteins which are precursors of coagulation factors II, VII, IX, X.
Acenocoumarol is rapidly absorbed from the gastrointestinal tract. Oral bioavailability is approximately 60%. A significant portion of S (-) – acenocoumarol enantiomer undergoes first-pass hepatic metabolism, whereas the bioavailability of R (+) – acenocoumarol enantiomer is 100%. The drug is strongly bound to plasma protein (99%). Peak plasma concentrations are achieved within 1 to 3 hours. The volume of distribution is 0.16 – 0.34 liter / kg. Acenocoumarol crosses the placenta and a small fraction is found in breast milk.
|Storage conditions, shelf-life, quality specification of the medicine||
Storage conditions: Protect from humidity and light, below 30 degrees C.
Composition: Each tablet contains:
Acenocoumarol . . . . . . . . . . . . . . . . . . . . . 4 mg
Cardboard box containing 3 blisters of 10 tablets; Cardboard box containing 10 blisters of 10 tablets.
– Heart disease causing embolism: Prevention of thromboembolic complications caused by atrial fibrillation, mitral valve disease, artificial valve.
– Myocardial infarction: Prevention of thromboembolic complications in myocardial infarction complications, such as thrombus adherent to cardiac wall, severe left ventricular dysfunction, left ventricular dysrhythmia causing embolism as a follow-up therapy alternative to heparin. Prevention of recurrence of myocardial infarction in patients who cannot take aspirin.
– Treatment of deep vein thrombosis and pulmonary embolism and prevention of recurrence as alternative to heparin.
– Prevention of venous thrombosis, pulmonary embolism in hip replacement surgery.
– Prevention of catheter-related thrombosis.