Drug ID: 1d00000013
Drug Name: Acenocoumarol
Generic Names: Acitrom (3 mg) | Nistrom (2 mg) | Nistrom (4 mg) | Acitrom (3 mg) | Acitrom (2 mg) | Nistrom | Acitrom (1mg) | Acitrom (4 mg) | Acebron | Acenotromb | Acenox | Acitrom | Antitrom | Azecar | Cumarol | Coarol | Fortanol | Mini-Sintrom | Neo-Sintrom | Nistrom | Pabi-Acenocoumarol | Sinkum | Sinthrome | sintrom mitis | syncumar | Trombostop
Category: Anticoagulants / Antithrombotics
Legal Status: Non Opioid Prescription only drug
Indication for Mother: Category X:
Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
Recommended Dose: Adult Dose: 4-12 mg on the 1st day and 4-8 mg on the 2nd day. Maintenance: 1-8 mg/day as a single dose.
Recommended In: This medication is an anticoagulant, prescribed for thromboembolic disorders. It inhibits vitamin K reductase, resulting in depletion of the reduced form of vitamin K.
Directions For Use: It comes as a tablet to take by mouth, with food.
Storage: Store it at room temperature (20-25°C) and in an airtight container.
Dosage Forms: Tablet |
Side Effects: Central Nervous System- Headaches, dizziness, or weakness.
Skin- Hair loss, rash, hives and itching.
Gastrointestinal- Loss of appetite, nausea, vomiting, pink or brown urine and diarrhea.
Respiratory- Sudden shortness of breath.
Liver - Liver damage.
Potentially Fatal- Severe bleeding.
Others- Feeling sick, unusual pain or swelling.
Potentially Fatal- Severe bleeding.
In Case of Overdose: The onset and severity of the symptoms are dependent on the individual's sensitivity to oral anticoagulants, the severity of the overdose and the duration of treatment.
Haemorrhage is the prominent feature of an overdose and may occur within 1 to 5 days after ingestion. Nose-bleeds, haematemesis, haemoptysis, gastro-intestinal haemorrhage, vaginal bleeding, haematuria (with renal colic), cutaneous haemorrhages, gingival bleeding, haematomata, and bleeding into the joints or menorrhagia may be experienced.
Further symptoms include tachycardia, hypotension, peripheral circulatory disorders due to loss of blood, nausea, vomiting, diarrhoea and abdominal pains.
Laboratory tests will show an extremely low Quick value (or high PT/INR value), pronounced prolongation of the recalcification time or thromboplastin time and disturbed gamma-carboxylation of factors II, VII, IX and X.
The necessity or desirability of the treatment by gastric lavage in addition to the activated charcoal and cholestyramine administration is controversial. The benefits of these treatments should be balanced against the risk of bleeding in each patient.
Emergency and supportive measures:
In emergency situations of severe haemorrhage, clotting factors can be returned to normal by administering fresh whole blood or fresh frozen plasma, complex concentrate or recombinant factor VIIa supplemented with vitamin K1.
Avoid If: Caution should be exercised in patients with history of bleeding disorders, peptic ulcer, severe wounds, allergies, stroke, stomach infections, liver or kidney impairment, elderly, children and breastfeeding.
Avoid alcohol consumption while taking this medication.
Drug Interaction: The anticoagulant effect may be potentiated by concomitant administration of the following drugs:
anti-arrhythmic agents (e.g. amiodarone, quinidine);
broad spectrum antibiotics (e.g. amoxicillin, co-amoxiclav) macrolides (e.g. erythromycin, clarithromycin); cephalosporins second and third generation; metronidazole; quinolones (e.g. ciprofloxacin, norfloxacin, ofloxacin); tetracyclines; neomycin; chloramphenicol.
imidazole derivatives, including topical administration (e.g. econazole, fluconazole, ketoconazole, miconazole);
sulfonamides (including co-trimoxazole);
fibrates (e.g. clofibric acid), its derivatives and structural analogues (e.g. fenofibrate, gemfibrozil);
oral antidiabetics (e.g. glibenclamide);
sulphonylureas (such as tolbutamide and chlorpropamide)
H2 antagonists (e.g. cimetidine);
thyroid hormones (including dextrothyroxine);
statins (e.g. atorvastatin, fluvastatin, simvastatin);
selective serotonin re-uptake inhibitors (e.g. citalopram,fluoxetine, sertraline,paroxetine)
5-fluorouracil and analogues;
proton pump inhibitors (e.g. omeprazole);
plasminogen activators (e.g. urokinase; streptokinase and alteplase);
thrombin inhibitors (e.g. argatroben);
prokinetic agents (e.g. cisapride);
antacids (e.g. magnesium hydroxide);
Inhibitors of CYP2C9 may potentiate the anticoagulant effect of acenocoumarol.
The anticoagulant effect may be diminished by concomitant administration of the following drugs:
antineoplastic drugs (e.g. azathioprine, 6-mercaptopurine);
barbiturates (e.g. Phenobarbital);
cholestyramine (see Section 4.9 Overdose);
HIV protease inhibitors (e.g. ritonavir, nelfinavir);
St. John's Wort/Hypericum perforatum;
Inducers of CYP2C9, CYP2C19 or CYP3A4 may diminish the anticoagulant effect of acenocoumarol.
Vitamin E and corticosteroids (e.g. methylprednisolone, prednisone) may diminish the anticoagulant effect of coumarin derivatives.
Unpredictable effect on anticoagulation, including both increase and decrease in anticoagulant activity have been reported with the following drugs:
protease inhibitors (e.g. indinavir, nelfinavir, ritonavir, saquinavir).
Effects of acenocoumarol on other drugs:
During concomitant treatment with hydantoin derivatives (such as phenytoin), the serum hydantoin concentration may rise.
Acenocoumarol may potentiate the hypoglycaemic effect of sulphonylurea derivatives e.g. glibenclamide, glimepiride.
Patients being treated with Acenocoumarol (especially those suffering from hepatic dysfunction) should limit their alcohol intake, since it is not possible to predict the severity of any drug interactions, nor identify any early signs of such interactions.
Cranberry juice should be avoided in patients receiving Acenocoumarol due to a theoretical risk of enhanced anti-coagulation. Increased medical supervision and INR monitoring should be considered for any patient receiving Acenocoumarol and regularly drinking cranberry juice. It is not known whether other cranberry products, such as capsules or concentrates, might also interact with Acenocoumarol. Therefore similar caution should be observed with these products.