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Acenokumarol

Tablets 4 mg 
ATC B01A A07
Prescription-only medicine
Reimburse by Health Insurance Fund

POSOLOGY AND METHOD OF ADMINISTRATION


Sensitivity to anticoagulants varies from patient to patient and may also fluctuate during the course of treatment. Therefore, it is essential to perform regular testing of prothrombin time (PT)/International Normalised Ratio (INT) and to adjust the patient’s dosage accordingly. If this is not possible, acenocoumarol should not be used.
Acenocoumarol should be given in a single oral dose at the same time every day.

Adults

Initial dosage: If the thromboplastin time is within the normal range before starting treatment, the following dosage schedule is recommended:

First day: Starting dose of 4 mg/day (lower doses may be required if patients are receiving heparin). The administration of a loading dose may not be necessary if the PT/INR value before treatment is within the therapeutic range.

Second day: 4 to 8mg. If the initial thromboplastin time is abnormal, treatment should be instituted with caution. Elderly patients, patients with liver disease or severe heart failure with hepatic congestion or malnourished patients may require lower doses during treatment initiation and maintenance.

Maintenance therapy: the maintenance dose of acenocoumarol varies from patient to patient and must be determined on the basis of regular laboratory estimations of the patient’s blood coagulation time. Adjustment of the maintenance dose can only be made by monitoring the Quick value of the international normalized ratio (INR) at regular intervals, ensuring that the dosage remains within the therapeutic range.

Depending on the individual, the maintenance dose generally lies between 1 to 8mg daily. Before the start of treatment, up to the time when the coagulation valency is stabilized within the optimum range, routine measurement of the thromboplastin time should be carried out daily in the hospital. Blood samples for laboratory tests should always be taken at the same time of day. The INR is the ratio of the patient’s plasma thromboplastin time and the normal thromboplastin time raised to a power determined for a reference thromboplastin. As the Quick value decreases, the patient’s thromboplastin time increases and the INR is greater. The therapeutic range generally lies between INR values of 2 to 4.5. Within this range, the majority of patients show no risk of severe haemorrhagic complications nor a recurrence of thrombosis. Generally, after the withdrawal of acenocoumarol, there is usually no danger of reactive hypercoagulability and therefore it is not necessary to give gradually diminishing doses. However, in extremely rare cases, in some high-risk patients (e.g. after myocardial infarction), withdrawal should be gradual.

Children

Not recommended.

Elderly

A dose lower than the recommended adult dose may be sufficient in elderly patients.


Medicine’s information on this web page is only a short description of its characteristics. Do not take them as recommendations for self-treatment of your health condition.

You must inform your physician and pharmacist and follow their recommendations before you use the medicine for treatment. Always read carefully the patient information leaflet.

COMPOSITION

Each tablet contains 4 mg acenocoumarol.

THERAPEUTIC INDICATIONS

Treatment and prophylaxis of thromboembolic diseases.

CONTRAINDICATIONS

Pregnancy. Known hypersensitivity to acenocoumarol and related coumarin derivatives or to the excipients of the medicine. Patients unable to co-operate (e.g. unsupervised and senile patients, alcoholics and patients with psychiatric disorders). All conditions where the risk of haemorrhage exceeds possible clinical benefit e.g. haemorrhagic diathesis and/or blood dyscrasia; immediately prior to, or after surgery on the central nervous system or eyes and traumatising surgery involving extensive exposure of the tissues; peptic ulceration or haemorrhage in the gastro-intestinal tract, urogenital tract or respiratory system; cerebrovascular haemorrhages; acute pericarditis; pericardial effusion; infective endocarditis; severe hypertension (due to occult risks); severe hepatic or renal disease; and in cases of increased fibrinolytic activity following operations on the lung, prostate or uterus.

PACKAGING

Box of 20 tablets of 4 mg in a blister package.