Acenocoumarol

ATC code

B01AA07

Therapeutic class

Vitamin K antagonist · Antithrombotic agent

Forms

oral tablet

Brand names

Sintrom (Global) · Acenocumarol Aurovitas (ES)

Overall confidence

medium

Regulatory sources consulted

Approved indications

Treatment and prophylaxis of thromboembolic disorders.

Contraindications

Absolute

Pregnancy.
Active bleeding or hemorrhagic diathesis.
Severe hepatic or renal impairment.
Severe uncontrolled hypertension.

Clinical warnings

Major warning · Risk of hemorrhage: Acenocoumarol has a narrow therapeutic index. Careful and frequent INR monitoring is required to minimize the risk of bleeding, which can be severe or fatal. — AEMPS SPC

Drug interactions

HighAmiodaroneC01BD01
Mechanism: Inhibition of acenocoumarol metabolism via CYP2C9, significantly increasing INR and bleeding risk.
Recommendation: Reduce acenocoumarol dose (often by 30-50%) when starting amiodarone and monitor INR very closely (e.g., every 2-3 days initially).
AEMPS SPC
HighFluconazoleJ02AC01
Mechanism: Potent inhibitor of CYP2C9, the main metabolic pathway for acenocoumarol. Drastically increases exposure and anticoagulant effect.
Recommendation: Avoid combination if possible. If unavoidable, significantly reduce acenocoumarol dose and monitor INR daily at initiation.
AEMPS SPC

Adverse events

Common (≥1%)

Hemorrhage

Rare but serious

Coumarin-induced skin necrosis · Calciphylaxis

Pregnancy and lactation

FDA category: X

Contraindicated during pregnancy due to its teratogenic effect (coumarin embryopathy) and risk of fetal hemorrhage. Passes into breast milk in minimal amounts; considered compatible with breastfeeding with infant monitoring.

Recent literature (PubMed)

Direct-acting oral anticoagulants in antiphospholipid syndrome: A systematic review.
Girón-Ortega JA, et al. · Med Clin (Barc) · 2023 · Relevance 5/5
Revisión sistemática que concluye que los anticoagulantes orales directos (ACOD) son menos eficaces que los antagonistas de la vitamina K (AVK) para prevenir la recurrencia de trombosis en pacientes con síndrome antifosfolípido (SAF) de alto riesgo. El riesgo de sangrado mayor fue similar. Los resultados desaconsejan el uso de ACOD en SAF trombótico, reforzando el papel de los AVK como el acenocumarol.
Clinical value of a tool for managing oral anticoagulation in nonvalvular atrial fibrillation in primary health care. Randomized clinical trial.
Dalmau Llorca MR, et al. · Rev Esp Cardiol (Engl Ed) · 2024 · Relevance 4/5
Ensayo clínico aleatorizado que evaluó una herramienta de soporte a la decisión para gestionar el tiempo en rango terapéutico (TRT) de pacientes con fibrilación auricular no valvular tratados con antagonistas de la vitamina K (AVK). La intervención se asoció con una reducción modesta pero significativa en ingresos por ictus y en mortalidad, sugiriendo que mejorar la gestión del TRT con AVK tiene beneficios clínicos.