Sinthrome

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Sinthrome

Method of action: Anticoagulant

Treatment option:

Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Sinthrome

Property Description
Active Ingredient Acenocoumarol (Nicoumalone)
Form Tablets
Pharmacological Class Anticoagulant, Vitamin K Antagonist (VKA)
Common Use Prevention of blood clot formation (Thromboprophylaxis)
Origin Synthetic organic compound (4-hydroxycoumarin derivative)

Defining Sinthrome: Identity, Composition, and Origin

Sinthrome is a specific medication whose sole active ingredient is Acenocoumarol, a clinically recognized anticoagulant often categorized by patients as a blood thinner. Chemically, Acenocoumarol is defined as a derivative of 4-hydroxycoumarin, establishing it within a class of structurally related compounds. The medication is formulated as a single-ingredient product and is prepared in tablet form, intended for oral administration. Unlike some other anticoagulants, Acenocoumarol has historically been noted for its comparatively shorter half-life.

What Type of Medicine is Acenocoumarol?

Acenocoumarol belongs to the pharmacological class of Anticoagulants and is specifically identified as a Vitamin K Antagonist (VKA). It carries the international designation of an antithrombotic agent with the Anatomical Therapeutic Chemical (ATC) code B01AA07. This classification means the compound works by interfering with the body's use of Vitamin K, a process essential for certain clotting proteins. As an established VKA, it is used in preventing thromboembolic events and serves as a tool in modulating the clotting mechanism.

General Purpose: Preventing Blood Coagulation

The primary purpose of Sinthrome is to provide antithrombotic therapy by reducing the blood’s natural ability to coagulate, thereby decreasing the risk of forming potentially harmful clots (thrombi) within the circulatory system. This is achieved through the inhibition of the enzyme responsible for recycling Vitamin K, which in turn limits the liver's ability to produce fully functional clotting factors (II, VII, IX, and X). The resulting controlled slowing of the coagulation cascade is the fundamental benefit of the medication, supporting the maintenance of adequate blood flow in patient groups susceptible to vascular events.

What side effects are possible with Sinthrome?

Possible side effects and safety information

The safety profile for Acenocoumarol (Sinthrome) is characterized by the potential for bleeding, which is consistent with its classification as an anticoagulant (Vitamin K Antagonist). Official regulatory documentation defines adverse reactions by frequency, system, and seriousness, and outlines specific constraints for use.

Officially Documented Adverse Reactions

The most prominent adverse reaction documented in the regulatory safety profile is haemorrhage (bleeding in any tissue or organ), which is classified as Common. Fatal or major haemorrhage is listed as a serious adverse reaction.

Less frequent adverse reactions are classified by regulatory standards:

  • Rare: Hypersensitivity reactions (e.g., rash, fever), alopecia, decreased appetite, nausea, and vomiting.
  • Very Rare: Vasculitis, haemorrhagic skin necrosis, and liver injury.
  • Frequency Not Known: Calciphylaxis and anticoagulant-related nephropathy.

Adverse effects are also categorized by the physiological systems affected, including Blood and Lymphatic System Disorders, Vascular Disorders, Hepatobiliary Disorders, and Skin and Subcutaneous Tissue Disorders.

Key Safety Constraints

The official labeling notes that the risk of bleeding may be more likely to occur during the initial phase of treatment. Population-specific safety notes state that Acenocoumarol is contraindicated in pregnancy. Caution is also required in older adults and those with hepatic or renal impairment, as these factors may alter the safety characteristics of the medicine. The drug's safety profile indicates that a high intensity of anticoagulation (e.g., International Normalized Ratio above 4.0) is a documented risk factor for bleeding events.

Overdose and Emergency Response

Overdose and When to Seek Help: Sinthrome (Acenocoumarol)

This section describes the officially documented signs of Acenocoumarol overdose and the emergency actions required, based strictly on government regulatory prescribing information.

Documented Manifestations of Overdose

The primary and major sign of toxicity from an Acenocoumarol overdose is excessive bleeding, which is an exaggerated form of the drug’s intended effect. Officially documented presentations include:

  • Visible Bleeding: Epistaxis (nosebleeds), gingival bleeding (bleeding gums), cutaneous bleeding, and haematomas.
  • Internal Bleeding: Haematuria (blood in the urine), uterine bleeding, gastrointestinal bleeding (including vomiting blood/haematemesis), and bleeding into the joints.

Severe Outcomes and Emergency Action

Blood loss resulting from an overdose can lead to severe complications. Regulatory sources document outcomes such as hypotension (low blood pressure), tachycardia (fast heart rate), and peripheral circulatory disorders.

Immediate medical attention is required upon the suspicion of an overdose or the appearance of any bleeding symptoms. The patient must be taken to the nearest medical facility, as treatment typically necessitates hospitalization and requires frequent monitoring of Prothrombin Time (PT)/INR to assess the coagulation status.

Management and Reversal

Official management protocols for Acenocoumarol overdose may include the administration of the specific reversal agent, Vitamin K. Supportive measures officially described for potential management include gastric lavage and activated charcoal.

Therapeutic Uses of Sinthrome

Main Uses and Benefits of Sinthrome

Sinthrome, which contains the active substance acenocoumarol, is an oral anticoagulant medication. It belongs to a group of medicines known as vitamin K antagonists. These medications work by interfering with the body's ability to use vitamin K, which is essential for the production of several clotting factors in the liver. By reducing the activity of these factors, Sinthrome slows down the process of blood coagulation.

Primary Therapeutic Uses

The medication is primarily used to treat and prevent conditions related to the formation of harmful blood clots (thrombosis). These applications include:

  • Treatment of Venous Thromboembolism: This includes deep vein thrombosis (DVT), where clots form in the deep veins of the legs, and pulmonary embolism (PE), where a clot travels to the lungs.
  • Prevention of Systemic Embolism: It is used in patients with specific heart rhythm disorders, such as atrial fibrillation, to prevent clots from forming in the heart and traveling to the brain or other organs.
  • Management after Heart Valve Replacement: Patients who have received mechanical heart valves require long-term anticoagulation to prevent clots from forming on the prosthetic valve surface.
  • Post-Myocardial Infarction: In certain cases following a heart attack, it may be used to reduce the risk of further thromboembolic events.

Benefits of Therapy

The primary benefit of Sinthrome therapy is the reduction of risk associated with blood clot formation. When blood clots occur within the circulatory system, they can block blood flow to vital organs, leading to serious complications such as stroke, organ damage, or death.

By effectively thinning the blood, Sinthrome helps to:

  • Prevent the growth of existing blood clots, allowing the body's natural processes to dissolve them over time.
  • Reduce the likelihood of new clots forming in high-risk patients.
  • Provide a long-term preventative strategy for individuals with chronic conditions that predispose them to abnormal coagulation.

Eligibility and Restrictions for Use

Sinthrome (acenocoumarol) is strictly contraindicated (prohibited) for several populations due to the high risk of serious bleeding.

Contraindicated Populations and Conditions:

  • Pregnancy (all trimesters) is an absolute contraindication, and women of child-bearing potential must use reliable contraception.
  • Individuals with known hypersensitivity to acenocoumarol or related coumarin derivatives.
  • Patients with severe hepatic impairment or severe renal impairment.
  • Any condition involving a high risk of haemorrhage, such as active peptic ulcers, cerebrovascular haemorrhage, or severe, uncontrolled hypertension.
  • Patients who are unsupervised, unable to co-operate, or unreliable (e.g., severe psychiatric disorders, senility) are not eligible for treatment.
  • Recent or planned major surgery on the central nervous system (CNS), eyes, or operations involving extensive tissue exposure.

Restrictions and Special Considerations:

  • Elderly patients (65 years) and the paediatric population require caution and close medical supervision, as they may be more sensitive to the drug’s effects.
  • Patients with mild to moderate hepatic or renal impairment must also be monitored closely.
  • Use requires a careful, documented assessment that the clinical benefit outweighs the increased risk of bleeding.

What should I know about interactions with other medicines?

Sinthrome Interactions with other medicines and products

Official regulatory information for Sinthrome (Acenocoumarol) documents several categories of interactions that affect its anticoagulant activity and bleeding risk. This profile is defined by two primary types of effects: the alteration of drug activity and the magnification of hemorrhage risk.

Documented Interaction Patterns

  • Pharmacodynamic Risk Magnification: Co-administration with agents that affect blood clotting by independent actions, such as Antiplatelet agents (e.g., Aspirin) and NSAIDs, is documented to increase the overall risk of hemorrhage due to additive effects.
  • Anticoagulant Effect Alteration: Certain medicines can either potentiate (increase) or reduce the effect of Acenocoumarol. Potentiating medicines include Amiodarone and some Antibiotics (e.g., Macrolides, Metronidazole). Medicines that reduce the effect include Rifampicin and Barbiturates.
  • Food, Supplements, and Lifestyle: The official label documents that consumption of Alcohol may potentiate the anticoagulant effect. The supplement Glucosamine is also listed as a substance that may increase the effect of Sinthrome, and caution is advised regarding certain Herbal products with antiplatelet effects.

Population and Restriction Notes

The interaction profile also includes specific constraints. The response to Acenocoumarol, and thus the potential for interactions, may be potentiated in the elderly and in patients with hepatic impairment. The co-administration of Sinthrome with other Coumarin derivatives is restricted due to the documented risk of cross-hypersensitivity.

Mechanism of Action

Molecular Mechanism: Vitamin K Antagonism

Acenocoumarol, the active component of Sinthrome, exerts its pharmacological effect as a competitive inhibitor of the enzyme Vitamin K epoxide reductase (VKORC1) within liver cells. This enzymatic inhibition is the critical step that prevents the essential metabolic recycling of inactive Vitamin K epoxide back into its functional cofactor form, Vitamin K H2 (hydroquinone).

This molecular interference leads to a subsequent failure of the liver’s gamma-carboxylation process, which is necessary to activate key coagulation proteins: Factors II, VII, IX, and X. These factors are released into circulation in a non-functional state. This resulting functional shortage of activated factors compromises the efficiency of the Coagulation Cascade, reducing the capacity to generate Thrombin and form a stable fibrin mesh. This sequence produces a state of systemic hypocoagulability. The time required for this physiological state to fully manifest is dependent on the natural clearance half-lives of the functional clotting factors already present in the bloodstream.

Dosage and Administration Information

How to Use Sinthrome — Official Administration Guidelines

Sinthrome (Acenocoumarol) is administered via the oral route as a tablet that is intended to be swallowed whole with water. The medication can be taken with or without food and is prescribed as a single dose once daily, ideally at the same time each day to maintain consistent blood levels.


The usage of Sinthrome is structured into two main phases. Treatment begins with an initial or loading dose, which typically ranges from 2 mg to 4 mg per day for the first one or two days. Following this initiation, the dose transitions to a highly individualized maintenance dose, generally falling between 1 mg and 8 mg daily.


Procedural Context and Special Instructions

The most critical procedural condition governing Sinthrome use is the absolute requirement for frequent, regular monitoring of blood coagulation status using the International Normalized Ratio (INR) test. The results of the INR test are the sole determinant for adjusting the exact daily maintenance dose.

For older adults (typically 65 years and over), lower doses may be required for both the starting and maintenance phases of treatment. Furthermore, a specific procedural protocol exists for a forgotten dose: if a dose is missed but remembered on the same day within the dosing window, it may be taken. However, patients are instructed never to take a double dose to compensate for a missed one.

This continuous, monitored adjustment process defines the long-term use of the medication, ensuring procedural adherence to the established treatment protocol.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Sinthrome (Acenocoumarol)

The research landscape for Sinthrome, which contains the active ingredient Acenocoumarol, is defined by long-standing clinical trials for the entire Vitamin K Antagonist (VKA) class and more recent real-world studies that specifically examine its use and the challenge of managing the medicine over defined time intervals.

Evidence for Stroke Prevention in Atrial Fibrillation (AF)

The foundational evidence for Vitamin K Antagonists (VKAs) in Atrial Fibrillation (AF) is derived from numerous Randomized Controlled Trials (RCTs). These studies provided the initial data regarding the utility of this class of medicine. More recently, large observational cohort studies and real-world evidence (RWE) have been applied in research exploring how Acenocoumarol compares to newer types of oral antithrombotic medications.

These studies were conducted during periods of increased risk for thromboembolic events, with research examining outcomes such as the incidence of ischemic stroke and systemic embolism in adult patients with AF. The primary way researchers monitored outcomes was by tracking the Time in Therapeutic Range (TTR), which measures how often a patient's blood clotting level (INR) stayed within the target range. Studies consistently monitored the Time in Therapeutic Range (TTR) to assess control, noting that the VKA class is associated with high inter-individual variability.

Evidence for Treatment and Prevention of Venous Thromboembolism (VTE)

Sinthrome was studied for use in the initial treatment and long-term prevention of Venous Thromboembolism (VTE), which includes deep clots like Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). Research explored how treatment impacts the risk of the condition recurring.

A specific area of research involves Randomized Clinical Trials that examined different dosing strategies. These trials focused heavily on anticoagulation control as the main outcome. Some studies exploring short-term changes reported that pharmacogenetic dosing was associated with a greater proportion of patients reaching the desired INR target quickly. However, other findings were mixed when observing the long-term maintenance of the TTR over periods like twelve weeks.

What Remains Uncertain About the Research

Scientific reviews and regulatory documents highlight several areas where data are still emerging or where research is insufficient:

  • Comparative Evidence: There is limited direct evidence from RCTs comparing Acenocoumarol against newer oral antithrombotic agents for key indications; comparisons largely rely on observational studies where evidence quality varies.
  • TTR Variation: The reasons behind the significant variability in control between individuals and between different VKAs are areas where research is ongoing to characterize the long-term clinical implications.
  • Special Populations: There is limited information for specific populations, such as pediatric patients or pregnant individuals, and research is ongoing in these groups. The primary findings describe group patterns, not personal outcomes.

Frequently Asked Questions (FAQ)

Common questions about Sinthrome (FAQ)


Q: Is Sinthrome the same kind of medicine as warfarin?

Sinthrome (Acenocoumarol) and warfarin belong to the same pharmacological category, which are known as Vitamin K Antagonists (VKAs) or coumarin derivatives. According to official classifications, they both function by a similar mechanism to reduce the ability of the blood to coagulate.


Q: What is the difference between Sinthrome and other anticoagulants?

Sinthrome is noted for having a comparatively shorter elimination half-life (8 to 11 hours) than other Vitamin K Antagonists. Unlike newer oral anticoagulants, Sinthrome's effect is associated with the need for regular monitoring using a blood test called the International Normalized Ratio (INR).


Q: How quickly does Sinthrome start to work after the first dose?

The full effect of Sinthrome on the blood clotting cascade is described in official documents as typically manifesting within 24 to 72 hours after the first dose. This timeframe is influenced by how quickly the body clears the clotting factors that were already present in the bloodstream.


Q: Does using Sinthrome mean I have to change my diet permanently?

Official information indicates that the key advice for Vitamin K Antagonists like Sinthrome is to maintain a consistent intake of foods containing Vitamin K. Official guidance emphasizes that changes in diet may affect the stability of the blood clotting level (INR), making careful monitoring essential.


Q: What common vitamins or minerals should be watched when taking Sinthrome?

Since Sinthrome is a Vitamin K Antagonist, maintaining a consistent daily intake of Vitamin K is a relevant consideration. Official documents also note that intake of Vitamin E is described as a substance that may influence the drug's effectiveness, along with alcohol and herbal supplements.


Q: How does Sinthrome differ in mechanism from the newer blood thinners?

Sinthrome works indirectly by inhibiting the synthesis of Vitamin K-dependent clotting factors in the liver. Newer oral anticoagulants (sometimes called DOACs) typically work directly by targeting and inhibiting only one specific clotting factor, and they do not interact with dietary Vitamin K.


Q: Is there any difference in how generic and brand-name Sinthrome work?

Sinthrome is the brand name for the active ingredient Acenocoumarol. Regulatory standards generally require that generic versions contain the exact same active ingredient and work in the same way as the brand-name product.


Q: Can Sinthrome interact with over-the-counter pain relievers?

The co-administration of Sinthrome with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), which are common pain relievers, is officially documented to increase the overall risk of hemorrhage due to additive effects. The risk of interaction for the broad category of OTC pain relievers is a point of necessary consideration, as described in official documents.


Q: What kinds of food or drinks are known to interact with Sinthrome?

The official label notes that consumption of alcohol may potentiate (increase) the anticoagulant effect of Sinthrome. Additionally, certain patient information materials advise patients to avoid or be cautious about drinking cranberry juice.


Q: Is Sinthrome treatment usually for a short time or long term?

The duration of treatment is highly individualized and is determined by the condition being treated. While some courses of treatment are advised for short periods (such as a few months), many patients may be directed to continue taking the tablets for a long-term duration.


Q: Can Sinthrome affect birth control pills?

Research has examined the co-administration of oral contraceptives with anticoagulants. Studies have found that contraceptives may influence the anticoagulant effect, and close monitoring of the blood clotting level may be utilized to manage potential influence on the drug's effect.


Q: Can I take Sinthrome if I am also taking an antidepressant?

Official research has examined the use of certain antidepressants, specifically Selective Serotonin Re-uptake Inhibitors (SSRIs), alongside coumarin anticoagulants. This combination has been associated with an increased risk of overanticoagulation or bleeding, indicating that monitoring is often utilized to manage this combination.


Q: Are there any known long-term effects of taking Sinthrome for many years?

The use of Sinthrome for many years is primarily managed by continuous monitoring of the International Normalized Ratio (INR). Studies and regulatory documents describe the need for continuous monitoring of the INR to manage the inherent risk of bleeding.


Q: Do cold and flu medicines interact with Sinthrome?

Regulatory guidance indicates a need for awareness, as many cold and flu medicines contain ingredients that may interact with anticoagulants. This includes antibiotics and NSAIDs, which are often components of combination cold and flu treatments.


Q: What is the therapeutic window for Sinthrome?

The therapeutic window refers to the optimal intensity of anticoagulation. This range is generally measured by the International Normalized Ratio (INR) test. Regulatory documents specify a target range, which is selected based on the patient's individual indication.


Q: Are there special precautions for travel while taking Sinthrome?

Patients taking Sinthrome are officially advised to carry an oral anticoagulant card or alert card at all times. This practice is described as a precautionary measure to ensure healthcare professionals are aware of the medication in the event of an emergency or injury.


Q: Why is it important to tell all my healthcare providers that I take Sinthrome?

Patient education guidelines describe the need to inform all healthcare providers, as many substances can interact with the anticoagulant, potentially affecting its safety and effectiveness. This is necessary before starting any new treatment or procedure.


Q: What is the process for switching from a different blood thinner to Sinthrome?

According to official documentation, the process for switching (e.g., from an injectable such as heparin) often involves a transition period. During this time, the prior anticoagulant may be continued alongside Sinthrome until the International Normalized Ratio (INR) has remained within the target range for at least two consecutive days.


Q: What happens if I stop taking Sinthrome suddenly?

Official documents state that abrupt cessation of anticoagulant therapy is generally not advised. While some data suggests no danger of reactive hypercoagulability, withdrawal is typically discussed with a healthcare provider.


Q: Are there any known interactions between Sinthrome and vaccines?

Research has examined the use of certain vaccines, such as the influenza vaccine, in patients on long-term Sinthrome therapy. These studies did not find significant changes in the International Normalized Ratio (INR) values or clinical complications.

How should Sinthrome be stored and disposed of?

Official Storage and Disposal Guidelines for Sinthrome (Acenocoumarol)

The official regulatory storage profile for Sinthrome tablets emphasizes maintaining drug stability and ensuring safety. The medicine must be stored at a temperature strictly below 30 C.

To preserve the product's integrity and protect it from environmental factors, the tablets must be kept in the original packaging to shield them from moisture. The labeled shelf life for the tablets, when stored according to these conditions, is typically five years.

For safety, Sinthrome must be stored out of the sight and reach of children.

Disposal requirements dictate that any unused or expired medicinal product or waste material must not be discarded with household rubbish. Disposal must be carried out in accordance with local requirements for pharmaceutical waste, often achieved by returning the product to a pharmacist or specialized collection program.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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