Викасол

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Викасол

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Викасол

Quick Facts

Property Description
Active ingredient Menadione sodium bisulfite
Forms Injection solution and Tablets
Pharmacological class Vitamin K Analog / Coagulant
General purpose Supporting normal blood clotting
Origin Synthetic

Что такое Викасол: Идентификация и Фармакологический Класс (What is Викасол: Identification and Pharmacological Class)

Викасол (Vikasolum) is a pharmaceutical preparation classified as a coagulant or hemostatic agent, fundamentally used to support the body’s essential ability to form blood clots. Its active component is the INN substance menadione sodium bisulfite. The active core, Menadione, falls under the ATC code B02BA02, which designates it as a Vitamin K analog.

This medication falls into the pharmacological class of agents that directly affect the blood's hemostasis cascade. The drug is a synthetic analog of Vitamin K, sometimes referred to as a pro-vitamin, because the administered compound is converted in the body to the biologically active forms of Vitamin K necessary for clotting processes.

Происхождение, Состав и Формы Выпуска (Origin, Composition, and Dosage Forms)

Викасол is a synthetic compound derived from the naphthoquinone Menadione, historically known as Vitamin K3. The specific chemical form, menadione sodium bisulfite, is a water-soluble derivative, making it suitable for versatile pharmaceutical preparations. The medication is commonly supplied in two primary dosage forms: a sterile injection solution for parenteral administration and as tablets for oral use.

Pharmacological evidence suggests that the bisulfite salt form offers high bioavailability, supporting its effectiveness as a synthetic substitute for natural Vitamin K sources. This structural feature is clinically recognized for providing a reliable route of administration when the absorption of fat-soluble vitamins may be compromised.

Общее Назначение и Ключевой Принцип Действия (General Purpose and Core Principle of Action)

The general purpose of Викасол is to manage conditions where there is a deficiency in the body’s ability to clot blood, particularly states of hypoprothrombinemia. The medication's core principle is to act as a crucial precursor that facilitates the liver's natural biochemical processes. Specifically, it ensures the effective creation of essential blood proteins known as coagulation factors, which include Factors II, VII, IX, and X. By helping to restore the body’s supply of these necessary factors, Викасол promotes the natural process of hemostasis and helps prevent or control excessive bleeding caused by this underlying deficiency.

What side effects are possible with Викасол?

Possible side effects and safety information

The safety profile for Викасол (menadione sodium bisulfite) is officially documented in government regulatory labeling, detailing known adverse effects and specific population risks. The listed reactions are generally classified as Not Known or Undetermined in frequency, reflecting their identification through postmarketing surveillance.

Documented Adverse Reactions

Adverse effects are categorized by the body system affected, known as System Organ Classes (SOC):

System Organ Class (SOC) Adverse Reactions (Examples)
Blood and Lymphatic System Hemolysis, Hemolytic anemia
Immune System Disorders Allergic reactions (e.g., skin rash, anaphylactoid reactions)
Gastrointestinal Disorders Nausea, vomiting, dyspepsia
Hepato-biliary Disorders Jaundice

Serious Adverse Reactions and Key Constraints

Serious Adverse Reactions documented in regulatory sources include the risk of Hemolysis (destruction of red blood cells) and Kernicterus (severe brain damage from excessive jaundice), particularly when administered to newborns and infants.

Safety Constraints (Contraindications): The drug is formally restricted in individuals with known Hypersensitivity to menadione sodium bisulfite, or pre-existing conditions involving increased blood clotting, such as Hypercoagulation states or Thromboembolism.

Population-Specific Safety: Due to the serious risk of hemolysis and kernicterus, regulatory labels indicate that use in newborns and infants is often avoided or requires extreme caution. Use in patients with severe hepatic impairment is also advised against, or requires careful consideration, due to complications with drug processing.

Overdose and Emergency Response

️ Overdose and When to Seek Help

Overdose with menadione sodium bisulfite is officially classified as a state of Hypervitaminosis K, reflecting an excessive level of the Vitamin K analog in the body. Due to the risk of severe complications, regulatory guidance mandates that immediate medical attention be sought if an overdose is suspected.

Documented Overdose Findings

Finding Category Documented Manifestations
Physiological Hyperprothrombinemia (excessive clotting factors), hyperbilirubinemia [Source 2.1, 2.9].
Clinical Signs Jaundice, gastrointestinal symptoms (nausea, diarrhea), cyanosis, and acute toxicity signs like convulsions [Source 3.5, 2.1].

Severe Outcomes and Emergency Action

Overdose-induced hypercoagulation is associated with serious outcomes. The most significant complications listed in official documents include the risk of thrombosis (blood clot formation) and hemolytic anemia (destruction of red blood cells). Large doses have been associated with cardiovascular collapse [Source 3.5].

  • Population-Specific Risk: Neonates and infants are at a heightened risk for the uniquely severe outcome of kernicterus (a form of brain damage) following overdose [Source 3.6].
  • Required Action: If an overdose is suspected, seek emergency medical treatment immediately [Source 3.3]. The initial procedural step is the discontinuation of the drug [Source 2.3].
  • Management: Treatment is symptomatic and supportive, and may involve the regulated use of anticoagulants to counteract the excessive clotting state, requiring continuous coagulation system monitoring [Source 2.7].

Therapeutic Uses of Викасол

Викасол is used to help with conditions associated with deficient blood clotting, supporting the body's ability to achieve hemostasis. As a synthetic Vitamin K analog, the medication may assist with managing conditions related to a failure in the body's natural clotting processes.

Controlling Hemorrhagic Symptoms and Deficiency States

This medication is commonly used to help with managing and preventing episodes of excessive or atypical bleeding, which are prominent symptomatic manifestations of a clotting deficiency. It is applied in addressing conditions where the essential clotting protein precursor, prothrombin, is low (hypoprothrombinemia), which is linked to deficient activity necessary for normal clotting.

Specific scenarios where this support is considered relevant include managing prolonged or heavy menstrual bleeding (menorrhagia), assisting with the control of capillary bleeding that may occur post-surgery, and addressing deficiencies linked to impaired nutrient absorption in conditions like jaundice or acute liver issues. The therapeutic benefit contributes to easing the symptomatic burden associated with this deficiency in clotting function.

“Applied in contexts where additional symptomatic support for maintaining blood coagulation is needed.”

Supporting Clotting Stability in High-Risk Scenarios

The medication is also considered relevant for intervention in specific medical contexts, notably for moderating the effects of certain oral blood thinners when their activity may be excessive. This supports clotting function in clinical settings that involve acute or unstable symptom patterns, such as preoperative settings, assisting with maintaining a sense of stability when symptoms are more noticeable.

Quick Fact: Relief for Coagulation Distress
Main Benefit: Provides support that helps ease the overall symptom burden associated with spontaneous or excessive bleeding.

Regulatory References

  1. FDA Verification Portal Drug Insert

Eligibility and Restrictions for Use

Eligibility and Contraindication Profile

Викасол (Menadione sodium bisulfite, a synthetic Vitamin K analogue) is a prescription medicine that must be used strictly according to official regulatory guidance regarding patient eligibility.

Classification Populations and Conditions
Contraindicated (Should not use) Hypersensitivity to the medicine's components
Conditions of hypercoagulation (increased blood clotting) and thromboembolism
Pregnancy and the period of lactation (breastfeeding)
Newborns and neonates (due to risk of hemolytic anemia and kernicterus)
Hemolytic disease of the newborn
Use with Caution/Restricted Patients with hepatic insufficiency (liver failure)
Patients with Glucose-6-phosphate dehydrogenase (G6PD) deficiency (risk of hemolysis)

Age-Related and Other Restrictions:

  • The tablet form is typically contraindicated for children younger than 3 years due to excipient content (e.g., lactose).
  • The medicine is formally stated as being ineffective in clotting disorders such as Hemophilia and von Willebrand disease, as its action is specific to factors produced in the liver, not platelet function or existing factor deficiencies.

This profile ensures the drug is withheld from individuals where the risks, particularly those related to excessive clotting or red blood cell damage, significantly outweigh its intended use. Regulatory bodies classify these as critical contraindications for patient safety.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The regulatory interaction profile for Викасол (Menadione sodium bisulfite) is characterized primarily by its documented pharmacodynamic counteraction to specific medications affecting blood coagulation. This classification is central to its official restrictions.

Interaction Type Interacting Substance/Condition Regulatory Finding
Pharmacodynamic Oral Anticoagulants Antagonistic effect; decreases the anticoagulant's action.
Population Restriction G6PD Deficiency Product is formally contraindicated in this patient population.

The key drug interaction documented in regulatory labeling involves the class of oral anticoagulants. Co-administration results in a direct antagonistic effect, where the action of Викасол decreases the therapeutic effect of the anticoagulant. Following the use of the product to manage the effects of an oral anticoagulant, a period of reduced response to renewed therapy with that same anticoagulant may persist for one week or more, as specified in the official prescribing information.

No specific metabolic interactions, such as those mediated by CYP450 enzymes, or drug transporter-based effects are explicitly documented in official regulatory labels. Furthermore, the official prescribing information does not mandate any timing or separation requirements for co-administering this product with other medicines. Regarding substances, no specific drug-food interactions are established, and the interaction with alcohol is not known. The most critical non-drug restriction noted in labeling is the formal product contraindication for individuals diagnosed with glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Mechanism of Action

Synthetic Precursor Activation of gamma-Carboxylase

The pharmacodynamic action of Викасол (Menadione sodium bisulfite) is focused on modulating a crucial biochemical pathway in the liver. The drug functions as a synthetic precursor that is converted within liver cells (hepatocytes) into the essential active form of the Vitamin K cofactor ( Menaquinone-4). This cofactor is immediately required by the primary biological target, the enzyme gamma-Glutamyl Carboxylase (GGCX). The resulting GGCX activity drives the carboxylation of precursor proteins, converting them to their active form.

Final Maturation and Systemic Coagulation Facilitation

The successful carboxylation creates gamma-Carboxyglutamic Acid ( Gla) residues on the clotting factors, primarily Factors II, VII, IX, and X. This Gla domain enables the factors to bind calcium ions ( Ca^2+). This Ca^2+-dependent anchoring to vessel injury sites accelerates the overall coagulation cascade. The resulting systemic physiological effect is the facilitation of the coagulation cascade.

Dosage and Administration Information

The administration of Викасол (menadione sodium bisulfite) is defined by official parameters concerning its route, dosing limits, frequency, and duration of use. The medicine is officially supplied for both Intramuscular (IM) injection and Oral administration in tablet form. The method of use is strictly governed by a cyclic regimen, not continuous therapy.

Dosing and Frequency

For adults using the injection solution, the maximum single dose is limited to 15 mg, and the total Maximum Daily Dose must not exceed 30 mg. The official instructions mandate that the total daily dosage be divided and administered in two separate administrations per day. The solution is typically prepared for direct IM use.

Treatment Cycle and Duration

Викасол is administered in a time-limited course of 3 to 4 days. Following the completion of this course, a mandatory 4-day break (or interval) must be observed before the cycle can be repeated, if clinically necessary. In specific preoperative contexts, administration is typically commenced 2 to 3 days immediately preceding the anticipated surgical procedure.

Population-Specific Use

Dosing instructions are adjusted for specific populations. The official label specifies pediatric dosing based on age group; for instance, infants under one year are assigned a regimen of 2–5 mg per day, while adolescents aged 10 to 18 years have a different maximum daily regimen of 15 mg per day.

Recent Clinical Evidence

Research Evidence / Overview of studies for Викасол

The research base for Викасол (Menadione Sodium Bisulfite) includes foundational biochemical research, historical clinical studies, and observations. The research structure for this compound, a synthetic form of Vitamin K, explores its application based on existing biochemical principles. The evidence is primarily drawn from studies that explored its fundamental function.

Evidence for Use in Hypoprothrombinemia

This section summarizes the structure of research that was studied for its association with changes in blood clotting in deficiency states. These studies generally focused on patients with bleeding risk secondary to conditions associated with acute or disruptive episodes that involve underlying issues with Vitamin K processing. Researchers primarily focused on objective laboratory values, such as changes in Prothrombin Time (PT). The compound was observed in studies exploring short-term changes in these deficiency-related outcomes. Research describes patterns observed in the studies related to clotting parameters, and the evidence contributes to understanding symptom patterns in populations studied.

Studies on Antagonism of Excessive Oral Anticoagulation

Research exploring short-term symptom changes described mixed findings, and comparative evidence is lacking to fully determine its application versus other compounds. The availability of other compounds has influenced the research landscape, meaning that studies on this specific use are now limited.

Research Gaps and Areas of Uncertainty

The evidence quality varies across studies, with much of the supporting information derived from older, non-randomized clinical observations. Comparative evidence is lacking, and data for certain groups remain insufficient. These research limitations mean that certainty remains low for certain applications, and research is ongoing in the broader field of Vitamin K analogues. The majority of research focuses on the acute response, and follow-up durations were limited. Because of this acute focus, there is limited information for long-term outcomes, and thus, the long-term effects are not fully established.

Key Studies & References

  1. The comparative effects of menadione sodium bisulfite and vitamin K1 on the hypoprothrombinemia induced by dicumarol

Frequently Asked Questions (FAQ)

Common questions about Викасол (FAQ)

Q: What is the chemical structure or formula of Menadione sodium bisulfite?

Official drug compendiums, which provide chemical identification data, state that the active substance, menadione sodium bisulfite, has a specific molecular formula. Its chemical composition is represented as C11 H9 NaO5 S. The molecular weight is approximately 276.24, which helps identify the substance for quality control purposes.

Q: What is the official brand name for the product?

The drug is officially identified by its active ingredient, menadione sodium bisulfite, and is primarily known and registered under the trade name Викасол (Vikasolum). This name is used in regulatory contexts to identify the specific pharmaceutical formulation.

Q: What are the symptoms of an overdose and what is the treatment?

Official information for patients does not typically list specific clinical overdose symptoms, but regulatory data addresses acute high-level exposure. General non-specific symptoms such as headache, nausea, and vomiting may be associated with an acute overdose. Regulatory sources generally indicate that the management of an overdose focuses on symptomatic and supportive care.

Q: Can I use the tablet form for my 2-year-old child?

According to the official prescribing information, the tablet form of Викасол is generally contraindicated (not advised for use) in children younger than 3 years of age. This restriction is often based on the content of excipients (inactive ingredients) in the tablet. The decision to use this medication in any pediatric population is a determination made by the prescribing healthcare professional.

Q: Is there a risk of the drug causing serious brain damage in infants?

Regulatory safety information documents a serious risk associated with the use of this medication in newborns and infants. This risk includes the potential for Kernicterus, a severe condition documented as a risk in this population. For patient safety, official prescribing information indicates that the use of Викасол in newborns and infants is often avoided or must be carefully considered by a healthcare professional.

How should Викасол be stored and disposed of?

Official Storage and Disposal Requirements

Storage of Викасол (Menadione Sodium Bisulfite) must strictly adhere to regulatory requirements to maintain product quality and safety.

Storage Category Requirement
Temperature Store at a temperature not exceeding 30 C and protect from intense heat and freezing.
Protection The product must be protected from light and stored in a dry, well-ventilated place away from moisture and strong acids.
Container Keep the medication in its original container and ensure the container is tightly closed.
Child Safety The product must be kept out of the sight and reach of children and stored locked up.

Disposal must be conducted in accordance with local, regional, and national regulations. Unused or expired medication and containers must not be disposed of in household garbage or flushed down drains, and release into the environment must be avoided.

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

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