Vikasol-Vial

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Vikasol-Vial

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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 Vikasol-Vial

Quick Facts

Property Description
Active ingredient Menadione sodium bisulfite
Form Solution for injection (Vial)
Pharmacological class Hemostatic agent (Coagulant)
General purpose To correct coagulation defects
Origin Synthetic analogue of Vitamin K

What is Vikasol-Vial? An Overview of Identity and Class

Vikasol-Vial is a prescription medicinal product classified as a powerful hemostatic agent or coagulant, primarily intended to manage conditions related to impaired blood clotting. Its core pharmacological purpose is to correct deficiencies in the body's natural coagulation processes, which defines it as a prothrombinogenic agent. The active pharmaceutical ingredient is Menadione sodium bisulfite, which is formally identified as a synthetic analogue of Vitamin K or Vitamin K3. The drug is characterized by its capacity to restore normal clotting mechanisms. This medicine belongs to a class of drugs that promote blood coagulation.

Composition and Form

Vikasol-Vial is specifically prepared as a sterile, clear solution for injection, contained within a sealed vial for parenteral administration. This formulation is a key differentiator, as the specific use of the water-soluble Menadione bisulfite salt ensures the medicine bypasses the digestive tract for rapid and predictable systemic delivery. The active compound is formulated in an aqueous base (water for injection). This unique composition and form are selected to maximize the bioavailability of the synthetic Vitamin K analog, which is critical for timely intervention in clinical scenarios requiring prompt restoration of clotting ability.

General Purpose of this Hemostatic Agent

The general purpose of Vikasol-Vial is to promote the cessation of bleeding by supporting the body’s innate ability to form blood clots. This mechanism works by supplying the synthetic Menadione component, which acts as an essential cofactor in the activation of key coagulation proteins. A typical use scenario involves administering the drug when a severe deficiency in blood clotting factors is identified, such as during episodes of hypoprothrombinemia. Vitamin K analogs are integral to synthesizing the coagulation factors needed for a normal clotting cascade.

What side effects are possible with Vikasol-Vial?

Possible Side Effects and Safety Information

The safety profile of Vikasol-Vial (Menadione Sodium Bisulfite) is defined by officially documented risks across several body systems, as reported in regulatory documents.

Serious and Systemic Safety Concerns

The most critical safety limitation involves use in newborns. The active ingredient, Menadione, has been officially associated with a risk of severe hemolytic anemia (destruction of red blood cells) and irreversible kernicterus (severe brain damage) when administered to this population, particularly at high doses. Regulatory authorities have therefore contraindicated its use in newborns.

Adverse Reactions and Chemical Component Risks

The formulation contains the chemical component bisulfite, which is officially linked to the potential for hypersensitivity reactions. These reactions can be severe, including symptoms similar to asthma, and in rare cases, life-threatening anaphylaxis (severe allergic reaction).

Other officially documented safety considerations include systemic effects across several organ systems:

  • Blood and Lymphatic System Disorders: Potential for hemolytic anemia and changes in blood clotting factors.
  • Immune System Disorders: Risk of hypersensitivity and allergic responses.
  • Hepatobiliary Disorders: Potential effects on the liver.
  • Nervous System Disorders: Documented potential for central nervous system effects, especially with prolonged or repeated exposure.

Safety Limitations

Official safety documents note the need for particular caution in patients with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency and those with existing compromised liver function due to increased susceptibility to adverse effects.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Vikasol-Vial (Menadione sodium bisulfite) outlines specific clinical and laboratory findings based strictly on documented overdose reports, with a primary focus on the effects observed in certain vulnerable patient groups.

Documented Manifestations

Regulatory texts cite a specific set of manifestations linked to overdose exposure, particularly in neonates and infants. The symptom profile involves multiple physiological systems.

Clinical and Physiological Findings:

  • Systemic Signs: Jaundice, agitation, and general malaise.
  • Gastrointestinal: Specific symptoms include abdominal pain, constipation, and soft stools.
  • Hepatic Markers: Laboratory findings documented in the official profile include Hyperbilirubinaemia (elevated bilirubin levels) and increased liver enzymes values.

Emergency Response and Documentation Scope

The official prescribing information for this agent concentrates on outlining the documented physiological changes observed in the neonate and infant population. The regulatory documentation does not contain explicit guidance for the general population on specific supportive management protocols, nor does it include a general statement mandating immediate contact with emergency services or medical help. Given the nature of these severe physiological changes, immediate consultation with a healthcare professional or emergency services is necessary upon any suspected overdose.

Therapeutic Uses of Vikasol-Vial

What Vikasol-Vial Treats: Main Uses and Benefits

The primary role of Vikasol-Vial is to provide support in situations involving systemic imbalance that leads to heightened bleeding risk. This is generally used to help address symptoms related to a severe Vitamin K deficiency or low levels of the necessary clotting factors (hypoprothrombinemia).

Prothrombin deficiency can lead to coagulation problems. In this context, Vikasol-Vial is commonly used to help with symptoms related to active bleeding or threatened hemorrhage in patients with conditions like malabsorption syndromes, certain liver disorders, or clotting impairment resulting from specific long-term antibiotic therapy.

“The injection is relevant when symptoms of deficiency create a noticeable physiological strain.”

This injectable solution is used to address symptom clusters that may become intense or disruptive, including excessive bruising, prolonged bleeding, or capillary bleeding after surgery. The core therapeutic benefit provided is the support that helps ease the overall symptom burden associated with a high bleeding risk and assists with maintaining functional stability.

Quick Fact: Support for Bleeding Symptoms
Primary Indication: Hypoprothrombinemia
Symptom Management: Addresses excessive bleeding and bruising.
Context of Use: Applied in situations requiring short-term symptomatic assistance.

Regulatory References

  1. MedlinePlus Medical Encyclopedia on Prothrombin Deficiency

Eligibility and Restrictions for Use

Eligibility Scope for Vikasol-Vial

Official regulatory information strictly defines the patient groups who are eligible or prohibited from using Vikasol-Vial (Menadione sodium bisulfite injection).

Classification Population Group / Condition
Absolute Contraindication Newborns and Neonates
Absolute Contraindication Patients with known G6PD deficiency
Absolute Contraindication Known hypersensitivity to Menadione or its components
Use Not Recommended Pregnant women
Use Not Recommended Breastfeeding women
Use with Caution Patients with severe hepatic (liver) impairment
Use with Caution Patients with renal (kidney) impairment
Permitted Use Adults and older children

Official Eligibility Statements

The medicine is absolutely contraindicated in newborns and neonates due to the documented risk of severe complications, including hyperbilirubinemia and hemolytic anemia. Use is also strictly prohibited in patients with Glucose-6-phosphate dehydrogenase (G6PD) deficiency because of the risk of causing red blood cell breakdown.

For age-related eligibility, the drug is permitted for use in adults and older children. Regarding reproductive status, the medicine is generally not recommended for women who are pregnant or breastfeeding. Furthermore, official labeling requires caution when the medicine is used in patients with pre-existing conditions affecting the liver or kidneys.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section summarizes the officially documented information regarding interactions between Vikasol-Vial (menadione sodium bisulfite) and other medicinal products or substance classes, as defined in authoritative regulatory documents.

Documented Interaction Profile

The interaction profile is primarily structured around two critical outcomes: the antagonism of co-administered agents and the reduction of Vikasol-Vial's own effectiveness.

1. Antagonism of Anticoagulants

Co-administration with indirect-acting anticoagulants, such as coumarin derivatives (e.g., Dicumarol), results in a reduced anticoagulant effect. This effect is due to the direct antagonistic relationship between the two drug classes concerning the coagulation process. Prescribers are required to closely manage combination therapies to account for this reduced efficacy.

2. Reduced Effectiveness of Vikasol-Vial

Several medicinal product classes may reduce the concentration or effectiveness of Vikasol-Vial:

  • Antibiotics and Sulfonamides: Broad-spectrum antibiotics and sulfanilamide derivatives may decrease the availability of the drug in the body.
  • Salicylates: High doses of salicylates may decrease the overall effectiveness of Vikasol-Vial.
  • Neomycin (Oral): When administered orally, the antibiotic Neomycin is documented to reduce the absorption of Vikasol-Vial from the gastrointestinal tract, potentially impacting its therapeutic effect.
  • Quinine and Quinidine: Derivatives of these compounds are reported to antagonize the action of Vikasol-Vial, further contributing to constraints on combination therapy management.

Note: This information is derived strictly from official regulatory labeling and does not constitute dosing instructions, mechanisms of action, or general safety summaries.

Mechanism of Action

Vikasol-Vial, through its active component Menadione, exerts a targeted effect by acting as a cofactor necessary for the synthesis and activation of critical blood coagulation proteins. This entire mechanism is focused exclusively on influencing the pathway of functional hemostasis at the molecular level.

Gamma-Carboxylation and Enzyme Cofactor Replenishment

The active form of the medicine provides the necessary cofactor for the enzyme Vitamin K-dependent gamma-carboxylase in the liver. This enzymatic activity chemically modifies specific Glutamic acid (Gla) residues on the precursor clotting factors II, VII, IX, and X. The physiological consequence is to ensure these newly synthesized factors possess the structure required for their factors' physiological activity within the coagulation cascade.

Modulation of Clotting Factor Synthesis

The mechanism operates within the pathway of hepatic zymogen synthesis, increasing the liver's production of functional coagulation factors. The resulting physiological consequence is a direct increase in the systemic concentration of fully active, pro-coagulant proteins, thereby resulting in an augmented state of hemostatic capacity.

Constraints on Mechanism Onset

This mechanistic cluster defines the inherent limitations of the drug's action. The overall effect profile is shaped by the time required for the liver to perform de novo protein synthesis and secretion. The physiological change in clotting capacity is a progressive process dictated by cellular biosynthetic rate.

Dosage and Administration Information

The administration of Vikasol-Vial (Menadione sodium bisulfite injection) is based on established protocols establishing how the medicine is delivered and dosed.

Administration Scope

Entity Detail
Route of administration Administration is conducted via the Intramuscular (IM) injection or the Intravenous (IV) injection routes.
Dosing schedule The standard adult dose is typically a single injection ranging from 2.5 mg to 10 mg.
Timing in relation to meals (if applicable) Not applicable; the medicine is administered parenterally.
Preparation requirements (if applicable) The product is a solution for injection. For IV use, dilution is required, and the medication must be infused slowly and carefully over a controlled period.
Age-group administration rules Pediatric dosage requires a specific adjustment based on age and body weight, following an established mg/kg schedule.
Missed-dose rules Not typically documented for this acute, short-term, medically-supervised injectable regimen.
Special procedural conditions The IM or IV route necessitates that administration is conducted under specialist supervision or within a dedicated clinical environment.

Instruction Classifications (High-Level)

Classification Detail
Administration method type Strictly Parenteral (Injection).
Frequency pattern The standard regimen is a once daily injection for the duration of the defined course.
Usage context Administration is confined to a clinical setting for short-term, acute use.

Resulting Procedural Structure

Standard step sequence:

  • The medication is prepared and measured to adhere to the low-milligram 2.5 mg to 10 mg dose range (for adults).
  • The injection is administered via the IM or IV route and repeated once daily for the duration of the prescribed course.
  • IV administration requires the appropriate dilution and a slow infusion rate to ensure procedural compliance.

Connection to the overall use protocol: Standard instructions define the procedural structure by limiting use to parenteral routes and specific, low-milligram dose ranges. This approach governs the timing and method of delivery, establishing the medicine's role as a controlled, short-term intervention within a supervised clinical environment.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Vikasol-Vial


Evidence for Use in Hypoprothrombinemia

This section will summarize the core research explored in conditions characterized by impaired blood clotting (hypoprothrombinemia). The review will cover the types of clinical and pharmacological studies that evaluated coagulation markers following administration of this synthetic Vitamin K analog.

Research exploring the compound in hypoprothrombinemia primarily consists of historical clinical studies, case series, and comparative biochemical studies. Research examined populations that included adults with underlying conditions such as malabsorption or chronic liver disorders, in research contexts involving fluctuating or unstable symptoms, such as excessive bleeding.

Studies monitored outcomes related to acute changes in the blood, such as changes in Prothrombin Time ( PT) test results. Research highlights changes measured during the study period, reporting that this compound was studied in association with an acute change measured in the PT biomarker. The findings describe patterns observed in the studies related to changes measured during the study period in key coagulation markers.


Evidence for Use in Anticoagulant-Induced Hypoprothrombinemia

This area of research is supported by early comparative clinical trials and case series that focused on exploring the compound when studied in individuals using certain oral anticoagulant medications. The summary will detail what kinds of short-term outcomes, such as measured short-term changes in Prothrombin Time ( PT), were evaluated in these studies.

Research explored the compound in conditions where symptoms of excessive anticoagulation became noticeable, such as prolonged clotting times. Data show patterns related to the measured PT when studied in the context of certain anticoagulant medications. Contemporary clinical guidelines for reversal primarily focus on alternative forms of Vitamin K.


Evidence in Special Populations: Neonates

This part will outline the historical and contemporary study landscape regarding the evaluation of Vitamin K compounds, including this synthetic analog, in newborns and infants. The evidence landscape is supported by systematic reviews, meta-analyses, and large-scale population-level surveillance studies which tracked outcomes related to episodic or acute changes, such as the incidence of bleeding events. Studies monitored patterns related to the overall Vitamin K Deficiency Bleeding ( VKDB) rates across wide populations where Vitamin K prophylaxis was applied.

However, the vast majority of the high-level evidence and current regulatory recommendations focus on the evaluation of Vitamin K1 (Phylloquinone) for newborn prophylaxis. While the K3 analog was used historically, direct, recent comparative research between the injectable K3 analog and K1 in this population remains insufficient.


What is Still Uncertain About Vikasol-Vial

The overall evidence quality varies across studies, with a reliance on historical clinical data and pharmacological testing rather than modern, large-scale randomized controlled trials. Specifically, comparative evidence is lacking when this synthetic analog is directly measured against the natural Vitamin K1 compound in contemporary settings and populations. Long-term effects are not fully established, and there is limited information for long-term outcomes such as durability of the change or sustained functional observations.

Key Studies & References

  1. Vitamin K - StatPearls (NCBI Bookshelf)

Frequently Asked Questions (FAQ)

Common questions about Vikasol-Vial (FAQ)

Q: Is Vikasol-Vial the same as Vitamin K injections?

A: Official information describes Vikasol-Vial as a synthetic analogue of Vitamin K, often referred to as Vitamin K3. While it functions similarly to natural Vitamin K by supporting the clotting process, current authoritative guidelines, especially for newborns, focus more on Vitamin K1 (Phylloquinone).

Q: Can Vikasol-Vial be used to stop bleeding right away?

A: The effect of this medicine is not immediate. Mechanistic data indicates the change in clotting capacity is a progressive process. The medicine's action is reliant upon the liver's creation of new, functional blood clotting proteins before an effect is observed.

Q: How long does Vikasol-Vial take to start working after it is given?

A: Official mechanistic data indicates that the physiological change in clotting capacity is progressive. The time it takes for the effect to be observed is dictated by the time required for the liver to synthesize and release new coagulation proteins into the bloodstream.

Q: Does Vikasol-Vial interact with common over-the-counter medicines?

A: Regulatory documents state that high doses of salicylates, which are found in some over-the-counter products, may decrease the overall effectiveness of Vikasol-Vial. No other specific, common over-the-counter medication classes are explicitly listed in official interaction profiles.

Q: Is Vikasol-Vial considered a blood thinner?

A: No. Vikasol-Vial is classified as a powerful hemostatic agent or coagulant. Its general purpose is to correct clotting defects and support the body’s ability to form blood clots, a function that is counter to that of a blood thinner.

Q: What should I do if I notice a reaction after receiving Vikasol-Vial?

A: If an adverse reaction, including signs of hypersensitivity or irritation, is observed, regulatory guidance indicates that a healthcare professional should be notified promptly. Management of the reaction is a clinical determination.

Q: Why do doctors need to know all my current medications before I receive Vikasol-Vial?

A: This is required due to known interactions documented in official sources. Certain medicines, such as anticoagulants, antibiotics, and sulfonamides, are documented to either reduce the effectiveness of Vikasol-Vial or have their own effects antagonized by it.

Q: What is the general duration of effect for a dose of Vikasol-Vial?

A: Official instructions define this medicine as a controlled, short-term intervention administered as a once daily injection for the defined course, indicating the effect is not a sustained, long-term correction.

Q: Can Vikasol-Vial be used during breastfeeding?

A: According to regulatory information, the medicine is generally not recommended for women who are breastfeeding. This is noted as a specific constraint on its use.

Q: Why does this medicine come in a vial instead of a pill?

A: Vikasol-Vial is specifically prepared as a sterile solution in a vial for injection. This parenteral route (injection) is selected to ensure rapid and predictable systemic delivery of the active ingredient, bypassing the digestive tract.

Q: Can taking Vikasol-Vial cause stomach upset?

A: General documentation of the active ingredient lists stomach discomfort and nausea as possible, though usually less common, side effects. Potential side effects are typically discussed with the professional overseeing the treatment.

Q: What happens if I miss a scheduled dose of Vikasol-Vial?

A: Regulatory information explicitly states that instructions for a missed dose are not typically documented for this acute, short-term, medically-supervised injectable regimen. Management of any changes to the administration schedule is handled by the prescribing professional.

Q: Can Vikasol-Vial cause skin irritation at the injection site?

A: The officially documented list of possible adverse reactions includes injection site reactions and cutaneous (skin) reactions. These are noted as possibilities when the medicine is administered.

Q: Are there any foods or drinks to avoid while using Vikasol-Vial?

A: Regulatory documentation concerning the active ingredient indicates that no specific food or drink interactions have been found or established.

Q: Does Vikasol-Vial have any known long-term side effects?

A: The drug is defined for short-term, acute use. Official research sections note that limited information exists for long-term outcomes such as durability or sustained functional observations.

Q: Can Vikasol-Vial be administered at home?

A: Official use constraints define administration as being confined to a clinical setting for short-term, acute use. The procedure necessitates specialist supervision.

Q: Does Vikasol-Vial cause drowsiness or affect the ability to drive?

A: General documentation suggests the medicine generally does not affect the ability to drive. However, regulatory sources mention potential for central nervous system effects.

Q: Is the medication Vikasol-Vial typically a one-time use or for long-term treatment?

A: The medicine is officially defined as a controlled, short-term intervention within a supervised clinical environment. It is not intended for sustained or long-term treatment.

Q: What type of healthcare professional can administer Vikasol-Vial?

A: Administration of the injection is required to be conducted under specialist supervision or within a dedicated clinical environment. This procedure indicates that the administration is restricted to a dedicated clinical environment.

Q: What happens if Vikasol-Vial is exposed to light or high temperatures?

A: Official instructions mandate storage in the original package and protection from light to maintain its stability. Exposure to extreme temperatures should be avoided.

Q: Are there any known interactions between Vikasol-Vial and alcohol?

A: Regulatory documentation concerning the active ingredient indicates that no specific interaction between this medicine and alcohol has been found or established.

Q: Can children older than infants receive Vikasol-Vial?

A: For age-related eligibility, regulatory information states the drug is permitted for use in adults and older children. However, it is strictly contraindicated for newborns and neonates.

Q: Are there different forms or strengths of Vikasol-Vial available?

A: The product is prepared specifically as a sterile solution for injection in a vial. Official adult dosage information mentions a typical single dose range from 2.5 mg to 10 mg.

Q: How does Vikasol-Vial relate to the body's natural processes?

A: The active ingredient acts as a synthetic cofactor that is necessary for the enzyme Vitamin K-dependent gamma-carboxylase. This enzyme's role is to create functional blood coagulation proteins in the liver, which are essential for normal blood clotting.

Q: Does age affect how a person reacts to Vikasol-Vial?

A: Yes. Regulatory documents define an absolute contraindication for newborns due to the risk of severe side effects. Pediatric dosage also requires specific adjustment based on age and body weight, as defined by national formularies.

Q: How is the effect of Vikasol-Vial monitored by a doctor?

A: Research studies on the medicine monitored outcomes by examining acute changes in the blood, such as changes in Prothrombin Time (PT) test results. This is a key coagulation marker used to assess clotting ability.

How should Vikasol-Vial be stored and disposed of?

Official Storage and Disposal Requirements

Regulatory documentation establishes strict conditions for the storage and disposal of Vikasol-Vial (Menadione sodium bisulfite injection) to maintain product stability and ensure environmental safety.

Mandatory Storage Conditions

Condition Requirement
Temperature Must not exceed 30 C.
Protection Store in the original package and protect from light and moisture.
Safety Keep the prescription medicine locked up and out of the sight and reach of children.

Disposal Rules

Official instructions mandate that unused or expired Vikasol-Vial must be discarded via an approved waste disposal plant or according to local regulations for pharmaceutical waste. The product must not be released into the environment, including drains, surface water, or sewer systems.

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

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