Advertisements

Fitomenadiona

Quick links to important sections

Fitomenadiona

Advertisements
Advertisements

Method of action: Antihemorrhagics

Treatment option:

Medically reviewed

Marina Burgos

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.

Advertisements

Overview of Fitomenadiona

Quick Facts

Property Description
Active ingredient Phytomenadione (Vitamin K1)
Form Injectable solution, Oral tablets/capsules
Pharmacological class Antihemorrhagic Agent, Procoagulant
General purpose Restores blood clotting capability
Origin Naturally occurring substance (used in synthetic form)

What is Fitomenadiona and Its Core Classification?

Fitomenadiona is the pharmaceutical designation for Phytomenadione, which is chemically identical to the essential nutrient known as Vitamin K1. This compound (C31H46O2) is officially classified as a fat-soluble vitamin. It is primarily categorized as an antihemorrhagic agent and a procoagulant, meaning it is used to prevent or stop bleeding. This classification is clinically recognized for correcting imbalances in the clotting system and aligns with its inclusion on international lists of essential medicines.

Composition, Origin, and Available Forms

The medication is a single-active ingredient product containing only Phytomenadione. Although the compound occurs naturally in plants, the drug is typically manufactured in a highly stable synthetic form for therapeutic purposes. Due to its intrinsic lipid-soluble nature, Fitomenadiona is formulated in various dosage form(s). These include a sterile injectable solution (often a colloidal or oil-based carrier) for parenteral routes (intramuscular, subcutaneous, or slow intravenous administration) and oral tablets or capsules.

General Purpose as a Hemostatic Cofactor

The general purpose of Fitomenadiona is to provide the required cofactor necessary for the hepatic biosynthesis of specific coagulation factors (II, VII, IX, and X). This action is crucial for enabling the activation of these proteins, which are essential for establishing normal prothrombin activity and efficient blood clotting. This means the drug’s core function is to maintain the body's capability to form a stable clot and ensure the functional integrity of the hemostatic system, a capability that is particularly valuable in cases of established deficiency or interference.

Advertisements

What side effects are possible with Fitomenadiona?

Possible side effects and safety information

The official safety profile for Fitomenadiona (Phytomenadione) is primarily structured around adverse reactions categorized by frequency and the organ systems affected, as documented in regulatory sources such as the FDA and EMA.


Serious Adverse Reactions

The most significant safety concern, particularly following parenteral (injectable) administration, is the potential for rare, severe hypersensitivity reactions. These include manifestations of anaphylaxis, shock, cardiac arrest, and respiratory arrest. Such events are documented as potentially fatal. Additionally, some formulations containing the benzyl alcohol preservative are associated with the risk of "Gasping Syndrome" in neonates.


System-Organ Classified Adverse Reactions

Adverse effects are documented across several body systems. Systemic reactions that are classified as rare include flushing sensations, brief hypotension, dizziness, profuse sweating (diaphoresis), and a rapid, weak pulse (tachycardia). These are categorized under Cardiac Disorders and Nervous System Disorders. Local reactions at the injection site, such as pain and swelling, are also documented, along with delayed and infrequent cutaneous reactions like scleroderma-like lesions that may appear after repeated use.


Population-Specific Safety Considerations

Regulatory labels specify risks for certain groups. For neonates and infants, there is a documented potential for hemolysis, jaundice, and hyperbilirubinemia, especially if doses exceed official recommendations. Safety limitations also note that administering large doses to patients with severely impaired liver function may further depress liver function. Officially documented safety constraints include the contraindication for use in individuals with known hypersensitivity to any component of the medication.

Advertisements

Overdose and Emergency Response

Overdose and when to seek help — Official Regulatory Information for Fitomenadiona

Overdose Scope

Domain Official Regulatory Statement
Documented overdose presentations Hypervitaminosis of Vitamin K1 is generally unknown; regulatory documents do not define a specific toxic syndrome resulting from acute overdose of the active substance.
Physiological systems affected The primary physiological system noted in the context of over-exposure is the coagulation system, requiring laboratory monitoring.
Dose-related or exposure-related factors Doses exceeding recommended amounts are specifically noted as a concern in the pediatric population.
Population-specific overdose notes Risk of hyperbilirubinemia and jaundice in newborns has been observed following doses above those recommended.
Emergency-response statements Management should consist of symptomatic and supportive treatment; no specific antidote is known for over-exposure.
When immediate medical help is required Seek immediate medical attention for suspected over-exposure or overdose event; contact a Poison Control Center for guidance.

Overdose Classifications (High-Level)

Classification Aspect Official Regulatory Statement
Severity classification The lack of a defined hypervitaminosis syndrome suggests a regulatory classification of low acute toxicity for the active substance itself.
Overdose-context constraints Management is constrained to monitoring of coagulation status and supportive care.

Resulting Overdose Structure

Official overdose statements:

  • Regulatory documentation states that Vitamin K1 hypervitaminosis is unknown, meaning acute overdose of the active ingredient does not have a specific, documented symptom profile.
  • In the event of suspected over-exposure, the official instructions mandate providing symptomatic and supportive treatment because no specific antidote is known.
  • Immediate medical attention must be sought for suspected over-exposure, and the patient's coagulation status (PT/INR) may require mandatory monitoring.
  • The regulatory label documents that doses above recommended amounts in newborns have been associated with the risk of hyperbilirubinemia and jaundice.

Connection to the overall overdose profile: Regulatory documents define the Fitomenadiona overdose profile by the absence of a defined toxic syndrome and focus on procedural safety mandates. The official guidance centers on the instruction to seek immediate medical attention for suspected over-exposure and outlines the necessity for supportive management and laboratory monitoring of coagulation parameters.

Advertisements

Therapeutic Uses of Fitomenadiona

What Fitomenadiona Treats: Main Uses and Benefits

Fitomenadione is commonly used to address a range of coagulation deficiencies (hypoprothrombinemia) and the associated symptoms of excessive bleeding or heightened hemorrhagic risk. This treatment is primarily relevant in contexts where the body's clotting ability is compromised. Conditions commonly addressed include anticoagulant-induced hypoprothrombinemia caused by blood thinners, Vitamin K-deficiency bleeding (VKDB) in newborns, and deficiencies linked to chronic issues like obstructive jaundice or malabsorption syndromes (such as celiac disease).

The core benefit helps support the body's clotting capability, offering symptomatic relief that helps patients cope more steadily with symptom fluctuations, such as easy bruising or persistent oozing. In acute scenarios, it may assist with managing symptoms associated with acute or disruptive episodes when the patient’s systemic imbalance is pronounced.

“The therapeutic benefit supports the avoidance of severe complications associated with compromised blood clotting.”


Quick Fact: Relief for Coagulation Failure
Primary Symptom Targeted Symptoms related to systemic imbalance, such as excessive, uncontrolled bleeding and high hemorrhagic risk.
Acute Scenario Applied in clinical settings that involve acute or unstable symptom patterns (e.g., rapid management of over-anticoagulation).
Chronic Scenario Relevant when supportive symptom management is appropriate (e.g., bleeding risk in patients with malabsorption conditions).
Benefit Assists with maintaining functional stability in hemostasis and helps improve day-to-day comfort.

Regulatory References

  1. NIH DailyMed label
Advertisements

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Fitomenadiona — official regulatory information


Eligibility scope

Populations for whom use is allowed (as stated in label): Adults with hypoprothrombinemia and neonates/infants for Vitamin K-Deficiency Bleeding.
Populations for whom use is not recommended (if applicable): Individuals with severe hepatic impairment, as the medicine's response may be unsatisfactory.
Populations for whom use is contraindicated: Patients with a known hypersensitivity to the active ingredient or any excipients.
Age-related eligibility rules: Neonates require benzyl alcohol-free formulations. Safety is not established for all pediatric patients. Older adults require cautious dose selection.
Condition-specific eligibility rules: Efficacy is limited in patients with severe hepatic disease whose condition is unresponsive to Vitamin K.
Pregnancy and lactation eligibility status (if explicitly documented): Conditional use (e.g., Pregnancy Category C); permitted only if the benefit clearly outweighs the potential risk. Caution is advised during lactation.
Eligibility-related restrictions: The intravenous (IV) and intramuscular (IM) routes are generally avoided due to the risk of severe hypersensitivity reactions.

Eligibility classifications (high-level)

Eligibility severity classification (as defined in official documents): Contraindicated, Restricted, Not Established.
Regulatory basis (EMA / FDA / etc.): FDA Prescribing Information, Summary of Product Characteristics (SmPC).
Eligibility-context constraints (as defined in official documents): Allergy history, age group, liver function status, and route of injection.

Resulting eligibility structure

Official eligibility statements:

  • Contraindicated for patients with known hypersensitivity to Phytomenadione.
  • Intravenous and intramuscular routes are restricted due to the risk of fatal hypersensitivity reactions.
  • Use in neonates must be with benzyl alcohol-free formulations, if available.
  • Use is not established for all pediatric age groups (e.g., 6 months to 17 years for some products).

Connection to the overall eligibility profile (2–4 sentences): The official regulatory profile defines eligibility for Fitomenadiona based on primary patient-specific criteria and administration risks. Use is prohibited for individuals with a documented allergy and is restricted by age, necessitating preservative-free formulations for infants. The profile further mandates that use be conditional in older adults and patients with severe liver impairment, reflecting the limits of the drug's utility.

Advertisements

What should I know about interactions with other medicines?

Fitomenadiona’s official interaction profile, documented across regulatory agencies, is structured around its role as a procoagulant and specific population-related constraints. No combinations are formally classified as universal contraindications based solely on drug-drug interaction risk.

Pharmacodynamic Interactions and Antagonism

The primary documented interaction is pharmacodynamic antagonism with prothrombin-depressing anticoagulants, such as Warfarin (Coumarin and Indanedione derivatives). Regulatory information states that Fitomenadiona's administration may induce a temporary resistance to the anticoagulant effect of these agents, especially when higher doses are used. However, Fitomenadiona will not counteract the anticoagulant action of Heparin.

Gastrointestinal and Exposure-Modifying Agents

Certain medicinal products interfere with the absorption of Fitomenadiona from the digestive tract. These include agents like Cholestyramine, Colestipol, and the lipase inhibitor Orlistat. The use of such agents is documented as potentially reducing the availability of oral Fitomenadiona. Consequently, regulatory summaries note that the administration of oral Vitamin K1 and Orlistat should be separated by a two-hour window to minimize this absorption interference.

Population-Specific Constraints

  • Excipient-Related Risk (Neonates and Infants): For injectable formulations containing the preservative Benzyl Alcohol, a serious risk of adverse reactions, including gasping syndrome, is officially documented. This risk is related to the cumulative metabolic load of benzyl alcohol from all sources in neonates and low-birth-weight infants.
  • Severe Hepatic Impairment: The drug's effects are noted to be potentially increased in patients with this condition, which is linked to the officially documented slower removal (clearance) of the medicine from the body.
Advertisements

Mechanism of Action

Facilitating Hepatic Cofactor Function

Fitomenadiona functions by providing an essential cofactor for the enzyme gamma-Glutamyl Carboxylase (GGCX) within liver cells. The molecule is integral to the Vitamin K Epoxide Cycle, which is the fundamental biochemical mechanism required for continuous enzymatic activity. The cofactor facilitates the GGCX enzyme, which acts upon precursor coagulation factors, enabling their post-translational activation.

Molecular Activation of Clotting Factors

This mechanism directly addresses the post-translational modification of specific protein substrates: Coagulation Factors II (Prothrombin), VII, IX, and X. The presence of the Fitomenadiona cofactor enables GGCX to perform gamma-carboxylation, a chemical change that creates gamma-carboxyglutamic acid (Gla) residues on these proteins. This modification renders the factors functionally active and able to bind calcium ( Ca^2+), thereby initiating the downstream steps of the coagulation cascade.

Systemic Effect on Hemostatic Potential

The cellular activation cascade in the liver culminates in the secretion of these functionally competent factors into the systemic circulation. This systemic delivery increases the plasma concentration of active factors, thereby supporting the integrity of the extrinsic and intrinsic coagulation pathways. The resulting physiological effect is the restoration of prothrombin activity, supporting the formation of a fibrin polymer structure.

Advertisements

Dosage and Administration Information

Official Dosing and Administration Guidelines

Fitomenadiona (Phytomenadione) is administered via multiple official routes, with the specific choice depending on the required speed of action and the patient’s condition.


Administration Routes and Preparation

Route Adult Dosing (Typical Initial Range) Administration Instructions
Oral (PO) 2.5 mg to 10 mg (Tablets) Requires concurrent bile salts for absorption if endogenous bile flow is deficient.
Subcutaneous (SC) 2.5 mg to 10 mg (Injectable Solution) Generally the preferred parenteral route for routine use.
Intravenous (IV) 5 mg to 10 mg (Severe Cases) Must be diluted with 0.9% Sodium Chloride or 5% Dextrose and injected very slowly, not exceeding 1 mg per minute.

Dosing Frequency and Age-Specific Rules

Adult Dosing: Subsequent doses are determined by monitoring the Prothrombin Time/INR response. The dose may be repeated in 6 to 8 hours if administered parenterally, or in 12 to 48 hours if given orally, should the initial response be unsatisfactory. The maximum recommended intravenous dose in a 24-hour period is often limited to 40 mg. Dosing for older adults should start at the low end of the recommended ranges.

Neonatal Use: For the prophylaxis of Vitamin K-deficiency bleeding (VKDB), the injectable form is typically given as a single intramuscular (IM) or subcutaneous dose of 0.5 mg to 1 mg within one hour of birth. Oral prophylactic regimens also exist in some regions, requiring three 2 mg doses over the first month of life. The IV solution must be administered immediately after preparation and requires protection from light at all times.

Advertisements

Recent Clinical Evidence

Fitomenadiona: Recent Clinical Evidence

Fitomenadiona, also known as Vitamin K1 or phytonadione, is essential for the body to produce blood clotting factors. Clinical research continues to examine its use in managing and preventing various coagulation disorders.


Use in Newborn Prophylaxis

Prophylaxis using fitomenadiona after birth is a widely studied and supported measure to prevent Vitamin K Deficiency Bleeding (VKDB), previously known as Hemorrhagic Disease of the Newborn (HDN). Studies consistently show that a single intramuscular dose is effective in preventing the classic form of VKDB.

Research comparing administration routes indicates:

  • Intramuscular (IM) Administration: Sufficient evidence supports the effectiveness of the IM route for preventing both classic and late VKDB.
  • Oral Administration: Studies on oral fitomenadiona for preventing late VKDB often rely on biochemical markers. The results are considered inconclusive due to the lack of scientific evidence correlating these markers with actual coagulation status, and oral regimens typically require multiple doses.

Reversal of Anticoagulation

Fitomenadiona is routinely examined for its role in rapidly reversing the effects of certain oral anticoagulant medications, such as warfarin. Clinical data suggests that intravenous administration may be effective for semi-urgent correction of prolonged anticoagulation before surgical or diagnostic procedures. Studies indicate that low doses used for this purpose may not significantly prolong the time required for a patient to return to therapeutic anticoagulation after treatment resumption.


Emerging Research Areas

Recent clinical trials have explored the potential influence of fitomenadiona in other patient populations, particularly those with Chronic Kidney Disease (CKD) on dialysis. Research has been conducted to determine whether supplementation can influence the development of vascular calcification. A systematic review and meta-analysis indicated that while fitomenadiona supplementation improved Vitamin K levels and reduced related calcification biomarkers, it did not show a significant benefit in reversing calcification scores or impacting mortality. Further randomized, well-powered studies are needed to establish a clear benefit in this area.

Key Studies & References

  1. Neonatal Vitamin K Administration for the Prevention of Hemorrhagic Disease: A Review of the Clinical Effectiveness, Comparative Effectiveness, and Guidelines
Advertisements

Frequently Asked Questions (FAQ)

Common questions about Fitomenadiona (FAQ)

Q: How quickly does Fitomenadiona start working after injection?

A: According to official product information, when Fitomenadiona is given intravenously (IV), its action is typically detectable within one to two hours. The goal of returning the prothrombin level (a measure of clotting ability) toward normal may often be achieved within 12 to 14 hours.

Q: Are there different forms of Fitomenadiona (pills, injection, liquid)?

A: Fitomenadiona (Phytonadione) is available in several forms for therapeutic use. These generally include oral forms, such as tablets, and a sterile injectable solution or emulsion designed for administration into the muscle, under the skin, or slowly into a vein.

Q: Is it normal to feel a brief warmth after getting an Fitomenadiona injection?

A: Feelings of warmth or flushing sensations are documented in official product information as possible, though rare, adverse reactions. This can occur particularly following an injection.

Q: How long does the effect of a single dose of Fitomenadiona last?

A: The exact total duration of the effect is generally not specified in official documents. However, subsequent doses may be considered for repeating within 6 to 8 hours for injectable routes, or 12 to 48 hours for oral routes, if the patient's prothrombin time does not show a satisfactory initial response.

Q: Can Fitomenadiona cause any skin reactions or irritation?

A: Local reactions at the injection site, such as pain and swelling, are documented as possible adverse effects. Rare and delayed skin reactions, including firm, localized patches known as scleroderma-like lesions, have also been reported after repeated parenteral administration.

Q: What does official guidance say about using Fitomenadiona with liver problems?

A: Official prescribing information advises caution regarding its use in patients with impaired liver function. The drug is noted to be potentially less effective in patients with severe liver disease, especially if their condition is unresponsive to Vitamin K.

Q: Is Fitomenadiona a natural or synthetic compound?

A: Fitomenadiona is chemically identical to the naturally occurring nutrient Vitamin K1 (Phytomenadione). However, for therapeutic pharmaceutical purposes, the drug is typically manufactured as a stable, synthetic compound.

Q: Why might a doctor prescribe Fitomenadiona instead of a simple Vitamin K supplement?

A: Fitomenadiona is classified as a prescription antihemorrhagic agent. It is specifically indicated for treating significant coagulation disorders and for reversing the effects of certain prescription oral anticoagulants, functions that go beyond the role of a standard dietary vitamin supplement.

Q: What are the signs of a serious, but rare, side effect from Fitomenadiona?

A: Serious, rare hypersensitivity reactions are possible, particularly with injection. Signs can include rapid weak pulse, flushing, dizziness, and profuse sweating, and can involve severe cardiopulmonary complications, according to official warnings.

Q: Why is the injectable form sometimes preferred over the oral form of Fitomenadiona?

A: The injectable form is often used in severe, urgent cases because it typically achieves a faster effect than the oral tablet. Oral absorption can also be less reliable if a patient has a bile deficiency or is taking medications that interfere with absorption.

Q: What should I do if the injection site for Fitomenadiona is painful?

A: Pain, swelling, and tenderness at the injection site are documented as possible local adverse reactions. Any reactions that are concerning, severe, or persistent should be discussed with a healthcare professional.

Q: Can Fitomenadiona be used during pregnancy or while breastfeeding?

A: Official information states that use during pregnancy is conditional and should only occur if the potential benefit clearly outweighs the potential risk. Official information indicates the need for caution during lactation (breastfeeding).

Q: Does Fitomenadiona interact with common over-the-counter pain relievers?

A: While the label’s main focus is on interactions with strong anticoagulants, regulatory documents warn of interactions with certain drug-induced hypoprothrombinemia, such as with salicylates. These should be reviewed by a healthcare provider.

Q: What does official guidance say about the use of Fitomenadiona in older adults?

A: Official prescribing information advises caution in dose selection for older adults. Regulatory guidance suggests that dosing typically starts at the low end of the recommended ranges due to potential age-related changes in organ functions (hepatic, renal, or cardiac).

Q: What is the success rate of Fitomenadiona in reversing anti-coagulation effects?

A: Clinical response to Fitomenadiona is primarily monitored by assessing the patient's prothrombin time (INR). For intravenous use, the effect is often detectable within one to two hours, and a satisfactory prothrombin level may be obtained within 12 to 14 hours.

Q: Why is a slow injection rate sometimes recommended for Fitomenadiona?

A: Slow injection is required for the intravenous route because rapid injection is associated with a greater risk of severe and potentially fatal hypersensitivity reactions. The rate should not exceed 1 mg per minute.

Q: Why is proper absorption of fats important for Fitomenadiona effectiveness?

A: Fitomenadiona is a fat-soluble vitamin. Regulatory documents note that if the patient has a deficiency in bile flow, bile salts must be administered concurrently to ensure adequate oral absorption.

Q: Why do people with Celiac disease sometimes need Fitomenadiona?

A: Fitomenadiona is indicated for conditions that limit the absorption of Vitamin K, which leads to hypoprothrombinemia (low clotting factors). Celiac disease, along with other conditions like ulcerative colitis or intestinal resection, is listed as a cause of such malabsorption.

Q: What does 'K-dependent clotting factors' mean in relation to Fitomenadiona?

A: Fitomenadiona is essential for the body to produce 'K-dependent' coagulation factors, which include Factor II (Prothrombin), Factor VII, Factor IX, and Factor X. These proteins require Vitamin K to be chemically modified (activated) so they can function properly in the blood clotting cascade.

Q: What are the benefits of Fitomenadiona in people with malabsorption syndromes?

A: The medicine is indicated for treating a lack of prothrombin (hypoprothrombinemia) that results from conditions causing malabsorption of Vitamin K. By correcting this deficiency, the drug helps restore normal blood clotting capability.

Q: Does Fitomenadiona have any effect on blood pressure?

A: Brief hypotension (low blood pressure) and changes in heart rate (tachycardia) are noted as possible rare systemic adverse reactions, according to official safety information.

Q: What kind of medical monitoring is needed when taking Fitomenadiona?

A: The official administration guidelines state that medical monitoring is necessary to determine subsequent doses. This monitoring relies on checking the patient's Prothrombin Time (PT) and International Normalized Ratio (INR) response.

Q: Is there any difference in how different brands of Fitomenadiona work?

A: Regulatory bodies require that generic injectable products demonstrate bioequivalence to the original formulation. This ensures that the various brands contain the same active ingredient and are expected to work in essentially the same way.

Q: Is it possible to take too much Fitomenadiona?

A: Yes, official warnings exist regarding dose limitations. Administering doses higher than those recommended in neonates is associated with potential risks of adverse effects, including hemolysis, jaundice, and hyperbilirubinemia.

Advertisements

How should Fitomenadiona be stored and disposed of?

Storage and Handling Requirements

Fitomenadiona (Phytonadione) must be stored at Controlled Room Temperature (20°C to 25°C), with allowed excursions up to 30°C. The product must be kept from freezing to maintain its formulation integrity. Due to its sensitivity, the medicine must be protected from light and stored in its original, tightly closed container until use. Before use, the solution must be visually inspected and should be clear; any solution that appears turbid, cloudy, or separated must be discarded.

Stability and Disposal Instructions

If the injectable solution is diluted for infusion, regulatory documents require it to be used immediately or refrigerated and used within 24 hours. Keep this medicine out of the sight and reach of children. Any unused, expired, or compromised product must be properly discarded. Disposal should not involve throwing the medicine into wastewater or household trash; instead, consult a healthcare professional for guidance on safe disposal.

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

Available in countries:

Equivalent of Fitomenadiona found in:

A-Z Index: