Konakion

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Konakion

Method of action: Antihemorrhagics

Treatment option:

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 Konakion

Konakion is a specific pharmaceutical brand manufactured by Roche that contains the active ingredient phytomenadione, the synthetic form of Vitamin K1. This prescription-only (Rx) medication is clinically recognized for its critical function in maintaining the body's hemostasis (blood clotting).

Property Description
Active Ingredient Phytomenadione (Vitamin K1)
Form Injection or oral solution/drops
Pharmacological Class Anti-hemorrhagic agent (Vitamin K)
Common Use Treating and preventing bleeding disorders caused by Vitamin K deficiency
Manufacturer Roche

The drug is classified pharmacologically as an anti-hemorrhagic vitamin, which directly addresses excessive bleeding caused by a deficiency of clotting factors. Phytomenadione is essential because it acts as a cofactor in the liver's production of key coagulation factors II, VII, IX, and X. Without sufficient Vitamin K, the body cannot produce these functional clotting proteins, leading to an increased risk of hemorrhage.

The therapeutic use of phytomenadione is long-established and well-recognized. A key distinction of the Konakion brand is its specialized formulation, often utilizing a mixed-micelle system, which allows for stable administration via both an injectable solution and oral drops. This formulation is used for reversing severe bleeding risks associated with anticoagulant medications, a medically necessary intervention to quickly restore the body's natural ability to form clots.

What side effects are possible with Konakion?

Possible side effects and safety information

The safety profile of Konakion (phytomenadione) is established through official regulatory documentation, which organizes potential adverse reactions by both the frequency of occurrence and the affected organ system. The most serious officially documented risks are related to hypersensitivity reactions (anaphylaxis and anaphylactoid reactions), which are classified as rare but potentially fatal events, including reports of cardiac or respiratory arrest, particularly following intravenous administration.

Less severe adverse reactions are categorized by regulatory agencies based on the body system involved. These include Injection Site Reactions (pain, soreness, local irritation) and various Skin and Subcutaneous Tissue Disorders, such as pruritus, skin rash, and, rarely, delayed reactions like scleroderma-like lesions, which may manifest up to a year after administration. Systemic effects listed in regulatory documents include transient sensations like facial flushing or feeling warm, and less commonly, dizziness or altered taste.

Official safety statements also delineate important constraints for specific populations. For newborns and infants, there is a documented risk of hyperbilirubinemia (jaundice) and hemolysis, especially if the administered doses exceed recommended levels. Furthermore, regulatory labels state that reversing anticoagulant effects may restore the underlying risk of thromboembolism (clot formation) that existed prior to treatment with anticoagulants. Administration is contraindicated in individuals with known hypersensitivity to the drug's active substance or any of its excipients.

Overdose and Emergency Response

Overdose and when to seek help

Official regulatory documentation emphasizes that hypervitaminosis of Vitamin K1 (phytomenadione) is unknown and no specific toxic syndrome is formally documented in labeling. The primary clinical concern following over-administration relates to the pharmacological effects on the coagulation system.

Domain Official Regulatory Statements
Documented Overdose Presentations Hypervitaminosis of Vitamin K1 is unknown; no specific toxic syndrome is formally documented in regulatory labeling.
Physiological Systems Affected The coagulation system may be over-corrected, potentially restoring conditions that originally permitted thromboembolic phenomena. Jaundice or hyperbilirubinemia has been noted in newborns when recommended doses were exceeded.
Emergency-Response Statements Immediate medical attention is required for any suspected overdose. Management is supportive, focusing on the patient's clinical state.
Classification Official Regulatory Statements
Severity Classification The primary concern is not toxicity but the risk of over-correction, potentially leading to clotting hazards.
Overdose-context Constraints Large doses may lead to resistance to the subsequent re-introduction of anticoagulant therapy. No specific antidote is known for phytomenadione overdose.

Resulting Overdose Structure

  • Hypervitaminosis from phytomenadione is not a known toxic syndrome.
  • Over-administration risks restoring conditions for thromboembolic phenomena (clotting).
  • Immediate medical attention is required for suspected overdose or severe reactions.
  • Careful INR monitoring is mandated for management.

Connection to the overall overdose profile Regulatory information defines the overdose profile by the absence of a known toxic syndrome, shifting focus to the dangers of over-correction in anticoagulated patients. This clinical consequence, coupled with the lack of a specific antidote, necessitates that all suspected cases require immediate medical assessment and supportive management, including careful monitoring of the INR. Special caution is noted for neonates regarding hyperbilirubinemia risk and for elderly patients due to their sensitivity to anticoagulant reversal.

Therapeutic Uses of Konakion

The primary therapeutic use of Konakion is applied in contexts involving systemic imbalance related to severe blood clotting impairment. The therapeutic uses are applicable across conditions marked by increased physiological stress associated with coagulation impairment, which is commonly used in settings marked by temporary physiological imbalance. The therapeutic applications address specific conditions such as coagulation risk due to anticoagulants, managing active haemorrhage, and providing supportive care for hypoprothrombinemia caused by chronic conditions like malabsorption syndromes.


The medication is generally used to help manage severe bleeding risk and active bleeding episodes. This includes managing symptomatic manifestations when clotting factors are deficient, which may arise from medication over-effect or underlying liver and gastrointestinal disorders. The overall patient benefit is that it provides supportive relief that helps ease the overall symptom burden by assisting with the management of impaired clotting function.

Quick Fact: Support for Clotting Imbalance

Konakion helps maintain a sense of stability when clotting parameters are more noticeable, supporting patients during episodes where bleeding symptoms interfere with routine activities.

Eligibility and Restrictions for Use

Who Can and Cannot Use Konakion (Phytomenadione)


The eligibility for Konakion is strictly defined by regulatory authorities based on population characteristics and existing conditions.

Absolute Contraindication

The medicine is contraindicated for any individual with a known hypersensitivity or allergy to the active substance, phytomenadione, or to any of the specific excipients in the formulation.

Age and Comorbidity Restrictions

Konakion is approved for use in adults to manage haemorrhage risk due to coumarin anticoagulants and in neonates and infants for the prevention and treatment of Vitamin K Deficiency Bleeding (VKDB). Use in children (aged 1–18 years) generally requires consultation with a specialist, and older adults may be more sensitive to the reversal effects. For patients with severe hepatic impairment, careful monitoring of blood clotting parameters (International Normalised Ratio or INR) is mandated by regulators.

Physiological States and Limitations

Use during pregnancy is conditional; it is recommended only when the benefit to the mother outweighs the potential risk to the fetus. Konakion is not recommended for the prophylaxis of newborn bleeding when administered to the mother (pregnant or nursing) due to poor placental/milk transfer. Specific formulations, such as preservative-free versions, are recommended for neonates and pregnant women to mitigate formulation-dependent risks.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for Konakion (phytonadione) is characterized by a significant pharmacodynamic antagonism with other substances. Konakion directly counteracts the effect of coumarin-type anticoagulants, such as Warfarin, reducing their ability to prevent clotting. Administration of Konakion may induce temporary resistance to the anticoagulant, which can require using larger doses of the anticoagulant when therapy is later re-instituted, as detailed in regulatory labeling.

Documented Exposure and Efficacy Modifiers

Interacting Substance/Class Official Interaction Pattern
Anticonvulsants (e.g., Phenytoin, Phenobarbital) Can impair the action of Vitamin K1.
Bile Acid Sequestrants (e.g., Cholestyramine) Can limit Konakion's absorption, reducing exposure.
Antibiotics / Salicylates Associated with causing hypoprothrombinemia, which Konakion is indicated to manage.

Population-Specific Interaction Notes

Official documents note that elderly patients are more sensitive to the reversal of anticoagulation. Additionally, patients with severely impaired liver function require careful monitoring, as the effects of the medicine may be increased due to slower removal from the body. No mandatory timing separation rules for co-administration are explicitly listed in regulatory information.

Mechanism of Action

Enzyme Cofactor and gamma-Carboxylation of Clotting Proteins

The action of Konakion (Phytomenadione) is centered on its role as a necessary cofactor for the enzyme gamma-Glutamyl Carboxylase (GGCX) in the liver. This enzyme requires Phytomenadione to perform the critical process of gamma-carboxylation on specific precursor proteins, notably the procoagulant factors II, VII, IX, and X. This modification gives the proteins the ability to bind calcium, converting them from non-functional precursors (PIVKAs) into active, circulating coagulation factors.


Sustaining the Vitamin K Oxidation-Reduction Cycle

Phytomenadione participates directly in the continuous Vitamin K Cycle. As the active cofactor is consumed by GGCX, it becomes oxidized to Vitamin K epoxide. The enzyme Vitamin K Epoxide Reductase (VKORC1) is responsible for recycling this epoxide back to the active hydroquinone form, contributing to the sustained availability of the cofactor required for the production of functional coagulation factors.


Physiological Consequence on the Coagulation Cascade

This molecular cascade directly results in an increase in the potential for coagulation factor function. The release of newly synthesized and correctly matured Factors II, VII, IX, and X into the bloodstream enables the intrinsic and extrinsic coagulation pathways to proceed. This process is dependent on the time required for the liver to perform the full synthesis and release of the functional proteins, which is limited by the time required for protein synthesis.

Dosage and Administration Information

How to Use Konakion: Official Administration Guidelines

Konakion (phytomenadione) is administered via multiple approved routes, with the specific route and dosage dictated by the patient's condition and age group.


Administration Routes and Dosing

Condition / Age Group Standard Labeled Dose Approved Route(s) Frequency
Severe Anticoagulation Reversal (Adults) 5, mg to 10, mg Intravenous (IV) Single dose, may be repeated based on INR response.
Asymptomatic High INR (Adults) 0.5, mg to 2.5, mg Oral or IV Single dose, followed by INR monitoring.
Neonatal Prophylaxis (Healthy, Term) 1, mg (single dose) or 2, mg (repeated dose regimen) Intramuscular (IM) or Oral At birth (IM) or multi-dose oral regimen.

Procedural and Population-Specific Rules

Intravenous Administration The IV route is used when rapid effect is required, but the injection must be given slowly, not to exceed 1, mg per minute. The solution should be administered into the lower part of a running infusion (such as Sodium Chloride 0.9% or Dextrose 5%) but should not be pre-mixed with other drugs. The maximum recommended IV dose in a 24-hour period should not exceed 40, mg.

Pediatric and Elderly Use For neonates and infants, the lower-strength Konakion MM Paediatric solution is required, with IM or oral doses used for prophylaxis within one hour of birth. Elderly patients are generally more sensitive to the reversal of anticoagulation, and the dosage should be kept at the lower end of the recommended adult range to prevent over-correction.

Recent Clinical Evidence

Konakion: Recent Clinical Evidence

Konakion (Phytomenadione) is a formulation of vitamin K that is essential for the body's clotting system. The majority of recent clinical research continues to focus on its role in two main areas: the prophylaxis of Vitamin K Deficiency Bleeding (VKDB) in newborns and the reversal of excessive anticoagulation caused by Vitamin K Antagonists (VKAs, such as warfarin).


Efficacy in Newborn Prophylaxis

Studies consistently support that administering vitamin K at birth is a cornerstone for preventing VKDB, a potentially fatal bleeding disorder. Comparative studies have investigated different administration routes and dosing schedules:

  • Intramuscular (IM) Administration: A single intramuscular dose remains the gold standard, demonstrating high efficacy in preventing all forms of VKDB, including late-onset VKDB, by ensuring reliable and sustained levels of vitamin K.
  • Oral Administration: Oral regimens have been studied as an alternative. While effective in preventing classic VKDB (occurring in the first week of life), the success of oral prophylaxis against late-onset VKDB is highly dependent on adherence to multiple doses over the first month of life. Research indicates that oral protection can be unreliable in infants with underlying conditions like cholestasis (impaired bile flow).

Reversal of Excessive Anticoagulation

In adults, Konakion is used to address high International Normalized Ratio (INR) values in patients taking VKAs, which indicates a risk of bleeding. Clinical data supports the following findings:

  • Route of Administration: Intravenous (IV) administration has been shown to achieve the quickest correction of elevated INR values, with significant effects on prothrombin time observed within 4 to 6 hours. Oral administration is also effective for managing asymptomatic, non-life-threatening high INR values.
  • Safety Profile: The current formulation of Konakion, a mixed micelle solution, has been associated with a decrease in the frequency of severe hypersensitivity reactions (anaphylactoid reactions) sometimes reported with older, less-allergen-neutralizing formulations following intravenous administration.

Frequently Asked Questions (FAQ)

Common questions about Konakion (FAQ)

Q: How quickly does Konakion start working after it is administered?

A: Official research and product information indicate that the speed of action depends on the route of administration. Following an intravenous (IV) injection, significant effects on blood clotting parameters are generally observed within 4 to 6 hours. When administered orally, the expected reduction in the International Normalized Ratio (INR) is typically seen within 24 to 48 hours.


Q: Is Konakion used during pregnancy or while breastfeeding?

A: Regulatory information states that use during pregnancy is conditional; it is recommended only when the clinical benefit to the mother is judged to outweigh the potential risk to the fetus. Official documents describe that administration to nursing mothers at therapeutic doses is generally not expected to pose a risk to the infant, as only a small fraction of the active substance enters breast milk.


Q: Does alcohol consumption impact the effectiveness or safety of Konakion?

A: Official regulatory information does not explicitly state a direct interaction between alcohol consumption and Konakion. However, regulatory patient information advises that patients share information about alcohol consumption with their healthcare team, especially if the patient is breastfeeding.


Q: Is Konakion typically a short-term or long-term treatment?

A: Konakion is primarily used for acute medical needs, such as quickly correcting excessive anticoagulation or providing routine prophylaxis (prevention) for newborns. While it is not intended for chronic long-term use, some approved oral regimens for newborn prophylaxis may involve multiple doses administered over the first month of life.


Q: What information is available regarding Konakion's long-term safety?

A: The official safety profile notes that rare, delayed side effects can occur, such as scleroderma-like lesions, which have been reported to manifest up to a year after administration. The primary safety consideration is that reversing the effect of blood thinners may restore the patient's underlying risk of forming blood clots (thromboembolism).


Q: Are there specific patient groups where Konakion is less studied?

A: Regulatory documents indicate that the use of Konakion in children aged 1 to 18 years generally requires consultation with a specialist. This suggests that while it is an established treatment for newborns and adults, use within this older pediatric group is not as broadly studied as in the primary approved populations.


Q: How is the effectiveness of Konakion typically monitored by a healthcare professional?

A: The effectiveness of the medicine in adult patients is generally monitored by checking the patient’s blood clotting status. The key laboratory test used for this purpose is the International Normalized Ratio (INR), which helps assess if the clotting ability has returned to the desired range.


Q: What is meant by the 'half-life' of Konakion?

A: The half-life is a scientific measurement that indicates the time it takes for the concentration of the medicine in the blood plasma to decrease by half. Official documents state that the half-life of Konakion in adults is approximately 6 hours. This process is considerably slower in newborn infants.


Q: What is Konakion used for besides treating bleeding problems?

A: Konakion (phytonadione) is indicated to manage conditions known as hypoprothrombinemia, which is a deficiency in the blood clotting factors. This use covers bleeding risk caused by factors other than blood-thinning medications, such as malabsorption issues or diseases that affect Vitamin K levels.


Q: Is Konakion considered a blood thinner?

A: No, Konakion is classified as an anti-hemorrhagic agent or an anticoagulant reversal agent, meaning it works to restore the body's natural ability to form clots. Its function is to directly counteract the effects of certain blood thinners, specifically the Vitamin K Antagonists (VKAs) like Warfarin.


Q: What is the expected duration of Konakion’s effects in the body?

A: The effect on the coagulation system can last longer than the time the medicine remains in the plasma. Official product information indicates that the use of higher doses of Konakion may cause a temporary state of warfarin resistance for a week or more, which provides an indication of the potential duration of the systemic effect.


Q: Why is Konakion sometimes given for liver disease?

A: The liver is where the body creates essential clotting factors using Vitamin K. Konakion may be used to manage the risk of bleeding (coagulopathy) that results from the impaired synthesis of these clotting factors due to liver disease. Careful monitoring of clotting parameters is mandated for patients with severely impaired liver function.


Q: What should be done if a potential side effect is noticed?

A: Official documents describe that seeking medical attention immediately is advised if serious symptoms, an overdose, or an adverse reaction is suspected. For less severe symptoms or general concerns related to the medication, consulting a medical professional is the recommended action.


Q: Can Konakion cause drowsiness or affect my ability to drive?

A: Official safety information lists systemic effects such as dizziness and a temporary altered taste sensation. Drowsiness is not specifically named in the regulatory documents. Dizziness and other systemic effects listed in the safety profile are factors that healthcare providers consider when assessing a patient's fitness to drive or operate machinery.


Q: Is it normal to receive Konakion more than once?

A: Yes, it is normal under specific medical conditions. Regulatory dosing tables state that for adults, a single dose used to reverse anticoagulation may be repeated if blood tests indicate that the clotting ability has not been corrected. Additionally, oral prophylaxis for newborns is often prescribed as a multi-dose regimen.


Q: Is there any research evidence supporting the use of Konakion in emergency situations?

A: Yes, regulatory documentation supports the use of the intravenous (IV) route of administration explicitly for situations where a rapid effect on blood clotting is required. This covers its necessary use in emergency clinical scenarios where immediate management of bleeding risk is needed.


Q: Does Konakion treat the underlying cause of a deficiency?

A: Konakion provides the essential Vitamin K cofactor necessary to create functional clotting factors in the body, which addresses the immediate symptoms of the deficiency (bleeding risk). While Konakion addresses the symptoms of deficiency, it generally does not correct the underlying medical issue (such as malabsorption or liver failure) that caused the original deficiency.


Q: What are the signs that Konakion is working?

A: The primary indication that Konakion is having its intended effect is the return of the patient’s blood clotting ability. This is confirmed by a healthcare professional monitoring the patient’s International Normalized Ratio (INR) test, showing that the clotting time is normalizing.


Q: Is it true that Konakion is stored in the liver?

A: Konakion is essential for the liver's function in producing clotting proteins, and it is consumed in this process. However, the medicine has a relatively short half-life in the bloodstream and is not known to be stored in the body for long periods; it is actively cycled or excreted after its use.


Q: Are there any reported studies on Konakion's use in pediatric populations?

A: Yes, extensive clinical research has been conducted on Konakion's use in newborns and infants for the prevention of Vitamin K Deficiency Bleeding (VKDB). This area of research is a key part of the official evidence, and specific dosing information is available for all pediatric age groups.


Q: Is Konakion used to reverse the effects of all types of blood thinners?

A: No, Konakion is an antidote specifically for coumarin-type anticoagulants (or Vitamin K Antagonists, like Warfarin). Regulatory documents state that it does not neutralize the effect of other common classes of blood thinners, such as heparin.


Q: Can people with certain genetic conditions use Konakion?

A: Official information indicates that Konakion is known to be ineffective in treating hereditary hypoprothrombinemia, which is a genetic condition. However, it is generally used to treat acquired deficiencies and bleeding in newborns, which typically occur without a genetic cause.


Q: Can Konakion be given to patients who are unconscious?

A: Yes, the intravenous (IV) route is an approved method of administration. General safety guidelines advise that in clinical settings, medication should not be given by mouth to patients who are unconscious. Therefore, the injectable form is used when IV administration is required, and general safety guidelines advise against oral administration in unconscious patients.


Q: Does Konakion interact with high-dose vitamin E supplements?

A: Research suggests that high doses of Vitamin E may potentially counteract the effects of Vitamin K. Standard medical practice is for patients to disclose all supplements and vitamins, including high-dose Vitamin E, to their healthcare team for review.


Q: What are the main research themes investigated for Konakion?

A: Clinical studies and research are predominantly focused on two major areas: the prevention of Vitamin K Deficiency Bleeding (VKDB) in newborns and the effective reversal of excessive anticoagulation in adult patients taking certain blood thinners.


Q: What is a "PIVKA"?

A: PIVKA stands for Protein Induced by Vitamin K Absence or Antagonism. These are non-functional precursor proteins of clotting factors that accumulate in the body when there is insufficient Vitamin K to activate them. When Konakion is administered, these precursors are converted into active, functional clotting proteins.


Q: Does Konakion interact with certain antibiotics/salicylates or is it a treatment for them?

A: Konakion is generally indicated as a treatment in cases where the bleeding risk is caused by certain antibiotics or salicylates. These substances can sometimes lead to a deficiency of clotting factors, which Konakion is approved to manage by providing the necessary Vitamin K.

How should Konakion be stored and disposed of?

Official Storage and Disposal Requirements

This information details the mandatory handling, storage, and disposal requirements for Konakion (Phytomenadione) as defined by authoritative regulatory documents.

Requirement Category Official Regulatory Statement
Temperature & Freezing Store below 25, C and do not freeze.
Light Protection Must be kept protected from light and stored in its original packaging.
Stability Use immediately after opening; discard any unused portions. Do not use if the solution is turbid or past the expiration date.
Child Safety Keep out of the sight and reach of children.
Disposal Do not dispose of via household waste or wastewater. Return expired or unused medicine to a pharmacist for proper disposal.

Konakion must be stored in its original carton to ensure light protection and stability. The disposal rules are mandatory and designed to protect the environment.

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

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