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Aquamephyton

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Aquamephyton

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

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

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Overview of Aquamephyton

Quick Facts

Property Description
Active ingredient Phytonadione (Vitamin K₁)
Form Injectable aqueous colloidal solution, Tablet
Pharmacological class Hemostatics, Vitamin K Products
General purpose Restores the ability of blood to clot
Origin Synthetic analog of a natural vitamin

What Type of Medicine is AquaMEPHYTON?

AquaMEPHYTON is a prescription medication whose active substance is phytonadione, which is the International Nonproprietary Name (INN) for a synthetic analog of naturally occurring Vitamin K₁ (phylloquinone). This single-ingredient medicine is classified as a high-level hemostatic agent and is specifically identified as a Vitamin K product and an anticoagulant reversal agent. Phytonadione is essential for the body's normal blood clotting mechanism. This action of promoting coagulation is associated with its designation as a critical blood modifier agent.

Composition and Form: What is Phytonadione Made Of?

AquaMEPHYTON is primarily supplied as a yellow, sterile aqueous colloidal solution specifically formulated for parenteral administration (injection). This specific form is necessary because the active compound, phytonadione, is a fat-soluble vitamin and is naturally insoluble in water; the colloidal solution stabilizes the compound within a water-based system. Injectable preparations may contain benzyl alcohol as a preservative.

What is AquaMEPHYTON’s General Purpose?

The general purpose of AquaMEPHYTON is to restore the body’s ability to initiate and maintain hemostasis—the process of stopping bleeding—by promoting the formation of critical clotting factors in the liver. Phytonadione acts as an essential cofactor that enables the liver to complete the synthesis of four key blood-clotting proteins: Factor II (prothrombin), Factor VII, Factor IX, and Factor X. This synthesis of clotting factors is the primary role of Vitamin K₁ products. This mechanism makes its ultimate function to serve as an effective anticoagulant reversal agent and therapeutic agent for conditions where clotting factor production is impaired.

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What side effects are possible with Aquamephyton?

Possible side effects and safety information

The safety profile of Aquamephyton (phytonadione) is primarily defined by the potential for serious hypersensitivity reactions and specific constraints related to its administration and use in certain populations, as documented in official regulatory labeling.

Serious Adverse Reactions

The most critical safety concern involves fatal hypersensitivity reactions, including anaphylactoid reactions, shock, and cardiac or respiratory arrest. These severe events are of Incidence Not Known and have been primarily associated with the intravenous (IV) and intramuscular (IM) routes of administration, often occurring during or immediately after the injection. This highlights a key safety constraint related to the delivery method.

Less Frequent and Systemic Effects

Adverse reactions classified as Rare in regulatory documents include temporary events such as a feeling of uneasiness, dizziness, brief hypotension (low blood pressure), and dyspnea (shortness of breath). Reactions affecting the skin and subcutaneous tissue, such as scleroderma-like lesions and persistent, erythematous plaques, have been observed and are sometimes characterized by a delayed onset following repeated injections.

Population-Specific Safety Notes

Official labeling addresses specific constraints for infants and newborns. The presence of the benzyl alcohol preservative in some injectable forms has been linked to the potentially fatal “Gasping Syndrome,” necessitating the use of preservative-free formulations in this group. Furthermore, large doses of phytonadione in newborns have been associated with hyperbilirubinemia (jaundice) and hemolytic anemia. The label also notes that in patients with severe hepatic impairment, large doses may further depress existing liver function.

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Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documents define the overdose profile of AquaMEPHYTON primarily by the risk of acute, severe reactions and population-specific toxicities from excessive doses.


Documented Manifestations and Severe Outcomes

The most severe outcomes are associated with intravenous (IV) or intramuscular (IM) administration, which may lead to fatal hypersensitivity reactions resembling anaphylaxis, including shock, cardiac arrest, and respiratory arrest. Documented signs of severe reaction can include flushing sensations, dizziness, brief hypotension, rapid and weak pulse, and dyspnea. Furthermore, overzealous therapy carries the risk of inducing thromboembolic phenomena (excessive clotting).


Neonatal and Infant Considerations

In neonates and infants, administration of doses above recommended limits can result in dose-related toxicity such as hyperbilirubinemia, jaundice, and hemolysis. Of critical note is the risk of benzyl alcohol toxicity—the “gasping syndrome”—characterized by central nervous system depression and metabolic acidosis, particularly in premature infants.


Required Emergency Actions

Immediate medical attention must be sought for any suspicion of overdose or the onset of severe reactions. Regulators mandate that management involves symptomatic and supportive care. No specific pharmacological antidote is documented in the official labeling. For severe bleeding, interim use of whole blood or component therapy may be required while closely monitoring the International Normalized Ratio (INR).

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Therapeutic Uses of Aquamephyton

What Aquamephyton Treats: Main Uses and Benefits

Aquamephyton (phytonadione) is used for managing symptoms related to systemic imbalance in the blood clotting process, and is applied in addressing conditions where the functional stability of blood clotting is affected. This medication is relevant across two main therapeutic domains.

Acute Management of Bleeding Risk

This medication is commonly used in clinical settings where a patient experiences anticoagulation that presents with heightened symptoms due to blood-thinning medicines like coumarin or indanadione derivatives (e.g., warfarin). The core benefit supports the process of symptomatic relief of the heightened risk of hemorrhage indicated by an elevated International Normalized Ratio (INR) that requires symptomatic assistance. It provides support to manage or prevent symptoms related to heightened physiological activity, such as significant internal or external bleeding that can occur when the blood is too thin.

Prevention and Supportive Care

Aquamephyton is commonly used for hypoprothrombinemia (impaired clotting) that results from Vitamin K deficiency or conditions limiting its absorption. This use is considered relevant in newborns where it may be part of symptomatic management as a prophylactic measure to prevent Vitamin K-Deficiency Bleeding (VKDB). It also provides supportive benefit to adults with conditions that interfere with nutrient absorption, such as celiac disease or other malabsorption syndromes, where it contributes to easing the overall symptom load related to clotting during periods of increased physiological stress.


Quick Fact: Symptom Management Context
Primary Focus Conditions causing impaired blood clotting (hypoprothrombinemia).
Key Scenarios Urgent reversal of excessive blood thinners (warfarin/coumarin), routine care for newborns.
Patient Benefit Provides supportive relief when symptoms interfere with routine activities.
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Eligibility and Restrictions for Use

The eligibility for using AquaMEPHYTON (phytonadione) is defined by one absolute prohibition and several conditional limitations, according to official regulatory documents.


Eligibility Scope

Classification Population Rule (As Stated in Label)
Contraindicated Patients with a known hypersensitivity to phytonadione or any component of the formulation.
Allowed Adults with acquired hypoprothrombinemia; Neonates for prophylaxis and treatment of Vitamin K-Deficiency Bleeding (VKDB).
Use Not Established Pediatric patients from 6 months to 17 years have not had safety and effectiveness established for the injectable emulsion.

Eligibility-Related Restrictions

  • Neonates and Infants: Formulations containing benzyl alcohol preservative should be avoided due to the risk of serious adverse reactions, requiring the use of a preservative-free formulation if available.
  • Pregnant and Nursing Women: Use is permitted only if clearly needed, and a preservative-free formulation is recommended for administration during pregnancy and lactation.
  • Liver Disease: Repeated large doses are generally not warranted if the patient’s condition does not satisfactorily respond to the initial use, as this may indicate the underlying coagulation defect is unresponsive to Vitamin K.

These official regulatory statements define the boundaries for use, ensuring that specific populations are either excluded or administered the medicine only under strict formulation constraints.

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What should I know about interactions with other medicines?

Aquamephyton Interactions with other medicines and products

Aquamephyton (phytonadione, a form of Vitamin K), generally has limited significant interactions, but it is critical to be aware of potential complications, especially concerning medications that affect blood clotting.

Primary Interaction: Anticoagulants

The most important interaction involves oral anticoagulants, particularly warfarin. Aquamephyton directly opposes the mechanism of warfarin, which works by blocking Vitamin K’s ability to produce clotting factors. Administering Aquamephyton can reduce or reverse the anticoagulant effects of warfarin, potentially leading to a risk of thromboembolism (blood clots). The dosage of both medications must be carefully monitored by a healthcare professional, especially when starting or stopping either drug.


Other Potential Interactions

Certain classes of drugs may affect the absorption or metabolism of Vitamin K, altering its effectiveness:

  • Mineral Oil and Orlistat: These agents can decrease the absorption of fat-soluble vitamins, including Vitamin K, from the gastrointestinal tract, potentially reducing the effectiveness of oral Aquamephyton.
  • Broad-Spectrum Antibiotics (e.g., Cephalosporins): These medicines can disrupt the normal gut flora responsible for synthesizing some forms of Vitamin K, which may be relevant in patients with poor dietary intake. However, this is generally less significant with parenteral (injected) Aquamephyton.
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Mechanism of Action

Molecular Cofactor for Enzyme-Mediated Protein Activation

The mechanism of phytonadione (Vitamin K1) is defined by its role as a necessary cofactor that directly enables the liver to activate proteins essential for coagulation. The mechanism acts within liver cells, targeting the enzyme gamma-Glutamyl Carboxylase (GGCX). Phytonadione, in its reduced form, serves as the essential cofactor that permits GGCX to perform a critical chemical modification: the addition of a carboxyl group to the inactive precursors of clotting factors, specifically Factors II, VII, IX, and X.

Systemic Restoration of Coagulation Potential

This molecular modification initiates the entire cascade required to produce functional coagulation agents. The drug provides substrate to rapidly restore the Vitamin K Cycle—the metabolic process that recycles Vitamin K back into its active form. The modification generates Gla residues on the proteins, structurally enabling them to bind calcium ions ( Ca^2+). This Ca^2+-binding capacity is the final step necessary for the factors to engage and trigger effective coagulation. The resulting increase in functional factors supports the blood's intrinsic capacity for hemostasis, a physiological process constrained by the hours required for protein synthesis and secretion from the liver.

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Dosage and Administration Information

Administration Routes and Conditions

The administration of Aquamephyton (phytonadione) is guided by specific procedural instructions regarding route, preparation, and rate of delivery. The medicine is primarily delivered via parenteral routes, including subcutaneous (SQ), intramuscular (IM), and intravenous (IV) injection. The subcutaneous route is the preferred method of administration when feasible. The oral tablet form of phytonadione is also an approved route for specific uses.

Official Dosing and Frequency Patterns

For the treatment of hypoprothrombinemia in adults, a single parenteral dose typically ranges from 2.5 mg to 10 mg, with higher amounts, up to 50 mg, utilized in more severe presentations. This acute, short-term use pattern allows the dose to be repeated after an interval of 6 to 8 hours only if the patient’s coagulation status, as measured by the International Normalized Ratio (INR), has not adequately improved. When administered intravenously, the solution requires dilution with approved fluids like 0.9% Sodium Chloride Injection and must be injected very slowly, with the rate not exceeding 1 mg per minute.

Population-Specific Use

For newborn prophylaxis against Vitamin K-Deficiency Bleeding, a standardized single dose of 0.5 mg to 1 mg (IM or SQ) is administered shortly after birth. For preterm infants weighing less than 2.5 kg, a lower, weight-adjusted dose is typically utilized.

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Recent Clinical Evidence

Research Evidence / Overview of studies for Aquamephyton


Evidence for Urgent Anticoagulation Management

Research has explored the use of Aquamephyton in adults who have experienced excessive blood thinning due to medicines like warfarin, in research contexts involving fluctuating or unstable symptoms related to clotting. Studies primarily monitored the International Normalized Ratio (INR) biomarker, examining its short-term change within 24 hours after administration. Findings from various trials described patterns related to this shift. Evidence for definitive patient-important outcomes—such as long-term survival—was limited and heterogeneous. This is because available research relies on small, modest trials, making it challenging to draw universally certain conclusions about patterns related to these specific endpoints.


Evidence for Preventing Newborn Bleeding (VKDB Prophylaxis)

The evidence related to the preventive use of Aquamephyton in newborns is based on decades of large-scale national and international surveillance studies. This research tracked the occurrence of Vitamin K-Deficiency Bleeding (VKDB) in infants. Historical research shows patterns related to a low incidence rate of all forms of VKDB following the introduction of routine prophylaxis. Studies monitored this condition over long-term follow-up periods extending up to six months. The high certainty level is derived from the historical shift in incidence rates tracked by global health surveillance.


What Remains Uncertain and Areas for Future Research

For urgent anticoagulation reversal, comparative evidence is lacking from large-scale randomized trials powered to measure major clinical endpoints like functional recovery. The evidence quality varies across studies, and findings were mixed when comparing Aquamephyton to other reversal agents. For newborn prophylaxis, a point of regulatory discussion is the evidence comparing the outcomes of different administration routes (e.g., single-dose oral regimens versus injectable regimens) in preventing late-onset VKDB. Data for certain administration groups remain insufficient to draw firm comparative conclusions about long-term outcomes.

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Frequently Asked Questions (FAQ)

Common questions about Aquamephyton (FAQ)

Q: How long does the effect of Aquamephyton last after it's administered?

Official product information describes the time required for the body to respond to the medicine. For the intravenous injection, the initial action is generally detectable within one to two hours. Clinical results show that bleeding is generally observed to be controlled within three to six hours, with a normal coagulation measure often seen in 12 to 14 hours.


Q: What happens if someone misses a scheduled dose of Aquamephyton?

Regulatory patient guidelines do not provide specific instructions for managing a missed dose. Instead, official patient information directs the user to contact their healthcare provider or pharmacist for guidance if a scheduled dose is missed.


Q: Is there a generic version of Aquamephyton available?

Aquamephyton is the brand name for the active ingredient phytonadione, which is a synthetic form of Vitamin K1. According to regulatory records, generic formulations of phytonadione injection are available on the market.


Q: Does Aquamephyton have any warnings for people with heart issues?

The official labeling includes warnings regarding the potential for serious hypersensitivity reactions, which may involve cardiovascular events such as cardiac arrest and shock. These specific risks are detailed in the warnings section of the product information.


Q: Why is the drug required to be protected from light?

Official storage guidelines mandate that Aquamephyton be protected from light at all times. This is because the active substance, phytonadione, is chemically sensitive and can be quickly degraded by exposure to light, which could affect its intended performance.


Q: What makes Aquamephyton a prescription-only medicine?

Aquamephyton is classified as a prescription-only medicine because its use is intended for serious, physician-diagnosed conditions like coagulation disorders. Due to the need for professional diagnosis, administration, and careful patient monitoring, the drug requires supervision by a healthcare professional.


Q: Is there an oral liquid form of Aquamephyton available?

The drug is officially supplied as an injectable solution, and the active ingredient is also available as an oral tablet form under a different brand name. An official stand-alone oral liquid formulation of Aquamephyton is not listed on the product label.


Q: What are the official sources describing the drug's safety profile?

The most authoritative sources for the drug’s safety information come directly from government health agencies. These include the official Prescribing Information (such as the FDA Package Insert) and the European Summary of Product Characteristics (SmPC), as well as publications from other national regulatory bodies.


Q: How quickly does Aquamephyton start to work?

Studies and official product information indicate the medication's effect starts quickly after administration. Following an intravenous injection, the initial coagulation effects are generally measurable within one to two hours, and improvement in the International Normalized Ratio (INR) is typically seen within one to eight hours.


Q: What are the common side effects people report for Aquamephyton?

The official label notes that certain systemic effects, such as brief dizziness, flushing, or temporary low blood pressure, have been reported, though these are described as rare. Separately, serious, potentially fatal hypersensitivity reactions have also been reported, but their overall incidence is not known.


Q: Are there any long-term concerns about using Aquamephyton?

Regulatory documents report that adverse skin reactions have been observed in some cases. These reactions, which can include delayed, persistent, or scleroderma-like lesions, have been associated with repeated injections of the medicine.


Q: Are there any known food or supplement interactions with Aquamephyton?

Official interaction information specifies that certain products may affect the absorption of the oral form of the medicine. Specifically, agents like mineral oil and the medicine orlistat may reduce the amount of the drug absorbed in the digestive tract.


Q: What kind of monitoring is typically done when a person is treated with Aquamephyton?

Regulatory information indicates that monitoring the patient's coagulation status is an important aspect of treatment. The International Normalized Ratio (INR), which measures how long it takes for blood to clot, is regularly checked, typically six to eight hours after administration, to assess the medicine’s effectiveness.


Q: What does 'reversal of anticoagulant effects' mean in simple terms for Aquamephyton?

Aquamephyton works to counteract the effects of certain blood thinning medicines, such as warfarin, by helping to restore the blood's natural ability to clot. However, the label warns that careful dosage management is needed, as excessive reversal could potentially restore conditions favorable to unwanted blood clot formation.


Q: Do studies show Aquamephyton helps with certain types of internal bleeding?

Official indications state that Aquamephyton is used to treat bleeding resulting from a faulty formation of blood clotting factors in the body. Its indication is tied to the underlying cause of the bleeding—such as Vitamin K deficiency—rather than on the specific anatomical location of the bleeding.


Q: Does the efficacy of Aquamephyton change based on the route of administration?

Efficacy is observed across the various administration routes, but the onset of action may vary. For example, the effect of the intravenous solution is detectable within one to two hours, while the effect of the oral tablet generally begins later, occurring within six to ten hours.

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How should Aquamephyton be stored and disposed of?

Storage and Disposal of AquaMEPHYTON (Phytonadione)

AquaMEPHYTON (phytonadione injectable emulsion) must be stored at 20°C to 25°C (68°F to 77°F), which is Controlled Room Temperature. Permitted excursions range from 15°C to 30°C (59°F to 86°F).

The product must be protected from light and stored in its original carton until the time of use. It is mandatory to not freeze the medicine, as this can cause the emulsion to separate. As with all medications, AquaMEPHYTON must be kept out of the reach of children.

For disposal, unused or expired AquaMEPHYTON should be discarded safely. The official labeling directs consulting a pharmacist or local waste disposal company for proper instructions.

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

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