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Anfotericina B Richet

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Medically reviewed

Rosario Oropesa

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 Anfotericina B Richet

Quick Facts

Property Description
Active ingredient Amphotericin B (Amfotericina B)
Form Lyophilized powder for injection (reconstituted solution)
Pharmacological class Systemic Antifungal Agent; Polyene Macrolide Antibiotic
Common purpose Treatment of serious fungal infections
Origin Natural Product (derived from Streptomyces nodosus)

What Type of Medicine is Anfotericina B Richet?

Anfotericina B Richet is a specific, prescription-only pharmaceutical preparation containing the active ingredient Amphotericin B (Amfotericina B), which is universally classified as a systemic antifungal agent. This category of medicine is specifically used to fight fungal infections that have spread throughout the body, known as invasive mycoses. Its chemical distinction is that of a polyene macrolide antibiotic. This drug is a recognized natural product, originally isolated from the bacterium Streptomyces nodosus.

Composition and Presentation: Amphotericin B Deoxycholate

The medicine is a single-ingredient product featuring Amphotericin B complexed with Sodium Deoxycholate. This specific composition is known as Amphotericin B Deoxycholate (ABD), representing the conventional formulation of the drug. Anfotericina B Richet, produced by Laboratorio Richet, is supplied as a lyophilized powder for injection that must be carefully reconstituted into a solution before administration. This presentation necessitates the intravenous route, ensuring the medication reaches the site of the systemic fungal infection directly.

What is the General Purpose of This Antifungal Agent?

The general purpose of this agent is to serve as a therapeutic tool against serious and potentially life-threatening fungal infections. The drug achieves this through a direct fungicidal action, meaning it actively kills the fungal cells. For example, it is used in treating established fungal infections in immunocompromised individuals. It works by binding to ergosterol, a molecule essential to the fungal cell membrane, which leads to the rapid disruption and destruction of the pathogen.

Regulatory References

  1. Amphotericin B Drug Monograph
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What side effects are possible with Anfotericina B Richet?

Possible Side Effects and Safety Information

The safety profile of Amphotericin B Deoxycholate (Anfotericina B Richet) is officially documented by regulatory authorities, distinguishing between expected, frequent adverse reactions and serious, less common events.


Frequency-Classified Adverse Reactions

Adverse effects are categorized by frequency of occurrence as classified in regulatory documents:

  • Very Common (occurring in ge 10% of patients): These highly expected effects include fever (pyrexia), chills/rigors, hypokalemia, and abnormalities in renal function tests such as azotemia and increased blood creatinine.
  • Common (occurring in ge 1% to < 10% of patients): Effects in this tier include anemia, headache, hypomagnesemia, nausea, and vomiting.

System-Organ Class and Serious Reactions

The primary safety concerns relate to the Renal and Urinary Disorders class, where nephrotoxicity leading to potentially permanent renal impairment or failure is recognized as a serious, dose-related risk. Other affected systems include Blood and Lymphatic System Disorders (e.g., anemia) and Metabolism and Nutrition Disorders (electrolyte imbalances). Serious adverse reactions explicitly documented in official labeling include anaphylaxis, cardiac arrest, and acute pulmonary edema.


Safety Constraints and Patterns

Regulatory documents highlight that infusion-related reactions (fever, chills) occur most frequently within the first hours of administration, often subsiding thereafter. In contrast, the risk of nephrotoxicity is officially stated to be associated with the cumulative dose and duration of treatment. Official safety constraints include a contraindication for known severe hypersensitivity to Amphotericin B and the requirement for a test dose prior to the first full therapeutic infusion.

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Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for an overdose of Amphotericin B Deoxycholate (Anfotericina B Richet) emphasizes the high potential for severe, life-threatening complications and the subsequent need for immediate medical intervention.

Overdose Scope

Domain Official Regulatory Statement
Documented overdose presentations Clinical manifestations may include Hypokalemia, Dysrhythmias, Jaundice, Oliguria, and Anuria (decreased or no urine output).
Physiological systems affected Overdose primarily affects the Cardiovascular and Renal systems, leading to the risk of Acute Renal Failure and Cardiopulmonary Arrest.
Emergency-response statements Therapy must be discontinued immediately, and a Poison Control Center should be contacted. Seek immediate medical attention for a suspected overdose.

Overdose Classifications (High-Level)

Classification Official Regulatory Statement
Severity classification Associated with potential for Permanent or Fatal outcomes, including Irreversible Nephrotoxicity.
Antidote availability No specific antidote is known for this overdose.
Management requirements Treatment is limited to Symptomatic and supportive treatment, with Hospitalization mandated for continuous cardiorespiratory and renal function monitoring.

Official Overdose Statements

  • Excessive administration carries the risk of permanent cardiac and cardiorespiratory arrest.
  • No specific antidote is known, making the management entirely reliant on supportive care.
  • The immediate required action is to discontinue therapy and seek immediate medical attention, requiring hospitalization for comprehensive physiological monitoring.
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Therapeutic Uses of Anfotericina B Richet

Anfotericina B Richet (Amphotericin B Deoxycholate) is an important therapeutic agent commonly used for managing severe, systemic fungal infections that present with noticeable physiological strain. Its application is relevant in clinical settings marked by increased discomfort and the need for timely support. This agent is relevant for conditions such as Aspergillosis, Cryptococcosis, Histoplasmosis, and Mucormycosis.


Main Therapeutic Focus

This medication is commonly used across conditions presenting with invasive systemic mycoses caused by a wide range of highly pathogenic fungi. The therapeutic support involves addressing the source of infection, which is relevant in contexts involving heightened systemic burden. For patients in these acute scenarios, it may provide support that helps ease the overall symptom burden and assists with symptomatic relief. It is applied in clinical settings that involve acute or unstable symptom patterns, often used when symptoms intensify and supportive relief is needed. This includes addressing symptom clusters that may become intense or disruptive, such as persistent, high-grade fevers and signs of organ or central nervous system involvement in critically ill, immunocompromised patient groups.

Quick Fact: Relief for Systemic Stress

This medication is commonly used to help manage the severe, widespread symptoms related to systemic imbalance, particularly in high-risk patients requiring immediate intervention.

Regulatory References

  1. NIH review on Antifungal Agents
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Eligibility and Restrictions for Use

Who can and cannot use Anfotericina B Richet?

The eligibility profile for Amphotericin B Deoxycholate (the active ingredient) is strictly defined by regulatory documents based on patient history and disease characteristics. This medication is reserved for the treatment of progressive and potentially life-threatening systemic fungal infections.


Populations Excluded or Contraindicated

The medicine is contraindicated in patients with a known history of hypersensitivity to Amphotericin B or any of its components. Additionally, regulatory labeling states the medicine must NOT be used for noninvasive forms of fungal disease, such as oral thrush, in patients with normal neutrophil counts.


Conditional Use and Age-Related Rules

Use in patients with reduced renal function is classified as conditional use and requires close clinical observation and frequent monitoring of kidney function.

For pregnancy, use is conditional, permitted only if the treating physician determines the benefit outweighs the risk to the fetus. During lactation, a decision must be made to either discontinue nursing or discontinue the drug due to unknown excretion.

Pediatric patients are generally considered eligible, as use is not expected to cause different problems than in adults. However, there is no specific comparative data documented for use in the elderly population.

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What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

Amphotericin B Deoxycholate (Anfotericina B Richet) has an officially documented interaction profile structured around specific pharmacodynamic reinforcement and administration constraints. The regulatory labeling does not classify any combinations as absolute contraindications, but interactions are noted to require caution due to enhanced toxicity or potentiated effects of the drug.

Interactions Affecting Organ Function

Co-administration with other nephrotoxic medications, such as aminoglycosides, cyclosporine, or pentamidine, may enhance the potential for drug-induced renal toxicity as documented in prescribing information. A similar effect on renal toxicity is noted with certain antineoplastic agents, including nitrogen mustard.

Interactions Related to Electrolyte Imbalance

Use with agents that potentiate potassium loss, such as corticosteroids, corticotropin (ACTH), and specific diuretics, may enhance Amphotericin B-induced hypokalemia (low potassium). This resulting hypokalemia may, in turn, potentiate the toxicity of digitalis glycosides and enhance the curariform effect of skeletal muscle relaxants.

Administration and Clearance Constraints

Regulatory information specifies constraints related to administration timing and clearance. The co-administration of Flucytosine may increase Flucytosine toxicity, potentially due to its impaired renal excretion and increased cellular uptake. Furthermore, acute pulmonary reactions have been reported when this medicine is administered during or shortly after leukocyte transfusions, necessitating the temporary separation of these infusions as far as possible.

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Mechanism of Action

Targeting the Fungal Cell Membrane

This mechanism centers on the molecule's high binding affinity for ergosterol, the primary sterol in the fungal cell membrane, which acts as the drug's key biological target. The binding leads to the rapid self-assembly of ion channels or pores that breach the cell's outer barrier, initiating a cascade of membrane permeabilization.

Cascade of Electrochemical and Oxidative Collapse

The formation of transmembrane pores results in the immediate, uncontrolled efflux of essential monovalent cations ( K^+) and protons ( H^+), causing the depolarization and catastrophic loss of the cell's electrochemical gradient. This primary fungicidal mechanism is supported by the drug's ability to induce Reactive Oxygen Species (ROS), which inflict secondary oxidative damage on the remaining intracellular components, contributing to the fungicidal outcome of the fungal organism.

️ Mechanism Selectivity and Immune Support

The drug's mechanism is defined by its differential binding selectivity between fungal ergosterol and mammalian cholesterol, where the varying affinity between the pathogen's sterol and host sterol establishes a constraint on its mechanistic action. Furthermore, the molecular action includes stimulating host phagocytic cells, which contributes to the systemic clearance of the destroyed fungal pathogens following the initial cell lysis.

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Dosage and Administration Information

How Anfotericina B Richet is Used: Administration Guidelines

Anfotericina B Richet, containing Amphotericin B Deoxycholate, is administered strictly via intravenous (IV) infusion only. Its use is limited to clinical settings under close medical observation, establishing it as a hospital-supervised therapy.


Dosing and Schedule

Administration begins with a mandatory initial test dose of 1 mg, which is infused over 20 to 30 minutes to gauge patient tolerance. Following the test, the initial daily dose is typically 0.25 mg/kg of body weight, administered once daily. The dose is then gradually increased daily until a maintenance range of 0.5 to 0.7 mg/kg is achieved, with the total daily dose not to exceed 1.5 mg/kg. If the treatment is interrupted for more than seven days, therapy must be restarted at the lowest initial dosage level.


Preparation and Procedural Rules

Procedural Requirement Standard Instruction
Route & Speed Slow IV infusion, typically over 2 to 6 hours (rapid infusion is avoided).
Reconstitution Vials (50 mg) must be reconstituted using Sterile Water for Injection (without bacteriostatic agent).
Final Dilution The reconstituted medicine must be diluted only using 5% Dextrose Injection; saline solutions are contraindicated.
Population Note The use of smaller daily doses (5 to 10 mg) is utilized when initiating therapy in patients with cardio-renal impairment.

These instructions define a controlled, standardized protocol for the administration and preparation of the medicine.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Anfotericina B Richet

Research for Anfotericina B Richet, which contains Amphotericin B Deoxycholate (ABD), has primarily focused on the clinical evaluation of severe invasive mycoses. The evidence base includes foundational studies and modern Randomized Controlled Trials (RCTs) where ABD often functions as a control or comparator against newer antifungal agents.

The research examined overall mortality and composite outcomes of Therapeutic Success, which includes measurements of patient survival and fungal clearance. Studies report how clinical status evolved in critically ill and immunocompromised patients, which make up the primary population studied.

ABD was also evaluated for use as empiric treatment—when a fungal infection is strongly suspected but not confirmed, particularly in febrile, neutropenic patients. Trials in this setting monitored outcomes related to changes in symptom activity, such as the pattern of fever, and a composite endpoint that includes measurements of survival.

While this formulation has a long history, evidence is limited in certain areas. Follow-up durations were often limited to the acute treatment phase, meaning long-term effects are not fully established. Comparative evidence is lacking against every current standard treatment, and results apply only to the specific populations studied, meaning subgroup findings remain uncertain.

Key Studies & References Amphotericin B - StatPearls - NCBI Bookshelf

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Frequently Asked Questions (FAQ)

Common questions about Anfotericina B Richet (FAQ)


Q: What should be monitored, and how often, when taking this medication?

According to official regulatory information, frequent monitoring of renal (kidney) function is recommended during treatment. Official product information notes that following the initial test dose, it is standard practice to monitor and record the patient's temperature, pulse, respiration, and blood pressure every 30 minutes for a period of 2 to 4 hours.


Q: What is the typical duration of treatment for systemic fungal infections?

Official product information indicates that the total dosage and duration required to eliminate specific systemic fungal infections are not fully defined in all cases. Prolonged therapy is typically necessary for effective treatment, and for some conditions, such as aspergillosis, treatment has been reported to last up to nearly a year.


Q: What should I do if I miss a scheduled dose?

Regulatory documents address the interruption of therapy. If the infusion is stopped for a period longer than seven days, the official guidance states that the protocol requires restarting treatment at the lowest initial dosage level before gradually increasing the amount again.

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How should Anfotericina B Richet be stored and disposed of?

Storage and Disposal of Anfotericina B Richet

Official regulatory guidelines define strict conditions for storing Anfotericina B Richet (Amphotericin B Deoxycholate) to ensure its integrity.


Storage Requirements

Product State Temperature Range Protection Requirement
Unopened Vial Refrigerated (2 C to 8 C) Protect from light
Reconstituted Solution Refrigerated (2 C to 8 C) Protect from light

The unopened vial must be kept in the refrigerator, protected from light. The reconstituted solution is stable for up to 7 days when refrigerated, but the final intravenous infusion solution must be used immediately after preparation. The product must not be frozen at any stage.


Disposal and Safety

All expired or unused medicine, including partially used vials, must be discarded according to official regulatory guidelines. The medication must be kept out of the sight and reach of children.

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

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