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Фосфомицин

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Фосфомицин

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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

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Overview of Фосфомицин

The following overview defines Фосфомицин, covering its classification, composition, and general purpose as a foundational component of antimicrobial therapy.

Property Description
Active ingredient Fosfomycin
Form Granules for oral solution, powder for intravenous infusion
Pharmacological class Antibiotic (Anti-Bacterial Agent, Miscellaneous group)
Origin Originally natural, now mostly synthetic

Фосфомицин: Definition and Classification as a Unique Antibiotic

Фосфомицин, known by its INN Fosfomycin, is an essential bactericidal antibiotic used to combat microbial growth and eliminate infections. It is classified as an Anti-Bacterial Agent and belongs to the miscellaneous antibiotics group because its chemical structure is distinct from other major antibiotic classes.

Chemically, the substance is defined as a phosphonic acid derivative with a unique epoxide structure. This molecule was originally discovered as a natural product from certain Streptomyces bacteria, but commercial production is now primarily synthetic. Its unique role as a bactericidal agent in its class is characterized by a distinct makeup that minimizes cross-resistance to many other conventional antimicrobial drugs.


Composition, Origin, and Available Forms

The medication contains the single active ingredient Fosfomycin, which is highly soluble and is typically formulated as salts, such as Fosfomycin tromethamine for oral administration or Fosfomycin disodium for intravenous use. The most common preparation for outpatient treatment is a sachet containing granules for an oral solution. For complex or systemic applications, the drug is also available as a powder for intravenous infusion. The availability of both the oral form and the parenteral formulation ensures flexibility for different clinical requirements.


General Purpose of Фосфомицин in Antimicrobial Therapy

The general purpose of Фосфомицин is to eliminate infections through a highly effective bactericidal action. It achieves this by directly and irreversibly blocking the first crucial step in the bacterial cell wall formation process. This distinctive mode of operation targets the initial building block of the bacterial structure, which is vital for its survival. The mechanism is fundamentally distinct from other antibacterial agents; the drug works differently than many others, making it a valuable alternative when fighting susceptible bacteria.

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What side effects are possible with Фосфомицин?

Possible Side Effects and Safety Information

The safety profile for Фосфомицин (Fosfomycin) is officially documented in government regulatory sources, classifying potential adverse reactions by frequency and the organ system affected. The most frequently observed events involve the nervous and gastrointestinal systems.

Frequency and Organ System Classification

Classification Examples of Documented Reactions
Common (ge 1/100 to <1/10) Headache, Dizziness, Diarrhoea, Nausea, Vulvovaginitis
Uncommon (ge 1/1,000 to <1/100) Vomiting, Abdominal Pain, Rash, Fatigue, Increased Transaminases

Adverse reactions are formally grouped by System-Organ Class, including Infections and Infestations, Nervous System Disorders, Gastrointestinal Disorders, and Skin and Subcutaneous Tissue Disorders.

Serious Adverse Reactions and Safety Constraints

The official labeling notes the possibility of rare but clinically significant events, which are generally classified as having a Frequency Not Known. These serious reactions include severe Immune System Disorders suchings as anaphylactic reactions (including shock) and angioedema. Furthermore, the potential for severe antibiotic-associated colitis (e.g., pseudomembranous colitis) is documented.

Mandatory safety constraints are defined for specific populations and conditions. The medicine is contraindicated in individuals with a known history of hypersensitivity to the active substance or excipients. Its use is also contraindicated in patients with severe renal impairment, typically defined as a creatinine clearance below 10 mL/min. Concomitant use with metoclopramide is noted as a safety consideration due to its potential to reduce Fosfomycin levels.

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Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documents define the overdose profile of Fosfomycin by documenting specific physiological and clinical manifestations that require immediate clinical monitoring.

Manifestation Cluster Officially Documented Findings (Regulatory Sources)
Neurological/Muscular Hypotonia (decreased muscle tone) and somnolence.
Physiological/Hematological Electrolytes disturbances (e.g., hypernatremia, hypokalemia, hypophosphatemia) and thrombocytopenia (low platelet count).
Sensory Impaired hearing and altered sense of taste (documented in oral overexposure).

If overexposure is suspected, emergency medical attention must be sought immediately. Regulatory authorities mandate that treatment should be strictly symptomatic and supportive. The patient must be monitored in a clinical setting following the event, with specific attention required for plasma/serum electrolyte levels due to the documented risk of imbalance. Management procedures officially described include rehydration, which is recommended to promote the urinary elimination of the active substance. For severe cases, regulatory information confirms that Fosfomycin is effectively cleared from the body by haemodialysis. The official guidance relies entirely on these supportive and clearance measures, as no specific antidote is listed.

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Therapeutic Uses of Фосфомицин

Фосфомицин (Fosfomycin) is commonly used to help manage certain bacterial infections, generally applied in therapeutic areas involving the urinary tract.


Management of Symptoms Related to Irritative States

This domain covers symptoms related to inflammatory or irritative states, such as painful or frequent urination, and other symptoms related to physical discomfort. Fosfomycin is commonly used across conditions presenting with acute episodes and conditions involving inflammatory or irritative processes. It provides supportive relief that helps patients cope more steadily with these noticeable and disruptive episodes. In contexts involving heightened systemic burden, the therapeutic use of fosfomycin remains a relevant application.

“It provides support that helps ease the overall symptom burden, contributing to improved comfort during periods of heightened symptoms.”

Quick Fact: Relief for Urinary Discomfort


Support for Increased Physiological Stress

This cluster relates to its use in scenarios involving increased physiological stress or conditions where symptoms may intensify temporarily. It is applied across domains where additional symptomatic support is needed for managing symptoms linked to organ-specific functional stress. It is considered relevant in clinical settings that involve acute or unstable symptom patterns, especially when conditions present with systemic or localized discomfort. This application helps ease the overall symptom load and supports general well-being during symptomatic phases.

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Eligibility and Restrictions for Use

Official Eligibility Rules for Фосфомицин

Regulatory documents define strict rules for who can and cannot use Fosfomycin.

Eligibility Status Population Group Condition/Limitation
Contraindicated Hypersensitivity Known allergy to Fosfomycin or its excipients.
Contraindicated Severe Renal Impairment Creatinine clearance CrCl < 10 mL/min or patients on dialysis.
Not Recommended Children < 12 years Safety and effectiveness are not established for the oral form.
Restricted Use Pregnant or Lactating Women Use is conditional and not recommended unless clearly needed; crosses the placenta/excreted in breast milk.
Restricted Use Renal Impairment (IV form) CrCl < 40 mL/min requires specific dose adjustment protocols.
Not Indicated Male Patients (Oral form) The oral form is indicated only for uncomplicated UTI in women and female adolescents.
Conditional Use (IV form) Cardiac/Hypertensive Patients High sodium content requires monitoring for fluid overload and hypernatraemia.

These eligibility rules reflect the standardized classifications used by regulatory authorities to define the safe scope of use, strictly excluding populations with high-risk conditions or insufficient data.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents describe specific interactions for oral fosfomycin primarily based on their effect on drug absorption and subsequent plasma and urinary concentrations.

Pharmacokinetic Interactions

Interacting Product Category Specific Examples Interaction Consequence Regulatory Action
Medicinal products that increase gastrointestinal motility (Prokinetics) Metoclopramide Significantly lowers serum and urinary concentrations of fosfomycin. Concomitant administration should be avoided.
Food Meal ingestion Delays and slightly decreases the absorption rate, lowering peak plasma and urinary levels. Timing constraint: The medicine is preferably taken on an empty stomach or approximately 2–3 hours after meals.

Other Co-administered Substances

Substance Interaction Consequence Regulatory Note
Cimetidine No clinically significant effect on the pharmacokinetics (absorption or elimination) of fosfomycin. No dose adjustment or timing constraint is necessary based on this interaction.

The overall interaction profile is structured around minimizing the reduction of systemic drug exposure. Regulatory guidance mandates that medicines that accelerate gastrointestinal transit, such as metoclopramide, be avoided due to the significant and undesirable decrease in fosfomycin concentration. The interaction with food results in a practical, timing-based constraint to ensure adequate drug absorption.

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Mechanism of Action

The pharmacological mechanism of Фосфомицин (Fosfomycin) is defined by its action as a bactericidal agent that halts the fundamental process of bacterial cell wall construction.


Blocking the Initial Step of Peptidoglycan Synthesis

This domain covers the primary molecular interaction: the irreversible disabling of the core enzyme responsible for cell wall precursors. The drug acts as an analogue of the natural substrate phosphoenolpyruvate (PEP) and forms a permanent covalent bond with the active site of the enzyme UDP-GlcNAc enolpyruvyl transferase (MurA). This immediate and irreversible blockade of MurA prevents the formation of the structural building blocks, triggering a molecular cascade that ensures the bacteria cannot assemble a protective outer layer.


Active Transport and Cell Lysis Cascade

Fosfomycin must be actively transported into the bacterial cytoplasm using the bacteria's own GlpT and UhpT nutrient transport systems, which it can access because of its structural mimicry. The subsequent lack of cell wall integrity reduces resistance to internal osmotic pressure, leading to the physical rupture and death (lysis) of the bacterial cell, the resulting physiological consequence.


Mechanism Limitations at the Transport Level

The drug’s reliance on the GlpT and UhpT transporters means that any natural or acquired mutations in these transporter genes can prevent the drug from entering the cell, rendering the cytoplasmic target (MurA) inaccessible. This resistance mechanism biologically constrains the mechanism's functional application.

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Dosage and Administration Information

Фосфомицин (Fosfomycin) is administered through two officially approved routes, establishing distinct protocols for its use: oral as a single-dose solution (Fosfomycin tromethamine) and intravenous (IV) infusion as a multi-dose powder (Fosfomycin disodium).

Administration Protocols

The oral regimen is typically a single 3 gram dose. For proper intake, the granules from the sachet must be completely dissolved in water before ingestion and must never be swallowed dry. Administration may occur without regard to food, though some protocols suggest intake on an empty stomach. This single administration defines the entire course of treatment for the approved oral use.

The intravenous protocol involves a multi-day course with a total daily dose typically ranging from 12 to 24 grams, administered in 2 to 4 divided doses. The powder requires both reconstitution and dilution before administration. Each dose is required to be given by slow intravenous infusion over a specific duration, which may be up to 60 minutes or longer for higher individual doses.

Population-Specific Use

Dose adjustment is required for patients with significant renal impairment (creatinine clearance < 40 mL/min), often involving a reduced maintenance dose or extended frequency. No dosage adjustment is specified for hepatic impairment. The standard adult dose is generally used for older adults, though caution is noted for higher dose ranges.

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Recent Clinical Evidence

Overview of Clinical Trials

Recent clinical research has focused on the role of fosfomycin in managing a variety of infections, particularly those caused by multidrug-resistant (MDR) organisms. In its oral form, fosfomycin is a recognized option for treating acute uncomplicated urinary tract infections (UTIs), where studies have found it to be comparable to other standard antibiotics in achieving both clinical and microbiological resolution.

Usage in Complex and Resistant Infections

Research involving parenteral (intravenous) administration of fosfomycin often evaluates its use in more complex scenarios, such as complicated UTIs, pneumonia, and bloodstream infections. Due to its broad activity against both Gram-negative and Gram-positive MDR bacteria, including those producing Extended-Spectrum Beta-Lactamase (ESBL), the drug is frequently studied as part of a combination therapy with other antibiotics.

Comparative and Safety Findings

Clinical trials have examined fosfomycin strategies against other oral agents for complicated UTIs. While some studies showed comparable clinical cure rates, the microbiological resolution rates have varied depending on the specific trial design and follow-up period. Regarding safety, studies suggest that intravenous fosfomycin is generally well-tolerated. However, protocols frequently specify monitoring of electrolytes, as imbalances such as hypokalemia or hypernatremia have been observed in some patient populations, particularly in those with pre-existing conditions.

Key Studies & References The Use of Intravenous Fosfomycin in Clinical Practice: A 5-Year Retrospective Study in a Tertiary Hospital in Italy

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Frequently Asked Questions (FAQ)

Common questions about Фосфомицин (FAQ)

Q: What kind of infections is Фосфомицин most commonly used for?

According to official regulatory documents, the oral form of Фосфомицин is primarily indicated for treating acute uncomplicated urinary tract infections (UTIs) in women. For more complex situations, the intravenous formulation has broader approved uses.

Q: Do people use Фосфомицин for things other than UTIs?

Yes. While the oral form is typically reserved for uncomplicated UTIs, a different, intravenous (IV) formulation of the medicine is approved for use in adults. This IV form can be used to treat complicated urinary tract infections (cUTIs) and other severe bacterial infections caused by susceptible organisms.

Q: Why is Фосфомицин often prescribed as a single dose?

The single-dose regimen is indicated in official documents for its approved use in acute uncomplicated UTIs in women. Clinical trials supporting this protocol found that repeating the daily dose did not lead to improved success compared to the single dose, according to regulatory summaries.

Q: Is Фосфомицин in the same class as penicillin?

No. Official classifications define Фосфомицин as an Anti-Bacterial Agent belonging to the miscellaneous antibiotics group. It is chemically a phosphonic acid derivative, meaning its structure and mechanism of action are distinct from those of penicillin and other major antibiotic families.

Q: How long does it typically take for Фосфомицин to start working?

Patient guidance from regulatory sources indicates that symptoms should begin to show improvement within two to three days after the single oral dose. If symptoms do not start to improve within this time frame, follow-up with a healthcare provider is generally advised.

Q: What does it mean if my symptoms don't improve after taking Фосфомицин?

Official patient information advises that if symptoms do not start to improve after two to three days, follow-up with a healthcare provider is generally advised. A lack of improvement may indicate that the infection is caused by bacteria that are not susceptible to Фосфомицин or that a different type of infection is present.

Q: Are there any long-term side effects associated with Фосфомицин use?

Regulatory documents note that long-term studies regarding side effects have not been conducted because the drug is intended for single-dose use for its approved indication in the oral form.

Q: Does Фосфомицин cause a yeast infection?

Official safety information lists vulvovaginitis as a common side effect of Фосфомицин. Vulvovaginitis is a term for inflammation of the external female genitals and vagina, which can be a symptom of a yeast infection (candidiasis).

Q: Does Фосфомицин cause interactions with common over-the-counter pain relievers?

The official product information primarily details interactions with motility agents like Metoclopramide and the effects of food. There are no specific interactions listed in the regulatory summaries for common over-the-counter pain relievers such as paracetamol or ibuprofen.

Q: Is there specific research showing how well Фосфомицин works compared to older treatments?

Research evidence for oral use in uncomplicated UTIs often indicates that the clinical and microbiological resolution rates are similar to those of other standard antibiotics. Studies confirm its unique mechanism of action, which can be effective against certain drug-resistant organisms.

Q: Why is the drug described as a broad-spectrum antibiotic in some sources?

Фосфомицин is considered broad-spectrum because official mechanism descriptions show it is effective against a wide range of bacteria. This includes activity against both Gram-negative and Gram-positive multi-drug resistant organisms, such as those producing certain resistance enzymes.

Q: What kind of evidence supports the single-dose treatment protocol?

The single-dose regimen for uncomplicated UTI is supported by clinical trials. These studies, as noted in regulatory precautions, showed that giving repeated daily doses did not improve clinical success but resulted in a greater incidence of adverse events compared to the single dose.

Q: What are the official guidelines regarding using Фосфомицин during pregnancy?

Regulatory labeling states that the medicine crosses the placental barrier. Because animal studies are not always predictive of human response, its use during pregnancy is conditional and should only be considered if clearly needed.

Q: Is it true that Фосфомицин is considered an older antibiotic?

Yes, official documents describe the medicine as a unique molecule that was originally discovered as a natural product from Streptomyces bacteria. Its original isolation from bacteria dates back to the 1960s.

Q: Can Фосфомицин be used to prevent infections?

The official regulatory labeling does not list the use of Фосфомицин for the prevention (prophylaxis) of infections. Its indicated use is for the treatment of established bacterial infections.

Q: Why do some people need a second dose of Фосфомицин?

The oral form is a single dose for uncomplicated UTIs. However, the intravenous (IV) formulation of Фосфомицин is used for more complex or systemic infections and is administered as a multi-day course with divided doses given daily.

Q: What are the signs that a side effect is serious and requires attention?

Regulatory information warns of rare, serious reactions. These include signs of anaphylactic reactions (such as severe dizziness, difficulty breathing, or swelling of the face/throat) and severe antibiotic-associated colitis (such as watery or bloody stools or fever).

Q: Do studies suggest Фосфомицин is less effective if taken with food?

Studies reviewed by regulatory bodies indicate that food ingestion delays and slightly decreases the rate and extent of drug absorption, lowering peak levels in the body. Official guidance often recommends taking it on an empty stomach to ensure adequate drug exposure.

Q: Does Фосфомицин interact with common supplements like iron or magnesium?

The official interaction profile primarily focuses on motility agents and food. No specific interactions are described in the summary of product characteristics for common mineral supplements like iron or magnesium.

Q: Is it possible to be resistant to Фосфомицин?

Yes, regulatory information describes documented mechanisms of bacterial resistance. Resistance can occur if bacteria develop a reduced ability to transport the drug into the cell or produce enzymes that inactivate the medicine.

Q: Can Фосфомицин treat infections that have already spread outside the bladder?

Yes, the intravenous formulation of the drug is approved for treating complicated urinary tract infections (cUTIs). This type of infection can involve organs outside the bladder, such as the kidneys (pyelonephritis).

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How should Фосфомицин be stored and disposed of?

How to Store and Dispose of Фосфомицин?

Regulatory authorities mandate specific storage and disposal rules for Фосфомицин (Fosfomycin) to maintain product stability and ensure public safety.


Official Storage Requirements

Storage Component Mandated Condition
Temperature Limit Store the product at or below 30, C; do not exceed this limit.
Protection Keep the medicine away from direct sunlight, heat, and moisture.
Packaging Store Фосфомицин in its original container (sachet or vial) until it is ready for use.
Prohibited Environment Do not freeze the product.

Stability and Child Safety

  • Stability After Preparation: The oral solution must be consumed immediately after reconstitution. Prepared intravenous solutions have a maximum stability of 24 hours when refrigerated.
  • Child Protection: The product must be stored out of the sight and reach of children.

Disposal Instructions

Expired or unused Фосфомицин must be disposed of according to local regulatory requirements. Medicines should not be discarded via wastewater or household waste to prevent environmental contamination.

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

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