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Флуконазол

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Флуконазол

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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 Флуконазол

What is Флуконазол? (Overview)

Property Description
Active ingredient Fluconazole
Form Tablet, oral suspension, sterile IV solution
Pharmacological class Triazole Antifungal Agent
General purpose Systemic defense against fungal infections
Origin Synthetic

Что такое Флуконазол и его класс (What is Fluconazole and its Class)

Флуконазол (Fluconazole) is the International Nonproprietary Name (INN) for a prescription synthetic triazole antifungal agent used for systemic treatment. It is the active ingredient in many popular antifungal medications and is clinically recognized for its reliable efficacy against a wide range of susceptible fungal pathogens.

This medication is entirely chemically synthesized, classifying it as a synthetic compound, and it is a single-ingredient product. Its categorization as a triazole antifungal is supported by its inclusion on the World Health Organization's List of Essential Medicines, confirming its global recognition as a crucial therapeutic agent for systemic fungal infections.

Состав и фармацевтические формы Флуконазола (Composition and Pharmaceutical Forms of Fluconazole)

The active ingredient is solely Fluconazole, a compound with the empirical formula C13H12F2N6O, prepared for both oral and intravenous administration, reflecting its versatile application.

Patients typically encounter Флуконазол as solid tablets or as a powder for oral suspension, both designed for administration by mouth. Additionally, it is manufactured as a sterile solution for intravenous use, an aqueous solution administered directly into the bloodstream, which is essential for patients unable to absorb medication orally.

Общее предназначение и принцип действия (General Purpose and Principle of Action)

The general purpose of Флуконазол is to provide a comprehensive systemic defense by halting the progress and spread of susceptible fungal pathogens inside the body.

This compound is considered a fungistatic agent; it works by blocking a key enzyme that fungal cells need to produce ergosterol, an essential component of their outer membrane. By preventing the synthesis of this vital material, the drug causes the fungal cell walls to become structurally compromised, thereby preventing the cells from growing and multiplying and allowing the patient’s own immune system to clear the infection.

Regulatory References

  1. WHO Essential Medicines List - Fluconazole
  2. Fluconazole Injection: MedlinePlus Drug Information
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What side effects are possible with Флуконазол?

Possible Side Effects and Safety Information

Fluconazole is generally well-tolerated, with common adverse reactions primarily affecting the gastrointestinal and nervous systems. These frequently reported events (in ge 1% of patients) include headache, abdominal pain, nausea, vomiting, diarrhea, and elevated liver enzymes (transaminases).

Serious and Clinically Significant Adverse Reactions

The most serious documented risks, though rare (in <0.1% of patients), involve the hepatobiliary, cardiovascular, and integumentary systems:

  • Hepatotoxicity: Serious hepatic toxicity, including cases of hepatic failure and necrosis, has been reported. These reactions are typically reversible upon discontinuation, but fatalities have occurred, primarily in patients with severe underlying medical conditions.
  • Cardiac Effects: Fluconazole has been associated with QT interval prolongation and very rare cases of torsades de pointes, which are life-threatening arrhythmias. Use is contraindicated with other medications known to prolong the QT interval and metabolized by the CYP3A4 enzyme.
  • Severe Skin Reactions: Exfoliative cutaneous reactions such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis (TEN) have been reported. Development of a rash, particularly in patients with systemic infections, requires close monitoring and potential discontinuation if the lesions progress.

Population and Safety Considerations

  • Pregnancy: Chronic, high-dose use (400–800 mg/day) during the first trimester has been associated with a distinct pattern of congenital abnormalities. Single-dose use has a lower, but still statistically noted, risk of spontaneous abortion and specific malformations. Effective contraception is advised for women of childbearing potential on high-dose, chronic therapy.
  • Renal and Hepatic Impairment: Caution is required in patients with pre-existing liver or kidney dysfunction. Dosage adjustment is necessary for patients with impaired renal function, and monitoring for hepatic injury is essential for those with liver disease.
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Overdose and Emergency Response

Overdose and When to Seek Help: Regulatory Core Information

The official regulatory documentation strictly defines the manifestations of Fluconazole overdose and the required emergency actions. Manifestations documented in the regulatory label include neurological disturbances such as hallucinations and paranoid behavior. Overdose may also lead to serious outcomes, including seizures and potential severe hepatotoxicity, which establishes the scenario as a serious, potentially life-threatening event.


Mandatory Emergency Action and Management

Seeking immediate medical attention is required for all suspected or confirmed overdoses, as mandated by prescribing information. Regulatory guidance states that emergency services should be contacted for severe symptoms like hallucinations or seizures.

No specific antidote is known for fluconazole overdose. Management is therefore focused on symptomatic treatment and supportive measures to maintain vital functions. Officially described procedural steps include the consideration of gastric lavage if ingestion was recent. Additionally, hemodialysis is an officially documented procedure that can significantly reduce the concentration of the drug in the plasma.

Hospital-based monitoring, including ECG monitoring, is required due to the potential for effects on cardiac rhythm, and both renal and hepatic function should be assessed.

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Therapeutic Uses of Флуконазол

What Флуконазол treats: Main Uses and Benefits

Fluconazole is commonly used to help with conditions presenting with systemic or localized discomfort caused by specific fungal pathogens. This medication is generally applied across domains where additional symptomatic support is needed to address a wide range of infections caused by Candida and Cryptococcus species.

The drug is commonly used for managing conditions characterized by periods of heightened symptoms, including candidemia (fungal infection in the bloodstream), disseminated candidiasis, and fungal infections of the central nervous system like Cryptococcal meningitis. It is also relevant for easing symptoms related to oral thrush (causing painful patches), esophageal candidiasis, and acute or recurrent vaginal candidiasis (causing itching and burning).

The medication provides supportive relief when symptoms interfere with routine activities. For instance, in managing mucosal discomfort, the medication helps improve day-to-day comfort during symptomatic periods. The application across different therapeutic contexts, spanning from severe systemic support to localized relief, assists with maintaining functional stability for the patient.


Quick Fact: Relief for Mucosal Discomfort

Fluconazole is commonly used to help manage symptoms related to inflammatory or irritative states, such as the intense itching and burning associated with recurrent vaginal and oral fungal infections. This application supports patients during episodes of heightened discomfort and assists with maintaining functional stability.

Regulatory References

  1. NIH MedlinePlus overview
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Eligibility and Restrictions for Use

Who can and cannot use Флуконазол? (Eligibility)

The eligibility criteria for using Флуконазол (Fluconazole) are strictly governed by official regulatory documents, defining specific populations who are approved for use and those who are absolutely prohibited.


Contraindications

Use of Флуконазол is prohibited (contraindicated) for individuals with a known hypersensitivity to fluconazole, its excipients, or other azole antifungal agents. It is also strictly contraindicated for patients concurrently taking specific medications known to prolong the QT interval (e.g., cisapride, astemizole, pimozide) due to the risk of serious cardiac issues.


️ Conditional Use & Restrictions

Population/Condition Regulatory Status
Renal Impairment Use requires mandatory dose adjustment based on the patient's renal function.
Hepatic Impairment Use requires caution and close monitoring of liver function.
Pregnancy Generally not recommended; use is restricted to severe or life-threatening infections when the benefit outweighs the risk.
Infants (< 6 months) Safety and efficacy have not been established for most indications.

Approved Age Groups

Флуконазол is officially approved for adults and for specific systemic and mucosal indications in pediatric patients generally ge 6 months of age. Use in older adults is approved but necessitates consideration of age-related decline in kidney function.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Fluconazole's official interaction profile is defined by its activity as an inhibitor of specific metabolic enzymes, particularly as a strong inhibitor of CYP2C9 and a moderate inhibitor of CYP3A4 and CYP2C19. This results in significantly increased plasma concentrations of many co-administered medicines that are metabolized by these pathways.


Formally Contraindicated Combinations

Specific drug combinations are strictly prohibited due to the risk of serious cardiac events (e.g., QT prolongation or Torsade de Pointes) resulting from the increased exposure of the interacting medicine. These formally contraindicated combinations include co-administration with Terfenadine, Cisapride, Pimozide, Quinidine, and Erythromycin.

Clinically Significant Pharmacokinetic Interactions

Co-administration with Warfarin increases the bleeding risk due to enhanced exposure. The exposure of Statins (HMG-CoA reductase inhibitors) is increased, raising the risk of myopathy. Immunosuppressants like Cyclosporine and Tacrolimus also have increased plasma levels. Conversely, co-administration with Rifampicin causes a documented decrease in Fluconazole plasma exposure due to metabolic induction.

Administration Timing Constraint

Regulatory documents specify an administration timing rule for Sucralfate, which must be taken at least 2 hours apart from Fluconazole to prevent reduced absorption of Fluconazole. No clinically significant interaction is documented with food.

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Mechanism of Action

Inhibiting the Fungal Ergosterol Biosynthesis Pathway

The action of Флуконазол is specific, selectively targeting the biological processes required for fungal cell integrity and multiplication. Its effect is primarily fungistatic, which involves the inhibition of fungal growth and cellular proliferation. The drug's mechanism centers on the targeted inhibition of lanosterol 14-alpha-demethylase (CYP51), an enzyme found exclusively in fungal cells. By blocking this enzyme, the drug prevents the production of ergosterol, the primary sterol component required to maintain the structural stability and fluidity of the fungal cell membrane.

Compromising Fungal Cell Structure and Replication

The resultant deficiency of ergosterol and the concurrent accumulation of toxic sterol precursors severely compromise the fungal cell membrane's function and structural integrity. This cellular damage impairs critical life processes, leading to the arrest of growth and replication (fungistasis), which promotes the clearance of the non-replicating fungal burden by the host's natural immune system.

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Dosage and Administration Information

Fluconazole is administered through two main official routes: oral (using tablets or suspension) and intravenous (IV) (using a sterile solution). The medication is designed for once-daily dosing across most maintenance regimens, and the daily dose remains the same when transitioning between the IV and oral forms.

The standard usage protocol often begins with an initial loading dose on the first day, typically calculated as double the subsequent once-daily maintenance dose. Maintenance doses generally fall between 50 mg and 400 mg per day, depending on the treatment plan, though a single 150 mg oral dose is utilized for specific acute conditions. The maximum daily dose for severe systemic use is up to 800 mg.

Treatment duration is highly variable, ranging from a single day up to several months for long-term suppressive therapy, continuing until official criteria for discontinuation are met. Oral forms can be taken without regard to food. The powder for oral suspension must be well shaken before measuring, and the intravenous solution must be infused slowly, not exceeding a rate of 200 mg per hour.

For specific patient groups, dose adjustments are mandated. For patients with impaired kidney function, the initial loading dose is given in full, but the subsequent daily maintenance dose must be reduced by approximately 50% if creatinine clearance is le 50 mL/min. Pediatric dosing is calculated using a weight-based regimen (mg/kg) rather than a fixed adult dose.

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Recent Clinical Evidence

Флуконазол: Recent Clinical Evidence

This overview describes the types of clinical studies that have been conducted for Fluconazole (Флуконазол) and what the research examined, providing context about the evidence landscape without offering treatment recommendations or individual predictions.


Evidence for Systemic Fungal Infections

Randomized Controlled Trials (RCTs) and comparative studies have extensively evaluated Fluconazole in hospitalized adults with severe fungal infections, such as candidemia (fungal infection in the bloodstream). Research examined key outcomes related to systemic or functional imbalance, including whether the fungus was cleared (mycological clearance) and all-cause mortality during the study period. Findings describe patterns observed when the medicine was studied as initial treatment or as step-down therapy in patients with susceptible Candida strains. However, evidence remains limited on its empirical use in critically ill, non-neutropenic adults.

Evidence for Central Nervous System and Mucosal Infections

Research has examined Fluconazole's use in Cryptococcal meningitis, primarily in HIV-infected adults. Studies used comparative trials, focusing on long-term consolidation and maintenance phases. Research highlights changes measured during the study period, indicating that high mortality rates were associated with Fluconazole monotherapy during the acute, initial phase.

For localized infections like oral thrush and esophageal candidiasis, clinical trials monitored clinical and mycological cure rates. Research describes patterns related to treatment-refractory (unresponsive) candidiasis in severely immunocompromised individuals and reports on the mechanisms of resistance.

Research Gaps and Uncertainty

The research provides insight into short-term changes but also highlights areas of uncertainty. Follow-up durations were limited for many indications, meaning long-term effects are not fully established. Comparative evidence is lacking for optimal treatment strategies against certain non-albicans Candida species. Additionally, data for certain groups remain insufficient, particularly regarding neurodevelopmental outcomes in very low birth weight infants beyond early childhood, and the long-term epidemiological effects of widespread use on antifungal resistance.

Key Studies & References

  1. Fluconazole: MedlinePlus Drug Information (General Indications and Safety)
  2. A meta-analysis of fluconazole for the prevention of invasive fungal infection in preterm infants
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Frequently Asked Questions (FAQ)

Common questions about Флуконазол (FAQ)

Q: Is Флуконазол used for skin infections?

Yes, official regulatory documents indicate that Phi луконазол is approved for treating certain fungal skin conditions. Specifically, it is indicated for conditions such as Dermatophytosis (which includes athlete's foot and ringworm) and Tinea Versicolor.

Q: Can Флуконазол affect sleep?

Regulatory reports on side effects indicate that Phi луконазол can indirectly affect the central nervous system. Somnolence, which means drowsiness or sleepiness, has been reported as an uncommon side effect in official product information.

Q: Is it normal to feel tired after taking Флуконазол?

Feeling tired or experiencing a lack of energy has been reported as an uncommon side effect in regulatory adverse reaction lists. The terms used in official documentation for this symptom are Fatigue and Asthenia (unusual tiredness).

Q: Does Флуконазол interact with common pain relievers?

Yes, Phi луконазол is known to interact with certain common pain relievers classified as non-steroidal anti-inflammatory drugs (NSAIDs). Regulatory labeling specifically mentions interactions with NSAIDs like celecoxib and naproxen, which may require careful monitoring.

Q: Is it safe to drink alcohol while taking Флуконазол?

Official information advises caution regarding liver function while taking Phi луконазол due to the risk of hepatotoxicity (liver damage). Official guidance related to liver risks is important context when making decisions about consuming alcohol.

Q: Is Флуконазол generally safe for people with liver conditions?

Official warnings state that the medication should be administered with caution to patients who have liver dysfunction. The use of the medication requires close monitoring for any signs of developing severe hepatic injury.

Q: How long does Флуконазол stay in the system after a dose?

The drug's elimination from the body is relatively slow. According to pharmacokinetics data in official labeling, the terminal plasma elimination half-life—the time it takes for half of the drug to be eliminated—is approximately 30 hours.

Q: Does Флуконазол affect birth control pills?

Regulatory drug interaction studies show that Phi луконазол can cause small and inconsistent increases in the plasma levels of hormones found in oral contraceptives. This means it may slightly affect how the body processes the hormones (like ethinyl estradiol) in the birth control pill.

Q: Can Флуконазол be used for fungal nail infections?

Yes, treating fungal nail infections is a recognized use for this medication. The official indications for Phi луконазол include the treatment of Onychomycosis, which is the medical term for fungal infection of the nails.

Q: What are the signs that Флуконазол is not working?

Regulatory bodies note that patients should be aware if symptoms of the infection do not improve or get worse during the course of treatment. This is the primary sign regulatory bodies identify for potential treatment issues.

Q: Can you drive after taking Флуконазол?

Regulatory documents advise patients to be cautious when driving vehicles or operating machinery. This warning is based on the fact that occasional side effects such as dizziness or seizures have been reported with Phi луконазол.

Q: Can Флуконазол be taken with herbal supplements?

Official regulatory documents generally advise that patients should discuss all other medications, including any herbal supplements, with their doctor. This is due to the potential for Phi луконазол to interact with other substances and alter their metabolism.

Q: Does Флуконазол interact with diabetes medication?

Yes, a documented interaction exists between Phi луконазол and certain oral medications for diabetes known as sulfonylureas (e.g., glipizide). Phi луконазол can inhibit the metabolism of these drugs, which may potentially lead to a decrease in blood sugar levels.

Q: Is Флуконазол used to prevent infections?

Yes, Phi луконазол is indicated for the prophylaxis (prevention) of certain fungal infections in specific high-risk patients. This is often recommended for individuals with compromised immune systems, such as those undergoing bone marrow transplantation or with prolonged neutropenia.

Q: Are allergies to Флуконазол common?

Severe hypersensitivity reactions, including a serious condition called Anaphylaxis, are considered rare. Regulatory reports indicate that these types of reactions have been reported rarely during the post-marketing experience of the drug.

Q: Is there a generic version of Флуконазол available?

Yes, the name Phi луконазол itself is the generic, non-proprietary name for the medicine. Official drug listings confirm that multiple manufacturers offer generic versions of the tablets and oral suspensions.

Q: How is Флуконазол eliminated from the body?

The drug is primarily cleared from the body through the urinary system. Official pharmacokinetic data shows that Phi луконазол is cleared mainly by renal excretion, with the majority of the dose passing into the urine as the unchanged, active drug.

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How should Флуконазол be stored and disposed of?

How to Store and Dispose of Fluconazole

Fluconazole tablets must be stored at Controlled Room Temperature, which is between 20°C and 25°C (68°F and 77°F). The container must be kept tightly closed to protect the medicine from moisture and heat. The sterile intravenous solution must not be frozen to maintain its integrity.

Stability and Disposal Rules

For the oral suspension, the reconstituted liquid is stable for 14 days when stored at or below 30°C; any unused portion must be discarded after this period. The medication must be stored out of reach and sight of children. Expired or unused fluconazole must be disposed of in accordance with all local and national regulations, and it should not be flushed down a toilet or poured into a drain to prevent environmental release.

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

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