Флуконазол-OBL

Quick links

Choose a section

Quick links to important sections

Advertisements

Флуконазол-OBL

Advertisements

Overview of Флуконазол-OBL

1. Флуконазол-OBL: Identity and Pharmacological Class

Флуконазол-OBL is a synthetic medicinal product classified as an azole antifungal agent, belonging to the triazole family. This classification establishes its fundamental purpose as a targeted intervention against the growth and spread of fungal pathogens. The medication is a prescription-only product intended for systemic antifungal therapy, functioning as a triazole derivative.

The active ingredient in this medication is Флуконазол (Fluconazole), presented as a monopreparat, containing a single therapeutic substance. The triazole structure of Fluconazole is characterized by its selectivity and high bioavailability, which facilitates absorption and distribution throughout the bloodstream.


2. Active Ingredient, Composition, and Origin

The product's core is the synthetic active ingredient, Флуконазол, combined with necessary excipients to create oral pharmaceutical forms or a sterile aqueous solution for infusion. As a synthetic compound, its composition is designed for consistent purity and therapeutic action.

This medication’s general purpose is to suppress the infectious fungal population. Its mechanism involves the selective inhibition of an enzyme crucial for fungal cell membrane integrity, thereby halting the organism's growth. This specific mechanism is the primary driver of its therapeutic effect against susceptible fungi.


3. Available Forms for Systemic Action

Флуконазол-OBL is manufactured in multiple presentations, including tablets, capsules, powder for suspension, and a solution for infusion. The availability of both internal (oral) and parenteral (infusion) forms indicates that the drug is designed for systemic use, providing flexible delivery options for various patient groups, including adults and children.

The existence of these distinct forms ensures that the active substance can be administered to achieve the necessary concentration of Флуконазол in the tissues. This dual-route capability allows for the management of fungal infections across different clinical requirements, from routine cases to those requiring intensive care.

Regulatory References

  1. Fluconazole on WHO Essential Medicines List
  2. EMA review of Diflucan (fluconazole)
Advertisements

What side effects are possible with Флуконазол-OBL?

Possible Side Effects and Safety Information

The safety profile of Флуконазол (Fluconazole) is organized by government regulatory bodies using standardized frequency classifications and System-Organ Class (SOC) groupings. The majority of documented adverse reactions fall into the Common and Uncommon categories.

Common adverse reactions (occurring in 1 to 10 out of 100 patients) generally involve the Gastrointestinal System, presenting as nausea, diarrhoea, vomiting, or abdominal pain, alongside Headache and elevations in liver enzymes (ALT, AST). Uncommon effects may include seizures, vertigo, insomnia, cholestasis, or hepatitis.

Rare adverse reactions (occurring in 1 to 10 out of 10,000 patients) are clinically significant and involve serious systemic events. These include life-threatening conditions such as Hepatic Failure and specific Cardiac Arrhythmias (e.g., QT interval prolongation and Torsade de Pointes), which require caution in individuals with pre-existing risk factors. Severe Cutaneous Adverse Reactions (SCARs), such as Stevens-Johnson Syndrome, are also documented in the rare classification, along with serious blood disorders like agranulocytosis.

Safety constraints noted in official prescribing information address the need for careful liver function monitoring throughout treatment, especially in patients with underlying hepatic impairment. Additionally, the label requires consideration for dosage adjustment in patients with Renal Impairment due to the medicine's clearance pathway. The official documents note that most hepatic events have been observed to be reversible upon discontinuing the medication.

Advertisements

Overdose and Emergency Response

The official regulatory profile for Флуконазол-OBL overdose is defined by specific neurological and cardiac risks. Overdose has been formally documented as accompanied by Central Nervous System (CNS) effects, including hallucination and paranoid behavior.

The high systemic concentration of the drug associated with overdose carries the potential for severe cardiovascular complications, such as QT interval prolongation and the life-threatening arrhythmia Torsade de pointes (TdP). Further severe outcomes reported in regulatory documents include seizures, collapse, and difficulty breathing.


Required Emergency Actions

In the event of suspected overdose, immediate medical attention is required as mandated by official guidance. Urgent contact with emergency services is necessary if the person exhibits critical symptoms like seizures, collapse, or difficulty breathing, as stated by national health authorities.

No specific antidote for Fluconazole is documented in regulatory labeling. Management consists of symptomatic treatment and supportive measures, with gastric lavage available if deemed clinically indicated. The drug is primarily cleared by renal excretion, a factor relevant to the potential for prolonged exposure in patients with impaired kidney function. Hemodialysis is documented as a procedure that can significantly aid elimination, reducing plasma levels by approximately 50% over a three-hour session.

Advertisements

Therapeutic Uses of Флуконазол-OBL

What Флуконазол-OBL Treats: Main Uses and Benefits

Флуконазол (Fluconazole) is used for the systemic control of fungal pathogens, providing therapeutic support across several domains where fungal growth leads to noticeable patient discomfort or illness. The medication may be part of symptomatic management for conditions such as systemic candidiasis, cryptococcal meningitis, recurrent vaginal candidiasis, oral and esophageal thrush, and extensive dermatomycoses (such as tinea infections).

This antifungal is applied in clinical settings marked by heightened patient distress caused by serious, deep-seated infections. For patients in critical care, the primary therapeutic benefit is to support the management of the disseminated infection, which may assist with maintaining functional stability.

For more common occurrences, the drug helps address symptom clusters that may become intense or disruptive, such as the severe itching, pain, soreness, and difficulty swallowing that create noticeable interference with daily stability. This use may support improved day-to-day comfort and can assist patients in coping more steadily with difficult episodes.

“This medication is commonly used in contexts where short-term symptomatic assistance is needed, providing support that helps ease the overall symptom burden.”


Quick Fact: Relief for Widespread Fungal Symptoms
Флуконазол may be considered relevant in clinical scenarios where systemic support is appropriate for managing invasive fungal diseases or recurrent mucosal infections where functional stability becomes affected.

Regulatory References

  1. NIH MedlinePlus overview
Advertisements

Eligibility and Restrictions for Use

Who Can and Cannot Use Флуконазол-OBL? — Official Regulatory Information

Official government regulatory information establishes specific criteria for patient eligibility and non-eligibility for this medicine, grounded in absolute contraindications and population-specific warnings.

Eligibility Status Patient/Condition Restriction Context
Contraindicated (Must Not Use) Known hypersensitivity to fluconazole or other azole derivatives. Exclusion is absolute due to allergy risk.
Contraindicated (Must Not Use) Concurrent use of specific CYP3A4-metabolized drugs. Drugs known to prolong the QTc interval (e.g., cisapride, pimozide, erythromycin) must be strictly avoided due to serious cardiac risk.
Use with Caution Renal Impairment (Kidney Dysfunction). Eligible for use, but requires dose adjustment for multiple-dose regimens to prevent accumulation.
Use with Caution Hepatic Impairment (Liver Dysfunction). Eligible, but requires caution due to the risk of serious liver toxicity; liver function should be monitored.
Not Recommended Pregnancy (especially first trimester, chronic high-dose). Generally avoided; use is only permitted for severe or life-threatening infections when benefits outweigh the significant potential fetal risk.
Not Recommended Rare hereditary sugar malabsorption disorders. Patients with hereditary fructose intolerance, glucose-galactose malabsorption, or similar conditions must avoid oral forms containing sucrose or lactose excipients.

Eligibility extends to adults and children aged 6 months and older for most indications, with specific dosing for pediatric populations down to neonates. Older adults without significant renal impairment may receive standard dosage.

Advertisements

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Fluconazole is primarily defined by its effect as an inhibitor of drug-metabolizing CYP enzymes, specifically CYP2C9, CYP3A4, and CYP2C19. This pharmacokinetic mechanism often leads to increased plasma concentrations (exposure) of co-administered medicines that are substrates for these enzymes, such as certain statins, benzodiazepines (e.g., Midazolam), and immunosuppressants (e.g., Tacrolimus, Cyclosporine).

Formally Contraindicated Combinations

Official regulatory documents classify certain co-administrations as contraindicated due to the high risk of serious adverse events, including QTc interval prolongation and Torsades de pointes. These prohibited combinations typically include substances whose metabolism is significantly impacted by Fluconazole and pose a cardiac risk, such as Cisapride, Astemizole, Pimozide, and Quinidine. Erythromycin is also listed as contraindicated. Co-administration of Terfenadine is restricted to Fluconazole doses below 400 mg daily.

Other Documented Interactions

Official labeling notes interactions that can alter drug exposure in both directions. For instance, the co-administration of Rifampicin can decrease fluconazole plasma levels. Conversely, Fluconazole may enhance the effect of Warfarin, resulting in an officially documented increase in Prothrombin Time (PT). Interactions with food are not considered clinically significant.

Advertisements

Mechanism of Action

Enzyme Inhibition and Cell Compromise

This medication works by selectively inhibiting the fungal enzyme 14alpha-lanosterol demethylase (CYP51) . This enzyme is a critical part of the ergosterol biosynthesis pathway; ergosterol is the main sterol required for constructing the fungal cell membrane.

The inhibition of CYP51 halts the production of ergosterol and simultaneously causes the accumulation of toxic methylated sterol precursors within the cell. This cascade results in a fundamentally compromised and structurally unstable fungal cell membrane. The damaged membrane can no longer regulate permeability or transport, leading to the disruption of cellular integrity and function. The resulting physiological state is characterized by impaired fungal growth and replication, which directly relates to the drug's intended pharmacodynamic activity.

Advertisements

Dosage and Administration Information

How to Use Флуконазол-OBL: Official Administration Guidelines

Флуконазол-OBL (Fluconazole) is provided for systemic administration via oral intake (capsules, tablets, or suspension) or intravenous (IV) infusion. The pharmacokinetic properties are comparable regardless of the route used.

Dosing and Frequency Principles

Feature Official Labeled Instruction
Starting Dose (Loading Dose) Treatment generally begins with a loading dose on Day 1, typically set at twice the usual daily dose (e.g., 200 mg or 400 mg).
Maintenance Dose Doses range from 50 mg to 400 mg once daily, with maximum doses of 800 mg per day reserved for severe infections.
Frequency Pattern The standard schedule for most systemic and maintenance therapies requires once-daily (q.d.) administration. A single 150 mg dose or once-weekly dosing is also used for specific conditions.
Course Duration The length of use is variable, ranging from a single dose to extended suppressive courses lasting 6 to 12 months.

Administration Specifics and Adjustments

Oral formulations may be administered with or without food. The intravenous solution must be administered via a slow infusion, not exceeding a rate of 200 mg per hour.

For specific patient populations, dose adjustments are standard clinical practice.

  • Renal Impairment: Patients with impaired renal function (Creatinine Clearance le 50 mL/min) require a dose reduction to 50% of the recommended daily dose after the initial loading dose.
  • Pediatrics: Dosing is determined on a weight-based scale (mg/kg) and is typically administered once daily.
  • Older Adults: Dose adjustment is not required unless there is evidence of co-existing impaired renal function.

If a once-daily dose is missed, it should be taken as soon as remembered. If it is nearly time for the next scheduled dose, the missed dose is typically skipped, and the regular schedule is resumed.

Advertisements

Recent Clinical Evidence

Research evidence / Overview of studies for Флуконазол-OBL

Evidence for Use in Systemic Fungal Infections

Research examined the drug in the context of serious fungal infections that have spread throughout the body, such as invasive candidiasis and cryptococcal meningitis. The evidence base includes multiple randomized controlled trials (RCTs) and comprehensive systematic reviews that examined different systemic antifungal study designs. Studies monitored the presence of fungal organisms and tracked survival-related endpoints in critically ill adults and non-neutropenic populations.

What remains uncertain is the relationship between drug exposure and outcomes in the most severely ill patient groups, as data show high variability in drug concentration. Additionally, data remain insufficient regarding activity against specific types of Candida that may exhibit reduced susceptibility.


Evidence for Use in Mucosal and Recurrent Fungal Infections

For conditions characterized by fluctuating or episodic manifestations, such as oral thrush, esophageal candidiasis, and recurrent vaginal infections, research has explored Флуконазол using RCTs and long-term observational studies. These trials assessed short-term or episodic symptom patterns and were used in studies examining patient-reported experiences.

Findings describe patterns observed in the studies related to clinical resolution and the clearance of the fungus from the affected areas. Studies monitored the rate and timing of recurrence when the drug was evaluated for long-term maintenance.


Evidence in Specialized and High-Risk Populations

Флуконазол was evaluated in research exploring several specialized groups, which include pediatric patients, particularly infants and children, and adults with specific comorbidities. Studies in critically ill adults show patterns related to high variability in drug concentration, indicating that subgroup findings remain uncertain for these groups.

The current research indicates that while data exist across these groups, follow-up durations were limited in some pediatric studies, and results apply only to the specific age groups studied. The research is ongoing to fully understand the risk of resistance developing with widespread or long-term use.

Key Studies & References

  1. Global guideline for the diagnosis and management of cryptococcosis: an initiative of the ECMM and ISHAM in cooperation with the ASM (2024)
Advertisements

Frequently Asked Questions (FAQ)

Common questions about Флуконазол-OBL (FAQ)


Q: Is Флуконазол-OBL the same as fluconazole from another company?

Флуконазол-OBL contains fluconazole, which is the standardized active ingredient used across all manufacturers. Generic versions of fluconazole are generally expected by regulatory bodies to demonstrate bioequivalence to the originator product, which indicates that they deliver the same amount of active ingredient to the bloodstream. These versions may contain varying non-active ingredients, known as excipients.

Q: How quickly does Флуконазол-OBL start working after I take it?

Clinical study data related to certain infections, such as vaginal fungal infections, has shown a median time to the start of symptom relief of approximately one day. It is noted that individual response times may vary based on the infection type and severity. Official information suggests that clinical effects are generally observable quickly.

Q: How long does the effect of a single dose of Флуконазол-OBL last?

The effect of fluconazole lasts long enough that regulatory guidelines allow for flexible treatment schedules. Depending on the condition, the drug is used in single-dose, once-daily, or even once-weekly regimens. For managing recurrent conditions, official documentation describes the use of a once-weekly maintenance dose over an extended period.

Q: Can I drink alcohol while taking Флуконазол-OBL?

According to official patient information, the consumption of alcohol is generally permitted while taking fluconazole. However, official patient information notes that alcohol consumption may contribute to or worsen common adverse reactions associated with the medication, such as nausea or headache.

Q: Does Флуконазол-OBL interact with birth control pills?

Regulatory documents indicate that fluconazole can interact with certain oral contraceptives because it can affect the way the body processes hormones like levonorgestrel. This may alter the concentration of the contraceptive. The official guidance emphasizes the importance of monitoring in patients using both medications.

Q: Can Флуконазол-OBL affect the results of blood tests?

The use of fluconazole is associated with potential changes in certain laboratory test results. Official product information notes that these can include abnormal liver function tests (elevated ALT/AST levels) and altered levels of cholesterol, triglycerides, and electrolytes. Monitoring of these markers may be required, especially during extended use.

Q: Can I take Флуконазол-OBL if I am currently breastfeeding?

Caution is advised in official documents when fluconazole is used by nursing women. Although data on short-term, low-dose use has not reported serious adverse reactions in infants, less is known about the effects of long-term or high-dose exposure on the breastfed infant. Decisions regarding the use of this medication while breastfeeding should involve consultation with a healthcare professional.

Q: What does 'OBL' stand for in the drug name?

The 'OBL' component is typically a brand or market designation used by the specific pharmaceutical company that manufactures this version. It serves to identify the particular product in the marketplace and does not alter the drug's active ingredient or official medical classification.

Q: How is Флуконазол-OBL eliminated from the body?

The primary pathway for this medication to leave the body is through the kidneys (renal clearance). This elimination route is the reason why official prescribing information requires a reduction in the dosage for patients who have impaired kidney function, as this helps prevent the drug from building up in the bloodstream.

Q: What is the risk of resistance developing to Флуконазол-OBL?

Regulatory documents and research have noted a potential for antifungal resistance to develop, particularly with widespread use or against specific fungal species. Resistance occurs when the fungus adapts and the drug becomes less effective. Official information indicates that ongoing research is tracking the prevalence of resistance.

Q: Are there different strengths of Флуконазол-OBL available?

Yes, official regulatory documents confirm that fluconazole is manufactured in several different strengths for oral use. These commonly include 50 text mg, 100 text mg, 150 text mg, and 200 text mg tablets or capsules to allow for flexible treatment regimens as prescribed.

Q: Why is it important to finish the full course of Флуконазол-OBL?

According to official regulatory guidance, completing the full course as prescribed is important even if symptoms resolve quickly. Stopping treatment too early is linked to an increased risk of the infection recurring. It is also a factor that potentially contributes to the development of drug-resistant fungal strains.

Q: What should I do if I forget to take a dose of Флуконазол-OBL?

Official patient information describes general guidance for handling missed doses. This often involves taking the dose when remembered, unless the next scheduled dose is imminent. For specific details on dose management, including once-weekly regimens, patients are generally directed to consult the official product documentation or their prescribing information.

Q: Can Флуконазол-OBL be used for skin or nail issues?

Yes, the therapeutic indications listed in official documents include several skin and nail conditions caused by fungi. These include various forms of ringworm (tinea infections) and nail infections (onychomycosis), which are treated with the oral formulation of fluconazole.

Q: Do you need a prescription for Флуконазол-OBL?

For the majority of its dosage forms and indications, fluconazole is classified by regulatory bodies as a prescription azole antifungal medication. This means it must be obtained with a valid prescription from a licensed healthcare professional.

Q: Are there any specific foods I should avoid when taking Флуконазол-OBL?

Official patient information indicates that there are no specific foods or drinks that must be strictly avoided while taking fluconazole. The medication can generally be administered with or without food.

Q: Can Флуконазол-OBL affect the way other vitamins or supplements work?

Fluconazole is known to inhibit certain enzymes in the body that metabolize (break down) many substances. For this reason, official drug information advises that fluconazole has the potential to alter the concentration of certain herbal or dietary supplements that share these metabolic pathways. Official product information notes that using these substances together requires careful consideration.

Q: Is Флуконазол-OBL effective against non-fungal infections?

Fluconazole is classified as an azole antifungal agent whose mechanism of action is highly selective for fungal enzymes. Its approved indications and general purpose are targeted only towards the control of various fungal and yeast pathogens, and it is not intended for use against bacterial or viral infections.

Q: Is it possible for the fungal infection to come back after using Флуконазол-OBL?

Yes, the return of a fungal infection, or relapse, can occur after treatment is finished, especially in cases of recurrent conditions. For this reason, research evidence supports and regulatory documents describe the use of long-term maintenance therapy in specific patient groups to help prevent the infection from returning.

Q: Can taking Флуконазол-OBL cause changes to my sense of taste?

Official product information notes that a change in or distortion of the sense of taste, known as taste perversion (dysgeusia), has been reported as an uncommon adverse reaction associated with fluconazole use.

Q: Is Флуконазол-OBL suitable for people who are lactose intolerant?

Many oral formulations, such as tablets and capsules, contain lactose as a non-active ingredient. Official prescribing information describes that the drug should be used with caution, or avoided, by patients with rare hereditary problems, such as galactose intolerance or glucose-galactose malabsorption, due to excipients like lactose.

Q: What is the difference between Флуконазол-OBL tablets and capsules?

Tablets and capsules are different physical forms designed to deliver the same active ingredient (fluconazole) at the same strength. While both are used for systemic action, regulatory documents show they may differ slightly in their inactive ingredients (excipients).

Q: Is Флуконазол-OBL used to treat internal infections only?

Fluconazole is approved for both widespread, internal infections (systemic use) and more localized conditions. This includes mucosal infections like oral thrush and specific skin conditions, making its use broader than just internal therapy.

Q: Can Флуконазол-OBL be used for preventing infections?

Yes, fluconazole is indicated for prophylaxis (prevention) in specific high-risk patient groups. This is often done to reduce the incidence of fungal infections in individuals with compromised immune systems, such as those undergoing bone marrow transplantation or those with long-term immunosuppression.

Advertisements

How should Флуконазол-OBL be stored and disposed of?

Storage and Disposal Requirements for Fluconazole

Storage of Fluconazole must adhere strictly to official regulatory conditions. Tablets and dry powder for oral suspension must be stored below 30°C (86°F). The reconstituted liquid suspension requires storage between 5°C (41°F) and 30°C (86°F).

Stability and Handling

The medication must be protected from freezing in all forms. The reconstituted oral suspension is stable for a limited time and must be discarded after 14 days [1.6]. For patient safety, all forms must be stored out of the sight and reach of children.

Disposal

Unused or expired fluconazole must be disposed of according to local and national regulations [2.1]. Sharps (needles/syringes) from the injection form require specific disposal instructions provided by a healthcare professional.

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

Available in countries:

Equivalent of Флуконазол-OBL found in:

A-Z Index: