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Fluconazol Supremase

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Fluconazol Supremase

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 Fluconazol Supremase

What is Fluconazol Supremase?

Fluconazol Supremase is a pharmaceutical formulation containing fluconazole, a synthetic compound belonging to the triazole class of antifungal agents. It is primarily utilized in clinical practice to address a broad range of fungal infections by inhibiting the growth and spread of the causative organisms.

Mechanism of Action

The active ingredient, fluconazole, works by disrupting the synthesis of ergosterol, an essential component of the fungal cell membrane. By inhibiting the fungal enzyme cytochrome P450 14-alpha-demethylase, the medication prevents the conversion of lanosterol to ergosterol. This depletion leads to structural instabilities and increased permeability in the fungal cell wall, ultimately resulting in the cessation of fungal growth or the destruction of the fungal cells.

Therapeutic Applications

Fluconazol Supremase is used to manage various types of infections caused by fungi and yeasts, particularly those belonging to the Candida and Cryptococcus species. Its applications generally include:

  • Systemic Infections: Management of invasive candidiasis and cryptococcal meningitis.
  • Mucosal Infections: Treatment of oropharyngeal (thrush), esophageal, and bronchopulmonary infections.
  • Genital Infections: Addressing acute or recurrent vaginal candidiasis (yeast infections) and fungal infections of the glans penis (balanitis).
  • Skin Infections: Use in cases of tinea pedis (athlete's foot), tinea corporis (ringworm), and tinea cruris (jock itch).

Pharmacological Profile

Fluconazole is characterized by its high oral bioavailability and its ability to penetrate various body fluids and tissues effectively. This pharmacological profile allows the medication to reach therapeutic concentrations in areas such as the cerebrospinal fluid, saliva, and skin, making it a versatile option for both localized and systemic fungal conditions.

Regulatory References

  1. Fluconazole
  2. MedlinePlus Fluconazole Information
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What side effects are possible with Fluconazol Supremase?

Possible side effects and safety information

The safety profile of Fluconazol Supremase, which contains the active ingredient Fluconazole, is based on official government regulatory classifications detailing potential adverse reactions and specific safety considerations.

Officially Classified Adverse Reactions and Frequency

Adverse reactions are grouped by System Organ Class (SOC) and frequency, consistent with regulatory summaries.

Common Adverse Reactions

Reactions frequently reported include headache, abdominal pain, nausea, vomiting, and diarrhoea (Gastrointestinal and Nervous System disorders). Laboratory changes include common increases in liver enzymes, such as ALT and AST.

Rare and Serious Adverse Reactions

Serious reactions, though rarely reported, include severe dermatologic conditions like Stevens-Johnson syndrome and Toxic Epidermal Necrolysis. Serious hepatotoxicity, including hepatic failure, has been documented. Potential Cardiac risks include QT prolongation and Torsade de pointes, a severe heart rhythm irregularity. Other rare effects include severe blood disorders like agranulocytosis.

Safety Considerations for Specific Populations

Regulatory labeling specifies cautions for certain patient groups:

  • Hepatic Impairment: Caution is advised, and patients must be monitored for serious liver injury.
  • Renal Impairment: The drug's elimination is reduced, requiring careful administration.
  • Pregnancy: Use is generally reserved for severe infections, given the observed increased risk of spontaneous abortion in the first trimester.

Safety Restrictions

Patients who develop a rash must be closely monitored; therapy should be discontinued if signs of severe cutaneous reactions develop. There is a documented risk of superinfection by Candida species that may be resistant to the medicine.

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Overdose and Emergency Response

Overdose and When to Seek Help

If you suspect an overdose with Fluconazol Supremase, seek immediate medical attention or call emergency services right away.

Taking too much fluconazole has been associated with specific central nervous system effects. Reported manifestations of an overdose include hallucination and paranoid behavior.

Overdose Management

If an overdose is suspected, treatment focuses on supportive and symptomatic care. Based on official regulatory guidance, measures that may be implemented include:

  • Supportive Measures and Symptomatic Treatment: General support is instituted to manage clinical manifestations.
  • Gastric Lavage: May be performed if clinically indicated to remove unabsorbed drug.
  • Hemodialysis: Fluconazole is primarily excreted in the urine. A three-hour session of hemodialysis is known to reduce plasma concentrations of the drug by approximately 50%.

Urgent Medical Attention

Immediate professional medical help is required if you experience any signs of overdose, such as changes in mental state, severe confusion, or the reported symptoms of hallucinations or extreme suspiciousness. Prompt intervention allows for appropriate clinical support and the implementation of procedures such as those described above.

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Therapeutic Uses of Fluconazol Supremase

What Fluconazol Supremase Treats: Main Uses and Benefits

Fluconazol Supremase is a prescription medication utilized in therapeutic regimens to address and manage various fungal and yeast infections. It is indicated for use in several different organ systems and clinical contexts.


Quick Facts

  • Addresses candidiasis (yeast infections) of the vagina, mouth, and throat.
  • Helps manage systemic Candida infections, including those affecting the blood, urinary tract, and abdomen.
  • Assists in the treatment of fungal meningitis, specifically when caused by Cryptococcus.
  • Offers support in reducing the occurrence of candidiasis in certain high-risk patient populations, such as those undergoing bone marrow transplantation.

The primary therapeutic domains include managing mucosal candidiasis, which refers to infections of the lining of the esophagus, mouth (oropharyngeal candidiasis), and vagina. The medication is also utilized to contribute to the treatment of systemic candidiasis, which are more widespread infections involving the lungs, abdomen (peritonitis), or bloodstream (candidemia).

Furthermore, Fluconazol Supremase is a therapeutic option for treating cryptococcal meningitis, a type of fungal infection affecting the brain and spinal cord. It is also administered to aid in the prevention of candidiasis in certain individuals who have a weakened immune status, such as patients receiving chemotherapy or radiation therapy before a bone marrow transplant.

Regulatory References

  1. NIH MedlinePlus guidance
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Eligibility and Restrictions for Use

Official Eligibility and Contraindications

The eligibility profile for Fluconazol Supremase is defined by regulatory authorities based on patient status, comorbidities, and age.

Classification Population Eligibility Status (Official Labeling)
Absolute Contraindication Patients with known hypersensitivity to fluconazole or other azole derivatives must not use the medicine. Use is also prohibited for patients taking co-administered drugs known to prolong the QT interval and metabolized via CYP3A4 (e.g., pimozide, cisapride, or erythromycin).
Restricted/Conditional Use Patients with impaired renal function require dose reduction for multiple-dose therapy (creatinine clearance le 50 mL/min). Use in individuals with hepatic (liver) dysfunction requires caution due to the potential for serious toxicity.
Pregnancy/Lactation Pregnancy is a restricted status; chronic, high-dose use during the first trimester has been associated with reports of congenital abnormalities. Use while breastfeeding is not recommended after high-dose or repeated therapy.
Age-Related Status The medicine is approved for use in adults, adolescents, children, and neonates. However, the safety and efficacy for treating genital candidiasis are not established in the pediatric population.

Connection to the overall eligibility profile: The regulatory documents establish eligibility by delineating populations who are absolutely prohibited from use (contraindicated populations) and by requiring close consideration for patients with compromised organ function (renal/hepatic impairment) and those in specific physiological states (pregnancy/lactation).

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What should I know about interactions with other medicines?

Interactions with other medicines and products

The most significant interactions with Fluconazol Supremase are rooted in its role as a potent inhibitor of Cytochrome P450 isoenzyme CYP2C9 and a moderate inhibitor of CYP3A4 and CYP2C19. This enzyme inhibition leads to increased systemic exposure and higher plasma concentrations of many co-administered medicinal products.

Contraindicated Combinations

Co-administration is strictly contraindicated with certain medicines known to prolong the QT interval that are also metabolized by CYP3A4. These include Astemizole, Cisapride, Pimozide, Quinidine, and Erythromycin, as the combination significantly raises the risk of life-threatening cardiac arrhythmias. The combined use of Fluconazole at daily doses of 400 mg or greater with Terfenadine is also prohibited.

Combinations Requiring Close Monitoring

Fluconazole requires careful co-administration and monitoring with several drug classes. The anticoagulant Warfarin necessitates frequent International Normalized Ratio (INR) checks due to the elevated risk of bleeding events. Immunosuppressants like Cyclosporine, Sirolimus, and Tacrolimus require close therapeutic drug monitoring, and their dosages often need to be reduced to avoid toxicity from increased exposure. HMG-CoA reductase inhibitors (Statins) metabolized by CYP2C9 or CYP3A4, such as Atorvastatin and Simvastatin, increase the risk of muscle toxicity (rhabdomyolysis), mandating careful patient observation. Finally, the co-administration of Rifampicin results in a notable reduction in Fluconazole exposure, meaning an increase in the Fluconazole dose should be considered.

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Mechanism of Action

Inhibition of Fungal Ergosterol Synthesis

Fluconazol Supremase exerts its pharmacodynamic effect primarily through selective inhibition of the lanosterol 14-alpha-demethylase (Cyp51) enzyme. This fungal cytochrome P450 enzyme is essential for converting lanosterol into ergosterol, the vital sterol component of the fungal cell membrane. The binding and subsequent blockade of Cyp51 halt a critical, early molecular step in ergosterol biosynthesis.

Disruption of Fungal Cell Membrane Structure

The resulting depletion of ergosterol and the simultaneous accumulation of toxic, methylated sterol precursors within the fungal cell are the direct consequences of this enzymatic inhibition. This mechanistic cascade structurally and functionally impairs the fungal cell membrane, leading to increased non-selective permeability and loss of critical regulatory function. This structural compromise destabilizes cellular processes, resulting in compromised cellular viability and reproductive capacity.

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Dosage and Administration Information

How to Use Fluconazol Supremase

The usage of Fluconazole is formally structured across several domains, dictating the standardized methods of administration and dosing as established in regulatory documents.


Administration and Dosage Principles

The medication is administered via two approved routes: oral (capsules, tablets, or reconstituted suspension) or intravenous (IV) infusion. The prescribed daily dose is numerically the same regardless of the chosen route, which allows for direct conversion between oral and IV administration. Oral formulations may be taken with or without food as specified in the official labeling.

For many multi-day regimens, including systemic infections, the official protocol specifies a loading dose on the first day, typically double the subsequent once-daily maintenance dose. This procedure is designed to achieve steady-state concentrations rapidly. For acute indications, such as uncomplicated vaginal candidiasis, the established regimen is a single 150 mg oral dose.


Population-Specific and Procedural Rules

Specific dosage modifications are required for certain populations. Patients with renal impairment (reduced kidney function) typically require a dose reduction to approximately 50% of the recommended daily amount after the initial standard dose. Pediatric dosing is calculated based on the child's body weight (mg/kg) to ensure accurate administration.

If the oral suspension is used, the regulatory instructions specify that the liquid must be shaken well before measuring. When administering the IV solution, it must be infused slowly, at a controlled rate generally not exceeding 10 mL/minute.

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Recent Clinical Evidence

Evidence for Systemic Fungal Infections

Research has studied fluconazole for systemic candidiasis using Randomized Controlled Trials (RCTs) and observational settings, focusing on critically ill and non-neutropenic adults. Studies monitored outcomes such as fungal clearance from the bloodstream and measurements of survival. Findings describe patterns observed in the studies of microbiological clearance. Long-term effects are not fully established, and research describes the potential for certain fungi to become less susceptible.


Evidence for Mucosal and Localized Fungal Infections

Fluconazole was studied for infections in the mouth and throat, relying on RCTs that examined outcomes related to physical discomfort and lesion resolution in immunocompromised adults. Findings describe measurements of symptom resolution after short-course administration. Follow-up durations were limited for fully characterizing the long-term durability, and research is ongoing regarding sustained susceptibility.


Evidence for Cryptococcal Meningitis

Research explored fluconazole's role for Cryptococcal Meningitis in advanced immunosuppression, monitoring fungal clearance from the cerebrospinal fluid and tracking relapse rates. Data show patterns related to less favorable outcomes when fluconazole was studied as a single treatment during the initial, most intense period. Certainty remains low for long-term outcomes, and comparative evidence is lacking for certain combination regimens.


Evidence for Prevention (Prophylaxis) in High-Risk Patients

Fluconazole was observed in research settings, primarily placebo-controlled RCTs, to reduce severe fungal infection rates in high-risk groups like bone marrow transplant recipients. Findings describe patterns observed in the studies concerning the incidence of infection. However, evidence quality varies across studies when examining a survival benefit in all high-risk groups.


What Remains Uncertain in the Research Landscape

Evidence quality varies across studies, and data for certain groups remain insufficient for broad conclusions. Comparative evidence is lacking when trying to evaluate fluconazole against all newer antifungal treatments. The overall evidence base highlights what is known and what is still uncertain about long-term susceptibility and optimal use in specific, complex clinical situations.

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Frequently Asked Questions (FAQ)

Common questions about Fluconazol Supremase (FAQ)


Q: Is Fluconazol Supremase indicated for use during pregnancy or while breastfeeding?

According to regulatory documents, the use of this medicine during pregnancy is generally restricted to severe infections due to reported risks, including an increased risk of spontaneous abortion, particularly with chronic, high-dose use in the first trimester. For breastfeeding, official information states that use is not recommended after high-dose or repeated therapy.


Q: What information is available regarding the interaction between Fluconazol Supremase and cholesterol-lowering medicines (statins)?

Official prescribing information indicates that co-administration with certain cholesterol-lowering medicines, known as statins, is associated with an increased risk of muscle toxicity that necessitates monitoring for signs of muscle pain or weakness. For this reason, official guidance emphasizes the need for careful patient observation during co-administration.


Q: What does the research evidence indicate about the rate of infection recurrence after using Fluconazol Supremase?

Studies have examined the risk of infection recurrence for specific conditions. For example, in high-risk patients with Cryptococcal Meningitis, the medicine is officially indicated for maintenance therapy to help prevent relapse. However, for some other infections, research acknowledges limited follow-up periods when fully characterizing the long-term durability or recurrence rates.


Q: How quickly is Fluconazol Supremase expected to start working for common infections?

Based on clinical information, symptom improvement for common infections like vaginal candidiasis may begin within 24 hours after administration. For more severe or deep-seated systemic infections, it may take a period of one to two weeks to fully resolve the infection, though signs of improvement are usually noticeable beforehand.


Q: What is the general timeline for symptoms to improve after taking Fluconazol Supremase?

Symptoms are generally expected to begin improving within the first few days of starting treatment. For complex or severe infections, however, full clearance can require several weeks, and official protocols describe that treatment typically continues until the active infection has subsided according to clinical parameters.


Q: If symptoms do not improve after the expected time, what is the informational next step?

Official patient information recommends consulting a healthcare provider if symptoms worsen or do not begin to improve after the expected time frame for the specific condition being treated. This allows for clinical reassessment of the underlying issue.


Q: Does Fluconazol Supremase actively 'flush out' the fungal infection from the body?

Official information describes the drug as primarily 'fungistatic,' which means it works by stopping the growth and reproduction of the fungus. This action allows the body’s own immune system to clear the weakened pathogen. Therefore, the medicine does not physically flush out the infection.


Q: What are the main reasons a course of Fluconazol Supremase might not resolve an infection?

Regulatory documents indicate that two potential reasons for non-resolution include an inadequate period of treatment, which can lead to recurrence. Additionally, some Candida species have developed resistance to the medicine, which may limit the drug's effectiveness against those specific pathogens.


Q: Does the effectiveness of Fluconazol Supremase differ based on the type of fungus it is treating?

Yes, the drug has a defined spectrum of activity, and its effectiveness can vary depending on the specific fungus involved. It has recognized activity against specific susceptible pathogens like Candida species and Cryptococcus neoformans. Its full range of susceptibility and resistance is detailed in the official product data sheet.


Q: How long do the mild, temporary side effects of Fluconazol Supremase typically last?

Common, mild side effects, such as a headache or nausea, are usually temporary. These effects typically last only a few days to weeks as the body adjusts to the medication. Official guidance recommends reporting persistent or worsening side effects to a healthcare provider.


Q: What information is available about the potential for hair loss (alopecia) when using this medicine?

Hair loss, also referred to as alopecia, has been reported in postmarketing surveillance. Regulatory documents often categorize this as a rare or uncommon side effect associated with the use of the medicine.


Q: Can Fluconazol Supremase cause or contribute to feelings of dizziness or lightheadedness?

Yes, official prescribing information lists dizziness as one of the commonly reported side effects of the medication. This effect is part of the officially classified adverse reaction profile.


Q: Are there any known long-term side effects associated with extended use of Fluconazol Supremase?

Official safety profiles indicate that potential serious side effects during extended therapy include serious cardiac risks, such as heart rhythm problems, and serious liver problems (hepatotoxicity). Patient monitoring is mandated during prolonged or high-dose administration to check for these risks.


Q: Is a mild, non-spreading skin rash a commonly reported reaction to Fluconazol Supremase?

Skin rash is listed as a potential common side effect in the general adverse reaction profile. Regulatory documents state that close monitoring is required if any rash develops, and therapy discontinuation is specified if the rash progresses to signs of a severe cutaneous reaction.


Q: Does the risk or type of side effect change with higher doses of the medicine?

Studies examining the drug’s behavior in the body indicate that the concentration in the bloodstream is proportional to the dose administered. Official information suggests that because of this relationship, higher doses may increase the risk or severity of certain side effects.


Q: Is the use of alcohol typically restricted when taking Fluconazol Supremase?

Although official regulatory documents do not list alcohol as a direct chemical contraindication, official warnings describe that alcohol consumption can increase the risk of liver problems, which is a known serious adverse reaction to this medicine. The consumption of alcohol may also exacerbate common temporary side effects like headache and nausea.


Q: Does grapefruit juice interact with Fluconazol Supremase?

Yes, official regulatory documents classify grapefruit juice as an inhibitor of the CYP3A4 enzyme. Since the medicine itself inhibits the same enzyme, concurrent consumption may potentially affect the concentration of co-administered drugs that rely on this enzyme for metabolism.


Q: Are there official warnings about combining Fluconazol Supremase with certain other antibacterial or antifungal medicines?

Yes, official documents include specific warnings about interactions with certain other medicines, including antibiotics. For instance, the antibiotic Rifampicin is known to significantly reduce the concentration of this medicine in the body, and the official protocol states that an increase in the Fluconazol Supremase dose should be considered.


Q: What is the official difference in general use conditions for the liquid suspension versus the tablet form?

The official information notes that the absorption of the medicine is similar for both the liquid suspension and the tablet form, and both may be taken with or without food. Official product information notes that the oral suspension requires shaking well before measuring a dose.


Q: Does the use of Fluconazol Supremase affect a person's ability to drive or operate machinery?

Because the drug may cause some people to experience dizziness, drowsiness, or reduced alertness, official patient safety information advises caution. Official patient safety information includes a recommendation to refrain from driving or operating potentially dangerous machinery until the patient is aware of the medicine's personal effects.


Q: How long does the medicine typically remain detectable in the body after the final dose?

Studies indicate that the medicine has a long plasma half-life of approximately 30 hours. Based on this pharmacokinetic profile, it typically takes about six days after the final dose for the drug to be largely cleared from the body, based on its pharmacokinetic profile.


Q: What are the general themes of research related to potential new applications of Fluconazol Supremase?

Current research themes in the broader antifungal field, which informs potential uses of this drug, focuses on key themes. These themes include developing strategies for managing drug-resistant fungal pathogens and optimizing existing treatments.


Q: Are there specific patient populations for whom Fluconazol Supremase has been studied extensively?

Yes, the medicine has been studied extensively in patient populations who have severe infections. This includes critically ill adults, non-neutropenic adults, and high-risk groups such as bone marrow transplant recipients and patients infected with HIV.


Q: How do official sources describe the overall research profile (e.g., long history, recent trials) of the drug?

Official sources describe the drug as a first-generation triazole antifungal with a long history, having been patented in 1981 and commercially available since 1988. It is recognized by the World Health Organization as an Essential Medicine.


Q: Is there public information available on the development or regulatory approval history of Fluconazol Supremase?

Yes, the medicine has a documented history of regulatory approval. For instance, the drug was initially approved by the U.S. FDA in 1990 and is a well-documented compound in major regulatory and public health databases.

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How should Fluconazol Supremase be stored and disposed of?

Storage and Disposal Requirements

Fluconazole products have specific storage requirements depending on the formulation. Tablets and the dry powder for oral suspension must be stored at or below 86 F (30 C) and kept in the original container, tightly closed. All forms must be kept out of reach of children.

Stability and Protection

Formulation Required Condition Stability Limit
Tablets / Dry Powder Store below 86 F (30 C) Until expiration date
Reconstituted Suspension Store between 41 F and 86 F (5 C and 30 C) Discard after 2 weeks
Injection Solution Protect from freezing Store between 41 F and 77 F (5 C and 25 C)

Fluconazole that is unused or expired must be thrown away by following official guidelines for the safe disposal of unused medicines.

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

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