Fluconazol Aurobindo

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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.

Overview of Fluconazol Aurobindo

Quick Facts: Fluconazole Identity

Property Description
Active ingredient Fluconazole
Form Tablet, Capsule, Solution for Infusion
Pharmacological class Systemic Antifungal Agent (Triazole)
General purpose Clearing internal or widespread fungal infections
Origin Synthetic Compound

What Type of Medicine is Fluconazol Aurobindo?

Fluconazol Aurobindo is a systemic antifungal agent used to manage internal or widespread fungal infections. This medicine is a generic drug that contains the active ingredient Fluconazole, classifying it as a triazole-subclass of the azole antifungal family. As a systemic agent, its therapeutic function is intended for deep-seated fungal growth, known as mycoses, circulating throughout the body to address pathogens that topical treatments cannot reach. This compound is used against a wide spectrum of fungal pathogens.


Composition, Origin, and Available Forms

The formulation of Fluconazol Aurobindo is a single-ingredient product, with Fluconazole being the sole pharmaceutically active substance. This product is manufactured by Aurobindo Pharma, an entity recognized globally for producing generic pharmaceuticals. This preparation is available primarily in forms suitable for systemic administration, including oral tablets or capsules that are swallowed, or as a sterile solution for infusion for administration directly into a vein. These physical forms, utilizing appropriate excipients or an aqueous solution base, ensure the active ingredient is delivered effectively into the bloodstream. Fluconazole is a prescription-only medication essential for treating systemic fungal conditions.


The General Purpose of This Antifungal Agent

The general purpose of this medicine is to halt the proliferation of fungal pathogens by disrupting their structural integrity. Fluconazole achieves this fundamental fungistatic action by targeting a specific enzyme crucial for the production of ergosterol, an essential building block of the fungal cell membrane. By preventing the fungus from properly constructing its protective outer wall, the medicine effectively stops the infection from advancing. Its main purpose addresses infections where the fungus has become systemic, such as in cases involving susceptible patient groups who require comprehensive internal management to clear the established fungal growth.

What side effects are possible with Fluconazol Aurobindo?

Official Safety Profile and Adverse Reactions

The safety profile of Fluconazole is formally documented by regulatory agencies, classifying potential adverse reactions according to frequency and the affected body system. These official classifications establish a structured overview of the medicine's risk characteristics, strictly separating common, expected effects from rare, serious reactions.

Frequency-Classified Adverse Reactions

Adverse reactions are organized into categories based on official regulatory standards:

  • Very Common (ge 1/10): This category includes headache and certain changes in laboratory findings, such as an increase in blood alkaline phosphatase.
  • Common (ge 1/100 to <1/10): Commonly documented effects involve the gastrointestinal system, such as nausea, abdominal pain, diarrhoea, and vomiting. Rash and increases in liver enzyme levels (ALT and AST) are also classified as common.
  • Uncommon (ge 1/1,000 to <1/100): Effects such as dizziness, seizures, constipation, dyspepsia, pruritus (itching), urticaria (hives), and anaemia are listed in this tier.

Serious Adverse Reactions and Restrictions

The regulatory label documents rare but clinically significant adverse reactions, which primarily affect the liver, heart, and skin. These include reports of severe hepatic toxicity that can lead to failure or necrosis. Rare but serious cardiovascular events, such as QT prolongation and the ventricular arrhythmia Torsade de pointes, are officially listed. Severe cutaneous reactions like Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN) are also documented.

This medicine is officially contraindicated in individuals with documented hypersensitivity to Fluconazole or related azole compounds. Furthermore, co-administration with certain other medications known to prolong the QT interval and metabolized by the CYP3A4 enzyme system is restricted due to the heightened risk of cardiotoxicity.

Overdose and Emergency Response

Overdose and When to Seek Help

The following information is derived from official governmental regulatory documents (e.g., FDA, EMA SmPC) regarding overdose with fluconazole.


Documented Overdose Presentations

Clinical evidence shows that an overdose of fluconazole can primarily affect the central nervous system (CNS). The core documented manifestations include:

  • Hallucinations (perceiving sensory input that is not real).
  • Paranoid behavior (extreme suspicion or fearfulness).

Serious cardiotoxicity, such as QT prolongation, is a recognized risk associated with high drug concentrations, necessitating urgent medical assessment.

Required Emergency Action

Immediate medical attention is required for any known or suspected overdose, even if no symptoms are apparent.

Contact a healthcare professional, hospital emergency department, or regional Poison Control Centre immediately.

Emergency services (such as 911) must be called immediately if the person:

  • Has collapsed.
  • Is experiencing a seizure.
  • Has trouble breathing or cannot be awakened.

Management and Treatment

There is no specific antidote for fluconazole overdose. Management focuses on supportive measures and removing the drug from the body. Because fluconazole is largely excreted in the urine, methods may include symptomatic treatment and, in severe cases, procedures like gastric lavage or hemodialysis, which can significantly reduce plasma levels.

Therapeutic Uses of Fluconazol Aurobindo

Fluconazol Aurobindo is commonly applied in addressing a variety of fungal and yeast infections throughout the body, providing essential symptomatic support in challenging clinical settings.


Targeting Widespread and Invasive Fungal Infections

Fluconazol Aurobindo may be part of symptomatic management for invasive mycoses, which are conditions involving systemic or deep-seated fungal pathogens that have spread to the bloodstream or major organs. The primary benefit is its role in reducing the overall pathogen load, which helps address symptoms related to systemic imbalance, such as persistent fever and generalized malaise, often associated with conditions where symptoms may intensify temporarily.

Addressing Mucosal and Esophageal Yeast Symptoms

The medication is relevant in clinical settings that involve infections affecting the mucous membranes, notably Oropharyngeal (mouth) and Esophageal Candidiasis. This use is relevant for easing symptoms related to inflammatory or irritative states like pronounced soreness, irritation, and difficulty in swallowing (dysphagia), and contributes to improved comfort during periods of heightened symptoms.


Quick Fact: Therapeutic Applications

Primary Use Case Symptom Relief Provided
Systemic Mycoses Eases symptoms related to systemic imbalance
Mucosal Candidiasis Assists with easing soreness, irritation, and swallowing difficulty
Prophylaxis Supports risk reduction in high-risk patient groups

Prophylaxis and Management of Recurrent Issues

This systemic antifungal is considered relevant in conditions characterized by frequently recurrent yeast infections, such as chronic vaginal candidiasis, where additional symptomatic support is needed. Its role includes use as prophylaxis in high-risk, immunocompromised patients; this may assist in reducing the risk of severe fungal disease onset, which supports general well-being during symptomatic phases.

The medication is commonly used across conditions presenting with acute episodes of systemic Candidiasis, fungal infections of the urinary tract, Cryptococcal Meningitis, and infections affecting the abdomen. It is commonly used when short-term symptomatic assistance is needed for symptoms that have become more disruptive during flare-ups.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Eligibility for Fluconazol Aurobindo Use: Official Regulatory Information

Category Regulatory Status & Statement
Populations for whom use is allowed Adults and the Geriatric population are eligible for use under standard labeled conditions. Pediatric patients (from infancy for certain indications) are eligible [1.1, 1.8].
Populations for whom use is contraindicated Patients with known hypersensitivity to fluconazole, other azole antifungals, or any formulation component. Use is strictly prohibited with concomitant medications that prolong the QT interval and are metabolized by CYP3A4, such as pimozide or quinidine [1.1, 2.7].
Populations for whom use is not recommended Pregnant women are not recommended for treatment unless necessary. Chronic high-dose use (400–800 mg/day) in the first trimester is contraindicated [1.6, 2.7]. Breastfeeding is not recommended after repeated or high-dose use, though a single 150 mg dose is often permitted [2.3].

Age-Related and Conditional Rules

The medicine is generally appropriate for adults and older adults, though age-related renal impairment may require dosage considerations. Safety and efficacy for the genital candidiasis indication have not been established in the pediatric population [2.4]. Use is restricted and requires caution in patients with impaired renal function or existing liver dysfunction [1.7, 2.2]. Caution is also mandated for patients with potential proarrhythmic conditions (e.g., severe electrolyte abnormalities or heart disease) [1.3]. Regulatory documents note that some oral forms are restricted for individuals with rare hereditary sugar problems like galactose or sucrose intolerance [1.7, 3.1].

Regulatory documents establish patient eligibility by defining absolute exclusions, such as hypersensitivity and cardiac-risk drug co-administration, and imposing restrictions based on organ function, reproductive status, and specific pediatric indications.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Fluconazole's interaction profile is defined by its inhibitory effects on specific liver enzymes responsible for drug metabolism, as documented in regulatory information.

Pharmacokinetic and Metabolic Interactions

Fluconazole is formally documented as a potent inhibitor of the CYP2C9 isoenzyme, a moderate inhibitor of CYP3A4, and an inhibitor of CYP2C19. This enzyme inhibition often results in increased exposure of co-administered medicines, such as Celecoxib and Alfentanil. Conversely, the co-administration of Rifampicin significantly decreases fluconazole exposure, reducing its Area Under the Curve (AUC) by 25%. Concomitant administration of Hydrochlorothiazide increases fluconazole plasma concentrations by 40%. The interaction with Warfarin is noted to increase prothrombin time and the risk of bleeding.

Formal Restrictions and Pharmacodynamic Risks

Co-administration is formally contraindicated with several medicinal products due to the risk of severe cardiac events, including Cisapride, Astemizole, Pimozide, Quinidine, and Erythromycin. This risk is categorized as a pharmacodynamic interaction (additive effect). Co-administration with Terfenadine is also restricted, being contraindicated at fluconazole doses of 400 mg/day or greater. No clinically significant impairment of fluconazole absorption is documented with food, Cimetidine, or Antacids.

Mechanism of Action

The mechanism of Fluconazol Aurobindo is characterized by highly specific interference with the fungal ergosterol biosynthesis pathway. The drug acts as a non-competitive inhibitor of the fungal enzyme Lanosterol 14alpha -demethylase (CYP51). This enzyme is essential for converting lanosterol into ergosterol, a critical sterol component of the fungal plasma membrane.

Inhibition of CYP51 results in two concurrent intracellular events: the depletion of ergosterol and the toxic accumulation of 14alpha -methylated sterol intermediates. This molecular imbalance compromises the structural integrity and function of the fungal cell membrane by increasing its fluidity and permeability . This structural failure impairs necessary cellular activities, resulting in a fungistatic physiological effect where fungal growth and replication are arrested.

This mechanism's inhibitory effect is subject to constraint by biological adaptation, specifically the over-expression of fungal efflux pumps (transporter proteins) or CYP51 gene mutations, which lower the drug's intracellular concentration and reduce its inhibitory effect against adapted strains.

Dosage and Administration Information

Fluconazol Aurobindo is administered through two officially approved routes: orally (as capsules, tablets, or liquid suspension) or via intravenous (IV) infusion. The oral form may be taken with or without food, as the medicine's absorption is not significantly affected by meals. For the IV solution, administration must proceed at a slow rate, not exceeding 10 mL/ minute.

Dosing for systemic infections typically begins with a higher loading dose on the first day of treatment, often double the subsequent daily amount. This strategy is followed by a maintenance dose, which is taken once daily for the duration of the therapy. Certain conditions, such as acute vaginal candidiasis, are managed with a 150 mg single oral dose, while others require intermittent or long-term suppressive schedules.

Administration Principle Labeled Guideline
Standard Frequency Once daily for most multi-dose uses.
Dose Adjustment Dose reduction is mandated for multi-dose regimens in adults with renal impairment (Creatinine Clearance le 50 mL/ min).
Duration Pattern Duration is highly dependent on the type of infection, ranging from a single dose to indefinite maintenance therapy for relapse prevention.

Pediatric dosing schedules are based on body weight (mg/ kg), and the time interval between doses is extended for neonates compared to older children. The same dosage is used when a patient switches between intravenous and oral administration.

Recent Clinical Evidence

Fluconazol Aurobindo: Overview of Research Evidence

This overview summarizes the official research structure used by regulatory bodies to evaluate medicines containing fluconazole. It focuses strictly on the types of studies conducted, the populations examined, and the kind of outcomes that were measured, without offering clinical guidance or making claims about the medicine's effectiveness for any individual.

Evidence for Use in Systemic and Invasive Fungal Infections

The research base consists primarily of Randomized Controlled Trials (RCTs) and systematic reviews. Research has explored the use of this medicine in the context of conditions such as Invasive Systemic Candidiasis and Cryptococcal Meningitis. Studies primarily involved adult populations, including non-neutropenic patients in critical care settings, tracking objective measures like fungal clearance in the bloodstream and patient survival rates. Findings from these studies included documentation of clinical outcomes measured during the study period.

Evidence for Use in Prevention (Prophylaxis) in High-Risk Patients

The medicine was evaluated in prophylactic research scenarios focused on prevention in highly vulnerable groups. This included controlled studies involving patients undergoing intensive medical procedures, such as bone marrow transplantation. Research highlights measurements recorded during the study period, including data on the incidence of infection observed during the patient's highest risk phase.

Evidence Gaps and Areas of Uncertainty

The body of research identifies specific areas where data are still emerging. While some studies tracked long-term outcomes, data for certain groups remain insufficient. Research notes limited information regarding the observed resistance patterns, particularly with repeated or extended use, and continued research is ongoing in this area. Furthermore, while some trials compared this medicine to alternatives, research focused on comparisons is limited in certain newer clinical settings.

Research provides context but not individual predictions; study results reflect the specific conditions under which they were conducted, and findings describe group patterns, not personal outcomes.

Frequently Asked Questions (FAQ)

Common questions about Fluconazol Aurobindo (FAQ)

Q: Does Fluconazol Aurobindo affect birth control pills?

A: Regulatory documents indicate that this medicine can alter the concentrations of certain components, such as levonorgestrel, found in oral contraceptives (birth control pills). This potential increase in exposure may be associated with symptoms like nausea, vomiting, or vaginal bleeding. This documented interaction is noted in official information.

Q: Is Fluconazol Aurobindo safe for people with liver concerns?

A: Official information states that fluconazole should be administered with caution to people who have pre-existing liver dysfunction. Serious hepatic toxicity (severe liver damage), which is rare and typically reversible, has been reported. Official guidance describes that monitoring of liver function tests is important, especially for those receiving prolonged treatment.

Q: Can older adults use Fluconazol Aurobindo?

A: Yes, the geriatric population is eligible for use. However, because fluconazole is primarily cleared by the kidneys, official guidance notes that dose adjustments are described as mandated for older adults who have reduced kidney function. This adjustment is based on a specific calculation of kidney function.

Q: Has Fluconazol Aurobindo been studied in children?

A: Yes, regulatory labels provide evidence for the medicine's use, efficacy, and safety in pediatric patients, including children from 6 months up to 17 years old for specific conditions. Dosing for younger patients is calculated based on body weight, and dosage intervals are often extended for newborns.

Q: Is Fluconazol Aurobindo known to interact with blood thinners?

A: Official information confirms an interaction with the anticoagulant (blood thinner) Warfarin. This interaction has been reported to increase prothrombin time, which measures how long blood takes to clot, and carries a risk of bleeding events.

Q: Can I drink alcohol in moderation while on Fluconazol Aurobindo?

A: General regulatory health resources indicate that there are no formal restrictions against drinking alcohol while taking fluconazole. Patients may consider that alcohol can independently affect the liver, and the medicine is associated with a risk of liver toxicity.

Q: Is Fluconazol Aurobindo described as having any specific risks during pregnancy?

A: Regulatory information advises that use during pregnancy is not generally recommended unless it is for a severe or life-threatening fungal infection. Chronic high-dose use for multiple weeks has been associated with reports of birth defects, and the risks should be carefully considered against the potential benefits.

Q: What is the connection between Fluconazol Aurobindo and kidney function?

A: Fluconazole is primarily cleared from the body by the kidneys. Therefore, the daily maintenance dose is reduced for adult patients with impaired kidney function, as the drug is cleared primarily by the kidneys.

Q: Does Fluconazol Aurobindo interact with common heartburn medications?

A: Fluconazole may increase the plasma concentration of Proton Pump Inhibitors (PPIs) used for heartburn by inhibiting how they are broken down in the body. Official documents state that patients taking this combination may be subject to monitoring for potential increased adverse effects of the PPI.

Q: Are there research findings that show how Fluconazol Aurobindo affects different types of fungal infections?

A: The research base summarized in official documents consists primarily of controlled trials that have examined the medicine's use in systemic and invasive fungal infections, such as those involving the bloodstream and nervous system. Studies track objective measures like fungal clearance and patient survival rates.

Q: What is the role of Fluconazol Aurobindo in preventing fungal infections?

A: Official research evidence notes that the medicine has been evaluated for Prevention (Prophylaxis) in highly vulnerable patient groups. This includes controlled studies focused on preventing infection in patients undergoing intensive medical procedures, such as bone marrow transplantation.

Q: Does Fluconazol Aurobindo treat athlete's foot?

A: Regulatory documents primarily focus on systemic and widespread fungal infections, such as candidiasis and cryptococcal meningitis. Non-systemic conditions like athlete's foot are generally not included among the formally listed approved indications for this oral medicine.

Q: How quickly does Fluconazol Aurobindo start working?

A: Regulatory pharmacokinetic data shows that the medicine is almost completely absorbed within two hours of oral administration. However, the time until a patient observes a clinical effect is highly variable and depends on the type and severity of the infection being treated.

Q: Does Fluconazol Aurobindo cause unusual tiredness?

A: The official safety profile of fluconazole lists effects such as fatigue and asthenia (unusual weakness) in the less common adverse reaction tiers. These are listed as potential effects in the regulatory documentation.

Q: Can Fluconazol Aurobindo be taken with other pain relievers?

A: Fluconazole can inhibit certain liver enzymes and increase the concentration of co-administered medicines, including the pain reliever Celecoxib. Monitoring or dosage adjustment of the pain reliever may be necessary when taken together, as documented in regulatory guidelines.

Q: Are there any food or drinks to avoid while taking Fluconazol Aurobindo?

A: The official prescribing information states that this medicine can be taken with or without food, as meals do not significantly affect its absorption. No specific foods or drinks are formally listed as being restricted due to interference with the drug's effectiveness.

Q: Is it normal to feel a mild headache after taking Fluconazol Aurobindo?

A: Yes, official regulatory standards classify headache as a Very Common ( ge 1/10) adverse reaction. This means it is frequently documented in patients using the medicine.

Q: What is the average duration of treatment with Fluconazol Aurobindo?

A: The duration is highly variable and dependent on the infection being treated, according to official guidance. Treatment ranges from a single dose for certain acute conditions to suppressive maintenance therapy that may last for six to twelve months for others.

Q: Do you need to stop driving while using Fluconazol Aurobindo?

A: Regulatory documents advise patients to consider the impact of occasional side effects, such as dizziness or seizures. Because these effects could potentially impact the ability to safely drive vehicles or operate machines, regulatory documents advise patients to consider the impact.

Q: Why might a doctor prescribe a high dose versus a low dose of Fluconazol Aurobindo?

A: For treating systemic infections, regulatory guidance typically includes administering a higher loading dose on the first day, followed by a lower, consistent maintenance dose. This strategy is described to quickly achieve the necessary therapeutic drug level in the body, which is considered important for systemic therapy.

Q: Does Fluconazol Aurobindo treat ringworm?

A: Regulatory documents primarily focus on systemic and widespread fungal infections, such as candidiasis and cryptococcal meningitis. Non-systemic conditions like ringworm are generally not included among the formally listed approved indications for this oral medicine.

Q: Is a metallic taste in the mouth sometimes reported with Fluconazol Aurobindo?

A: The medicine's official safety profile includes reports of changes in taste or taste perversion (dysgeusia) in the Uncommon adverse reaction category.

Q: Are there any specific laboratory tests required before starting Fluconazol Aurobindo?

A: Official guidance indicates that obtaining baseline liver function tests (LFTs) and renal function tests is considered important, especially for patients receiving prolonged treatment.

Q: How long does Fluconazol Aurobindo stay in the body after the last dose?

A: The elimination half-life of fluconazole is approximately 30 hours, with a reported range of 20 to 50 hours. The half-life is the time it takes for half of the drug to be cleared from the body.

Q: Why is Fluconazol Aurobindo sometimes given as a single-dose treatment?

A: Single-dose regimens are used for certain acute conditions, such as vaginal candidiasis. This dosing approach is supported by the drug's long elimination half-life, which allows one dose to remain at therapeutic levels for an extended period.

Q: Are mood changes listed as a potential side effect of Fluconazol Aurobindo?

A: Official safety documents include reports of effects such as mental depression and generalized mood changes in the post-marketing or uncommon adverse reaction categories.

Q: Can Fluconazol Aurobindo be used by people with diabetes?

A: Fluconazole is known to interact with certain oral hypoglycemic drugs (sulfonylureas) used for diabetes. Official regulatory information notes that monitoring of blood sugar levels may be necessary for patients with diabetes using this medicine.

Q: Does Fluconazol Aurobindo interact with caffeine?

A: Regulatory information indicates that fluconazole may slow down the body's clearance of caffeine. This may increase the potential for experiencing common caffeine-related side effects, such as jitteriness or a fast heartbeat.

How should Fluconazol Aurobindo be stored and disposed of?

Storage and Handling Requirements

The storage requirements for Fluconazole Aurobindo are determined by the medication's form, as defined in official regulatory documents.

Fluconazole tablets and the dry powder for oral suspension must be stored below 30°C (86°F). The medicine must be kept in its original container, which should be tightly closed when not in use.

Product Form Required Storage Conditions
Tablets / Dry Powder Store below 30°C
Reconstituted Suspension Store between 5°C and 30°C; Do not freeze

For the reconstituted oral suspension, the liquid must be protected from freezing, and any unused portion must be discarded after 14 days (2 weeks).

Disposal and Safety

All forms of this medicine must be kept out of the sight and reach of children. Unused or expired fluconazole and its container must be disposed of according to local and national regulations using an approved waste disposal plant. The product must not be released into the environment (such as drains or wastewater).

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

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