Fluconazole STADA

Quick links to important sections

Fluconazole STADA

Selected form

Medically reviewed

Rosario Oropesa

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 Fluconazole STADA

What is Fluconazole STADA?

Fluconazole STADA is a medicinal product belonging to a group of drugs known as antifungals. The active substance, fluconazole, is a triazole derivative designed to inhibit the growth and spread of various types of fungi.

Mechanism of Action

The medication works by interfering with the synthesis of ergosterol, a vital component of the fungal cell membrane. By disrupting the formation of this membrane, the medication causes the fungal cells to become unstable and eventually die, thereby stopping the infection from progressing.

Primary Uses

Fluconazole STADA is utilized for the management of a broad range of fungal infections. These typically include:

  • Mucosal Candidiasis: Infections affecting the lining of the mouth, throat, or denture-related soreness.
  • Genital Candidiasis: Yeast infections of the vagina or penis.
  • Skin Infections: Fungal conditions such as athlete's foot, ringworm, jock itch, and nail infections.
  • Systemic Infections: More serious internal fungal infections, such as those found in the bloodstream, urinary tract, or lungs, particularly in individuals with weakened immune systems.
  • Cryptococcal Meningitis: A specific fungal infection affecting the tissues covering the brain.

Prevention

In addition to treating active infections, this medication may be used to prevent the recurrence of specific fungal conditions or to protect individuals who are at a higher risk of developing an infection due to a compromised immune system.

What side effects are possible with Fluconazole STADA?

Possible Side Effects and Safety Information

Fluconazole's safety profile is formally classified by regulatory authorities based on the frequency and the physiological systems affected. Adverse reactions are grouped into categories such as Common, Uncommon, and Rare, as determined through clinical studies.


Official Adverse Reaction Frequencies

Classification Examples of Documented Adverse Reactions
Common Headache, nausea, vomiting, diarrhea, abdominal pain, increases in liver enzyme tests, rash.
Uncommon Dizziness, fatigue, somnolence, insomnia, pruritus (itching), dry mouth, hypokalaemia.
Rare Anaphylaxis, agranulocytosis, Torsade de Pointes, hepatic failure, Stevens-Johnson syndrome.

Safety Considerations and Restrictions

The most frequently observed adverse reactions, including headache and gastrointestinal disturbances, are often reported early in the course of treatment. The regulatory label emphasizes that serious events are rare but documented, particularly concerning the Hepatobiliary Disorders and Cardiac Disorders organ systems.

Serious adverse reactions officially documented include severe cutaneous reactions, such as toxic epidermal necrolysis, and significant effects on the liver, including rare cases of hepatic failure. Due to the potential for QT interval prolongation, Fluconazole is formally contraindicated for use with specific other medicines known to affect heart rhythm. Specific safety cautions are also noted for use in patients with pre-existing hepatic or renal impairment, necessitating observation consistent with the official product labeling.

Overdose and Emergency Response

Overdose and when to seek help

This information is based on official government regulatory documents (e.g., FDA, EMA) and outlines the documented consequences of fluconazole overdose and the required emergency response.


Documented Overdose Manifestations

Official reports indicate that an overdose of fluconazole can primarily affect the Central Nervous System (CNS).

Category Manifestations (as documented in regulatory sources)
CNS Effects Hallucinations (seeing or hearing things that are not there) and paranoid behavior.
Severe Outcomes Seizures, collapse, trouble breathing, or inability to be awakened.

Required Emergency Action

Immediate medical attention is required if an overdose is suspected or if any severe outcomes occur. Regulatory documents explicitly state that you must:

  • Call emergency services or the poison control helpline immediately.
  • Seek immediate emergency treatment if the victim has collapsed, is having a seizure, has trouble breathing, or cannot be awakened.

Management Considerations

Treatment for fluconazole overdose is symptomatic and supportive. For healthcare providers, it is noted that approximately 50% of the fluconazole in the blood can be removed by a three-hour hemodialysis session, which is a key management option.

Therapeutic Uses of Fluconazole STADA

What Fluconazole STADA Treats: Main Uses and Benefits

Fluconazole STADA is a systemic antifungal agent used to provide internal support in managing several domains of fungal infection, which contributes to easing the overall symptom load and helps manage the underlying condition.

This medicine is commonly used to address groups of symptoms that may become intense or disruptive, such as the burning, itching, and soreness of vaginal candidiasis (yeast infection) and oral or esophageal thrush. It is applied in scenarios where topical agents may be insufficient due to the extent or recurrence of symptoms. The medication is also relevant for managing severe systemic illness and organ-specific functional stress, including Candidemia and Cryptococcal Meningitis.

Furthermore, Fluconazole is used in high-risk contexts for supportive management in managing the risk of fungal infections (prophylaxis) in immunocompromised patients. It assists with maintaining functional stability and supports long-term stability by helping manage the recurrence of symptoms.


Quick Facts: Therapeutic Domains

  • Systemic Relief: Applied across domains where additional symptomatic support is needed for conditions presenting with systemic or localized discomfort.
  • Mucosal Symptom Focus: Relevant for managing symptoms that interfere with daily comfort, particularly in recurrent or episodic candidiasis.
  • Prophylactic Support: Used in high-risk scenarios involving heightened systemic burden to help manage the risk of fungal infections.

Regulatory References

  1. NIH DailyMed overview

Eligibility and Restrictions for Use

Fluconazole STADA is an antifungal medication generally used to treat various fungal and yeast infections. It is typically prescribed for adults and can be used in children and adolescents, but often requires close medical supervision, especially for young children.

Contraindications and Precautions

Do not take Fluconazole STADA if you:

  • Have a known allergy to fluconazole, other azole antifungal agents (such as ketoconazole, itraconazole), or any other ingredients in the medicine.
  • Are taking certain medications that can interact dangerously, such as quinidine, pimozide, or erythromycin, which are known to prolong the QT interval on an ECG.

Special caution is required if you have:

Condition Reason for Caution
Heart conditions (especially rhythm problems like QT prolongation or arrhythmias) Increased risk of serious heart rhythm changes.
Liver disease Fluconazole is associated with rare cases of serious liver toxicity; liver function may need monitoring.
Kidney problems Dosage may need adjustment as the drug is mainly excreted by the kidneys.
Electrolyte imbalances (e.g., low potassium or magnesium levels) May increase the risk of heart rhythm disturbances.
Pregnancy or Breastfeeding Use during pregnancy is generally avoided, particularly in the first trimester, due to potential risks to the fetus; consult a doctor. Fluconazole passes into breast milk, and caution is advised.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Co-administration of Fluconazole is formally prohibited with specific medicines due to the documented risk of QT interval prolongation and potential for Torsades de Pointes. These contraindicated agents include Pimozide, Astemizole, Cisapride, Quinidine, and Erythromycin. The restriction for Terfenadine applies specifically when Fluconazole is administered at doses of 400 mg per day or greater.

Fluconazole is a documented potent inhibitor of CYP2C9 and CYP2C19, and a moderate inhibitor of CYP3A4. This pharmacokinetic property results in altered systemic exposure for many co-administered drugs. For Coumarin-type anticoagulants, such as Warfarin, this inhibition leads to an increased Prothrombin Time (PT) and heightened risk of bleeding. The combination with HMG-CoA reductase inhibitors (Statins) increases the officially documented risk of myopathy. Pharmacodynamic interactions, such as those with Amiodarone, may further increase the potential for QTc prolongation.

Other medicines also alter Fluconazole's systemic exposure. Rifampicin is documented to decrease Fluconazole's AUC by 25%. Conversely, the diuretic Hydrochlorothiazide causes a 45% mean increase in Fluconazole's AUC due to reduced renal clearance. Official regulatory text confirms that food does not cause any clinically significant impairment of Fluconazole absorption. Patients with reduced renal function should be monitored due to the drug's dependence on renal clearance.

Mechanism of Action

Targeting the Fungal Cell's Structural Foundation

Fluconazole functions by disrupting the internal workings of the fungal cell, specifically targeting the enzyme Lanosterol 14-alpha-demethylase (CYP51). This molecular action blocks the metabolic pathway required for ergosterol synthesis, which is the primary sterol responsible for the structural integrity and functionality of the fungal plasma membrane.

Cascade of Membrane Failure and Growth Arrest

The enzymatic blockade triggers a damaging cascade within the fungus: essential ergosterol is depleted, while toxic, methylated sterol precursors accumulate in the cell membrane. This combined effect causes the fungal membrane to become abnormally permeable and structurally compromised, leading to growth arrest (a fungistatic effect) rather than immediate killing. This physiological halt allows the host's immune system to participate in clearance of the pathogen.

Mechanism Limitations and Resistance

The drug's mechanism is constrained by fungal defenses, such as genetic mutations in the CYP51 enzyme that reduce drug binding affinity, or the overexpression of specialized efflux pumps. These pump mechanisms actively transport Fluconazole out of the cell, limiting the effective intracellular concentration required for target inhibition.

Dosage and Administration Information

How to Use Fluconazole STADA: Official Administration Guidelines

Fluconazole is a medication utilized through systemic administration, meaning it is taken either orally (as tablets, capsules, or suspension) or via intravenous (IV) infusion. Due to the drug's high bioavailability, the total daily dosage remains the same when switching from the IV route to the oral route, or vice versa.

Dosing and Frequency Patterns

The standard protocol for multi-dose therapy involves administering a loading dose on the first day, which is typically twice the daily maintenance dose. This strategy is intended to allow plasma concentrations near steady-state to be achieved more rapidly. Following the loading dose, the medicine is generally administered once daily.

Treatment duration varies significantly by the specific condition being managed, ranging from a single oral dose for acute indications up to a long-term suppressive course of several months or more for relapse prevention in high-risk patients. The oral forms may be taken with or without food.

Special Procedural Instructions

For the intravenous form, the solution must be administered via infusion at a rate not exceeding 10 mL per minute.

Dose adjustments are mandatory for certain populations. In adult patients with renal impairment (kidney function impairment), the recommended daily dose is typically reduced by 50% after the initial loading dose. Conversely, patients undergoing hemodialysis should receive a full daily dose following each dialysis session. Furthermore, pediatric dosing is calculated based on a weight-based (mg/kg) schedule rather than standard adult fixed doses.

Recent Clinical Evidence

Research evidence / Overview of studies for Fluconazole STADA


Evidence for Use in Mucosal and Superficial Fungal Infections

The evidence base includes Randomized Controlled Trials (RCTs), systematic reviews, and evidence from authoritative clinical guidelines for conditions such as oral thrush and vaginal yeast infections. Studies were applied in research contexts involving immunocompetent and immunocompromised adults, monitoring outcomes related to physical discomfort and fungal clearance. Long-term follow-up and the durability of the medicine's effect remain areas of uncertainty, and research on microbiological resistance is ongoing.


Evidence for Use in Severe Systemic Fungal Infections

Fluconazole STADA was studied for severe internal conditions, including Candidemia. Research examined the medicine in multicenter RCTs involving hospitalized, non-neutropenic adults. Studies monitored outcomes monitoring physiological strain and clearance rates. Evidence is limited regarding the medicine's role against certain non-albicans species of Candida (such as C. krusei), and data on long-term functional outcomes after recovery are not extensively characterized.


Evidence for Use in Prevention (Prophylaxis)

Research explored Fluconazole STADA as a tool for managing the risk of fungal infections (prophylaxis) in groups with significant systemic imbalance. Randomized Controlled Trials (RCTs) focused on high-risk populations, including Allogeneic Stem Cell Transplant recipients and very low birth weight (VLBW) infants. Studies monitored outcomes related to systemic or functional imbalance, tracking the incidence of Invasive Fungal Infection (IFI). Findings describe group patterns related to IFI incidence, but the development of drug resistance during prophylactic use is a matter for ongoing research.


Long-Term Studies, Special Populations, and Uncertainty

Studies have explored the medicine's role in maintenance therapy for conditions like Cryptococcal Meningitis, tracking the rate of symptom relapse over extended time intervals. Research has also explored its use in special subgroup populations, including preterm infants and adults with various levels of immune compromise. However, the comparative evidence is lacking in some contexts, and follow-up durations were limited for many acute infection trials. Data for certain groups (e.g., pregnant populations) remain insufficient.

Key Studies & References

  1. Guidelines for Diagnosing, Preventing and Managing Cryptococcal Disease Among Adults, Adolescents and Children Living with HIV - WHO (2022 Update)
  2. Label: FLUCONAZOLE tablet - DailyMed (FDA-regulated Product Information)
  3. A meta-analysis of fluconazole for the prevention of invasive fungal infection in preterm infants

Frequently Asked Questions (FAQ)

Common questions about Fluconazole STADA (FAQ)


Q: Is Fluconazole STADA considered an antibiotic?

A: No. Fluconazole STADA contains the active ingredient fluconazole, which is classified by regulatory authorities as a synthetic triazole antifungal agent, also known as an antimycotic drug. This means it is designed to fight fungal infections, not bacterial infections, which are treated with antibiotics.


Q: Is Fluconazole STADA the same as over-the-counter yeast infection treatments?

A: Fluconazole STADA is designated as a prescription-only (Rx) medication. This classification distinguishes it from certain lower-strength, non-systemic treatments that may be available for purchase over-the-counter.


Q: What is the difference between Fluconazole and Fluconazole STADA?

A: Fluconazole is the generic name for the active drug component. Fluconazole STADA is a brand-name product that contains this active ingredient. Multiple manufacturers offer fluconazole under its generic name or various brand names.


Q: How quickly does Fluconazole STADA start working for a thrush infection?

A: According to official pharmacokinetic data, the medicine is quickly absorbed after an oral dose. Peak concentrations in the bloodstream are generally reached within 1 to 2 hours. However, the patient-reported experience and the time required to notice symptom relief vary based on the type and severity of the infection.


Q: How long does the medicine stay in your system?

A: Official information indicates the terminal elimination half-life is approximately 30 hours (range: 20 to 50 hours) in healthy adults. This means it takes about 30 hours for half of the drug to be cleared from the plasma. The body’s process for clearing the substance is consistent with the elimination half-life time frame.


Q: Does Fluconazole STADA affect birth control pills?

A: Studies on drug interactions indicate that higher doses of fluconazole (e.g., 200 mg) can increase the systemic exposure to the components found in many oral contraceptives (birth control pills). This suggests a potential for altered concentrations of the birth control components. If you are using oral contraceptives, it is noted that altered concentrations may occur.


Q: Is it okay to drink alcohol while using Fluconazole STADA?

A: Official drug labels do not list alcohol as a direct drug-drug interaction. However, both alcohol consumption and fluconazole use are associated with side effects such as headache, nausea, and potential liver-related effects. Combining them carries the possibility of increased incidence of these side effects.


Q: Are there different strengths of Fluconazole STADA available?

A: Yes, regulatory documents list that fluconazole is available in various strengths for oral administration, commonly including capsules or tablets of 50 mg, 100 mg, 150 mg, and 200 mg. The oral suspension is also available in different concentrations for liquid dosing.


Q: Does Fluconazole STADA interfere with cold and flu medications?

A: Fluconazole is known to inhibit certain liver enzymes (CYP2C9, CYP2C19, and CYP3A4) responsible for breaking down many other drugs. Although specific cold and flu medications are not universally listed, any co-administered drug that relies on these enzymes may have an altered concentration in the body.


Q: Can Fluconazole STADA cause hair thinning or hair loss?

A: While not listed as a Common or Uncommon side effect in all primary regulatory documents, official regulatory documentation acknowledges that post-marketing reports have described an association between long-term use and a type of hair loss known as alopecia.


Q: Does taking antacids or stomach acid reducers affect Fluconazole STADA?

A: Official interaction studies show that taking a common antacid (e.g., one containing magnesium hydroxide) immediately before a dose of fluconazole has no clinically significant effect on the absorption or elimination of fluconazole.


Q: Can Fluconazole STADA affect blood sugar levels?

A: Yes. Fluconazole is documented to interact with certain oral medications used to treat high blood sugar (oral hypoglycemic agents), such as Glipizide. If taken together, this combination can lead to a significant increase in the blood sugar-lowering effect (hypoglycemia). This interaction may be a consideration when managing overall treatment.


Q: Are there known interactions between Fluconazole STADA and herbal supplements?

A: Specific herbal supplements are not universally listed in regulatory documents. However, because fluconazole inhibits key liver enzymes like CYP3A4, any herbal product metabolized by these same enzymes may experience increased concentrations in the body.


Q: Does Fluconazole STADA change the way certain painkillers work?

A: Official interaction data confirms that certain opioid pain medications, such as Fentanyl and Methadone, are metabolized by the same enzymes that fluconazole inhibits (CYP3A4). Taking fluconazole can increase the systemic concentrations of these painkillers, and this interaction is a documented consideration when managing co-administration.


Q: Does the medicine come with a patient information leaflet (PIL)?

A: Yes. Regulatory requirements globally mandate that prescription medication dispensed to a patient must be accompanied by a Patient Information Leaflet (PIL) or Medication Guide. This guide provides critical information on proper use, known risks, and safe storage.


Q: Does Fluconazole STADA treat all types of fungal infections?

A: The medicine is indicated for treating infections caused by susceptible species of Candida and Cryptococcus. However, official information clarifies that it is not effective against all fungal species, such as Candida krusei, and is therefore not an appropriate treatment for all types of fungal infections.


Q: Can Fluconazole STADA cause changes in mood or sleep?

A: The medicine is associated with documented side effects that affect the Central Nervous System (CNS). These include dizziness, insomnia (difficulty sleeping), and somnolence (drowsiness). These effects are classified within the nervous system disorders.


Q: Is Fluconazole STADA used to treat skin infections or just internal ones?

A: Regulatory indications confirm that fluconazole is used to treat both systemic (internal) and mucosal/superficial fungal infections. This includes those involving the skin, such as dermatophyte infections (e.g., ringworm) and fungal infections of the nails (onychomycosis).


Q: Why is it sometimes described as a 'broad-spectrum' antifungal?

A: Fluconazole is often characterized as 'broad-spectrum' because, according to official microbiology data, it is active against a wide range of fungi. It is indicated for infections caused by Candida and Cryptococcus genera, providing versatile use compared to antifungals that are restricted to very specific fungal species.


Q: Are there any risks associated with taking a single high dose?

A: Official administration guidelines include a strategy to ensure high drug concentrations are achieved quickly. This involves an initial dose that is larger than subsequent daily doses. The side effect profile for a single high dose is similar to daily dosing, but the risk of dose-related adverse effects is a documented factor for any higher-than-usual dose.


Q: Are there specific times of day that the medicine is usually taken?

A: Official patient information states that the medicine can be taken with or without food and is generally administered once daily. For consistent therapeutic effect, it is recommended to take the medication at the same time each day.


Q: What is the likelihood of a fungal infection returning after treatment with Fluconazole STADA?

A: The risk of infection returning (relapse) varies widely and is dependent on the specific condition treated and the individual's immune status. Clinical study data is available which shows that for certain indications, the rate of relapse can be low in the weeks following treatment.


Q: Can Fluconazole STADA be used by older adults (seniors)?

A: Yes. Official guidelines confirm that older adults (65 years and over) can use the medicine. However, because kidney function naturally declines with age, regulatory labels often require that the dose be adjusted based on calculated kidney function to avoid drug accumulation.


Q: Does Fluconazole STADA work against dermatophytes?

A: Yes. Official indications and usage information confirms that fluconazole is approved for treating types of fungal infections called Tinea (which includes common skin conditions like ringworm and jock itch) caused by dermatophytes.


Q: Is Fluconazole STADA effective for fungal infections of the nails?

A: Yes. Fluconazole is listed in official regulatory documents as indicated for the treatment of certain fungal infections of the nails, known medically as onychomycosis.

How should Fluconazole STADA be stored and disposed of?

The storage and disposal of Fluconazole must adhere to official regulatory conditions to maintain product integrity and safety.

Storage Requirements

Dosage Form Required Storage Conditions
Tablets / Dry Powder Store below 86 F (30 C). Keep in the original container, tightly closed
Reconstituted Suspension Store between 41 F (5 C) and 86 F (30 C). Protect from freezing

All forms of the medicine must be stored out of the sight and reach of children.

Stability and Disposal

The fluconazole oral suspension, once mixed, has a limited shelf-life and must be thrown away if unused after 14 days. Any expired or no longer needed Fluconazole should be discarded following official guidelines, such as those provided by the FDA, to ensure proper handling and environmental safety.

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

Available in countries:

Equivalent of Fluconazole STADA found in:

A-Z Index: