Sterinazol

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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 Sterinazol

What is Sterinazol? Defining its Identity and Class

Property Description
Active ingredient Fluconazole
Form Tablets, Sterile solution, Oral suspension
Pharmacological class Triazole Antifungal
Common purpose Systemic control of fungal growth
Origin Synthetic chemical

Sterinazol is a pharmaceutical preparation whose sole active ingredient is Fluconazole, classifying it as a potent systemic antifungal agent. This medicine belongs formally to the triazole class of antifungals, a group of drugs designed to inhibit the proliferation of fungal organisms throughout the body.

The classification of Sterinazol as a triazole antifungal confirms its nature as a synthetic compound that is structurally distinct from earlier azole agents. Fluconazole is clinically recognized for its established therapeutic role, offering widespread utility in combating systemic fungal issues. This systemic capability represents a key differentiator from medications used only for topical fungal applications.

Composition and Available Pharmaceutical Forms

The foundation of Sterinazol is the active substance, Fluconazole, designated by the empirical formula C13H12F2N6O.

This active ingredient is prepared in several dosage forms for systemic use, ensuring flexibility in delivery and patient management. These forms include tablets for oral administration, powder for the reconstitution of an oral suspension, and a sterile solution suitable for intravenous infusion. This capability for both convenient oral administration and essential intravenous delivery is utilized to simplify therapeutic requirements across various clinical settings.

Mechanism and General Therapeutic Purpose

The general therapeutic purpose of Sterinazol is to achieve systemic control over fungal proliferation by functioning as a potent fungistatic agent. This action prevents the targeted fungal organisms from growing and replicating effectively.

The core mechanism relies on Fluconazole being a selective inhibitor of a key fungal enzyme, which disrupts the synthesis of ergosterol, a lipid essential for maintaining the structural integrity of the fungal cell membrane. This targeted biological interruption is fundamentally why the medicine is used to suppress the growth and spread of pathogenic fungi that may affect internal systems.

Regulatory References

  1. Fluconazole - StatPearls - NCBI Bookshelf

What side effects are possible with Sterinazol?

Possible side effects and safety information

Regulatory documents organize the safety profile of Sterinazol (Fluconazole) by classifying documented adverse reactions based on their frequency and the physiological systems affected. This framework establishes the official, non-advisory description of possible side effects.

Frequency-Classified Adverse Reactions

The most common adverse reactions reported in regulatory sources generally involve the gastrointestinal system (Nausea, Vomiting, Diarrhoea, Abdominal pain) and the Nervous System (Headache). Increases in certain liver enzyme levels (ALT, AST, ALP) are also classified as Common.

Adverse reactions classified as Uncommon include Anaemia, Insomnia, Dizziness, Seizure, and various skin reactions such as Urticaria and Pruritus.

Serious Adverse Reactions and Safety Constraints

Specific low-frequency events are highlighted as serious. These Rare adverse reactions include severe dermatologic conditions like Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), significant changes in blood cell counts (e.g., Agranulocytosis), and severe liver injury, including Hepatic Failure.

Safety constraints noted in official labeling include a contraindication for individuals with known hypersensitivity to azole antifungals. Additionally, caution is noted for patients with pre-existing conditions that predispose them to cardiac arrhythmias, due to the rare documented risk of QT prolongation and Torsade de Pointes. Safety considerations are also noted for the pediatric population and patients with underlying hepatic impairment.

Overdose and Emergency Response

Overdose has been officially documented to result in severe central nervous system (CNS) manifestations. These regulator-noted presentations include hallucinations (seeing, hearing, or feeling things that are not there) and paranoid behavior, alongside extreme fearfulness or suspiciousness. The cardiovascular and hepatic systems are physiological systems potentially affected. Severe outcomes documented in the regulatory profile include QT prolongation and the risk of Torsades de Pointes, a life-threatening ventricular arrhythmia, and the potential for serious hepatic toxicity.

Urgent medical contact is mandated; the patient must seek immediate medical attention or contact a poison control center or emergency room at once when excessive amounts are taken. The overdose profile classifies potential outcomes as severe and potentially life-threatening, as defined by regulatory labeling. Management is restricted to symptomatic and supportive treatment because no specific antidote is known.

Fluconazole is primarily cleared by renal excretion, a factor that influences management. Hemodialysis is an officially documented procedural measure: a three-hour session is known to decrease the drug’s plasma concentration by approximately fifty percent, aiding in drug removal.

Therapeutic Uses of Sterinazol

What Sterinazol Treats: Main Uses and Benefits

Sterinazol (Fluconazole) is commonly used to provide comprehensive therapeutic support against yeast and fungal infections. Its application is considered relevant across domains where the infection is widespread, deep-seated, or recurrent, offering benefits that extend beyond simple localized relief.

Primary therapeutic domains include managing severe systemic and disseminated candidiasis (e.g., in the bloodstream or organs), Cryptococcal Meningitis, and infections of the mucous membranes such as oropharyngeal (mouth/throat), esophageal, and vulvovaginal candidiasis.

This medicine is applied in addressing conditions that involve inflammatory or irritative processes and helps address symptom clusters that may become disruptive. For instance, it is relevant for easing symptoms linked to organ-specific functional stress and physical discomfort like soreness and burning in mucosal areas. It supports the patient by addressing the underlying fungal issue.

The medication is commonly used to help prevent the onset of fungal infections in individuals with significantly weakened immune systems. This action provides support that helps ease the overall symptom burden and supports general well-being during symptomatic phases.

Quick Fact: Therapeutic Support Domains
Sterinazol is used for managing severe infections of the bloodstream and central nervous system, and may assist with preventing recurrence of mucosal candidiasis.

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Sterinazol — Official Regulatory Information

This section outlines population eligibility strictly based on government regulatory documentation (e.g., FDA, EMA).

Category Official Regulatory Statement
Populations for whom use is contraindicated: Patients with known hypersensitivity to the drug or any component. Concomitant use with organic nitrates in any form or with guanylate cyclase stimulators is strictly prohibited.
Age-related eligibility rules: Use for specific indications is restricted to adults 18 years and older. Use in children younger than one year is generally not established; specific pediatric use rules apply to older children (1–17 years) for approved indications.
Condition-specific eligibility rules: The medicine is contraindicated in patients with a recent history of stroke or myocardial infarction and certain severe cardiovascular disorders. Caution is advised for patients with severe hepatic impairment or severe renal impairment due to reduced drug clearance.
Pregnancy and lactation eligibility status: Data is insufficient to clearly determine risk in pregnancy; use is often decided by physician assessment of the mother's risk from untreated disease. Drug levels are excreted into breast milk, and caution is advised.

Official regulatory documents define the eligible population by establishing absolute contraindications (e.g., co-medication and allergy) and specific age limitations. Use is restricted to patients without specific severe comorbidities or organ dysfunction.

What should I know about interactions with other medicines?

The official interaction profile for Sterinazol (Fluconazole) is primarily defined by its classification as a potent inhibitor of CYP2C9 and CYP2C19 isoenzymes, and a moderate inhibitor of CYP3A4. This established metabolic mechanism results in reduced clearance and a clinically significant increase in the systemic exposure (AUC/Cmax) of many co-administered medicinal products that are substrates of these enzymes.

Contraindicated Combinations and Pharmacodynamic Risk

Formal prohibitions exist for co-administration with specific drugs, including Pimozide, Astemizole, and Erythromycin. These combinations are strictly contraindicated due to the high risk of severe ventricular arrhythmias, stemming from a documented pharmacodynamic additive effect on QT interval prolongation.

Exposure Modification and Substance Interactions

Co-administration is known to increase the plasma concentrations of critical drugs, such as certain immunosuppressants (e.g., Cyclosporine), oral anticoagulants (e.g., Warfarin), and Statins. Conversely, drugs that induce metabolism, such as Rifampin, are documented to decrease the plasma concentration of Fluconazole itself. The regulatory documentation notes that absorption is not affected by food. The potential for these pharmacokinetic interactions persists for four to five days after discontinuing treatment. Population-specific notes also indicate that clearance is markedly affected by renal impairment.

Mechanism of Action

Targeting the Fungal Sterol Synthesis Enzyme

The mechanism of Sterinazol (Fluconazole) initiates by selectively inhibiting the enzyme lanosterol 14-alpha-demethylase (CYP51), found in fungal organisms. This targeted inhibition blocks a critical step in the ergosterol biosynthesis pathway, which is critical for fungal cell structural integrity.

Disruption of Fungal Membrane Integrity

By preventing ergosterol production, the drug causes the fungal cell membrane to become structurally deficient, overly permeable, and functionally unstable. This failure in cellular integrity is compounded by the accumulation of toxic sterol precursors, which ultimately halts the cell's ability to grow and replicate, which establishes the mechanism's fungistatic nature.

Limits to Mechanistic Efficacy

The mechanism's action is biologically constrained by fungal resistance development. These constraints include mutations in the ERG11 gene (reducing the drug's affinity for the target) and the upregulation of efflux pumps that actively expel the medicine, defining the biological limits of the mechanism.

Dosage and Administration Information

How to Use Sterinazol: Official Administration Guidelines

Sterinazol (Fluconazole) administration is standardized for ensuring consistent systemic exposure to the active ingredient. The medicine is officially administered through two main routes: oral intake, using tablets or the reconstituted oral suspension, and intravenous (IV) infusion, typically reserved for severe infections or when oral administration is not feasible.

Dosing and Frequency Patterns

Administration schedules are often structured with an initial loading dose on Day 1, which is generally twice the subsequent daily amount, followed by a lower maintenance dose taken once daily (QD). For acute, uncomplicated conditions like vaginal candidiasis, the established standard is a single 150 mg oral dose. Oral forms can be taken independently of meals.

Contextual and Population-Specific Use

Treatment duration varies significantly based on the condition being addressed, ranging from short-term single-dose use to long-term regimens of several months for deep-seated infections such as Cryptococcal Meningitis. Procedural constraints dictate that the IV solution must be infused slowly, at a rate not exceeding 200 mg per hour, in a supervised setting. Furthermore, the daily dose must be reduced by 50% for patients with significant renal impairment (creatinine clearance le 50 mL/min), following the initial full loading dose, to prevent accumulation of the medicine in the body. For pediatric patients, dosing is calculated based on body weight, while older adults receive standard dosing unless kidney function is reduced.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Sterinazol

Evidence for Use in Systemic and Disseminated Candidiasis

Research exploring the use of Sterinazol for serious, widespread fungal conditions, such as Candidemia (bloodstream infection), primarily involves Randomized Controlled Trials (RCTs). These trials were conducted during periods of increased symptom activity and often compared Sterinazol to other antifungal agents or examined its use as a transition therapy following an initial intravenous agent. Studies monitored physiological strain or stress, often measuring clinical stabilization and the rate of fungal clearance (mycological eradication) from the bloodstream and deep tissues.

Findings describe patterns observed in these studies related to rates of fungal clearance and mortality measured at defined time points. The evidence contributes to understanding symptom patterns and primarily involves the observation of non-critically ill adults with infections determined to be susceptible during the study. For patients in non-critical condition, the evidence level is characterized as high for this specific context, with research describing short-term changes.

Evidence for Use in Cryptococcal Meningitis

Studies conducted during periods of increased symptom activity have examined Sterinazol's role in treating infections of the Central Nervous System (CNS), often in combination with other agents, across the different treatment phases: initial (induction), intermediate (consolidation), and long-term maintenance. Studies monitored outcomes related to systemic or functional imbalance by measuring fungal clearance rates in the Cerebrospinal Fluid (CSF), patient survival, and the frequency of infection recurrence.

Studies monitored rates of recurrence, with data showing patterns observed when Sterinazol was used for long-term suppressive therapy. For the consolidation and maintenance phases, the evidence level is characterized as high. Research exploring the initial, high-symptom-burden induction phase has more limited evidence regarding the use of Sterinazol as a monotherapy (alone).

Evidence for Use in Mucous Membrane Candidiasis

Randomized trials have studied Sterinazol for conditions characterized by fluctuating or episodic manifestations affecting the mucous membranes. Research examined short-term symptom changes, comparing various doses or durations of the medicine to placebo or other local treatments. Studies monitored outcomes linked to inflammatory or irritative states, such as patient-reported outcomes describing perceived discomfort, physical discomfort, and rates of fungal clearance (mycological eradication).

Research highlights changes measured during the study period, with studies reporting measured outcomes related to clinical status across the various mucosal sites studied. The evidence level is generally characterized as high for susceptible infections, particularly for the short-term outcomes related to physical discomfort.

Frequently Asked Questions (FAQ)

Common questions about Sterinazol (FAQ)

Q: How quickly should I expect Sterinazol to start working?

How quickly Sterinazol starts to work depends on the condition being treated. For acute, uncomplicated infections, the medication is often administered as a single dose, which is consistent with a quick onset of therapeutic effect for that indication. For more severe or deep-seated infections, the drug levels required for optimal therapeutic activity may be reached within approximately 5 to 10 days of once-daily administration, particularly when an initial loading dose is administered.


Q: Are there any long-term side effects from using Sterinazol?

Regulatory documents classify the known adverse reactions by frequency, ranging from common to rare and severe effects like liver failure. While the official documents do not provide a dedicated summary of long-term risks, clinical studies note that adverse effects observed during long-term therapy may necessitate clinical monitoring. The full safety profile is continually monitored through ongoing post-marketing surveillance.


Q: Why does Sterinazol sometimes cause a burning sensation when I apply it?

Official product information notes that a burning or uncomfortable feeling is a common symptom associated with the fungal infection itself. If the medicine is used in a form that contacts the skin, some redness and soreness have been associated with both the underlying infection and potential skin reactions that are documented in the adverse events profile.


Q: Is it normal to see some redness right after applying Sterinazol?

Redness (erythema) is frequently cited as an inflammatory symptom of the underlying fungal infection being treated. Official adverse reaction lists also include general skin reactions like hives and itching (pruritus), which may involve some degree of redness or irritation at the application site.


Q: Can Sterinazol make my skin thinner if I use it for too long?

Skin thinning (atrophy) is a risk primarily associated with long-term use of topical steroids. Because Sterinazol (Fluconazole) is classified as an antifungal agent, its mechanism does not, in itself, typically lead to skin thinning. However, other rare, severe skin reactions are documented in the safety information.


Q: What is the main difference between Sterinazol and other common skin creams?

Sterinazol (Fluconazole) is a synthetic triazole antifungal agent designed for the systemic control of fungal growth throughout the body. The primary difference is that Sterinazol is typically used to treat systemic or deep-seated fungal infections. Many common skin creams are used only for localized topical application and may target different types of conditions, such as simple dryness or bacterial issues.


Q: Can Sterinazol be used for conditions other than skin infections?

Yes, Sterinazol is primarily approved for the treatment of serious, widespread fungal conditions. Its official indications include systemic fungal infections such as Candidemia (a bloodstream infection), Cryptococcal Meningitis (an infection of the central nervous system), and various forms of candidiasis affecting the mouth or esophagus.


Q: Why do some people report feeling dizzy or nauseous after using Sterinazol cream?

Official regulatory documents list Nausea, Vomiting, and Dizziness as Common adverse reactions related to the systemic effects of the medication. This means that these effects are frequently reported in patients using the medication, regardless of the formulation.


Q: Is Sterinazol similar to hydrocortisone in its effects?

No, Sterinazol is not similar to hydrocortisone. Sterinazol is an antifungal that specifically stops fungal cells from growing, while hydrocortisone is a corticosteroid used to reduce inflammation and suppress immune responses. They belong to two entirely different drug classes.


Q: What is the role of the inactive ingredients in the Sterinazol formulation?

Inactive ingredients are components added to the medicine to provide its physical form, such as the shape of a tablet or the consistency of a liquid. They are essential for stabilizing the product and ensuring that the active ingredient is properly absorbed by the body. The regulatory labels list these components alongside the active ingredient.


Q: What happens if I stop using Sterinazol too early?

Regulatory guidelines stress the need to complete the full prescribed course of treatment, even if symptoms begin to improve. Stopping the medicine too early can lead to the recurrence of the infection. Furthermore, prematurely ending treatment may contribute to the development of drug-resistant fungal organisms.


Q: Does Sterinazol make the skin more sensitive to the sun?

The official regulatory documents list general skin reactions like rash and pruritus (itching) among the possible side effects. However, the primary labeling does not explicitly list photosensitivity or require special sun-avoidance precautions.


Q: Why do some people confuse Sterinazol with a simple antibiotic?

Both antibiotics and Sterinazol are used to treat infections caused by harmful organisms, which can lead to public confusion. However, Sterinazol is strictly an antifungal agent that targets fungi, while antibiotics target bacteria. Official information states that Sterinazol is not effective against infections caused by bacteria or viruses.


Q: How long does the effect of one application of Sterinazol usually last?

Sterinazol (Fluconazole) has a relatively long half-life, meaning it remains active in the body for an extended period. For adults with normal kidney function, the plasma half-life is approximately 30 hours. This long duration of effect supports the medicine's once-daily or single-dose administration for many indications.


Q: Is there a generic version of Sterinazol available?

Yes. The active ingredient in Sterinazol is Fluconazole. According to regulatory information, Fluconazole is widely available as a generic drug in various strengths and pharmaceutical forms in addition to the brand-name product.


Q: Does Sterinazol lose its effectiveness over time after opening the tube?

The stability of the medication after opening depends on the formulation. Official labeling specifies that the oral suspension form, once mixed, must be discarded after 14 days, even if refrigerated. Other forms, such as tablets and IV solutions, maintain effectiveness until their printed expiration date, provided they are stored according to the stated conditions.


Q: Is Sterinazol known to interact with common pain relievers like ibuprofen?

Yes, official regulatory documents note that Sterinazol can interact with Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), which includes common pain relievers like ibuprofen. Co-administration is known to increase the concentration of the NSAID in the body, which may increase the need for clinical observation.


Q: Is Sterinazol considered a 'strong' or 'mild' topical medicine?

Sterinazol is formally classified in regulatory documents as a potent systemic antifungal agent. The term 'potent' reflects its high effectiveness in inhibiting the fungal enzyme target. It is not given a formal strength rating in the same way that topical steroid creams are rated.


Q: How does Sterinazol get absorbed into the skin?

Studies on the drug’s distribution show that after oral administration, Sterinazol is well-distributed throughout the body. Concentrations of the drug in skin and blister fluid have been documented to exceed those in the blood plasma, supporting its effective distribution into the dermal layers.


Q: Is it better to apply Sterinazol in the morning or at night?

Official administration instructions state that the medicine should be taken at the same time each day to maintain consistency. Regulatory documents indicate the medicine can be taken with or without food, and do not specify whether morning or night is superior.


Q: What are the ingredients that patients might be sensitive to in Sterinazol?

Regulatory documents state that the medicine is contraindicated if you have a known hypersensitivity to the drug or any of its components. The official labels provide a list of both the active ingredient, Fluconazole, and all inactive ingredients (e.g., colorants, binders, and fillers) that could potentially cause a reaction.


Q: Does Sterinazol cause hair growth or loss in the area of application?

Hair loss, or alopecia, has been reported as an adverse effect in regulatory documents. This adverse effect has been reported by patients, particularly those receiving longer courses of treatment.


Q: Can Sterinazol be used on pets like cats or dogs?

Official regulatory documents and labeling only address the use and safety of Sterinazol for human patients. Any use of this medication in animals is considered off-label and must be determined and managed solely by a qualified veterinarian.


Q: Are there any documented cases of resistance developing to Sterinazol's active ingredients?

Yes, the official regulatory documents acknowledge that resistance to the active ingredient, Fluconazole, is a known potential. The documents state that resistance mechanisms, such as changes in the fungal enzyme or increased expulsion of the drug from the cell, have been documented and are monitored in various fungal species.


Q: Is Sterinazol effective for treating yeast infections?

Yes, Sterinazol (Fluconazole) is indicated for the treatment and prophylaxis of infections caused by Candida species. These are the organisms most commonly responsible for the conditions publicly known as 'yeast infections,' such as vaginal or esophageal candidiasis.


Q: Can Sterinazol be stored at room temperature, or does it need to be refrigerated?

Storage depends on the specific form. Tablets and dry powder should be stored below 30 C (86 F), which is consistent with room temperature. However, the intravenous solution and the reconstituted oral suspension have specific temperature requirements and must be kept protected from freezing.

How should Sterinazol be stored and disposed of?

The storage and disposal instructions for Sterinazol (Fluconazole) are defined by regulatory requirements to maintain product quality and safety.

Official Storage Conditions

Dosage Form Required Storage Temperature
Tablets / Dry Powder Below 30°C (86°F)
IV Solution 20°C to 25°C (68°F to 77°F)

All forms of Sterinazol must be stored in the original container, kept tightly closed, and protected from freezing. The medicine must be stored out of the reach of children.

Stability and Disposal

The reconstituted oral suspension has a limited shelf-life and must be discarded after 14 days. Unused or expired Sterinazol must be disposed of safely by following established governmental guidelines for safe medicine disposal.

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

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