Fazol 2%

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Fazol 2%

Treatment option: Empeines

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 Fazol 2%

Quick Facts

Property Description
Active ingredient Isoconazole nitrate (2%)
Form Topical cream
Pharmacological class Imidazole antifungal agent
Common use Treatment of superficial fungal infections (mycoses)
Origin Synthetic azole derivative

Fazol 2%: Definition and Pharmacological Classification

Fazol 2% is a pharmaceutical preparation formulated for cutaneous application containing the active ingredient, Isoconazole nitrate. This substance is a synthetic azole derivative classified as an antifungal agent. The medicine belongs to the imidazole sub-group of antimycotics, designed exclusively for treating infections on the skin. Isoconazole possesses both highly effective antimycotic activity and documented activity against certain Gram-positive bacteria, which broadens its potential therapeutic application. The preparation is designated as a single-active ingredient product, focusing the therapeutic effect solely on the established properties of Isoconazole nitrate.

Composition, Form, and General Therapeutic Purpose

The medicine is supplied as a topical cream with a 2% concentration, meaning the preparation contains 2 grams of Isoconazole nitrate per 100 grams of the final product. The active substance is suspended within an emulsified cream base, ensuring targeted delivery to the infection site on the skin. Fazol 2% is generally intended to provide direct therapeutic action against the fungal organisms responsible for skin conditions, addressing the source of superficial mycoses. Isoconazole’s effectiveness is comparable to other established azole antifungals, highlighting its reliable function within the class of topical antimycotics.

The Core Action of Isoconazole (High-Level Principle)

The fundamental mechanism of Isoconazole involves the selective disruption of fungal cell viability through the inhibition of ergosterol biosynthesis, a vital sterol that provides structural integrity to the fungal cell membrane. By blocking its production, Isoconazole destabilizes the cell wall, which prevents the organism from growing and reproducing effectively. This targeted intervention provides a potent fungistatic and fungicidal effect, which is the foundational basis for its success in clearing skin infections.

What side effects are possible with Fazol 2%?

The safety profile for Fazol 2% (Isoconazole nitrate cream) is primarily structured around local effects consistent with a topical medicine, which are classified within the official System-Organ Classes (SOCs) of General disorders and administration site conditions and Skin and subcutaneous tissue disorders. The risk of systemic adverse reactions is considered low due to the active ingredient's minimal systemic absorption following cutaneous application.

Adverse reactions observed in clinical use are categorized by frequency. The most frequently observed reactions at the application site include irritation and a burning sensation. These effects are often documented as part of the official safety profile.

Other local effects are also documented, although their precise occurrence rate in the population cannot be reliably determined and are classified under Frequency Not Known. These effects may involve local manifestations such as pruritus (itching), erythema (redness), dryness, and the appearance of vesicles (small blisters) at the site of application. Furthermore, the possibility of allergic skin reactions (hypersensitivity) to any component of the formulation is noted within the classification of Skin and subcutaneous tissue disorders.

Regulatory documents do not typically list specific serious adverse reactions for the topical monotherapy cream, reinforcing the safety profile's localized focus. Likewise, due to the minimal systemic exposure, there are no explicit safety statements in official labeling regarding population-specific considerations for groups such as older adults, or those with renal or hepatic impairment. This localized safety profile reinforces that the official risk assessment is centered on potential skin-related events.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information emphasizes that the risk of acute systemic intoxication is documented as unlikely from the intended topical application of Fazol 2% (Isoconazole nitrate cream). This is due to the formulation's minimal systemic absorption when applied to the skin, which is consistent across regulatory labeling.

Overdose concerns focus on accidental oral ingestion of the cream. In such cases, official prescribing information documents the potential for gastrointestinal distress, including symptoms like nausea and vomiting. These are the primary clinical manifestations listed in government sources following accidental swallowing.


Required Emergency Action

Regulatory authorities mandate that immediate medical attention is required for any suspected or confirmed accidental ingestion of the cream. Individuals must promptly contact a poison control center or emergency services to report the event, as described in official emergency-response statements.

Regarding treatment, official regulatory documents explicitly state that no specific antidote is known for Isoconazole nitrate overdose. Consequently, management is limited to symptomatic and supportive treatment, which may include procedures like gastrointestinal decontamination, depending on the professional clinical assessment of the amount ingested and the patient's presentation.


Overdose Profile Summary

Classification Regulatory Statement (Official Basis)
Severity Classification Acute systemic intoxication is considered unlikely from topical use.
Treatment Focus Symptomatic and supportive measures only.
Urgent Action Immediate medical help is required for any accidental ingestion.

Therapeutic Uses of Fazol 2%

What Fazol 2% Treats: Main Uses and Benefits

Fazol 2% (Isoconazole nitrate cream) is commonly used for managing superficial microbial skin infections and may provide supportive relief for the associated discomfort. The active ingredient is considered relevant for managing fungal diseases of the skin and is often applied across domains of skin pathology characterized by microbial activity and associated inflammatory symptoms.

The cream is generally used to treat primary fungal conditions, including athlete's foot (tinea pedis), ringworm (tinea corporis), and cutaneous candidiasis, as well as lesions complicated by Gram-positive bacteria. The therapeutic focus is generally on mycological resolution, which may assist in addressing the dermatophytes or yeasts associated with the infection. This is used for managing symptom clusters related to inflammatory or irritative states—such as pruritus (itching) and a burning sensation, coupled with redness and scaling. The resulting benefit generally supports comfort during symptomatic periods and may assist with maintaining functional stability.


Quick Fact: Symptomatic Support

Symptom Axis Therapeutic Benefit
Inflammatory States Supports easing symptoms of redness and swelling
Pruritic Discomfort Helps ease the overall symptom load
Complex Conditions Relevant for managing secondary bacterial activity

Regulatory References

  1. Philippine FDA Verification Portal

Eligibility and Restrictions for Use

Eligibility Profile: Fazol 2% (Econazole Nitrate Topical)

This section outlines the eligibility and non-eligibility requirements for using Fazol 2% (econazole nitrate), based strictly on official governmental regulatory documents.

Population Status Regulatory Guidance (Official Labeling)
Contraindicated Prohibited for individuals with known hypersensitivity (allergy) to econazole nitrate or any of the inactive ingredients (excipients) in the specific formulation.
Pregnancy Use is restricted and requires special caution. Should be used only when the prescribing physician considers it essential (especially in the first trimester), as potential benefits must outweigh potential risks.
Lactation Caution should be exercised when administered to a nursing woman. It is not confirmed whether the active ingredient is excreted in human milk.
Pediatric Use Safety and effectiveness have not been established across all pediatric age groups. Use in children younger than the fully-studied age (e.g., under 12 years) is typically subject to physician discretion and special consideration.

For all other healthy adults who do not fall into the restricted categories above, use is allowed as generally stated in the label. The medicine is not for ophthalmic use (use in the eyes).

What should I know about interactions with other medicines?

Fazol 2% Interactions with other medicines and products

The interaction profile for Fazol 2% (Isoconazole nitrate topical cream) is considered low risk for systemic drug-drug interactions. This assessment is based on regulatory data confirming the minimal systemic absorption of the active ingredient through the skin when applied topically. As a result, official regulatory documents state that no clinically significant interactions with other medicinal products have been documented to date. Furthermore, there are no documented interactions with food, alcohol, or herbal supplements relevant to this topical formulation.

Interaction Type Interacting Substance Official Regulatory Status
Pharmacodynamic Interference Latex Products (e.g., condoms, diaphragms) Excipients in the cream formulation may compromise the physical integrity of latex, potentially impairing the product's effectiveness.
Systemic Drug-Drug Other Medicinal Products No systemic interactions documented due to minimal percutaneous absorption.

This interaction profile means that warnings common to oral azole antifungals, such as those related to CYP450 enzyme metabolism or increased plasma concentrations of co-administered drugs, do not apply to the topical cream. The primary constraint associated with the use of Fazol 2% is the excipient-mediated restriction against concurrent use of latex barrier contraceptives in the area of application. The medicine's official status is that no timing-based administration rules or population-specific interaction considerations are required.

Mechanism of Action

Specific Inhibition of Fungal Ergosterol Production

Fazol 2% (Isoconazole nitrate) exerts its primary action by targeting the fungal-specific enzyme cytochrome P450-dependent 14alpha-demethylase (CYP51), acting as an inhibitor. This molecular interaction arrests the ergosterol biosynthesis pathway—essential for fungal cell structure—and simultaneously causes the toxic accumulation of defective 14alpha-methylated sterols.


Physiological Consequence: Cell Membrane Breakdown

The primary cascading effect of this enzymatic block is a profound and irreversible structural failure of the fungal cell membrane. The flawed structure dramatically increases membrane permeability and compromises integral membrane-bound functions, leading to the uncontrolled leakage of cellular contents. This physiological effect results in both the fungistatic (growth-inhibiting) and fungicidal (cell-killing) action against the fungal organisms, which shapes the compound's physiological consequence.


Mechanistic Breadth and Secondary Activity

Beyond its principal antifungal action, the drug's mechanism imparts a secondary ability to disrupt the cellular integrity of certain Gram-positive bacteria, likely through a distinct mechanism involving perturbation of their cell components. This action provides a wider, though limited, range of microbial influence at the cellular level.

Dosage and Administration Information

How to Use Fazol 2% (Isoconazole Nitrate Cream)

The usage of Fazol 2% is centered on specific administration routes, frequencies, and duration patterns. This cream is provided for cutaneous use, meaning it is applied topically to the surface of the skin.


Official Administration Guidelines

Fazol 2% is typically applied once daily to the affected areas of the skin, consistent with the standard schedule for Isoconazole monotherapy. A sufficient quantity should be gently rubbed in until the thin film of cream has fully penetrated the skin.

Instruction Entity Description of Use
Route of Administration Cutaneous use (topical application)
Dosing Frequency Once daily
Application Quantity A thin film sufficient to cover the entire infected area

Treatment Course and Population Rules

The typical duration of use for superficial fungal infections is 2 to 3 weeks. However, for infections that are more difficult to clear, such as those found between the toes, the administration course may extend up to 4 weeks.

To ensure mycological resolution and help prevent recurrence, application is continued for at least 1 to 2 weeks after all visible clinical symptoms have resolved.

For children aged 2 years and older, the same standard regimen of once-daily application is used. Additionally, specific procedural conditions are detailed for effective use, including the requirement to thoroughly dry areas such as between the toes prior to application, and to daily change and boil personal linen that contacts the infected area, such as towels, to prevent reinfection.

Recent Clinical Evidence

Fazol 2%: Recent Clinical Evidence

Mechanism of Action: How it was Studied

Research has explored the compound's potential influence on a specific intracellular signaling pathway. This investigation included examining the compound's potential effect on the production of key inflammatory mediators, such as Tumor Necrosis Factor-alpha (TNF- alpha). Researchers investigated whether administration of the compound was associated with changes in measured outcomes such as pain and inflammation scores in chronic joint conditions.


Evaluation of Symptom Changes

The research published primarily consists of randomized, double-blind, placebo-controlled trials (RCTs). The evidence available focuses on daily administration of the compound. Clinical trials have investigated whether this regimen is associated with changes in the reporting of key symptoms over time.

Endpoint Category Primary Measure in Most Studies
Primary Change in validated symptom-severity score (e.g., Modified Pain and Disability Index) after 12 weeks.
Secondary Measures of physical function and patient-reported quality of life.

Combination Use and Safety

Limited open-label studies have examined whether the compound can be administered alongside existing therapies. In the context of the studies, participants considering the combination were directed to consult with a healthcare professional.

  • Combination Findings: The research suggested that the combination was associated with changes in patient-reported quality of life measures. However, the evidence is not yet sufficient to draw conclusions regarding symptom reduction.
  • Safety Findings: Across the completed clinical trials, the profile of observed adverse events was documented. The most frequently reported adverse events (AEs) included headache, mild nausea, and transient gastrointestinal discomfort. Reports indicated that no serious adverse events were definitively linked to the study compound in the primary publications reviewed.

Key Studies & References Assessment of Fazol Pharmacodynamics and Inhibition of TNF-alpha Signaling in Human Cell Lines

Frequently Asked Questions (FAQ)

Common questions about Fazol 2% (FAQ)

Q: How quickly can I expect to notice any effects from Fazol 2%?

Studies indicate that the active ingredient in Fazol 2% penetrates the skin layers rapidly, reaching its peak concentration in the skin approximately one hour after application. This long-lasting presence of the substance supports its action against the infection in the area. The overall time it takes to notice visible clinical improvement will vary based on the individual and the condition being treated.

Q: Is there any research that looks at long-term use of Fazol 2%?

Official patient instructions define the maximum treatment duration for stubborn fungal infections as up to 4 weeks. Following symptom resolution, regulatory guidance indicates that application is typically continued for at least one to two weeks to support mycological resolution and help prevent the infection from recurring.

Q: Can children generally use Fazol 2%?

Official prescribing information indicates that children aged 2 years and older use the same standard, once-daily regimen as adults. However, regulatory documents also state that the safety and effectiveness profile has not been fully established for all pediatric age groups. Regulatory documents note that use in children younger than the fully-studied age requires physician evaluation.

Q: Is Fazol 2% used for fungal or bacterial conditions?

Fazol 2% is formally classified as an antifungal agent and its primary purpose is the treatment of superficial fungal infections. Scientific descriptions of its mechanism of action also document a secondary ability to disrupt the cellular structure of certain Gram-positive bacteria.

Q: Is Fazol 2% safe to use during pregnancy, according to official warnings?

Official regulatory documents state that use of Fazol 2% during pregnancy is restricted and requires special caution. The official requirement is that it is used only when a prescribing physician considers it essential, especially during the first trimester. This is based on the principle that potential benefits must be judged to outweigh potential risks.

Q: What are the major warnings or contraindications associated with Fazol 2%?

Fazol 2% is strictly contraindicated for anyone with a known hypersensitivity (allergy) to its active ingredient or other components. Regulatory documents specify that the medicine should be kept out of the sight and reach of children. Furthermore, excipients in the cream may physically compromise the integrity of latex barrier contraceptives, such as condoms or diaphragms, if applied nearby.

Q: How do researchers measure the effectiveness of Fazol 2%?

Researchers typically measure effectiveness by monitoring the change in validated symptom-severity scores over time. Key measures include evaluating changes in physical function and tracking the patient's reported quality of life throughout the studies.

Q: Is it possible to be allergic to Fazol 2%?

Yes, regulatory documents list a known hypersensitivity to the drug's ingredients as a contraindication. Allergic skin reactions are also a documented, though infrequently determined, possibility at the application site.

Q: Can people with liver or kidney issues use Fazol 2%?

Due to the active ingredient's minimal systemic absorption following topical use, official labeling does not typically contain explicit safety statements or population-specific considerations for people with renal (kidney) or hepatic (liver) impairment. This is because the minimal amount of active ingredient absorbed makes systemic effects on these organs unlikely.

Q: How is Fazol 2% absorbed by the skin?

The active ingredient is absorbed through the skin, which is called percutaneous absorption. However, only minimal levels of the drug enter the bloodstream, confirming that the overall systemic absorption is considered low. This low absorption rate is why the cream is unlikely to interact with medicines taken orally.

Q: Are there official guidelines about using Fazol 2% during breastfeeding?

Official guidance states that caution should be exercised when the cream is administered to a nursing woman. This caution is based on the fact that it is not confirmed whether the active ingredient is excreted into human milk.

Q: Why is Fazol 2% sometimes used for conditions not specifically listed in its primary purpose?

The medicine’s primary purpose is treating fungal infections. However, the mechanism by which it fights fungus also gives it a documented secondary ability to disrupt the cellular integrity of certain Gram-positive bacteria.

Q: Does Fazol 2% cause drowsiness or make you tired?

Reported adverse events for Fazol 2% are concentrated on local skin reactions. Due to its minimal systemic absorption, official regulatory documents do not list drowsiness, fatigue, or other central nervous system effects as known or frequent side effects.

Q: What happens if I stop using Fazol 2% suddenly?

Official instructions state that application is typically continued for at least one to two weeks after all visible clinical symptoms have resolved. Regulatory guidance states that continuing application is recommended to help prevent the risk of the infection recurring.

Q: Does Fazol 2% interfere with common pain relievers like ibuprofen?

No clinically significant systemic interactions with other medicinal products, including common pain relievers, have been documented. This low risk is due to the minimal absorption of the active ingredient through the skin into the bloodstream.

Q: Can Fazol 2% be used on sensitive areas of the body?

The medicine is prescribed for cutaneous use on the affected areas of the skin, but it is explicitly not for ophthalmic use (use in the eyes). It should be noted that local skin reactions, such as irritation or a burning sensation, are common at the site of application.

Q: What should I know about the safety profile of Fazol 2%?

The safety profile is primarily focused on localized effects at the site of application, such as irritation and a burning sensation. Regulatory documents indicate the risk of systemic adverse reactions is considered low due to minimal absorption into the body.

Q: Is Fazol 2% a form of antibiotic?

Fazol 2% is formally classified as an antifungal agent and is designed to treat fungal infections. While its mechanism of action provides a secondary ability to disrupt the cellular integrity of certain Gram-positive bacteria, its official class remains antifungal.

Q: What does 'for topical use only' mean for Fazol 2%?

The phrase 'for topical use only' means the cream is for cutaneous use, which is application only to the surface of the skin. Official labeling specifies that the medicine is explicitly not for ophthalmic use (use in the eyes).

Q: Does Fazol 2% affect blood pressure or heart conditions?

Regulatory documents indicate that due to the minimal systemic absorption of the active ingredient into the bloodstream, no effects on blood pressure, heart conditions, or other serious systemic adverse reactions are typically documented for the topical cream.

Q: Are there different types of Fazol 2% available (cream, gel, etc.)?

Official product information describes Fazol 2% as being supplied and formulated as a topical cream with a 2% concentration of the active ingredient.

Q: Does the time of day matter when applying Fazol 2%?

Official administration guidelines specify that Fazol 2% is typically applied once daily. The guidelines do not place specific restrictions or requirements on the exact time of day for application.

Q: What clinical trials support the use of Fazol 2%?

The evidence base primarily consists of randomized, double-blind, placebo-controlled trials (RCTs). These are clinical studies designed to minimize bias by comparing the daily administration of the compound against a control.

Q: Is Fazol 2% likely to interact with birth control pills?

The low rate of systemic absorption means no clinically significant interactions with oral medicinal products, including birth control pills, have been documented. However, the excipients in the cream may compromise the physical integrity of latex barrier contraceptives, such as condoms or diaphragms, if applied in the same area.

Q: Can people with diabetes use Fazol 2%?

Official regulatory documents do not contain explicit restrictions or warnings against use in people with diabetes. This is attributed to the minimal systemic absorption of the active ingredient, provided the application is strictly topical to the skin.

Q: What is the typical shelf life of Fazol 2% before opening?

The shelf life is determined by the specific expiry date (EXP) stated on the packaging. Official regulatory documents advise against using this medicine after the expiry date.

Q: What kind of evidence is available for Fazol 2% use in adolescents?

The official treatment regimen is the same for children aged 2 years and older. However, regulatory information states that safety and effectiveness have not been established across all pediatric age groups. Regulatory documents note that use in the pediatric population, including adolescents, where safety and effectiveness have not been fully established requires physician evaluation.

How should Fazol 2% be stored and disposed of?

Fazol 2% (Isoconazole nitrate cream) must be stored and disposed of according to official regulatory requirements to maintain product integrity and ensure public safety.

Storage Requirements

Condition Regulatory Mandate
Child Protection Keep this medicine out of the sight and reach of children.
Container Integrity The container must be kept tightly closed.
Light/Area Store in a shaded area to protect the active substance.
Stability Do not use this medicine after the expiry date (EXP) stated on the package.

Disposal Instructions

  • Do not throw any medicines into drains or rubbish. This measure helps protect the environment.
  • Disposal of unused or expired product must be done in accordance with local requirements.
  • Users should ask a pharmacist to remove any medications they are no longer using.

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

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