Mycoderil

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Mycoderil

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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 Mycoderil

What is Mycoderil? Definition and Classification

Property Description
Active ingredient Naftifine Hydrochloride
Form Topical solution and cream
Pharmacological class Allylamine Antifungal
General purpose Counters fungal growth and proliferation
Origin Synthetic derivative

Mycoderil is a synthetic, single-active ingredient medicinal preparation classified as a specialized Antifungal agent intended for external use. Its component, Naftifine Hydrochloride, is a chemically synthesized allylamine derivative. This specific compound is used for its broad spectrum of activity against many common fungal pathogens. The designation as an Allylamine antifungal positions the medication within a group known for disrupting the structural integrity of fungal cells.

Naftifine Hydrochloride: Composition and Topical Forms

The drug’s composition is defined by its active component, Naftifine Hydrochloride, presented as a single-active ingredient product (monotherapy). It is prepared for delivery via the topical route in two primary dosage forms: a hydroalcoholic solution and an emulsion cream. The availability of both a solution and a cream allows the medicine to be applied to diverse body areas, such as the skin folds or the scalp. This preparation ensures the Naftifine is concentrated directly where fungal processes occur.

The General Purpose of Allylamine Antifungals

The overall therapeutic purpose of an Allylamine antifungal is to counter the growth and survival of fungal organisms on accessible tissues, typically for the resolution of superficial fungal conditions. The key mechanism involves inhibiting the enzyme squalene epoxidase. This focused action allows the drug to display both fungicidal (cell-killing) and fungistatic (growth-stopping) activity. This dual action offers the combined benefit of eliminating the pathogen while its inherent anti-inflammatory property assists in mitigating the associated local irritation and redness.

Regulatory References

  1. Label: NAFTIN- naftifine hydrochloride cream - DailyMed - NIH

What side effects are possible with Mycoderil?

Possible Side Effects and Safety Information

The safety profile for Naftifine Hydrochloride (Mycoderil) is primarily characterized by adverse reactions that occur locally at the application site, as documented in official regulatory sources. The most common adverse reaction (ge 1%) reported in clinical trials for the cream formulation is pruritus (itching). Other frequently documented local reactions include a burning sensation, stinging, erythema (redness), and dryness.

Systemic and Serious Reactions

The safety labeling includes documented adverse reactions identified through postmarketing experience, where the frequency is not reliably estimable. These reports include effects on several organ systems, such as headache and dizziness (Nervous System Disorders). Rare but severe systemic events reported include the hematologic disorders leukopenia and agranulocytosis (Blood and Lymphatic System Disorders).

Safety Restrictions and Specific Populations

Official regulatory documents define certain safety limitations. The medicine is contraindicated in individuals with known hypersensitivity to naftifine or any component. Treatment should be discontinued if irritation or sensitivity develops at the application site.

Safety and effectiveness for all indications are established for pediatric patients aged 12 and older, with adverse reaction rates similar to adults; however, safety has not been established for all indications in children younger than 12 years of age. Data for use in pregnancy and during lactation are limited.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory guidance for Mycoderil (Naftifine Hydrochloride) focuses primarily on the very low risk of systemic exposure due to its topical nature. Due to minimal absorption through the skin, topical application, even in excessive amounts, is generally not expected to result in specific systemic symptoms or severe outcomes.

Overdose Context Official Regulatory Statement
Documented Overdose Manifestations No specific clinical signs, symptoms, or laboratory abnormalities are formally documented as expected outcomes following topical overdose.
Exposure of Concern The primary scenario addressed in regulatory labeling is accidental oral ingestion (swallowing) of the external-use product.

When to Seek Emergency Medical Attention

Regulatory documents are explicit regarding the required course of action for accidental exposure via the oral route.

Required Action Label-Derived Instruction
Immediate Help Required If the topical medication is accidentally swallowed, immediate medical attention must be sought.
Mandated Emergency Response Contacting a Poison Control Center or seeking emergency medical services is the official instruction for accidental ingestion.
Management Principle Treatment is limited to symptomatic and supportive measures, as no specific antidote for Naftifine Hydrochloride is currently documented.

Since no specific antidote is known, any management initiated by a healthcare professional following accidental ingestion is described as symptomatic and supportive treatment. Monitoring may be required to assess the patient's condition after exposure.

Therapeutic Uses of Mycoderil

What Mycoderil Treats: Main Uses and Benefits

Mycoderil may be part of symptomatic management, used in areas where short-term symptom management is appropriate for fungal skin conditions. It is relevant in conditions characterized by periods of heightened symptoms, such as Tinea pedis (Athlete’s foot), Tinea cruris (Jock itch), and Tinea corporis (Ringworm of the body), which are caused by organisms like Trichophyton rubrum. This may be part of symptomatic management applied in situations involving episodic or fluctuating manifestations, and supports the patient during difficult episodes by easing distress.


The medication is relevant for managing symptoms that interfere with daily comfort, particularly persistent itching (pruritus) and the localized burning sensation. It is also relevant for easing symptoms related to inflammatory or irritative states, such as visible redness (erythema) and local irritation associated with the condition. This supportive symptomatic relief contributes to improved comfort during periods of heightened symptoms and assists with maintaining functional stability. It is commonly used when short-term symptomatic assistance is needed, including in areas prone to moisture, like skin folds.

“It is relevant in contexts involving heightened systemic burden and helps maintain a sense of stability when symptoms are more noticeable.”


Quick Fact: Supports management of Itching and Burning

Mycoderil is relevant in conditions where symptoms may intensify temporarily, which can include visible changes such as scaling or cracked skin.

Regulatory References

  1. US National Institutes of Health (NIH) DailyMed label information

Eligibility and Restrictions for Use

Who Can and Cannot Use Mycoderil? — Official Regulatory Information

The eligibility profile for Mycoderil (Naftifine Hydrochloride) is defined by regulatory agencies based on population restrictions, age, and physiological status.


Eligibility Scope

Classification Population/Condition Regulatory Status
Contraindicated Individuals with known hypersensitivity to Naftifine Hydrochloride or any component in the formulation. Absolute Exclusion
Conditional Use Pregnant Women: Use only if clearly needed (potential benefit outweighs potential risk to the fetus). Use Restricted
Conditional Use Nursing Mothers: Caution should be exercised; it is not known whether the drug is excreted in human milk. Use Restricted

Age-Related Eligibility Rules

  • Adults (18 years and older): Use is established for specified topical indications.
  • Adolescents (12 to 17 years): Safety and effectiveness have been established for certain topical uses (e.g., interdigital tinea pedis).
  • Children (2 years and older): Safety and effectiveness have been established for Tinea corporis with certain formulations.
  • Pediatric Patients (< 12 years): Safety and effectiveness for many topical indications have not been established.

Eligibility-Related Restrictions

Mycoderil is strictly for topical use only and is not for ophthalmic, oral, or intravaginal administration. Regulatory labels do not document specific restrictions related to hepatic or renal impairment for the topical formulation.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Mycoderil (Naftifine Hydrochloride) is governed by its pharmacokinetic status as a topical preparation with minimal systemic absorption.

Following application, only negligible amounts of the active ingredient are absorbed into the bloodstream. This characteristic is the foundation for the drug's interaction structure, resulting in the following official summary:


Interaction scope

Category Official Regulatory Documentation
Medicinal product categories with documented interactions None documented.
Specific interacting medicines (if explicitly listed) None documented.
Mechanistic basis of interactions None documented. (Due to negligible plasma concentrations)
Timing-based interaction rules None documented.
Population-specific interaction notes None documented.
Interaction-related restrictions No restrictions stated regarding food, alcohol, or herbal products.

Interaction classifications (high-level)

Classification Official Regulatory Documentation
Interaction severity classification Not applicable. (No systemic interactions are categorized as severe or moderate.)
Regulatory basis FDA Prescribing Information / EMA SmPC.

Resulting interaction structure

Official regulatory documents confirm that Mycoderil does not have documented systemic drug–drug, drug–food, or drug–substance interactions that require specific warnings or restrictions. Because the drug achieves only negligible plasma levels, no formal contraindications related to co-administration, no specific pharmacokinetic interactions (such as with CYP enzymes), and no mandatory administration timing rules are detailed in the official prescribing information.

Mechanism of Action

Core Mechanism: Targeting Fungal Cell Survival

The primary mechanism of action involves the highly specific inhibition of the fungal enzyme Squalene Epoxidase (SEC). By blocking this critical enzyme, the active ingredient, Naftifine, halts the synthesis of Ergosterol, which is essential for fungal cell membrane rigidity, simultaneously causing the toxic accumulation of the precursor Squalene. This dual biochemical attack leads to the disintegration of the fungal cell membrane, initiating a cascade that results in both the cessation of proliferation (fungistatic effect) and the elimination of the pathogen (fungicidal effect).

Modulation of Local Physiological Responses

In addition to its direct action against the pathogen, Naftifine possesses an inherent, secondary mechanism that acts as a modulator of localized inflammation. This property engages physiological pathways to help dampen the heightened local tissue responses that accompany the pathogenic activity. This modulation supports the calming of the local tissue environment, which contributes to the molecule's overall mechanistic output by modulating the host response simultaneously with its action on the pathogen. This combination results in both the control of the underlying pathogenic process and the modulation of associated local tissue effects.

Dosage and Administration Information

How Mycoderil is Used: Administration Guidelines

This section outlines the usage instructions for Mycoderil (Naftifine Hydrochloride), focusing solely on the procedural rules for administration.

Feature General Instruction
Route of administration Topical (External/Dermal Use Only).
Dosing schedule (Adults) 2% forms: Apply a thin layer to the affected area plus an approximate 1/2 inch margin of healthy surrounding skin.
1% forms: Apply a sufficient quantity and gently massage into the affected and surrounding skin areas.
Frequency pattern Once daily for 2% cream and gel. Once daily (for cream) or Twice a day (for gel) for 1% formulations.
Course duration Typically 2 weeks for 2% formulations; often 4 weeks for certain uses of 1% formulations.
Age-group rules Safety and effectiveness are established for patients 12 years of age and older for 2% gel. Safety has not been established for children under 12 years of age.

Administration Instructions and Constraints

The proper use of Mycoderil involves specific procedural steps and limitations:

  • Application: Gently massage the product into the affected skin and the surrounding margin of healthy skin.
  • Post-Application: The hands should be washed thoroughly after application to the skin.
  • Forbidden Sites: The product is not intended for ophthalmic (eyes), oral, or intravaginal use.
  • Dressing Use: Avoid the use of occlusive dressings or airtight wrappings over the treated area unless specifically directed.

This protocol describes the application method, specific frequency rules (e.g., once daily for 2% strength), and includes a defined treatment duration (e.g., 2 weeks) for consistent use.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Mycoderil


Research Evidence for Tinea Pedis (Athlete's Foot)

The research base for the use of Mycoderil in Tinea pedis (Athlete's foot) relies primarily on short-term, randomized, double-blind trials. These studies are applied in research contexts involving fluctuating or unstable symptoms where research monitored outcomes in subjects using the medicine against outcomes in subjects using an inactive substance (vehicle).

Researchers tracked two primary goals: whether the studies measured the end-point of fungal infection clearance (Mycological Cure), and the end-point of resolution of visible signs (Clinical Cure). The populations studied for this condition included adults and adolescents over 12 years of age. Findings described patterns of measured differences in the composite outcome (Complete Cure) between the medicine and the inactive vehicle control.


Research Evidence for Tinea Cruris and Tinea Corporis (Jock Itch and Ringworm)

For Tinea cruris and Tinea corporis, the evidence base also features multiple randomized, vehicle-controlled trials, with outcomes also examined in systematic reviews. The populations evaluated included adults and adolescents, and studies monitored both the status of the fungal culture and the severity of visible skin signs. For Tinea corporis, research has explored its use in pediatric populations; studies monitored children aged 2 years and older, reporting patterns related to the Mycological Cure endpoint in this group.


Long-Term Evidence and Observation Periods

The clinical trials that form the core evidence base generally focus on short-term symptom patterns and clearance. Follow-up durations were typically limited to the period immediately after the treatment ended, often ranging from two to six weeks. There is limited information for long-term outcomes, meaning that the durability of the initial measured outcomes are not fully established over extended periods, such as six months or a year after stopping treatment.


Key Uncertainties and Research Gaps

One of the main research limitation frames is the short duration of the clinical trials, meaning that long-term effects are not fully established, particularly concerning relapse rates. Furthermore, comparative evidence is lacking; research has not widely examined outcomes when Mycoderil is directly compared against a range of other active antifungal treatments. Regulatory documents indicate that the evidence for use in children younger than 2 years of age for Tinea corporis is not established.

Key Studies & References Naftifine Hydrochloride Topical Solution and Cream: Regulatory Monograph and Labeling Information (FDA/DailyMed)

Frequently Asked Questions (FAQ)

Common questions about Mycoderil (FAQ)

Q: What is the difference between Mycoderil and other common treatments?

Mycoderil is an allylamine antifungal, a classification of medicine that targets the fungal cell structure. This specific mechanism is described as having a dual effect: it both stops the growth of the pathogen and initiates its elimination.


Q: How long after starting Mycoderil can I expect to see its full effect?

According to clinical studies, the full course of treatment is typically 2 to 4 weeks, depending on the specific formulation being used. Significant improvement in the appearance of the infection is often noted within this timeframe, as demonstrated in research.


Q: Are there any widely reported concerns about the long-term use of Mycoderil?

The clinical trials that form the core evidence base generally focus on short-term outcomes and symptom patterns. Official research summaries state that the durability of the initial results over extended periods, such as six months or a year after stopping treatment, is not fully established.


Q: Can I take pain relievers while using Mycoderil?

Mycoderil is a topical medicine with minimal absorption into the bloodstream. Official documentation indicates that no systemic drug-drug interactions are documented due to this characteristic.


Q: Does Mycoderil interact with herbal remedies like St. John's Wort?

Official documentation indicates that no restrictions related to herbal products, including St. John's Wort, are stated. This is based on the drug achieving only negligible concentrations in the bloodstream following topical application.


Q: Are there ongoing studies or clinical trials involving Mycoderil?

Records from authoritative research databases, such as those maintained by the NIH, show that various studies have been conducted. This includes clinical trials examining the medicine's safety and effectiveness which may be ongoing.


Q: How is Mycoderil typically stored?

Regulatory documents describe that the medicine should be kept in its original, tightly closed container at Controlled Room Temperature, which is 25 C or 77 F. It is specified that the product must be protected from excess heat, moisture, and kept from freezing.


Q: Do patients commonly report feeling dizzy after taking Mycoderil?

Dizziness has been identified in voluntary post-approval reports from patients. However, regulatory documents state that because these reports are not collected systematically, it is not possible to reliably estimate how often this reaction occurs in the general population.


Q: How quickly does Mycoderil start to affect the body?

The onset of action is generally described in patient information as occurring within a few days after starting the treatment. The speed of visible response can vary depending on the severity and location of the infection.


Q: Does Mycoderil work the same way for everyone who takes it?

While clinical studies report overall effectiveness in the populations examined, the way the medicine works can differ slightly from person to person. This natural biological variability can impact an individual's specific response to the treatment.


Q: Can Mycoderil change the way I feel day-to-day?

Clinical trial data describes the possibility of local reactions at the application site. These include common adverse reactions such as itching, burning, redness, and dryness, which may affect how the area feels.


Q: Does taking Mycoderil with food make a difference?

Official product information indicates that there are no restrictions stated regarding the use of the medicine in relation to food.


Q: Can Mycoderil be taken at night instead of in the morning?

Official guidelines focus on the required frequency of application, which is either once or twice daily depending on the formulation. Regulatory documents do not mandate a specific time of day (morning or night) for administration.


Q: What happens if a dose of Mycoderil is missed?

Official patient information often describes that if a dose is missed, the general guidance is to apply it as soon as it is remembered, or to skip it if it is almost time for the next scheduled dose.


Q: How do people describe the feeling of starting Mycoderil?

The most commonly reported experiences at the application site are local skin sensations. These include pruritus (itching), a burning sensation, stinging, redness, and dryness, as noted in clinical trials.


Q: Is it a common experience to have mild headaches when first starting the medicine?

Headache has been identified in post-approval reports from the general population. Because the reports are voluntary, its frequency is not reliably estimable, and regulatory documents do not specify its occurrence relative to the start of treatment.


Q: What does the research say about Mycoderil's effectiveness compared to a placebo?

Clinical studies for the drug's approved uses are described as randomized, vehicle-controlled trials. These studies examined the measured differences in achieving complete cure (composite outcome) when comparing the medicine to an inactive substance (vehicle).


Q: Is Mycoderil known to interact with caffeine?

Official documents do not list specific restrictions regarding the use of the medicine with caffeine or similar non-medicinal substances.


Q: Are there known cases where Mycoderil was found to be less effective than expected?

Official patient information indicates that if the infection does not clear up or appears to worsen after the recommended treatment duration, a re-evaluation of the condition by a healthcare professional may be needed.


Q: What is the typical duration of treatment for someone using Mycoderil?

The stated duration of treatment is typically 2 weeks for the 2% cream and gel formulations. For certain uses of the 1% formulations, the typical duration is often 4 weeks, as specified in administration guidelines.


Q: Does Mycoderil have any specific warnings for people with heart issues?

Official safety information indicates that serious heart symptoms, such as fast, irregular, or pounding heartbeats, are described as needing prompt reporting to a healthcare professional.


Q: Is Mycoderil the same as the drug with a different name in another country?

The active ingredient in Mycoderil, Naftifine Hydrochloride, is recognized internationally. It is marketed under various trade names across different countries.

How should Mycoderil be stored and disposed of?

Storage Requirements

Mycoderil must be stored at Controlled Room Temperature, which is 25 C (77 F). The product's stability permits brief temperature excursions between 15 C and 30 C (59 F and 86 F).

Protection is required from environmental factors. Regulatory documents mandate storage away from excess heat and moisture, and the medication must be explicitly kept from freezing. To maintain product integrity, keep the medicine in the original container and ensure the container is tightly closed at all times.

Child-Safety and Disposal

Consistent with official labeling, the container must be stored out of the sight and reach of children.

Disposal of outdated or unused medicine is required. Official instructions state that you must ask your healthcare professional how you should dispose of any medicine you do not use. This ensures proper handling according to regulatory procedures for pharmaceutical waste.

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

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