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Мизол Эвалар

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Мизол Эвалар

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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.

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Overview of Мизол Эвалар

The drug known by the trade name Мизол Эвалар is a specialized antifungal medicine, with its identity and action rooted in the synthetic active substance, Naftifine Hydrochloride.

Property Description
Active ingredient Naftifine Hydrochloride (INN)
Form Topical Solution, Cream, or Gel
Pharmacological class Allylamine Antifungal Agent
Common use Addressing superficial fungal infections of the skin
Origin Synthetic derivative

What is Мизол Эвалар and its Pharmacological Class?

Мизол Эвалар is a specific commercial formulation that delivers the active ingredient, Naftifine Hydrochloride, a synthetic allylamine derivative. This compound is classified under the Allylamine Antifungal pharmacological class, representing one of the initial successful antifungal medications developed from this group. The medicine is prepared as a single active ingredient product, focusing on its specialized function as an agent against mycotic pathogens.

Composition and Pharmaceutical Form: A Topical Solution

The medication is strictly formulated for dermal application and is most frequently supplied as a topical solution containing the active substance, commonly at a 1% concentration. This solution utilizes an aqueous-alcoholic base, which is designed to ensure efficient and localized delivery of the Naftifine Hydrochloride to the affected skin surface. The active substance is capable of penetrating the outer layer of the skin in sufficient concentrations, supporting its action in addressing superficial infections.

General Purpose: Fungal Elimination and Local Relief

The general purpose of the medicine is the swift clearance of fungal pathogens and relief from associated symptoms. Naftifine Hydrochloride exhibits strong fungicidal activity against dermatophytes, which means it directly works to destroy the fungal cells themselves. Furthermore, it possesses an anti-inflammatory effect. This dual action suggests the drug works to clear the source of the skin infection while helping to soothe the discomfort, redness, and irritation that commonly accompany such conditions.

Regulatory References

  1. National Library of Medicine
  2. Allylamine Antifungal
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What side effects are possible with Мизол Эвалар?

The safety profile for this topical antifungal, containing Naftifine Hydrochloride, is primarily defined by local application site reactions documented in official regulatory sources.

Adverse Reaction Scope

Category Common Reactions (ge 1% Incidence) Postmarketing Reports (Frequency Not Known)
Skin Disorders Burning/stinging, pruritus (itching), dryness, local irritation. Blisters, crusting, inflammation, maceration, swelling, serous drainage.
Other System Classes None officially classified as common. Headache, dizziness, leukopenia, agranulocytosis.

Serious Adverse Reactions: Rare systemic events, including leukopenia and agranulocytosis, have been identified through postmarketing surveillance. The medicine is formally contraindicated in individuals with known hypersensitivity to any of its components.

Population-Specific Safety Considerations

Official regulatory documentation includes specific statements for certain populations:

  • Pediatric Use: Safety and effectiveness have not been established in certain younger pediatric age groups (e.g., typically under 12 years of age for some indications or formulations).
  • Pregnancy and Lactation: There are no adequate and well-controlled studies in pregnant women. Caution is advised for nursing mothers as it is not known whether the drug is excreted in human milk.

Safety-Related Restrictions

If signs of irritation or sensitivity develop at the application site, such as severe burning or swelling, the official label advises that treatment should be discontinued. The product is for topical use only and not for application to the eyes, mouth, or other mucous membranes.

The official safety profile provides a clear regulatory understanding that the most frequently documented adverse effects are minor, localized skin reactions. The inclusion of rare systemic events reported postmarketing and specific constraints for use in vulnerable populations defines the overall risk boundaries.

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Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Мизол Эвалар (Naftifine Hydrochloride Topical) addresses overdose primarily based on the route of exposure. Due to the very low level of systemic absorption documented in official prescribing information, acute systemic toxicity from excessive topical application is not expected to be dangerous. The most documented local manifestation from applying an excessive amount may include irritation or sensitivity at the site of use. Should localized irritation or sensitivity develop, regulatory documents advise that product use be discontinued.

Required Emergency Actions

Immediate medical attention is specifically required in the event of accidental ingestion of the topical solution or cream. If Мизол Эвалар is swallowed, regulatory instructions mandate that an individual seek immediate emergency medical attention or contact a certified Poison Help line. This action is required due to the risk of internal exposure.

Overdose Management

Management for an overdose is officially described as providing symptomatic and supportive treatment. This is because official regulatory labeling states that no specific antidote is known for Naftifine Hydrochloride overdose. No severe systemic complications are formally documented following topical misuse, and no population-specific overdose risks are detailed in the official prescribing information.

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Therapeutic Uses of Мизол Эвалар

What Мизол Эвалар treats: Main Uses and Benefits

This medicine is specifically utilized in the clinical context of dermatomycoses, primarily used in situations involving the clearance of fungal pathogens responsible for common conditions. It is commonly used to help with the treatment of tinea pedis (athlete's foot), tinea cruris (jock itch), and tinea corporis (ringworm), including infections caused by organisms such as Trichophyton rubrum.

Мизол Эвалар is relevant in contexts marked by increased discomfort or tension, as it helps address symptom clusters that may become intense or disruptive, including local redness (erythema), intense itching (pruritus), and general dermal irritation. It offers symptomatic relief that helps patients cope more steadily with difficult episodes, supporting comfort during periods of heightened symptoms.

“The treatment helps address the overall condition and contributes to easing the manifestation of acute symptoms.”

The medication is commonly used across conditions presenting with localized discomfort where the affected skin requires temporary assistance in symptom stabilization and the restoration of its healthy appearance. This contributes to the healing of skin manifestations and assists with maintaining functional stability when symptoms are more noticeable.


Quick Fact: Relief for Inflammatory Symptoms

The medicine is applied across domains where additional symptomatic support is needed, assisting with the symptomatic relief of itching and inflammation associated with common fungal skin infections.

Regulatory References

  1. NIH DailyMed Prescribing Information
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Eligibility and Restrictions for Use

Who Can and Cannot Use Мизол Эвалар?

The official eligibility criteria for Мизол Эвалар (Naftifine Hydrochloride topical) are based on patient history, age, and physiological state, as defined by regulatory documents.


Contraindications and Restrictions

The medicine is contraindicated in individuals with a known history of hypersensitivity (allergic reaction) to Naftifine Hydrochloride or any other component in the topical formulation. This is the only absolute prohibition stated in the official labeling.

Population Group Eligibility Status (Regulatory Labeling)
Adults (≥18 years) Use is established.
Children/Adolescents (12+ years) Use is established for certain indications.
Children (<12 years) Safety and effectiveness not established for some indications.
Pregnant Women Use is restricted; permitted only if clearly needed.
Nursing Mothers Caution is advised, as excretion into human milk is unknown.

Eligibility is established across the adult population. For pediatric use, safety and effectiveness are established down to age 12 for certain infections, and down to age 2 for others. Due to the minimal systemic absorption, no specific eligibility restrictions are listed regarding pre-existing hepatic or renal conditions.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Naftifine Hydrochloride, the active substance in Мизол Эвалар, indicates that this topical antifungal agent has a unique interaction profile defined by minimal systemic absorption.

Due to the very low plasma concentrations achieved after application to the skin, no clinically relevant systemic drug-drug interactions are documented in the official prescribing information from government health authorities, such as the FDA and NIH DailyMed.

Category Official Regulatory Status
Interacting medicinal products None explicitly listed
Pharmacokinetic basis (e.g., CYP) None documented
Contraindicated combinations None documented due to interaction risk

The absence of documented systemic interactions means that regulatory labels specify no mandatory timing separation rules for administration with other oral medicines. Furthermore, no specific restrictions are listed concerning co-administration with food, alcohol, herbal products, or supplements that would modify the drug's exposure or effect.

This interaction structure reflects the consensus in regulatory pharmacology that the concentration of naftifine in the systemic circulation is insufficient to trigger clinically significant metabolic or pharmacodynamic interaction concerns with other substances.

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Mechanism of Action

The mechanism of action for Мизол Эвалар (Naftifine Hydrochloride) is defined by a dual pharmacological profile: a primary mechanism focused on the inhibition of fungal cell function and a secondary modulation of the host’s local immune response.

Targeting Fungal Ergosterol Biosynthesis

This primary mechanism involves the direct and selective inhibition of the fungal enzyme, squalene 2,3-epoxidase. This interference blocks a critical step in the ergosterol biosynthesis pathway, which leads to the profound depletion of structural lipids in the fungal cell membrane and a simultaneous toxic accumulation of the precursor, squalene. This molecular cascade results in the fungicidal physiological effect for susceptible dermatophytes via structural compromise.

Modulation of Local Host Inflammation

The compound also engages a secondary mechanism by modulating local host inflammatory pathways. This action includes the inhibition of components in the prostaglandin synthesis cascade and a reduction in the activity of immune cells such as polymorphonuclear leukocytes (PMNs) at the site of infection. This dampening of the host's physiological response contributes to the modulation of physiological responses associated with local tissue inflammation.

Mechanism-Driven Sustained Retention

The high lipophilicity of the active molecule allows it to interact strongly with the skin barrier, creating a sustained reservoir in the outermost layer of the stratum corneum. This physical depot mechanism ensures the maintenance of relevant concentrations at the site of fungal activity long after initial application, contributing to the sustained presence of the active molecule at the site of action, enabling prolonged functional engagement with the target.

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Dosage and Administration Information

Official Administration Guide

Route and Frequency

This product is for topical administration only, applied directly to the surface of the affected nail. The dosing regimen follows two phases to ensure comprehensive treatment of the affected area and the growth of a new, healthy nail.

Phase Dosing Frequency Duration
Initial Treatment Twice a day (morning and evening) Continuous for the first 4 weeks
Maintenance Once a day Until the affected nail has fully grown out

Procedural Steps

  1. Preparation: Before the first application, and at the start of each treatment week, the affected nail surface should be cleaned and any nail polish should be removed.
  2. Filing: Once weekly, the affected nail's surface should be gently filed down using the provided files to improve the serum's penetration.
  3. Application: Apply a small, thin layer of the product to the entire surface of the nail. After application, the nail should be allowed to dry for 1–2 minutes to ensure adherence and effectiveness.
  4. Duration: Treatment must be continuous and is typically required for several months until the healthy nail is completely restored, which is often 3 to 6 months for a full toenail.

Age and Missed Dose Rules

Specific guidelines may be provided for children, with some similar products indicating suitability for ages 4 and older. If a dose is missed, it should be applied as soon as possible; however, if it is nearly time for the next scheduled application, the missed dose should be skipped to maintain the regular treatment schedule.

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Recent Clinical Evidence

Research evidence / Overview of studies

Evidence for use in Schizophrenia

Research has explored the drug in studies involving individuals with schizophrenia, using short-term Randomized Controlled Trials (RCTs) and maintenance studies. Findings describe patterns observed regarding measured changes in symptoms and outcomes related to recurrence. However, long-term effects are not fully established, as follow-up durations were limited in many primary trials, and data for certain groups with complex health issues are limited.


Evidence for use in Bipolar I Disorder (Manic/Mixed Episodes)

The drug was evaluated in research involving conditions characterized by heightened symptom activity (manic/mixed episodes). Studies monitored responses over defined time intervals, examining outcomes related to the maintenance of mood state. Long-term effects are not fully established regarding sustained stability, and data for groups with fast symptom cycles are limited.


Evidence for use in Major Depressive Disorder (Adjunctive Treatment)

The drug was evaluated in research exploring combination use with existing antidepressants for adults with inadequate initial response. Research describes changes measured during the short study period using established symptom scales. A limitation is the short follow-up duration of primary trials, meaning there is limited information for long-term outcomes regarding the sustained measured changes of this adjunctive strategy.


Evidence for use in Other Indications (Autism and Tourette's Disorder)

The drug was evaluated in research involving irritability in pediatric populations with Autistic Disorder and in pediatric patients with Tourette’s Disorder (tic manifestations). Research describes short-term changes observed in the studies. However, evidence is limited, sample sizes were modest, and long-term effects are not fully established for these specific uses.


Overarching Research Limitations

Beyond specific indications, data for follow-up durations extending over many years are limited. Long-term effects are not fully established overall. Research has included adolescents and pediatric patients, but data for other groups, such as older adults or those with significant comorbid health issues, are limited. Evidence quality varies across studies, and study results reflect group patterns, not individual outcomes.

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Frequently Asked Questions (FAQ)

Common questions about Мизол Эвалар (FAQ)

Q: Can Мизол Эвалар be used on the skin, besides the nails?

A: The active substance in this product, naftifine hydrochloride, is indicated for the topical treatment of various superficial fungal infections of the skin. This includes conditions like athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). Official regulatory documents specify that the medicine is used for these common skin infections on the body.

Q: How can one distinguish a normal reaction (e.g., slight burning) from an undesirable side effect?

A: Official product information notes that burning, stinging, or localized irritation are common, often minor reactions at the application site. However, if any irritation or sensitivity becomes severe, official instructions state that treatment should be discontinued. The product label indicates seeking consultation if one experiences symptoms that are worsening or concerning.

Q: What special precautions exist for the use of Мизол Эвалар?

A: The medicine is strictly intended for external, topical application only. Regulatory documents state that the product is not intended for application to the eyes, mouth, or other mucous membranes. Furthermore, the label indicates avoiding the use of an occlusive (airtight) dressing or bandage over the application area unless specifically instructed.

Q: Which specific types of fungus is Мизол Эвалар intended to treat?

A: The active substance is approved for use against specific fungal organisms that cause superficial skin infections. These commonly include dermatophytes such as Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum. These organisms are generally responsible for the fungal conditions the medicine is indicated to treat.

Q: Is there a list of all indications in the official instructions for Мизол Эвалар?

A: Yes, official regulatory labels contain a defined list of approved uses for the active substance. The uses generally include the topical treatment of specific fungal infections such as tinea pedis (athlete's foot), tinea cruris (jock itch), and tinea corporis (ringworm of the body). This list defines the official scope of the medicine's intended use.

Q: How many days or weeks until the first visible improvements from Мизол Эвалар can be expected?

A: Clinical studies for the active substance often use a four-week period to evaluate treatment response. Official instructions indicate that if a patient does not observe clinical improvement after approximately four weeks of use, a re-evaluation is necessary. The time until the first noticeable change can vary depending on the severity and specific type of infection.

Q: What happens if one accidentally stops using Мизол Эвалар as soon as symptoms disappear?

A: Official patient counseling information states that the medication is intended to be used for the entire duration prescribed, even if symptoms appear to clear up quickly. Stopping treatment early can increase the risk of the infection returning (relapse). Completing the full course helps ensure that the fungal organisms are adequately eliminated.

Q: Is it true that fungus can become resistant to the action of Мизол Эвалар?

A: Official instructions highlight the importance of adhering to the prescribed regimen to avoid potential complications. Regulatory patient counseling states that skipping doses or discontinuing treatment prematurely can increase the risk of developing an infection that is resistant to the medication. The risk of resistance is noted to be mitigated by adherence to the defined treatment plan.

Q: Do studies indicate the possibility of infection recurrence after a course of Мизол Эвалар treatment?

A: Clinical studies assess patients for the achievement of mycological cure, which refers to the absence of the causative fungus at defined follow-up points. Regulatory instructions state the importance of continuing use for the full intended duration. This process supports the maintenance of successful treatment outcomes.

Q: Does Мизол Эвалар help with fungal infections in the groin area or between the toes?

A: Yes, the active substance is specifically indicated for the local treatment of fungal infections in these areas. This includes tinea cruris (often called jock itch, which affects the groin area) and tinea pedis (athlete's foot), which frequently involves the skin between the toes.

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How should Мизол Эвалар be stored and disposed of?

Storage and Disposal Requirements

Storage Condition Official Regulatory Requirement
Temperature Store at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F), with permitted excursions up to 30 C (86 F).
Environmental Protection The product must be kept from freezing and stored away from excessive heat, moisture, and direct light.
Container & Safety Keep the medicine in its original container, tightly closed, and stored out of the sight and reach of children (safety caps must be locked).

Disposal Instructions

Unused or expired Мизол Эвалар must be disposed of according to official guidelines. The preferred method is using a drug take-back program. As the product is not on the FDA flush list, it must not be flushed down the toilet or poured down a drain. If a take-back option is unavailable, the product may be mixed with an undesirable substance (e.g., dirt) in a sealed bag and discarded in household trash. All personal information must be scratched out on the packaging prior to disposal.

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

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