Fungisil MK

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Fungisil MK

Medically reviewed

Marina Burgos

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 Fungisil MK

Property Description
Active ingredient Terbinafine Hydrochloride (INN)
Form Topical Cream
Pharmacological class Allylamine Antifungal Agent
General purpose Clearing fungal contamination from the skin
Origin Synthetic

What is Fungisil MK and How is it Classified?

Fungisil MK is a medicine whose active component is Terbinafine Hydrochloride, classifying it as a synthetic allylamine antifungal agent. This categorization signifies that the compound was laboratory-designed for specific therapeutic action.

As an antimycotic, Fungisil MK's function is centered on countering the presence of fungal contamination on the epidermis. It belongs to the allylamine class, a distinct group of medicines developed to provide a powerful and directed means of eliminating these microscopic threats. The general purpose of this medicine is therefore to address the source of the infection, which underpins the symptomatic relief it provides in a common scenario, such as a superficial skin rash caused by a fungal invasion.


Composition: Terbinafine Hydrochloride and Dosage Form

The product's identity is defined by its single primary active ingredient, Terbinafine Hydrochloride (INN), which is formulated into a topical cream dosage form for application. This specific cream formulation is intended to deliver the active ingredient effectively to the skin's surface.

The use of a cream ensures that the medicine is administered via the topical route of administration, allowing the substance to be applied directly onto the affected skin. This physical form is essential for achieving a high local concentration of the active synthetic substance exactly where the infection resides, limiting unnecessary systemic exposure while maximizing local therapeutic efficacy.


Core Antifungal Action and General Purpose

The core function of Fungisil MK is described as fungicidal, meaning it actively works to kill the fungal organisms that cause the infection, rather than simply suppressing their growth. This potent action is achieved by interfering with a specific biological process the fungus requires to build and maintain its vital cell wall structure.

By effectively disrupting the fungal cell wall's integrity, the medicine prevents the organism from surviving and proliferating. The overall goal and general purpose of applying Fungisil MK cream are to ensure the complete elimination of the fungal population, thereby clearing the skin of the infection and facilitating the restoration of healthy tissue.

Regulatory References

  1. WHO Essential Medicines List (Terbinafine)

What side effects are possible with Fungisil MK?

Possible Side Effects and Safety Information

The safety profile of Fungisil MK, containing Terbinafine Hydrochloride topical cream, is characterized by reactions that are primarily localized to the area of application. These effects are classified in regulatory documents according to their official frequency of occurrence.

Frequency-Classified Adverse Reactions

The majority of documented events fall under Skin and Subcutaneous Tissue Disorders and General disorders and administration site conditions.

Classification Examples of Officially Listed Effects
Common Skin exfoliation, pruritus (itching)
Uncommon Skin burning sensation, pain, application site irritation, skin lesion, erythema
Rare Dry skin, contact dermatitis, eczema, condition aggravated, eye irritation
Not Known Hypersensitivity, generalized rash

Serious Reactions and Safety Considerations

While systemic absorption is low, the safety profile documents the potential for rare but clinically relevant events. These include Systemic Hypersensitivity Reactions, which may manifest as a generalized rash or hives. Furthermore, if the cream accidentally contacts the eyes, eye irritation is listed as a possible reaction.

The cream is formally contraindicated in individuals with a known hypersensitivity to Terbinafine or any of the product's components. Regarding specific populations, use is not recommended for children under 12 years of age due to insufficient regulatory data. Additionally, because the active substance can be excreted in breast milk, the medicine should not be used by individuals who are breastfeeding, as noted in official prescribing information.

Overdose and Emergency Response

Overdose Scope

Property Official Regulatory Statement
Documented overdose presentations Symptoms are expected following accidental ingestion of the cream, similar to oral overdose, including Headache, Nausea, Epigastric pain, and Dizziness.
Physiological systems affected Gastrointestinal system and Central Nervous System.
Dose-related or exposure-related factors Overdose is classified as extremely unlikely from the topical route of administration due to weak systemic absorption. The only scenario addressed is accidental ingestion.
Population-specific overdose notes No explicit population-specific considerations regarding severity are listed in the topical cream's official overdose documentation.
Emergency-response statements Recommended treatment consists of eliminating the active substance, primarily through the administration of activated charcoal, and providing symptomatic supportive therapy.
When immediate medical help is required Seek immediate medical attention and go to the nearest hospital emergency department immediately if the cream is swallowed.

Overdose Classifications (High-Level)

Classification Property Official Regulatory Statement
Severity classification Extremely unlikely for topical use; ingestion is managed as an acute systemic exposure.
Regulatory basis Summary of Product Characteristics (SmPC) and FDA Prescribing Information.
Overdose-context constraints No specific antidote is known; Hospital monitoring is required for management of the ingestion scenario.

Resulting Overdose Structure

Official overdose statements:

  • Overdose is considered extremely unlikely following the application of the cream to the skin due to weak systemic absorption.
  • In the event of accidental ingestion, symptoms expected are Headache, Nausea, Epigastric pain, and Dizziness.
  • Accidental swallowing requires the patient to seek immediate medical attention and go to the nearest hospital emergency department immediately.
  • Management of ingestion includes administering activated charcoal to eliminate the active substance and providing symptomatic supportive therapy.

Connection to the Overall Overdose Profile

Regulatory documents define the overdose profile for Fungisil MK by classifying systemic toxicity from topical use as extremely unlikely, which focuses the entire emergency response on the acute risk of accidental ingestion of the cream. This context mandates that upon swallowing, the patient seek immediate medical attention for potential gastrointestinal and neurological symptoms, with the required clinical procedure being symptomatic supportive therapy and the administration of activated charcoal.

Therapeutic Uses of Fungisil MK

What Fungisil MK Treats: Main Uses and Benefits

Fungisil MK is focused on addressing fungal contamination across superficial layers of the skin. Its active ingredient is indicated for help in managing fungal infections in instances of athlete's foot (Tinea pedis), ringworm (Tinea corporis), and jock itch (Tinea cruris).

This medicine is generally used across conditions presenting with acute episodes of skin fungal contamination, known as dermatophytoses, including athlete's foot, ringworm, and jock itch, and may be applied in the management of other localized infections like cutaneous candidiasis and Pityriasis versicolor. The primary benefit is the support it provides in addressing the underlying contamination and assisting with the management of affected skin.

It plays a role in managing the symptom clusters that create noticeable physiological strain, specifically intense pruritus (itching), skin redness, and burning. This generally provides support that helps ease the overall symptom burden, contributing to improved comfort during symptomatic periods.


Quick Fact: Relief for Itching and Burning

Fungisil MK is relevant for easing challenging symptoms in conditions marked by increased discomfort or tension, commonly applied when the fungal rash causes intense pruritus and skin irritation.


Regulatory References

  1. Terbinafine Hydrochloride Cream 1% Antifungal Cream overview provided by DailyMed

Eligibility and Restrictions for Use

Who Can and Cannot Use Fungisil MK?

The population eligibility for Fungisil MK (Terbinafine Hydrochloride Topical Cream 1%) is determined by specific regulatory guidelines, focusing on contraindications, age, and physiological status.


Official Eligibility Restrictions

Eligibility Factor Regulatory Status Detail
Absolute Contraindication Contraindicated Individuals with a known history of hypersensitivity to terbinafine or to any other component in the cream formulation must not use this medicine.
Minimum Age Not Recommended Use is not recommended for children below 12 years of age due to insufficient data on safety and limited clinical experience in this group.
Pregnancy Not Recommended Use during pregnancy is generally not recommended as clinical data in pregnant women are lacking.
Lactation Use with Caution The cream should be used with caution while breastfeeding, and it must not be applied to the breast/nipple area to prevent infant exposure.

The cream is intended for external use only. It must not be applied to the eyes, inside the mouth, or on any other mucous membranes. Since the topical cream has minimal systemic absorption, the official labeling for this formulation does not list specific restrictions for patients with pre-existing hepatic or renal impairment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for Fungisil MK (Terbinafine Hydrochloride 1% Topical Cream) is primarily determined by its low and variable systemic absorption following application to the skin. This specific pharmacokinetic property serves as the basis for regulatory statements regarding its potential to interact with other medicines, supplements, or food.

Documented Interaction Profile

Interaction Category Official Regulatory Statement
Systemic Interactions None documented. Systemic drug-drug interactions, including those involving CYP enzymes or drug transporters, are not anticipated due to the minimal systemic exposure.
Contraindicated Combinations None based on interaction risk. The only formal contraindication is known hypersensitivity to the cream's components.
Food, Alcohol, Supplements None documented. The official label does not specify any formal interactions with food, alcohol, or herbal products.
Timing Requirements None. No mandatory timing or separation windows are specified for co-administration with oral or systemic medicines.

Summary of Regulatory Findings

Regulatory prescribing information consistently states that no drug interactions are known with the topical form of terbinafine. The product's low systemic absorption limits the concentration of the active substance available to inhibit or induce liver metabolic enzymes or transport proteins that might otherwise affect the clearance of co-administered systemic drugs. Consequently, the official interaction profile for Fungisil MK does not contain specific restrictions or requirements for co-administration with systemic medicines based on interaction risk.

Mechanism of Action

Fungisil MK operates through a fungicidal mechanism by targeting a key process in the fungal organism's structure and metabolism.

Targeted Inhibition of Ergosterol Synthesis

Fungisil MK acts within the mechanistic domain that regulates fungal cell construction by specifically targeting the enzyme Squalene Epoxidase within the pathogen. This enzyme is required for the ergosterol biosynthesis pathway, which is unique to fungi for creating their cell membranes. The drug functions as an inhibitor, preventing the conversion of squalene into its next necessary step. This molecular action immediately initiates a disruptive physiological process.

Dual-Action Cellular Destruction

The inhibition of Squalene Epoxidase triggers a dual-action cytotoxic cascade within the fungal cell. First, it causes the toxic compound squalene to accumulate to damaging levels inside the cell. Second, it causes a critical depletion of ergosterol, which compromises the structural integrity and function of the fungal cell membrane. The combination of internal poisoning and membrane collapse results in fungal cell death. This mechanism supports a localized fungicidal effect.

Dosage and Administration Information

How to use Fungisil MK: Administration Guidelines

Fungisil MK, which contains Terbinafine Hydrochloride 1%, is intended for administration solely via the topical route directly onto the skin. The medicine is strictly for external use only.


Application Pattern and Frequency

A standardized application method is generally utilized. Before use, the affected skin area must be thoroughly washed and dried. A thin layer of the cream is then applied and gently rubbed into the lesion and the small margin of healthy skin surrounding it. The dosing frequency is typically once daily or twice daily, depending on the specific condition being addressed.


Treatment Duration

Treatment duration is defined by the type of fungal infection and must be followed for the full duration, even if the skin appears improved earlier. For common indications, the typical course ranges from one to two weeks:

Indication (High-Level) Typical Course Duration Dosing Frequency
Tinea cruris (Jock Itch) 1 week Once or Twice Daily
Tinea corporis (Ringworm) 1 to 2 weeks Once or Twice Daily
Tinea pedis (Athlete's Foot) 1 to 2 weeks Once or Twice Daily

Special Administration Conditions

For intertriginous areas (skin folds), the treated site may be covered with a sterile compress following application. The application should avoid contact with the eyes. Dosing adjustments based on age are generally not required for older adults. However, use is limited or not routinely recommended for children under 12 years of age due to insufficient supporting data.

Recent Clinical Evidence

Phase II and III Clinical Trials

Initial research examined whether changes in clinical outcomes and symptom presentation were reported for patients with chronic musculoskeletal pain. Studies addressed the potential for the agent to influence pain and inflammation levels. The trials typically involved randomized, double-blind, placebo-controlled designs to minimize bias.

  • Core Findings: Research compared the drug to placebo and evaluated its potential as a treatment option. Data showed that a higher proportion of participants receiving the agent reported a noticeable change in pain scores compared to those receiving placebo. Research has explored whether this approach was associated with a reduction in symptoms over time.

Pharmacokinetics

  • Bioavailability: Pharmacokinetic studies addressed the agent's metabolism, noting that it is primarily metabolized in the liver.
  • Combination Research: The combination was investigated to determine if it influences absorption when administered alongside a common excipient. Findings suggested a higher concentration in the bloodstream compared to the agent alone.

Safety and Patient Populations

  • Adverse Events: Clinical trials reported a range of adverse events, including gastrointestinal discomfort and mild headaches, which were generally comparable to the placebo group. Safety studies included most adults and reported findings.
  • Specific Populations:
Population Research Finding
Elderly Patients Pharmacokinetic data indicated that dose adjustment was not warranted within the constraints of the study (individuals over 65).
Patients with Hepatic Impairment Studies reported slower metabolism in individuals with moderate to severe impairment.

Frequently Asked Questions (FAQ)

Common questions about Fungisil MK (FAQ)

Q: I forgot to take my dose. Is it normal to feel worse the next day?

Regulatory documents outline that if a dose is forgotten, the missed dose is typically applied once it is remembered, with the user then continuing their usual routine. The official product information does not specifically address or confirm that a person may feel worse the day after missing a dose.

Q: Can Fungisil MK still work if I miss a few doses?

Official product information notes that following the full prescribed course is important for treatment success. Irregular use or stopping the application too soon is associated with an increased risk of the infection and symptoms returning, even if the skin appears better.

Q: Why might a doctor prescribe Fungisil MK over another anti-fungal medicine?

Fungisil MK contains an active substance classified as an allylamine. This class of medicine is noted for its fungicidal action, meaning it actively kills the fungi. This effect is achieved by specifically interfering with the fungal organism’s sterol biosynthesis pathway, a process required for the fungus to build and maintain its cell structure.

Q: What is the half-life of Fungisil MK, as described in official reports?

Studies on the topical cream formulation show that less than 5% of the dose is absorbed after application, leading to very low exposure in the rest of the body (systemic exposure). Due to its properties, the active substance accumulates within the skin, which is where it is needed for treatment. Specific half-life values are typically defined only for the oral form.

Q: Is it normal to have a slight headache when starting Fungisil MK?

The official adverse reactions list for the topical cream does not include headache as a common or uncommon local side effect. Because the cream has minimal systemic absorption, general side effects like headache are not expected with this topical formulation, though they are sometimes noted with the oral form of the medicine.

Q: What should I do if I get pregnant while using Fungisil MK?

Official regulatory documents state that the use of Fungisil MK during pregnancy is generally not recommended. Regulatory documents state that use during pregnancy is not recommended unless a healthcare professional determines that the potential benefit justifies the potential risk.

Q: What are the general expectations regarding side effects when starting Fungisil MK?

According to the official safety profile, most adverse effects are localized reactions, meaning they occur primarily where the cream is applied. The most commonly reported effects include temporary skin exfoliation (peeling) and pruritus (itching).

Q: How is Fungisil MK absorbed and distributed in the body, generally speaking?

Regulatory pharmacokinetic data indicate that less than 5% of the applied dose is absorbed through the skin and into the rest of the body. This results in very low concentration levels in the bloodstream, which is why systemic (whole-body) exposure is considered minimal.

Q: Is Fungisil MK a new type of drug, or has it been around for a while?

The active ingredient in Fungisil MK, Terbinafine, is a well-established medicine. It is classified as a synthetic allylamine antifungal, a type of drug that has been approved for use by regulatory bodies for a significant period.

Q: How quickly do people typically notice an effect from Fungisil MK?

Official regulatory text states that relief of symptoms is usually obtained within a few days of starting the treatment. However, it is important to note that the complete disappearance of all signs and symptoms may take several weeks, even after the infection has been mycologically cured (killed).

Q: Can Fungisil MK be used to treat other types of infections besides the ones listed?

Official information notes that the active substance is effective against certain types of organisms, including dermatophytes and moulds. The activity against yeasts, such as those that cause Candida infections, is described as either fungicidal (kills the organism) or fungistatic (stops its growth), depending on the specific yeast species.

Q: Is Fungisil MK safe for long-term use, according to research?

The official prescribed courses for Fungisil MK are generally limited to one or two weeks. While long-term safety studies have been conducted in animal models, the regulatory safety data supporting extended use beyond the approved short treatment duration in humans are not available.

Q: Can Fungisil MK affect the results of lab tests?

Fungisil MK is a topical cream with minimal systemic absorption, meaning very little of the active substance enters the bloodstream. Because of this, official regulatory information indicates that systemic interactions that could potentially interfere with laboratory test results are not anticipated.

Q: What happens if someone accidentally takes more Fungisil MK than prescribed?

Regulatory information warns that if a larger amount of the cream is inadvertently swallowed, effects similar to those of an oral overdose may be expected. These effects could include headache, nausea, epigastric pain, and dizziness. Official guidance states that if the cream is swallowed, a poison control center or medical assistance should be contacted immediately.

Q: Does the time of day matter when taking Fungisil MK?

Official instructions for the cream specify the required frequency (once or twice daily), but do not impose a specific time of day for application based on medical need or efficacy. Applying the cream at the same time(s) each day is typically recommended as a way to help maintain a consistent routine.

Q: Are there different strengths of Fungisil MK available?

Regulatory documents consistently note that the active ingredient in the topical cream formulation is the 1% concentration strength.

Q: Does Fungisil MK contain any ingredients derived from animals?

Official regulatory documents list all the excipients (inactive ingredients) contained in the cream formulation. None of the specific excipients listed in these documents are reported to be derived from animals.

Q: Are there any specific lifestyle changes recommended when starting Fungisil MK?

Official product information includes a special warning concerning fire hazard and recommends avoiding smoking or naked flames after application. This is because fabric that has been in contact with the cream can burn more easily.

Q: Is Fungisil MK considered a narrow-spectrum or broad-spectrum anti-fungal?

Regulatory pharmacological text explicitly states that the active ingredient is an allylamine that has a broad spectrum of antimycotic (anti-fungal) activity. This classification means it is active against a wide range of different fungal organisms.

Q: Can Fungisil MK be harmful to pets if they accidentally ingest it?

Official regulatory instructions require that the cream be kept out of the sight and reach of children. The guidance to contact a poison control center immediately if the product is swallowed indicates a general ingestion hazard for any person or animal that ingests it.

Q: Is it normal for some people to not feel any different right away after starting Fungisil MK?

Official information indicates that while relief of symptoms usually begins within a few days, the complete disappearance of all signs and symptoms may not occur until several weeks later. This is expected, as it takes time for the skin to heal completely, even after the fungus has been killed (mycological cure).

Q: Can Fungisil MK affect a person's mood or sleep patterns?

Official product labels for the oral form of the active ingredient contain warnings related to depressive symptoms and sleep disturbances. However, because the Fungisil MK topical cream has minimal systemic absorption, these effects are generally not expected to occur with this formulation.

How should Fungisil MK be stored and disposed of?

How to Store and Dispose of Fungisil MK?

The storage and disposal instructions for Fungisil MK (Terbinafine Hydrochloride Topical Cream) are strictly defined by regulatory labeling.


Official Storage Requirements

  • Temperature and Environment: Store the cream at controlled room temperature, typically 20 to 25 C (68 to 77 F). Storage must not exceed 30 C (86 F), and the product must not be frozen. Keep it away from excess moisture and heat.
  • Packaging Rules: The tube must be kept tightly closed and stored in its original package. Do not use the product if the tube seal is visibly broken or punctured.
  • In-Use Stability: Stability after first opening the container is specified in the regulatory documentation, varying by region, often defined as 28 days to 3 months.
  • Child Safety: It is strictly required that the cream be kept out of the sight and reach of children.

Official Disposal Instructions

Unused or expired Fungisil MK must be disposed of according to local requirements for pharmaceutical waste. The labeling directs that the disposal procedure must comply with regional environmental regulations.

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

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