Ламизил

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Ламизил

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Ламизил

Quick Facts

Property Description
Active Ingredient Terbinafine Hydrochloride
Form Oral Tablets, Topical Cream/Solution/Spray
Pharmacological Class Antifungal Agent, Allylamine subclass
General Purpose To eliminate fungal pathogens
Origin Synthetic (Chemically synthesized)

What is Ламизил and What is its Primary Purpose?

Ламизил is a specialized, synthetic medicinal entity defined by its core active ingredient, Terbinafine Hydrochloride, and is classified as a potent antifungal agent. Its primary purpose is the targeted elimination of the microorganisms responsible for fungal infections, serving as a means of clearing the underlying pathogen. Terbinafine is classified pharmacologically as an allylamine antifungal.

The Composition and Pharmacological Class of Terbinafine

The drug's activity stems from the Terbinafine substance, a single-ingredient product synthesized chemically to ensure potency against its target. Terbinafine belongs to the distinct Allylamine class, which acts by inhibiting the fungal squalene epoxidase enzyme. This mechanism leads to a fungicidal action against common dermatophytes.

Available Forms and Differentiation

Ламизил is manufactured in multiple dosage forms to facilitate both systemic and localized treatment. The product utilizes the same Terbinafine Hydrochloride substance whether supplied as oral tablets for systemic use, which are typically Prescription-only, or as various topical preparations such as cream, solution, or spray, which are often available Over-The-Counter (OTC) for superficial concerns. These different forms allow for specific routes of administration: tablets for deep-seated conditions like nail infections, and topical applications for localized skin infections.

Regulatory References

  1. clinically recognized by the United States National Library of Medicine

What side effects are possible with Ламизил?

Possible Side Effects and Safety Information

The safety profile of Terbinafine (Ламизил) is organized by official regulatory bodies into frequency categories and affected physiological systems. Adverse reactions are classified based on the likelihood of their occurrence in clinical use.

Commonly Documented Adverse Reactions

The highest frequency categories (Very Common and Common) frequently include effects involving the Gastrointestinal Disorders and Nervous System Disorders. These generally consist of headache, abdominal pain, diarrhea, nausea, and rash/urticaria.

Frequency Category Representative Effects
Very Common (ge 1/10) Headache, Nausea, Diarrhea, Rash, Joint or Muscle Pain
Uncommon (ge 1/1,000 to <1/100) Taste disturbance (Dysgeusia/Ageusia), Dizziness, Visual disturbance

Serious Adverse Reactions and Constraints

Official labels document rare but clinically significant adverse reactions, categorized in the Hepatobiliary Disorders and Blood and Lymphatic System Disorders classes. These include cases of hepatic failure (hepatotoxicity), severe skin reactions (such as Stevens-Johnson Syndrome), and rare blood count abnormalities, including agranulocytosis and neutropenia.

Due to the risk of liver damage, the medicine is formally contraindicated in patients with pre-existing chronic or active liver disease. Regulatory texts require immediate treatment discontinuation if specific signs appear, such as evidence of liver injury (e.g., persistent nausea, jaundice) or a severe, progressive skin rash. Certain adverse effects, such as taste disturbance, may be prolonged, but liver enzyme elevations typically resolve upon treatment cessation.

Overdose and Emergency Response

Overdose and when to seek help

Acute overdose of Ламизил (terbinafine) may result in documented systemic manifestations, primarily affecting the gastrointestinal and central nervous systems. Symptoms reported in cases of acute ingestion of large amounts (e.g., up to 5 grams) include nausea, vomiting, abdominal pain, headache, dizziness, rash, and frequent urination. The regulatory profile notes that inadvertent ingestion of a large amount of the topical cream is expected to result in similar adverse effects.

Immediate medical intervention is mandated if severe outcomes manifest. Urgent medical attention is required when the individual exhibits signs of collapse, seizures, severe breathing difficulty, or symptoms suggestive of severe hepatic dysfunction (such as persistent, unexplained nausea, jaundice, or dark urine) or severe skin reactions. Official emergency-response statements advise contacting a Poison Help line or emergency services.

The management of overdose is primarily supportive and symptomatic, as no specific antidote is officially known or documented. Procedures described in regulatory information include the administration of activated charcoal to eliminate the active substance. Furthermore, immediate evaluation of liver function is specifically required if there are clinical signs of hepatic injury. The official overdose statements define the required help-seeking conditions based on these documented risks.

Therapeutic Uses of Ламизил

What Ламизил Treats: Main Uses and Benefits

Ламизил (terbinafine) is applied in situations involving infections of the skin and nails, which manifest through specific symptoms. It is used for the management of conditions that can become intense and affect overall comfort.

The preparation is relevant for managing symptom clusters in conditions associated with common fungal diseases of the skin and nails. These conditions can include those affecting the feet, body, as well as the nail plates.

“Treatment helps alleviate groups of symptoms that can become intense, and provides supportive relief to improve general well-being.”

Ламизил can contribute to the relief of distressing symptoms, including itching, burning, as well as physical manifestations such as redness, peeling, and changes in the appearance of the nail plate. This contributes to maintaining functional stability and comfort in situations where symptoms become more noticeable.

Quick Fact: Supports Easing Discomfort

Ламизил contributes to the relief of symptoms associated with inflammatory or irritating conditions and can assist in improving the appearance of the skin and nails.

Eligibility and Restrictions for Use

Eligibility for Oral Terbinafine (Ламизил)

The official regulatory profile strictly defines who may be prescribed oral Terbinafine, with rules established based on physiological status, pre-existing conditions, and age.

Eligibility Scope Status as per Regulatory Documents
Contraindicated Populations Individuals with a history of hypersensitivity to oral terbinafine or with chronic or active liver disease are strictly prohibited from use.
Age-Group Rules Use is established for adults and for children aged 4 years and older for certain approved pediatric indications. Safety and efficacy have not been established in children under 4 years of age.
Organ Function Restriction The medicine is not recommended for patients with severe renal impairment (Creatinine Clearance leq 50 mL/min), as pharmacokinetics are altered in this population.
Reproductive Status Use is not recommended during pregnancy due to limited clinical data. Breastfeeding mothers should not receive treatment as the drug is known to be excreted into breast milk.
Conditional Use Patients with pre-existing conditions such as Psoriasis or Lupus Erythematosus require specific caution, as regulatory labels note the potential for these conditions to be exacerbated.

These eligibility classifications define a clear regulatory boundary, with non-eligibility ranging from absolute prohibition (contraindicated) to conditional use (not recommended or use with caution).

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for Terbinafine is defined by its role as a potent inhibitor of the CYP2D6 enzyme. This pharmacokinetic interaction reduces the clearance and significantly increases the systemic exposure (AUC/Cmax) of co-administered medicines that are predominantly metabolized by this pathway.

Interactions are officially documented with specific classes, including tricyclic antidepressants (e.g., Desipramine), beta-blockers (e.g., Metoprolol), and Type 1C antiarrhythmics (e.g., Propafenone, Flecainide). For these substances, Terbinafine alters their metabolism, which may require monitoring.

Influence on Terbinafine Exposure

Terbinafine's own plasma concentration is subject to pharmacokinetic interaction. Co-administration with enzyme inhibitors, such as Cimetidine or Fluconazole, officially results in a significant increase in Terbinafine exposure due to reduced systemic clearance. Conversely, enzyme inducers, such as Rifampicin, are officially stated to accelerate clearance, resulting in a clinically significant decrease in Terbinafine plasma concentration.

Other Documented Substance Effects

The regulatory label notes that Terbinafine may increase the clearance of Cyclosporine. Rare cases of changes in International Normalized Ratio (INR) have been reported with co-administration of Warfarin. The drug may be taken without regard to food, as co-administration with meals does not significantly alter systemic exposure. The potential for interaction effects is officially stated to be of particular relevance in patients with pre-existing hepatic impairment.

Mechanism of Action

Selective Blockade of Fungal Enzyme Activity

Ламизил’s mechanism begins with the highly selective non-competitive inhibition of the fungal enzyme squalene epoxidase (SE), a molecular target critical to the pathogen’s metabolism. SE is essential for the ergosterol biosynthesis pathway; by blocking this enzyme, the drug initiates a metabolic disruption unique to the fungal cell.


Dual Cascade: Toxicity and Membrane Destruction

The enzyme blockade triggers a dual-mechanism cascade that leads to fungal cell death. First, the precursor squalene accumulates to toxic concentrations inside the cell, physically damaging internal structures. Concurrently, the essential membrane component ergosterol is critically depleted. The combination of internal toxicity and external membrane failure leads to the disintegration of the pathogen.


Mechanism-Enabling Tissue Accumulation

The pharmacological outcome is supported by the molecule’s high lipophilicity, which drives the drug to accumulate and be retained in lipid-rich compartments like the skin and nail plate. This mechanism-enabling property ensures that fungicidal concentrations are maintained directly at the site of infection for extended periods, supporting the continuation of the cellular destructive process.

Dosage and Administration Information

How to Use Ламизил: Official Administration Guidelines

This section outlines the standardized administration and dosing instructions for Ламизил (terbinafine).


Approved Administration Routes and Forms

Ламизил is approved for two primary administration routes, depending on the infection's location and extent:

  • Oral: Systemic use via 250 mg tablets for infections like onychomycosis (nail fungus).
  • Topical: Localized use via cream, solution, or spray for superficial skin infections.

Standard Labeled Dosing and Duration (Adult Oral Tablets)

Condition (Systemic Use) Standard Dose Typical Duration
Fingernail Onychomycosis 250 mg once daily 6 weeks
Toenail Onychomycosis 250 mg once daily 12 weeks
Tinea/Cutaneous Infections 250 mg once daily 2 to 6 weeks

The standard adult oral dose is 250 mg taken once daily. Topical preparations are typically applied once or twice daily for a shorter, condition-specific period, often ranging from 1 to 4 weeks.


Contextual Use and Administration Rules

Oral tablets may be taken with or without food, though they should ideally be taken at the same time each day. The tablets are scored and can be divided if needed. If a dose is missed, it should be taken as soon as remembered unless it is almost time for the next dose, in which case the missed dose should be skipped; a double dose must never be taken. Ламизил use is not recommended in patients with severe renal impairment (Creatinine Clearance < 50 mL/ min) or chronic liver disease.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Ламизил (Terbinafine)

This overview summarizes the structure of the official research evidence for terbinafine, focusing on the types of studies conducted and the outcomes they explored, without offering clinical recommendations or advice.


Evidence for Use in Onychomycosis (Fungal Nail Infections)

The body of research for the oral tablet form of terbinafine in fungal nail infections primarily consists of numerous controlled studies, including Randomized Controlled Trials (RCTs) and comprehensive systematic reviews and meta-analyses. These studies focus mainly on adults diagnosed with fungal infections of the fingernails or toenails. Researchers monitored two core outcomes: Mycological Cure (defined as laboratory evidence of pathogen absence) and Complete Cure (a composite measure tracking both pathogen status and the presence of unaffected nail growth).

Research exploring short-term symptom changes reported how symptoms evolved in the observed populations. The evidence is considered well-established, reflecting the volume of controlled research in adult populations, but findings were mixed in terms of outcome definitions.

Evidence for Use in Tinea Infections of the Skin

The evidence for topical terbinafine preparations, which are applied directly to the skin, was evaluated in numerous short-term RCTs. These studies explored skin conditions characterized by fluctuating or episodic manifestations, such as Tinea Pedis (Athlete's Foot), Tinea Corporis (Ringworm), and Tinea Cruris (Jock Itch). Research examined whether participants achieved a Mycological Cure and tracked outcomes linked to inflammatory or irritative states, such as measurements of changes in signs like redness, scaling, and itching. Research also describes trials conducted for Pityriasis Versicolor, with studies monitoring physiological strain or stress by measuring the status of scaling and changes in pigmentation.


Evidence for Long-Term Outcomes and Recurrence

For onychomycosis, long-term prospective studies were evaluated in research examining temporary physiological imbalance and the durability of change. These studies monitored patients for extended periods, sometimes for more than four years following the end of the tablet treatment, specifically tracking the Recurrence Rate of the fungal infection. Studies observed how this evidence contributes to the broader evidence landscape by providing context for the persistence of results over an extended period. The follow-up durations were limited in the sense that they only tracked patients for a set number of years, meaning information regarding lifetime recurrence risk is not fully established.

What Research Gaps and Uncertainties Exist

Despite the volume of controlled research, certain gaps and limitations are noted in the evidence landscape for terbinafine.

  • Evidence quality varies across studies due to the inconsistent use of definitions for clinical success in older trials, which may make it difficult to precisely compare findings.
  • Data for certain groups remain insufficient, particularly for long-term outcomes and recurrence rates after topical use in skin infections, as follow-up durations were limited.
  • Emerging research describes patterns related to fungal resistance in some parts of the world, with studies exploring short-term symptom changes in cases where initial pathogen clearance was not observed.

Frequently Asked Questions (FAQ)

Common questions about Ламизил (FAQ)


Q: Is Ламизил an antibiotic?

A: Official information classifies Ламизил as an allylamine antifungal medicine. This means its mechanism is specifically designed to target and treat infections caused by fungus, and it is not indicated for the treatment of bacterial infections.


Q: Does Ламизил treat all types of fungal infections?

A: The official uses of Ламизил are specified for certain infections caused by specific fungi, such as dermatophytes and certain Candida species. Effectiveness can vary across different fungal types, and regulatory documents specify the exact types of tinea and onychomycosis it is approved to treat.


Q: How quickly does Ламизил start working?

A: Pharmacokinetic data in regulatory documents indicate that the active ingredient, terbinafine, is detected at the site of infection in the skin and nails after administration. However, the visible clearance and resolution of the fungal infection typically takes longer, often several weeks, depending on the infection's location and type.


Q: Can I stop using Ламизил once my symptoms disappear?

A: Patient instructions and official guidance consistently advise that the established course of treatment be completed. Stopping treatment prematurely, even if symptoms appear to have cleared up, may risk allowing the infection to return.


Q: What's the difference between Ламизил cream and tablets?

A: The key difference lies in their use: tablets are taken orally for systemic (internal) use, typically for widespread or severe infections like nail fungus. Creams and topical products are applied locally to the skin for superficial infections.


Q: Is there a generic version of Ламизил?

A: Yes, the active ingredient in Ламизил is terbinafine hydrochloride, which is available in generic forms. Regulatory bodies require that generic versions demonstrate bioequivalence to the original branded product.


Q: Does Ламизил cause drowsiness?

A: Official prescribing information generally does not list drowsiness as a common side effect of Ламизил. While other CNS-related effects like dizziness have been reported infrequently, drowsiness is not noted as a frequently reported adverse reaction.


Q: Are there any foods I should avoid while using Ламизил?

A: Oral tablets may be taken with or without food. However, official documents note that the medication may affect the metabolism of caffeine, and they may mention this in the context of dietary intake.


Q: Is it normal to feel a tingling sensation when applying Ламизил cream?

A: Topical product information describes local reactions at the application site as common or very common. These local reactions can include temporary irritation, burning, or tingling sensations.


Q: Can children use Ламизил?

A: Official documents specify that the use of Ламизил in children requires particular consideration. Pediatric dosing has been established by some regulators for certain conditions, such as fungal infections of the scalp (tinea capitis).


Q: What is the guidance on using Ламизил during pregnancy?

A: Oral Ламизил is generally not recommended during pregnancy due to limited data in humans. While topical forms have very low systemic absorption, official guidance often notes that the potential risks and benefits should be considered by a healthcare provider before use.


Q: Can I use Ламизил if I am breastfeeding?

A: Regulatory information indicates that the active substance from the oral tablet is known to pass into breast milk. Consequently, official guidance often indicates that its use is not advised while breastfeeding.


Q: Does Ламизил interact with common pain relievers?

A: Official interaction lists typically do not mention specific interactions with over-the-counter pain relievers like ibuprofen or acetaminophen. However, the drug can affect the metabolism of certain other medicines, and official information notes that a review of all concurrent medications is described as necessary.


Q: Can I drink alcohol while taking Ламизил tablets?

A: While official patient information does not usually list a direct contraindication for alcohol, given the drug's known potential for hepatic (liver) effects, the official guidance often suggests a cautious approach to alcohol intake during treatment.


Q: What is the main ingredient in Ламизил?

A: The main active substance in Ламизил that provides the antifungal effect is terbinafine, which is typically found as terbinafine hydrochloride.


Q: How long can I use Ламизил cream for?

A: The typical duration of use for the topical cream is specified in regulatory documents based on the type of infection being treated. The length of use generally ranges from 1 to 4 weeks.


Q: Does Ламизил have an expiration date?

A: Yes, all pharmaceutical products, including Ламизил, must have an expiration date printed on the packaging. This date is required to indicate the time period during which the manufacturer specifies the product maintains its stated potency and quality when stored under labeled conditions.


Q: Is a prescription required for all forms of Ламизил?

A: No, a prescription is not required for all forms. While the oral tablets are classified as prescription-only medicine, some lower-concentration topical creams or gels are available without a prescription (Over-the-Counter or OTC) in many regions.


Q: Why do official documents mention potential changes in taste or smell with Ламизил?

A: Changes in taste sensation, including loss of taste, and disturbances in the sense of smell have been reported and documented as adverse reactions in official prescribing information for the oral form. These are reported based on data gathered during clinical trials and post-marketing surveillance.


Q: Can Ламизил interact with herbal supplements?

A: Yes, official documents advise caution with certain herbal products. For instance, St. John’s wort may potentially reduce the concentration of terbinafine in the bloodstream, which is noted as a possibility for drug interaction.


Q: What are the most commonly reported side effects of Ламизил?

A: Official sources for the oral form list the most common or very common side effects as gastrointestinal issues (like nausea, diarrhea, abdominal pain) and certain skin reactions (like rash or hives).


Q: Does Ламизил cause skin sensitivity to the sun?

A: Increased sensitivity to sunlight (photosensitivity) is not listed as a common effect. However, regulatory reports have mentioned it as a rare adverse reaction observed during post-marketing experience.


Q: Is there research evidence showing how Ламизил affects different types of tinea?

A: Yes, regulatory documents include summaries of clinical trials. These studies demonstrate the drug's effectiveness against specific infections, such as tinea pedis (athlete's foot), tinea cruris, and tinea corporis.


Q: Can Ламизил be used for fungal infections of the scalp?

A: The oral tablets are approved by certain regulatory bodies for the treatment of tinea capitis (fungal infection of the scalp), which often requires systemic treatment, especially in children.


Q: What should I do if the side effects of Ламизил bother me?

A: Patient guidelines describe the need to contact a healthcare professional to report any side effects that are persistent, bothersome, or concerning. Instructions for immediate medical attention are provided for signs of severe adverse reactions, such as symptoms of liver problems.


Q: Is it possible to be allergic to Ламизил?

A: Yes, known hypersensitivity, which is an allergic reaction to terbinafine or any other component in the medicine, is listed in official documents as a contraindication (a reason not to use the drug).


Q: Do studies support the use of Ламизил for athletes' foot?

A: Clinical study data and regulatory approvals specifically support the use of both the oral tablets and topical forms for the treatment of tinea pedis, commonly known as athlete's foot.


Q: Are older adults typically treated differently with Ламизил?

A: Official documents state that there is no indication for required dosage adjustment solely based on age for older adults. Treatment modifications are generally only necessary if the patient has impaired kidney or liver function.


Q: Does Ламизил affect birth control pills?

A: Regulatory documents indicate that oral terbinafine does not appear to interfere with the effectiveness of common hormonal oral contraceptives.


Q: Does Ламизил treat bacterial infections as well?

A: Ламизил is classified only as an antifungal agent. Its mechanism of action specifically targets fungal cells, and it is not indicated for the treatment of bacterial infections.


Q: Is the mechanism of action of Ламизил explained in official sources?

A: Yes, official documents explain that the drug works by interfering with the fungus’s ability to produce essential sterols (cell components). This action is described as fungicidal, meaning it leads to the death of the fungal cells at the site of infection.


Q: Can Ламизил interact with heart or blood pressure medications?

A: Regulatory documents mention potential interactions with certain heart medications. Oral Ламизил may interact with some beta-blockers and antiarrhythmics that are metabolized by a specific liver enzyme (CYP2D6).


Q: What if I accidentally swallow a small amount of Ламизил cream?

A: Topical formulations are for external use only. Official guidance for any accidental oral ingestion of the cream or solution specifies contacting a healthcare provider or poison control center.


Q: Are there any specific safety warnings for people with pre-existing conditions mentioned for Ламизил?

A: Yes, official warnings mention that oral use is not recommended for individuals with chronic liver disease and requires precautions for those with renal impairment. Additionally, it is noted that the medication may potentially worsen existing conditions like lupus erythematosus.


Q: Do studies show a difference in effectiveness between brand-name and generic terbinafine (Ламизил)?

A: Regulatory standards require generic versions of terbinafine to be bioequivalent to the brand-name product. This means they must contain the same active ingredient and achieve the same concentration in the body, ensuring they are expected to have the same effect.


Q: What does 'terbinafine' mean in the context of Ламизил?

A: Terbinafine is the non-proprietary or generic name for the active antifungal chemical substance. Ламизил is the branded name under which the product containing terbinafine is marketed.


Q: How is the safety of Ламизил monitored after it is approved?

A: Regulatory bodies actively monitor post-marketing surveillance data, which involves collecting and documenting any rare or serious adverse reactions. This data is reported by patients and healthcare professionals after the product has been approved and is in use.


Q: Can Ламизил be used on mucous membranes?

A: Instructions for the topical forms commonly advise caution and warn against contact with sensitive areas such as the eyes, mouth, and other mucous membranes.


Q: Does Ламизил stop the fungus from growing or kill it?

A: Official documents describe the drug's action as fungicidal. This means that at the concentrations reached at the site of infection, the drug works to lead to the death of the fungal cells.


Q: Are there specific instructions in official documents about what to do during an adverse reaction to Ламизил?

A: Yes, official guidance instructs that if a patient experiences signs of a severe reaction, such as a serious rash or symptoms indicating liver problems, they should discontinue the medication immediately and seek urgent medical attention.


Q: Do official sources clarify the meaning of 'systemic' side effects of Ламизил?

A: Regulatory documents differentiate side effects into application-site (local) and systemic (internal) effects. Systemic effects are those absorbed into the bloodstream, often including those affecting the liver or gastrointestinal tract.


Q: What kind of evidence is usually presented for the use of Ламизил in pediatric populations?

A: Regulatory data typically includes results from controlled clinical trials that specifically assess the safety and effectiveness of the drug in children for approved indications, such as tinea capitis.


Q: Can I apply other creams or ointments while using topical Ламизил?

A: Patient instructions generally advise against applying other topical products to the treatment area simultaneously. This caution is advised to prevent potential unknown interactions or dilution of the active medicine.


Q: What are the general expectations regarding cure rates mentioned in research about Ламизил?

A: Clinical study summaries included in regulatory documents provide data on success rates. These documents typically report mycological cure rates and clinical cure rates for the specific conditions the drug is indicated to treat.


Q: Is there a known effect of Ламизил on fertility?

A: Based on animal studies, the drug has not shown evidence of impairing fertility. There is currently no known evidence from human data that the medication reduces fertility.


Q: Does exposure to heat affect the stability of Ламизил cream?

A: Official storage instructions specify that the product must be kept at a defined temperature, typically room temperature, to maintain its stability and effectiveness. Warnings are usually included against freezing the cream.

How should Ламизил be stored and disposed of?

How to Store and Dispose of Lamisil (Terbinafine)

Official regulatory guidelines mandate specific conditions for storing and disposing of Lamisil tablets or oral granules to maintain product stability and safety.

Storage and Handling Requirements

  • Temperature: Store at controlled room temperature, typically below 25 C (77 F), with permitted excursions. Do not store in environments prone to excess heat, and keep the medication from freezing.
  • Protection: The product must be protected from light and moisture; keep it in the original container and ensure the container is tightly closed.
  • Child Safety: Always store this medication securely out of the sight and reach of children, utilizing locked safety caps as available.

Disposal Rules

  • Any unused, expired, or waste medication must be disposed of in accordance with local regulatory requirements. These rules ensure proper environmental management and safe handling of pharmaceutical waste.

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

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