Lisoderma

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Lisoderma

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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 Lisoderma

Lisoderma is a specialized external preparation defined by its fixed-dose combination of two therapeutically distinct active substances. It is designed to provide simultaneous antibacterial protection and active support for tissue repair in damaged skin.

Property Description
Active Ingredients Acexamic Acid, Gentamicin Sulfate
Form Topical Preparation (Cream or Ointment)
Pharmacological Class Wound Healing Agent and Topical Antibiotic
General Purpose Dual action for tissue repair and infection prevention
Origin Synthetic derivative and Natural derivative

What Type of Medicine is Lisoderma?

Lisoderma is a fixed-dose combination dermatological preparation intended exclusively for topical administration directly to the skin surface. Its pharmacological classification is dual, combining the properties of a Wound Healing Agent and a Topical Aminoglycoside Antibiotic. This dual classification confirms the product's suitability for situations requiring both microbial defense and accelerated tissue restoration, distinguishing it from general single-action antiseptic or barrier creams.


Composition and Origin: Acexamic Acid and Gentamicin Sulfate

The core efficacy of Lisoderma is derived from its two active ingredients: Acexamic Acid and Gentamicin Sulfate. The formulation is delivered via a topical cream or ointment base. Acexamic Acid is a synthetic derivative of epsilon-aminocaproic acid, known for its trophic activity, a property clinically recognized for supporting cellular proliferation and aiding the covering of injured skin.

Gentamicin Sulfate, the antibiotic component, is naturally derived from the Micromonospora species, providing the necessary antibacterial defense against a wide range of common skin pathogens. The intentional pairing of these two substances ensures that the regenerative efforts of the skin are secured against secondary bacterial infection.


General Purpose: Dual Action for Skin Repair and Protection

The general purpose of Lisoderma is to facilitate the complete and efficient recovery of minor skin damage by implementing a dual-action model. This preparation is specifically formulated to actively support the body’s healing process by encouraging cellular regeneration (via Acexamic Acid) while simultaneously maintaining a sterile environment through its antibacterial coverage (via Gentamicin Sulfate). The dual application principle aims to accelerate the natural restoration of the skin barrier function.

Regulatory References

  1. MedlinePlus: Drug Information

What side effects are possible with Lisoderma?

Possible Side Effects and Safety Information

The safety profile of Lisoderma, a fixed-dose combination containing Acexamic Acid and Gentamicin Sulfate, is primarily shaped by the regulatory classification of its antibiotic component, topical gentamicin. The officially documented adverse reactions are categorized by frequency and the organ system affected.

Local Adverse Reactions and Frequency

The most frequent adverse events listed in regulatory documents are local skin reactions at the application site, classified within Skin and Subcutaneous Tissue Disorders. These effects are generally categorized as occurring in a small percentage of cases, or less common, and include: pruritus (itching), erythema (redness), and localized irritation or swelling.

Serious Systemic Safety Considerations

Although rare with proper topical application, the official safety profile notes the potential for systemic toxicity associated with aminoglycosides. This risk is primarily linked to significant absorption, leading to possible irreversible ototoxicity (damage to the auditory nerve affecting hearing and balance) and nephrotoxicity (kidney function impairment). These serious adverse reactions are more likely if the medicine is applied to large, denuded skin areas or used for prolonged periods.

Population and Duration Constraints

Official labels note specific safety constraints related to patient status and duration of use. Patients with impaired renal function or older adults are considered more susceptible to systemic toxicity should significant absorption occur. The risk of superinfection—the overgrowth of non-susceptible organisms, including fungi—is associated with prolonged use of the preparation. The medicine is contraindicated in individuals with a known history of sensitivity or allergic reactions to any of its components.

Overdose and Emergency Response

Overdose and When to Seek Help

The official overdose profile for Lisoderma is determined by the potential for systemic absorption of its antibiotic component, Gentamicin Sulfate, which may occur with excessive application, prolonged use, or use on large areas of broken skin.

Documented Overdose Manifestations and Risks

Feature Official Regulatory Statement
Documented Manifestations mathbfNephrotoxicity (impaired renal function, increased serum creatinine) and mathbfototoxicity (auditory or vestibular nerve damage, hearing loss, dizziness) [Gentamicin Toxicity].
Severe Outcomes mathbfIrreversible mathbfhearing mathbfloss and mathbfrespiratory mathbfparalysis (due to neuromuscular blockade) are officially documented serious risks.
High-Risk Populations Increased susceptibility to toxicity is noted for mathbfelderly mathbfpatients and those with mathbfpre mathbfexisting mathbfrenal mathbfimpairment.

Emergency Actions and Clinical Management

Immediate medical attention is mathbfmandated if any signs of systemic toxicity are observed. This includes contacting emergency services or a poison control center upon noticing changes in hearing, dizziness, or a decrease in urination. No mathbfspecific mathbfantidote is known for this type of overdose. Management is mathbfsymptomatic mathbfand mathbfsupportive. Regulatory guidance requires mathbfclose mathbfmonitoring of Gentamicin serum levels and renal function (BUN/Creatinine) to manage the officially documented toxic risks. Haemodialysis may be utilized to aid in drug clearance.

Therapeutic Uses of Lisoderma

What Lisoderma Treats: Main Uses and Benefits

The therapeutic use of Lisoderma is centered on a dual approach to managing damaged and contaminated skin. The primary role of its antibiotic component is to address both infection and impaired healing.

Dual Management of Infected Skin Lesions

This medicine is commonly used to help manage superficial bacterial infections of the skin, including primary pyodermas like impetigo and folliculitis, as well as secondary infections that may develop in pre-existing conditions or trauma. It is applied to address symptomatic clusters such as oozing, crusting, and pustule formation that are characteristic of bacterial overgrowth. This use generally assists with controlling the presence of bacteria, which contributes to easing the overall symptom load associated with the infection.

Support for Tissue Repair and Wound Recovery

Lisoderma is considered relevant for managing skin that has suffered trauma, cuts, abrasions, minor burns, or chronic localized damage where the healing process may be compromised. It specifically helps manage the state of delayed wound closure. The preparation supports the healing process. This supports general well-being during symptomatic phases related to localized tissue damage. Its application is common in clinical scenarios where the skin's integrity is compromised and infection is present or highly probable.


Quick Fact: Relief for Dual Skin Concerns
Lisoderma is relevant when the skin presents with both signs of infection (e.g., crusting, pustules) and a state of delayed wound closure, providing combined symptomatic assistance in these challenging situations.

Regulatory References

  1. DailyMed listing for Gentamicin Sulfate

Eligibility and Restrictions for Use

Who Can and Cannot Use Lisoderma?

Eligibility for Lisoderma (Acexamic Acid/Gentamicin Sulfate) is determined by regulatory agencies based on patient characteristics and pre-existing conditions. These rules define who can safely receive the medicine.

Absolute Contraindications (Do Not Use)

The medicine is officially contraindicated in the following groups:

  • Hypersensitivity: Individuals with a known allergy or history of sensitivity to Gentamicin Sulfate or any other aminoglycoside antibiotic (due to known cross-sensitivity).
  • Pediatric Age: Children under 1 year of age are generally not recommended to use this medicine.

Populations and Conditions Requiring Caution

Some populations require conditional use, as documented in official prescribing information:

Population/Condition Restriction Type
Compromised Skin Barrier Use with caution on extensive areas of damaged skin (e.g., severe burns or ulcers) due to the risk of increased systemic absorption.
Severe Renal Impairment Conditional use; requires consideration due to potential systemic effects if absorption occurs.
Pregnancy Restricted use; the benefit must outweigh the potential risk, as systemic Gentamicin is associated with fetal risk.
Breastfeeding Generally acceptable, as minimal risk is expected for the infant.

Lisoderma is officially indicated only for skin lesions with a susceptible bacterial component and is not approved for treating viral or fungal infections.

What should I know about interactions with other medicines?

The official interaction profile for Lisoderma, a fixed-dose topical preparation containing the antibiotic Gentamicin Sulfate, is defined by the risks associated with potential systemic absorption of the aminoglycoside component. This is relevant when the medicine is applied to large surface areas or to skin where integrity is significantly compromised.

Restrictions on Concurrent Medicinal Products

Co-administration with other potentially neurotoxic drugs should be avoided. This restriction is based on the documented risk of additive neurotoxicity if sufficient systemic exposure to the antibiotic component occurs. Similarly, concurrent use of other potentially nephrotoxic drugs must also be avoided due to the documented risk of additive nephrotoxicity.

Exposure-Altering and Toxicity Risks

The use of potent diuretics, such as Ethacrynic acid and Furosemide, should be avoided during Lisoderma application. This is because potent diuretics may independently contribute to ototoxicity, and their combination with an aminoglycoside may increase the overall risk of ototoxicity as defined in regulatory labeling.

Interaction Type Entities with Documented Risk
Additive Toxicity Potentially Nephrotoxic Drugs, Potentially Neurotoxic Drugs
Increased Ototoxicity Risk Potent Diuretics (e.g., Furosemide)

Population-Specific Considerations

Regulatory information specifies that patient factors such as advanced age and the presence of dehydration are conditions that may increase the potential for systemic toxicity from the aminoglycoside component. No interactions with food, alcohol, herbal products, or supplements are documented in the official regulatory text for this topical preparation.

Mechanism of Action

How Lisoderma Works

Lisoderma's mechanism is defined by the complementary pharmacodynamic actions of its two components, focusing on targeted bacterial elimination and the modulation of tissue repair processes.


Targeting Bacterial Protein Synthesis

The antibiotic component, Gentamicin Sulfate, acts at the molecular level by binding directly to the bacterial 30S ribosomal subunit . This interaction disrupts the Bacterial Translation Pathway, causing the creation of non-functional proteins that destabilize the bacterial cell, resulting in bacterial cell death (bactericidal effect). The physiological consequence of this mechanism is the elimination of local microbial pathogens, which secures the environment for subsequent repair processes.


Trophic Modulation of Tissue Regeneration

Acexamic Acid functions as a trophic modulator, primarily by stimulating the activity of fibroblasts and promoting the synthesis of collagen and the Extracellular Matrix (ECM). This mechanism modulates the Proliferative Phase of tissue repair, stimulating the formation of granulation tissue and the closure of the compromised surface (epithelialization). It is also linked to stabilizing the fibrin clot, reducing early tissue breakdown.


Mechanistic Coupling

The two mechanisms are mechanistically coupled: the Gentamicin mechanism achieves local microbial elimination, while the Acexamic Acid mechanism modulates cellular repair. This coupling ensures the proliferative mechanisms proceed within a secured, non-contaminated biological setting, providing the necessary conditions for the reconstruction of tissue.

Dosage and Administration Information

How to Use Lisoderma: Administration Guidelines

Lisoderma, a fixed-dose combination topical preparation, is used according to specific instructions that govern its application, frequency, and duration. These instructions provide a structured approach to its use.


Administration Scope

The preparation is intended exclusively for topical application to the skin. The choice between the available cream or ointment formulation depends on the condition of the lesion; the cream is generally preferred for wet, oozing lesions, while the ointment is better suited for dry or eczematous skin.


Standard Dosing and Frequency

Application involves applying a small amount of the preparation to the affected area, creating a thin, even film over the lesion. This process is repeated three to four times a day. The concentration of the antibiotic component (Gentamicin) is fixed at 0.1% in the final preparation.

Age-Group Rules: The topical preparation is approved for use in children over 1 year of age.


Contextual Use and Duration

Procedural Steps: For certain infected lesions, such as impetigo contagiosa, any crusts must be gently removed before the preparation is applied to maximize contact with the affected tissue. The treated area may optionally be covered with a sterile gauze dressing.

Course Duration: Use is intended to be short-term, typically constrained to a course of seven to ten days. The full course should be completed, even if visible improvement occurs quickly. If a dose is missed, it should be applied as soon as possible, unless the next application is almost due, in which case the missed dose should be skipped to maintain the regular schedule.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Lisoderma

Evidence for Use in Infected Skin Lesions

Research has explored the combination of a topical antibiotic (Gentamicin Sulfate) and Acexamic Acid, which has been studied in research exploring skin restoration, in conditions involving bacterial presence and damaged skin. Studies of the antibiotic component have included short-term clinical trials and observational studies in patients with common primary skin infections, such as impetigo and folliculitis, as well as secondary infections in pre-existing skin issues.

These investigations monitored outcomes related to physical discomfort and were used in research exploring how symptoms change over time, specifically looking at the monitoring of signs like crusting and oozing that was associated with bacterial activity. Findings described patterns observed in the studies regarding the reduction or clearance rate of specific susceptible bacteria (like Staphylococcus aureus) over defined time intervals, usually within a short-term treatment course of 7 to 14 days. These studies contribute to the broader evidence landscape related to topical antibiotics in conditions involving periods of heightened symptoms due to infection.


Evidence Supporting Tissue Repair and Wound Recovery

Research has also examined the dual application context of Lisoderma, specifically how studies explored the Acexamic Acid component in relation to wound closure. The repair agent was studied for its inclusion in studies involving trauma, minor burns, or other localized damage where the process of skin restoration may be delayed. Studies in this area have included preclinical laboratory models focusing on tissue regeneration and clinical studies in various wound care settings.

What is Still Uncertain About the Research for Lisoderma

The research provides context for the individual actions of the two components, but comparative evidence is lacking for the fixed-dose combination against all other standard topical therapies. Furthermore, some studies, particularly those focused on the Gentamicin component, have research examined its dermal penetration, with findings describing that target concentrations were observed in some studies. Evidence quality varies across studies, and sample sizes were modest in many of the trials examining the dual-action outcomes. Research is ongoing to provide further clarity on the combined properties and the consistency of reported findings across various types of wounds and infected skin conditions.

Key Studies & References

  1. Gentamicin Sulfate Topical Ointment and Cream (DailyMed Drug Labeling)

Frequently Asked Questions (FAQ)

Common questions about Lisoderma (FAQ)


Q: What is Lisoderma used for?

Lisoderma is indicated for the topical treatment of certain skin conditions, specifically mild to moderate facial acne vulgaris in patients who are 9 years of age or older. The medication is formulated to treat the visible symptoms and contributing factors of the condition. Official product information confirms its use in this specific dermatological setting.


Q: How long does Lisoderma take to work?

Regulatory documents state that patients may begin to observe initial improvement in their skin condition after approximately two weeks of treatment. However, the official product information notes that the full therapeutic effects may take up to twelve weeks of continuous use to be achieved. Information regarding the duration of use should be discussed with the prescribing healthcare professional.


Q: What happens if I miss a dose of Lisoderma?

According to the official product information, if an application of Lisoderma is missed, you should apply the next dose at the regular scheduled time. There is no instruction to apply extra product to compensate for the missed application. Adhering to the prescribed dosing schedule is generally considered helpful for maintaining the desired therapeutic effect.


Q: Can I use makeup while using Lisoderma?

Studies and official information indicate that cosmetics can be used on the areas where Lisoderma is applied. The product information recommends that any such cosmetics should be non-comedogenic to avoid potentially blocking pores. Product labeling provides guidance on the appropriate order of application for Lisoderma and other topical products, which should be reviewed by the patient.


Q: Should I apply sunscreen while using Lisoderma?

Official product information emphasizes that limiting sun exposure is advised for individuals using Lisoderma, which includes avoiding sunlamps or tanning beds. This is because the medication may increase the skin's sensitivity to the sun (photosensitivity). For unavoidable sun exposure, the product label suggests that the use of sunscreen and protective clothing is important.

How should Lisoderma be stored and disposed of?

How to Store and Dispose of Lisoderma

The storage and disposal of Lisoderma must strictly follow regulatory requirements to maintain the stability of the active ingredients and ensure public safety.


Storage Requirements

Lisoderma must be stored at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F). It is essential to protect the product from light and keep it away from excess heat and moisture.

  • Prohibitions: Do not refrigerate or freeze the medication.
  • Container: Store the product in the original package, ensuring the container is kept tightly closed.
  • Child Safety: The medication must be kept out of the sight and reach of children.

Disposal Instructions

Disposal of any unused or expired Lisoderma must be conducted in accordance with local pharmaceutical waste regulations. Patients should utilize drug take-back programs when available and should not dispose of the medicine in household trash or wastewater.

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

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