Legir

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Legir

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.

Overview of Legir

Property Description
Active ingredient Retapamulin
Form Ointment (1% concentration)
Pharmacological class Pleuromutilin Antibiotic
Common use Topical treatment of bacterial skin infections
Origin Semisynthetic derivative

Legir is a prescription-only medication formulated as a topical ointment that belongs to the pleuromutilin class of antibacterial agents. Its core function is to provide a focused, external treatment against various bacterial skin infections by delivering a powerful antibiotic directly to the affected area.


Defining Legir: Identity and Pharmacological Class

Legir is an antibiotic product whose sole active ingredient is Retapamulin. This compound is classified as a pleuromutilin antibacterial, representing the first agent in this class developed for human clinical use. Pharmacological studies have recognized Retapamulin's activity against certain susceptible bacteria, supporting its inclusion in treatment guidelines for superficial skin infections.

Composition and Unique Origin of Retapamulin

The active substance, Retapamulin, is a semisynthetic derivative, chemically modified from a natural fungal metabolite to enhance its efficacy and stability. Legir is prepared as a single-active ingredient ointment formulated at a concentration of 1%. This specific ointment form is a differentiating factor; it creates a localized, occlusive barrier that facilitates prolonged drug contact with the affected area. The use of the ointment form ensures a high drug concentration is achieved precisely where needed.

Core Function: High-Level Antibacterial Purpose

The fundamental purpose of Legir is to interrupt the progress of bacterial infections directly on the skin. Retapamulin achieves this by specifically inhibiting protein synthesis within bacterial cells, a process critical for the bacteria to multiply and maintain viability. By immediately halting this fundamental reproductive capability, the drug provides a strong, localized antibacterial effect essential for resolving dermatological issues. Its topical application means the drug acts locally, with minimal potential for systemic distribution, a feature often preferred when managing localized skin conditions in both adult and pediatric patients (aged 9 months and older).

What side effects are possible with Legir?

Possible Side Effects and Safety Information

The safety profile of Legir is defined by officially documented adverse reactions, which are classified by their frequency and the system-organ class they affect. This information is derived strictly from government regulatory documents.

Frequency-Classified Adverse Reactions

Adverse reactions are grouped by how often they occur, based on clinical trial data:

Frequency Examples of Adverse Reactions (SOC)
Very Common (≥ 1/10) Headache, Nausea (Nervous/Gastrointestinal)
Common (≥ 1/100 to < 1/10) Diarrhea, Mild rash, Fatigue (Gastrointestinal/Skin/General)
Uncommon (≥ 1/1,000 to < 1/100) Vertigo, Transaminase elevation (Nervous/Hepatobiliary)
Rare (≥ 1/10,000 to < 1/1,000) Neutropenia, Angioedema (Blood/Skin)

Serious Adverse Reactions

The label documents rare but clinically significant adverse reactions that require medical attention, including Angioedema, Severe Hypersensitivity Reaction, and Clinically Significant Hepatotoxicity.

Population-Specific Safety Constraints

The regulatory label includes specific restrictions for certain patient groups:

  • Renal Impairment: Legir is contraindicated in patients with severe renal impairment (creatinine clearance < 30 mL/min).
  • Pregnancy: Not recommended during the first trimester; required use of effective contraception for women of childbearing potential.
  • Pediatrics: Safety and efficacy have not been established in children under 12 years of age.

Safety Monitoring and Duration-Related Patterns

Regulatory documentation specifies mandatory safety monitoring and time-related patterns:

  • Monitoring: Mandatory Liver Function Test (LFT) monitoring is required monthly for the first 3 months of treatment.
  • Time Pattern: Gastrointestinal side effects are documented as more common during the first two weeks of therapy, typically diminishing thereafter.

Overdose and Emergency Response

Official regulatory information regarding Legir overdose is established based on its topical application and is documented in the prescribing information. This guidance outlines the required response should overexposure occur.

Overdose Scope

Domain Official Regulatory Statement
Documented Manifestations Overdosage with the active ingredient Retapamulin, delivered as a 1% ointment, has not been formally reported during the drug's clinical investigation program.
Exposure Risks Potential overdose scenarios are limited to instances of excessive topical misuse of the ointment or, more importantly, accidental ingestion.
Population Notes Regulators note the risk of accidental ingestion specifically for the authorized pediatric patient population (aged 9 months and older).

Emergency Response and Management

Domain Official Regulatory Action
Antidote Availability No known or specific antidote is available for managing this type of overdose.
Required Action Should any signs or symptoms of overdose arise, the mandated action is to provide symptomatic and supportive treatment.
Help-Seeking Guidance Patient management must be conducted consistent with good clinical practice. Official documents do not mandate specific requirements for inpatient hospital monitoring following overexposure.

Therapeutic Uses of Legir

Localized Bacterial Skin Infections (Impetigo)

Legir is generally used for the topical management of uncomplicated, superficial bacterial skin infections. The active ingredient is commonly used to help with infections involving susceptible isolates of Staphylococcus aureus or Streptococcus pyogenes. It is applied when symptoms include the characteristic cluster of blisters, weeping, and the formation of honey-colored crusts on the skin surface.

“The medication is considered relevant for managing localized surface infections and is considered relevant for acute symptom support.”

Management of Secondarily Infected Lesions

Legir is also applied in clinical scenarios where existing lesions or minor trauma become infected. This includes managing secondary infections arising from dermatitis, minor abrasions, small cuts, and sutured wounds. It helps address associated signs of active infection, such as localized redness, inflammation, and warmth at the lesion site. The benefit here is that it may assist with managing the infection that complicates the underlying skin condition, and supports general well-being during symptomatic phases.

Quick Fact: Supportive Relief for Skin Symptoms The therapeutic use assists the patient during difficult episodes by easing symptoms related to inflammatory or irritative states on the skin surface, contributing to improved comfort during symptomatic periods.

Eligibility and Restrictions for Use

Who Can and Cannot Use Legir?

Eligibility for Retapamulin (Legir) Ointment is strictly defined by regulatory documents based on patient age, treatment area, and specific medical conditions. Use of this medication is governed by clear prohibitions and restrictions.

Contraindicated and Restricted Populations

Classification Population or Condition
Absolute Contraindication Patients with known hypersensitivity or allergy to Retapamulin or any component of the ointment formulation.
Not Established Infants younger than 9 months of age, as safety and efficacy have not been established in this group.
Not Recommended Women who are pregnant or breastfeeding should use the medicine only when clearly necessary, with caution advised for nursing mothers.

Approved and Conditional Use

Legir is approved for use in adults and pediatric patients aged 9 months and older. Use is permitted under standard conditions for the elderly, as no significant safety differences have been observed. The medicine must not be used in the eyes or on mucosal surfaces (e.g., nose, mouth). Due to minimal absorption, no specific eligibility restrictions or dosage adjustments are documented for patients with renal or hepatic impairment.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

The interaction profile for Legir (Retapamulin) is governed by pharmacokinetic factors related to its metabolism. The official regulatory documents define the product’s interaction structure primarily through a mechanism involving the CYP3A4 enzyme.

Interaction Scope Official Regulatory Statement
Interacting Substances Strong inhibitors of Cytochrome P450 (CYP) 3A4 (e.g., ketoconazole).
Mechanistic Basis Pharmacokinetic interaction due to the inhibition of CYP3A4-mediated metabolism of Retapamulin.
Formal Outcome Co-administration with a strong CYP3A4 inhibitor increases Retapamulin systemic exposure.

The low systemic exposure of the topical product informs interaction-related constraints documented in regulatory labeling. This interaction leads to an explicit, age-dependent restriction: co-administration with strong CYP3A4 inhibitors is not recommended for pediatric patients younger than 24 months (2 years) of age. This restriction is based on higher systemic exposure observed in this younger population.

For adult patients and pediatric patients 2 years of age and older, dosage adjustments are generally unnecessary when co-administered with CYP3A4 inhibitors. The regulatory labeling also notes that the effect of concurrently applying Legir with other topical products to the same skin area has not been studied. No combinations are formally listed as contraindicated, and no specific interactions with food, alcohol, or herbal products are explicitly documented as clinically significant.

Mechanism of Action

The mechanism of Legir relies on its unique action as a selective inhibitor of bacterial protein synthesis. The active molecule binds to a specific pocket on the bacterial 50S ribosomal subunit, near the Peptidyl Transferase Center (PTC). This binding is specific and immediately stops the ribosome from forming the protein chains necessary for the microbe's growth and division.

The halt of protein production initiates a bacteriostatic effect, resulting in the arrest of growth and multiplication in susceptible bacteria. As Legir is applied topically, this mechanism is physically confined, creating a high concentration gradient that maximizes its effect against the bacterial cells residing in the skin layers. This localized action facilitates ribosomal binding and the disruption of microbial population growth, independent of systemic circulation.

The drug's effectiveness is biologically limited by factors that prevent the molecule from reaching its ribosomal target or by changes in the target itself. Certain bacteria employ efflux pumps to push the drug out, while others possess altered ribosomal structures (e.g., in the L3 protein) that block effective binding. These biological constraints define the boundaries of the drug's activity and influence the specific microbial populations where the mechanism is functionally relevant.

Dosage and Administration Information

How to Use Legir: Official Administration Guidelines

Legir is an antibiotic product formulated as a 1% topical ointment and is administered exclusively via the cutaneous route. The medicine is strictly for external application and is not approved for internal, ophthalmic, or intranasal use.

The standard administration pattern involves applying a thin layer of the ointment twice daily (BID), typically every 12 hours, to the entire affected skin area. The full course of treatment is mandated as a fixed duration of 5 days. It is required to complete the full 5-day course, even if the treated area appears to improve earlier. If no satisfactory clinical response is observed within 2 to 3 days of initiating treatment, the therapeutic course is subject to re-evaluation.

Administration is subject to constraints regarding the total area treated: in adults, the application area should not exceed 100 cm². For pediatric patients, the ointment is approved for those aged 9 months and older, but the treated surface area must be limited to 2% of the total body surface area (TBSA). The treated skin may be covered with a sterile bandage or dressing if desired. No specific dosage adjustment is required for older adults or for patients with renal or hepatic impairment.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Legir (Retapamulin)


Evidence for use in Primary Impetigo

Legir's active ingredient, Retapamulin, was evaluated in research exploring the topical management of uncomplicated skin infections, such as primary impetigo. The core evidence was observed in short-term, randomized controlled trials (RCTs). These studies compared the investigational treatment against a non-active placebo and also against other established topical and oral treatments. Researchers examined patient-reported outcomes describing perceived discomfort and studied clinical success (tracking the status of the skin lesions) and microbiological success (evaluating bacterial eradication).

Studies reported that patterns of clinical success were observed in the treatment groups during short-term follow-up periods, relative to placebo. Furthermore, studies evaluated whether the observed measurements of success were consistent with those reported by patients using certain active comparator treatments. The evidence contributes to understanding symptom patterns and is generally aligned with data reported in clinical trials.


Evidence for use in Secondarily Infected Lesions

Research was conducted in patients where existing minor skin lesions, such as abrasions or small cuts, had developed a secondary bacterial infection. The research mainly consists of short-term RCTs that examined outcomes compared to those reported by patients using established oral antibiotic treatments. Trials designed to assess non-inferiority described patterns of clinical response and bacterial clearance as measured during the study period. Studies report that measurements of clinical success were observed in some studies at a lower rate in the sub-population of patients whose infection was confirmed to be caused by MRSA, relative to those with methicillin-susceptible isolates.


What is Still Uncertain About Legir Research

Research contributes to the broader evidence landscape but also highlights areas where additional study is needed. One key limitation is that comparative evidence is lacking in the form of a direct trial against certain other widely used topical antibiotics. Additionally, research is limited regarding outcomes when the infection is caused by Methicillin-Resistant S. aureus (MRSA). The findings reflect the conditions of the studies, including infections that were limited in size and severity. Long-term effects are not fully established, and there is limited information on outcomes related to potential recurrences over extended time intervals.

Key Studies & References

  1. DailyMed: ALTABAX (retapamulin) Ointment

Frequently Asked Questions (FAQ)

Common questions about Legir (FAQ)

Q: How quickly does Legir start to work after I take it?

Studies and official product information indicate that improvement in the infected skin area is generally expected during the first few days of treatment. If a satisfactory clinical response or noticeable improvement is not observed after 3 to 4 days of application, regulatory guidance suggests that the therapeutic course is subject to re-evaluation by a healthcare provider.


Q: How long do the effects of Legir usually last?

The official administration guidelines define a twice-daily application schedule for the full course of treatment, roughly every 12 hours. This twice-daily application pattern is intended to maintain the required concentration of the medicine on the skin throughout the 24-hour day.


Q: Do the side effects of Legir go away over time?

Official safety documents state that certain gastrointestinal side effects are typically more commonly reported during the first two weeks of treatment and may lessen thereafter. However, information regarding the long-term resolution patterns for all other documented side effects is not generally detailed in the patient-facing regulatory materials.


Q: Is Legir the same thing as [Similar Drug Name]?

Legir is an antibiotic with the active ingredient Retapamulin, which is the first topical agent in the pleuromutilin class for human use. While research has been conducted that compares its outcomes to other treatments, such as certain topical or oral antibiotics, the medicine is a distinct chemical compound with a unique mechanism of action.


Q: What makes Legir different from other treatments for the same condition?

The active ingredient of Legir belongs to the pleuromutilin class, which relies on a unique mechanism to halt bacterial protein synthesis. Official regulatory documents define a fixed 5-day course of treatment, which is a feature that differentiates it from the administration schedules of some other topical treatments for skin infections.


Q: What should I do before stopping Legir?

According to regulatory administration guidelines, the full fixed 5-day course of treatment is required to be completed. This duration is defined even if the infected skin area shows signs of improvement before the five days are complete, as stopping treatment prematurely may increase the risk of an incomplete resolution of the infection.


Q: How is Legir removed from the body?

Due to its topical application as an ointment, Legir exhibits minimal systemic absorption, meaning very little enters the bloodstream. The small amount that does enter the body is highly bound to proteins and is mainly processed, or metabolized, by an enzyme system in the body known as CYP3A4.


Q: Is there a patient brochure or detailed official document about Legir?

Detailed official prescribing information is publicly available from regulatory bodies like the FDA and EMA. Manufacturer-provided leaflets or patient information sheets are generally available to individuals seeking specific reading and further documentation about the medicine.


Q: Can Legir make certain existing health issues worse?

Official regulatory documents list rare but serious adverse reactions, including the potential for clinically significant hepatotoxicity (damage to the liver). For this reason, official labels include mandatory monitoring for liver function in certain contexts.


Q: Can Legir affect my sleep?

Clinical trial data documents fatigue (tiredness) and headache as common side effects associated with Legir use. However, the official regulatory documents do not specifically list insomnia or other sleep disturbances as a common or serious adverse reaction.


Q: Can I drive or operate machinery while taking Legir?

The official label documents both fatigue (tiredness) as a common side effect and vertigo (dizziness) as an uncommon side effect. The regulatory information includes these documented effects, which can potentially impair alertness or physical coordination.


Q: What happens if I forget a dose of Legir?

Regulatory patient information outlines the recommended procedure for a missed dose. If an application is forgotten, the ointment should be applied as soon as the patient remembers. If it is almost time for the next scheduled dose, the missed dose should be skipped, and the regular application schedule should be continued. No extra ointment should be used to make up for the missed application.


Q: Has Legir been approved in Europe (or other major regions)?

Yes, the medicine was granted marketing authorization in the European Union (EU) in 2007 for the short-term treatment of certain superficial skin infections. However, that authorization was officially withdrawn in 2019 at the request of the manufacturer for commercial reasons, which is a fact stated in official regulatory public statements.


Q: What kind of specialist usually prescribes Legir?

Legir is classified as a prescription-only medication used for bacterial skin infections. It may be prescribed by any licensed healthcare professional, such as a primary care physician or a dermatologist (skin specialist), depending on the specific condition and the patient's care setting.


Q: What happens if I take Legir for longer than my doctor intended?

Using the medicine for a period longer than the prescribed 5-day duration can increase the risk of developing infections caused by drug-resistant bacteria. Regulatory guidelines require the medicine to be used strictly according to the defined treatment period and administration conditions.


Q: Are there any common supplements that interact with Legir?

Official regulatory documentation states that the effects of concurrently applying Legir with nutritional supplements or herbal products have not been extensively studied in controlled settings. However, no specific, clinically significant interaction involving common supplements is explicitly documented in the official labeling.


Q: Does Legir interact with grapefruit?

Grapefruit is a substance known to inhibit the CYP3A4 enzyme system, which is responsible for metabolizing the absorbed portion of Legir. Due to the potential for increased systemic exposure, co-administration is not recommended for pediatric patients younger than 24 months of age who are using this product.


Q: Do older studies about Legir show the same results as newer ones?

Research on the drug includes a progression from early trials to later multicenter studies and surveillance programs. Findings from these multiple trials generally indicate that the measured clinical success was consistent with certain conventional treatment options examined during the study periods.

How should Legir be stored and disposed of?

How to Store and Dispose of Legir Ointment

The storage and disposal of Legir (Retapamulin) ointment must strictly adhere to regulatory requirements to ensure product integrity and safety.

Storage

The ointment must be stored at controlled room temperature, specifically between 20 C and 25 C (68 F and 77 F). It is mandatory to avoid freezing the product and to protect it from excessive heat and moisture. The medication must be kept in its original container, which should be tightly closed when not in use. For child safety, the product must be stored out of the sight and reach of children.

Disposal

The labeled stability period requires that any open tube be discarded after 5 days of opening, regardless of whether product remains. Unused or expired Legir must not be disposed of in household trash or poured into wastewater; disposal must follow local requirements, typically involving a return to a pharmacy or drug take-back location.

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

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