Lomexine

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Lomexine

What is Lomexin? Identity and General Purpose

Property Description
Active ingredient Fenticonazole Nitrate
Form Vaginal Capsules, Vaginal Cream, Cutaneous Cream, etc.
Pharmacological class Broad-spectrum Antimycotic Agent
General purpose Local elimination of fungal and related infections
Origin Synthetic, Imidazole derivative

Lomexin is a medication whose active component is Fenticonazole Nitrate, a synthesized chemical compound classified as a broad-spectrum antimycotic agent belonging to the imidazole derivatives class. It is a single-ingredient product designed exclusively for targeted topical and intravaginal use. The compound's high fungicidal efficacy has been clinically recognized for clearing various fungal microorganisms and yeasts, establishing it as a standard local therapy for mycoses.

Fenticonazole distinguishes itself by having a broad range of activity. In addition to its primary fungicidal effect against fungi, the agent exhibits supplementary antibacterial action against specific Gram-positive bacteria and is active against the protozoan Trichomonas vaginalis. This multi-target action is valuable because fungal infections are often accompanied by these other microorganisms, allowing the medication to address a wider range of potential pathogens present at the local site of infection.

The medication is available in specialized dosage forms for optimal delivery. These include vaginal capsules (or ovules) for internal use, and various cutaneous creams for external application. These preparations utilize a cream base or fatty excipients to ensure the Fenticonazole Nitrate stays concentrated on the affected tissue, maximizing therapeutic effect and reinforcing its purpose as a decisive local treatment.

What side effects are possible with Lomexine?

Possible Side Effects and Safety Information

The safety profile for Fenticonazole Nitrate (Lomexine) is characterized by reactions primarily occurring at the site of application, reflecting its intended local use as an antimycotic. Due to the drug's poor systemic absorption following topical or vaginal administration, widespread or internal side effects are generally not expected, according to regulatory documents.

Adverse Reactions and Classification

The officially documented adverse effects are classified by the affected system and frequency:

System-Organ Class Adverse Reaction Regulatory Frequency
Reproductive system Vulvovaginal burning sensation Very Rare (mathrm<1/10,000)
Skin and subcutaneous tissue Pruritus, Erythema, Rash Very Rare (mathrm<1/10,000)
General disorders Application site hypersensitivity Not Known

Serious adverse reactions are chiefly related to local sensitivity. The development of local sensitisation or a confirmed allergic reaction is the main safety concern that necessitates discontinuation of the product.

Safety Patterns and Constraints

Official labeling includes specific notes related to exposure and administration:

  • Timing of effects: A mild, transient burning sensation may be experienced immediately after application.
  • Duration of use: Prolonged use of topical products carries a documented risk of potentially causing sensitisation.
  • Hypersensitivity: The medicine is contraindicated in individuals with known hypersensitivity to the active substance or any excipients.
  • Excipient Risk: Due to the inclusion of soya lecithin in some formulations (vaginal capsules), the medication is contraindicated in patients with a history of peanut or soya allergy.

Population and Interaction Safety Notes

Regulatory documents address specific safety considerations for patient groups and concurrent use:

  • Pregnancy and Lactation: Low systemic exposure is anticipated following vaginal administration. Use during these periods requires a medical safety assessment, as animal data indicates excretion into milk.
  • Contraceptives: The fat excipients and oils in the vaginal capsules may damage latex barrier contraceptives (such as condoms or diaphragms). Furthermore, any local vaginal treatment is stated to likely inactivate a local contraceptive spermicide.

Overdose and Emergency Response

Overdose and When to Seek Help

This section outlines the official information regarding overdose for the topical and vaginal preparations of Lomexine (fenticonazole), as defined in regulatory documents and official patient information.

Overdose Scope

The regulatory labeling for Lomexine vaginal and topical products explicitly addresses overdose by stating that the section detailing “Symptoms and instructions in case of overdose” is “Not applicable.” This is due to the low systemic absorption of the drug when applied topically or intravaginally, meaning the risk of systemic toxicity and acute overdose symptoms is minimal under normal circumstances.

Overdose Parameter Regulatory Status (Label-Derived)
Documented Overdose Presentations Not Applicable (explicitly stated in labeling)
Physiological Systems Affected None listed in official overdose sections
Dose-Related or Exposure Factors None listed in official overdose sections

Emergency Actions and Medical Attention

Given the low risk profile for a classic systemic overdose, official regulatory documents do not include specific procedural instructions, required emergency actions, or detailed symptom clusters for overdose.

  • When to seek immediate medical help: While specific overdose guidance is absent from the official labeling, a general rule for all medications is to seek urgent medical attention if the product is accidentally ingested or if you experience any severe or unusual symptoms, such as an allergic reaction, after use.

Accidental Ingestion

In the event of accidental oral ingestion, particularly by a child, contact a poison control center or seek medical assistance immediately. The clinical effects of a large oral dose may differ from the intended local application, though the official regulatory profile is focused solely on the low-risk topical/vaginal use.

Therapeutic Uses of Lomexine

What Lomexine Treats: Main Uses and Benefits

Lomexine (Fenticonazole Nitrate) is primarily relevant in clinical settings marked by acute local infections, providing supportive assistance for symptom management directly at the site of discomfort. The therapeutic use is relevant for managing vulvovaginal infections and superficial dermatomycoses. The medication is commonly used across conditions presenting with acute episodes of discomfort, including symptomatic vulvovaginal candidiasis (thrush), dermatomycoses (such as ringworm and Athlete's foot), and local infections that may involve mixed symptomatic patterns.

This medication helps address symptom clusters that may become intense or disruptive, such as pronounced itching, burning, soreness, and the presence of abnormal discharge or scaly skin patches. It is applied across domains where additional symptomatic support is needed. The treatment may assist with maintaining a sense of stability when symptoms are more noticeable. The supportive nature of this treatment may assist with general well-being and contributes to easing the overall symptom load during periods of heightened discomfort.


Quick Fact: Support for Symptoms of Local Inflammation

Lomexine is relevant for easing symptoms related to inflammatory or irritative states, and may assist with maintaining comfort in situations involving episodic or fluctuating manifestations.

Regulatory References

  1. Summary of Product Characteristics - HPRA

Eligibility and Restrictions for Use

Who Can and Cannot Use Lomexine?

The eligibility for Lomexine (Fenticonazole Nitrate) is strictly defined by regulatory guidelines based on population factors and formal contraindications.

Eligibility Scope Official Regulatory Statement
Populations for Whom Use is Contraindicated Use is strictly contraindicated in patients with known hypersensitivity to the active substance, any excipients, or individuals with cross-sensitivity to other imidazole derivatives. Specific formulations are also prohibited for those with documented soya or peanut allergies.
Age-Related Eligibility The medicine is approved for adults. Vaginal formulations are generally not established for use in children or adolescents under 16 years of age. Cutaneous cream is permitted for children from 3 years of age. Women over 60 require prior physician consultation.
Conditional Use Status Use is not recommended during pregnancy or lactation; conditional use requires physician supervision. The product is restricted for use with latex contraceptives as excipients may cause material damage. Patients with a history of sexually transmitted disease must also seek consultation.

Resulting Eligibility Structure

Regulatory documentation classifies use based on the severity of the restriction: from Contraindicated (e.g., allergies) to Not Recommended (e.g., pregnancy) or Not Established (e.g., pediatric vaginal use). This framework formally defines eligibility constraints.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Fenticonazole Nitrate, the active component of Lomexine, is administered topically and intravaginally. Due to the minimal systemic absorption observed after local application, the potential for systemic drug-drug interactions involving metabolic enzymes or drug transporters is formally documented as unlikely by regulatory authorities.

Documented Local Product Interactions

The primary official interaction warnings concern the formulation's excipients and their effect on co-administered local products, rather than the drug’s systemic pharmacology.

Interacting Product Category Official Interaction Description
Latex or Rubber Barrier Contraceptives The oily or fatty excipients present in the vaginal formulations can damage the material integrity of barrier contraceptives (e.g., condoms and diaphragms), officially impairing their efficacy and leading to a loss of barrier function.
Spermicides The concurrent use of any local vaginal treatment, including Fenticonazole Nitrate preparations, may officially inactivate the contraceptive action of local spermicides.

These official constraints mean that relying on latex or rubber barrier methods or spermicides for contraception is restricted during the period of treatment. No official interactions are documented with food, alcohol, or herbal products for the local formulations.

Mechanism of Action

How Lomexine Works: Mechanism of Action

Lomexine's mechanism of action is defined by a multi-target engagement strategy resulting in the destruction of microbial cells at the local site of application. The primary mechanism involves the structural alteration of fungal cells.

Fenticonazole acts as an inhibitor of the enzyme lanosterol 14alpha-demethylase, which is crucial for the formation of ergosterol, a key structural lipid in the fungal cell membrane. This blockade results in the accumulation of toxic intermediate compounds and the ultimate failure of the membrane's integrity, leading to the lysis and death of the fungal cell (fungicidal action).

Beyond this, the drug extends its effect to target oxidative enzymes essential for the cellular respiration of specific Gram-positive bacteria and the protozoan Trichomonas vaginalis. Concurrently, the molecule inhibits virulence enzymes (like SAP) used by fungi to adhere to and penetrate host tissue. This broad-spectrum interference with metabolic and invasion processes results in the suppression of co-existing microbial populations.

The overall mechanism is concentration-dependent, requiring high local levels to transition from fungistatic (growth inhibition) to full fungicidal action. A distinct secondary mechanism also contributes to modulating the localized physiological response triggered by the microbial presence.

Dosage and Administration Information

How to Use Lomexine

The administration of Lomexine (Fenticonazole Nitrate) is strictly local, utilizing either the intravaginal route for capsules and cream, or topical application for cutaneous cream. The specific dosage form dictates the course and frequency of use, with regimens standardized according to specifications.


Official Administration Regimens

Dosage Form & Strength Dosing Schedule Course Duration
Vaginal Capsule 600 mg Single capsule Single administration only
Vaginal Capsule 200 mg One capsule per day Three consecutive days
Vaginal Cream 2% 5 g (one full applicator) Typically once or twice daily

Procedural and Contextual Guidelines

Administration of the vaginal capsules or ovules is typically scheduled at bedtime to ensure the medication remains localized for an extended period. The capsule must be inserted deeply into the vagina, preferably while the patient is in a lying position. For the 600 mg single-dose regimen, the course may be repeated after three days if the initial administration does not achieve the intended objective.

Use is standardized for individuals 16 years and above; the official labels do not establish safety or efficacy for children under 16 years. When using the cream forms, applicators should be washed thoroughly after each use to maintain hygiene. Treatment should generally not be interrupted during menstruation.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Lomexine

Evidence for use in Vulvovaginal Candidiasis (VVC)

Research examining Lomexine for vaginal yeast infections involves different types of studies, including controlled trials where groups of patients are compared, and some studies with extended follow-up that track outcomes over defined time intervals. Researchers have explored different administration schedules for the treatment. These studies were primarily used in research exploring how symptoms change over time and included adult women diagnosed with uncomplicated VVC.

The studies monitored several key factors, including whether the yeast was undetectable (mycological clearance) and how outcomes related to physical discomfort, such as itching and discharge, evolved during the observed time intervals. Some trials reported patterns observed in the studies related to changes in these measured outcomes following administration of the treatment. Research also describes the observed recurrence rates over periods of a few months.

Evidence for use in Cutaneous Fungal Infections (Dermatomycoses)

Lomexine cream has was evaluated in trials for various fungal skin infections, such as tinea infections and specific forms of candidiasis. These studies often involved randomized designs that compared Lomexine against other topical antifungal creams. The trials examined patients with confirmed fungal pathogens.

Research highlights the changes measured in the studies regarding microbiological status and how the visible signs of infection, such as scaling and redness, evolved in the observed populations. Findings from these studies contribute to the broader evidence landscape regarding symptom patterns and microbiological status at the end of the treatment period, which typically lasted a few weeks.

Long-Term Studies and Follow-up Data

Studies specifically exploring the long-term status beyond the initial treatment period for VVC research describes the patterns of recurrence observed over defined periods, such as three to six consecutive menstrual cycles. While this evidence provides insight into short-term changes and immediate post-treatment responses, there is limited information for long-term outcomes that would describe the observed condition status over extended time periods. Follow-up durations were limited in a majority of the controlled trials, meaning the overall durability of the findings is not fully established.

Understanding the Research Quality and Limitations

The evidence quality varies across studies that have examined Lomexine. While there are randomized controlled trials, many of the supportive data come from smaller, open-label, or older studies. This variety means that the certainty of the findings remains low in certain areas. Furthermore, sample sizes were modest in many trials, which can limit the ability to generalize the results to the broader population. The findings describe group patterns, not personal outcomes, and research does not determine whether an individual will respond similarly.

Key Studies & References

  1. Topical Fenticonazole Exposure in Pregnant Women: Risks for the Pregnancy and Foetus? A Comparative Study in the EFEMERIS Databa
  2. Fenticonazole nitrate for treatment of vulvovaginitis: efficacy, safety, and tolerability of 1-gram ovules, administered as ultra-short 2-day regimen
  3. Fenticonazole - Patient Information (Source used for general context and long-term data limitation confirmation)

Frequently Asked Questions (FAQ)

Common questions about Lomexine (FAQ)


Q: What specific types of infections is Lomexine typically prescribed to treat?

According to official product information, Lomexine is indicated for treating vulvovaginal candidiasis (often called thrush), which is caused by Candida species. It is also approved for addressing mixed vaginal infections that may involve specific types of Gram-positive bacteria or the protozoan Trichomonas vaginalis alongside the fungus.

Q: How quickly is Lomexine generally expected to start relieving symptoms?

Relief from common symptoms like itching and discharge is typically observed within a few days of starting the treatment. Regulatory documents state that if symptoms are not reduced within seven days or if they worsen, it is a reason to consult a healthcare provider.

Q: Is it normal to experience a temporary burning sensation after using Lomexine?

A mild, transient (temporary) burning sensation is noted in regulatory documents as an experience that may occur immediately after the medicine is applied. This sensation usually disappears quickly and is an expected occurrence at the application site.

Q: Are there any side effects of Lomexine that are considered systemic (affecting the whole body)?

Systemic adverse effects are generally considered unlikely because the active ingredient, Fenticonazole, is only minimally absorbed into the bloodstream after local application. The medication is designed to work primarily at the site where it is applied.

Q: Can Lomexine cream or ovules be used for fungal skin infections in other areas of the body?

The vaginal ovules (capsules) are strictly for intravaginal use only. However, Fenticonazole is also available in cutaneous (skin) cream formulations that may be indicated for various fungal skin infections, such as tinea, subject to specific regulatory approvals for that product.

Q: Is Lomexine considered safe to use during pregnancy according to official sources?

Official product information states that use is not recommended during pregnancy. The condition for use is that a physician must assess the potential benefits and determine that its use is essential for the patient's welfare.

Q: Can Lomexine be used by individuals under the age of 18?

The vaginal formulations are generally not established for use in children or adolescents under 16 years of age. However, some regulatory labels approve the cutaneous cream formulation for use in children starting from 3 years of age, depending on the specific product and local regulation.

Q: What should a patient do if their symptoms get worse or don't improve after a few days of using Lomexine?

Official guidance advises that if local symptoms of the infection do not improve within seven days, or if they worsen, consulting a doctor is indicated. The medicine should also be discontinued if any localized irritation or a sensitivity reaction develops.

Q: Can using Lomexine for a long time cause an allergic reaction or sensitization?

Regulatory documents note that the prolonged use of any topical medication carries a documented risk of potentially causing sensitization, which is a localized allergic reaction. If this occurs, regulatory information advises that discontinuation of treatment is necessary.

Q: Does using Lomexine affect a person's ability to drive or use machinery?

Regulatory information indicates that because the medication is for localized use and is minimally absorbed, Lomexine has no documented influence on a person's ability to drive or operate machinery.

Q: Why is it generally advised not to start Lomexine treatment during menstruation?

It is generally advised not to begin treatment during menstruation because the flow of blood may reduce the amount of medication that remains at the site of infection. This can potentially decrease the overall effectiveness of the treatment.

Q: What information is available regarding the duration of effect of Lomexine after the treatment course is finished?

Clinical studies often track the status of the infection and the absence of the infecting organism for various periods following the end of treatment, sometimes up to 28 days. These monitoring periods help researchers understand the short-term outcomes after the treatment course is completed.

Q: Can Lomexine be used if a patient has had recurrent infections recently?

Official guidance often recommends that prior consultation with a doctor is necessary if a patient has experienced more than two infections in the last six months. This is to ensure the most appropriate course of action is taken.

Q: Does Lomexine affect fertility according to regulatory information?

Regulatory and pre-clinical data indicate that Fenticonazole does not interfere with the function of male or female reproductive organs. Studies have not shown that the drug modifies the first phases of reproduction.

Q: Is there a risk of the infection returning after stopping Lomexine?

Studies examining the drug's use monitored the observed rates of recurrence over defined time periods following the completion of treatment.

Q: Can Lomexine interact with other topical vaginal products like douches or spermicides?

The use of any local vaginal treatment, including Lomexine, may inactivate the contraceptive action of local spermicides. Additionally, it is generally advised not to use vaginal douches during the course of treatment.

Q: Are there specific symptoms that indicate the treatment is causing a sensitivity reaction rather than just expected irritation?

While mild burning may be expected immediately after application, the development of irritation, sensitivity, or a rash that does not resolve or that worsens may indicate a sensitivity reaction. If these symptoms occur, official guidance indicates that stopping treatment and seeking medical advice is required.

Q: Is there a version of Lomexine available specifically for men to treat related fungal issues?

Lomexine is a trade name for Fenticonazole, which is available in a cutaneous cream formulation. This skin cream may be used by men to treat certain fungal skin infections, such as tinea, following medical consultation.

Q: Can Lomexine be used if a patient is over 60?

The official patient information requires that women over 60 years old must seek prior consultation with a physician before using the vaginal formulation of the medication.

Q: Does Lomexine only treat vaginal candidiasis, or does it have other uses?

In addition to vulvovaginal candidiasis, the drug is indicated for mixed vaginal infections. Furthermore, Fenticonazole is available in a cutaneous cream form used to treat various fungal skin infections (dermatomycoses).

Q: What common side effects of Lomexine can be experienced?

Regulatory documents list vulvovaginal burning sensation as a common effect at the application site. Other effects such as pruritus (itching) and erythema (redness) have also been reported, though these are documented as very rare occurrences.

Q: Why are some ingredients in Lomexine noted as potentially causing delayed allergic reactions?

Some formulations contain excipients, such as ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, which are known substances that may cause allergic reactions. These specific reactions are noted because they can potentially be delayed in onset.

Q: What is the purpose of the long list of warnings and precautions found in the official leaflet for Lomexine?

The purpose of the comprehensive warnings and precautions in the leaflet is to meet regulatory requirements. It ensures that patients and healthcare providers are fully informed about the conditions for safe use, potential risks, contraindications, and necessary steps to take during treatment.

Q: Is it necessary to complete the entire course of Lomexine treatment even if symptoms disappear early?

Official patient information generally states that the full course of treatment should be completed and that doses should not be skipped, even if symptoms have improved. This practice is advised in order to successfully eliminate the infection.

Q: What is the distinction between a 'very rare' side effect and a 'common' side effect for Lomexine?

Regulatory frequency classifications are used to describe how often side effects occur in observed populations. The official definitions state that a 'very rare' side effect is one affecting less than 1 in 10,000 people, whereas a 'common' side effect affects 1 in 10 to 1 in 100 people.

Q: Are there specific excipients in Lomexine that people with certain allergies (like peanut or soy) should be aware of?

Yes, the presence of soya lecithin in some formulations is noted in official documentation. It is an established contraindication for patients with a documented history of either a peanut or a soya allergy.

Q: What does official research evidence indicate about the effectiveness of Lomexine for its approved use?

Clinical studies summarized in official documents indicate that Fenticonazole has demonstrated high effectiveness in producing symptomatic relief and mycological sterilization—meaning the elimination of the fungus—in patients with vulvovaginal candidiasis.

Q: Can the ingredients in Lomexine interact with latex barrier contraceptives?

Regulatory warnings state that the oily or fatty excipients (inactive substances) present in the vaginal formulations can physically damage the material integrity of latex barrier contraceptives, such as condoms and diaphragms. This officially impairs their barrier efficacy.

Q: What types of birth control or medical devices should be avoided while using Lomexine?

Official warnings advise patients not to rely on latex or rubber barrier methods (like condoms or diaphragms) for contraception during treatment, as the product's excipients may cause damage. Additionally, the concurrent use of spermicides is advised against.

Q: Can Lomexine affect or interact with oral contraceptive pills?

Due to the minimal systemic absorption of Fenticonazole following local application, the potential for drug-drug interactions involving systemic medications, such as oral contraceptive pills, is officially documented as unlikely.

Q: What does the available information say about using Lomexine while breastfeeding?

Official information states that use during breastfeeding requires medical supervision. Animal data indicates that the drug or its metabolites can be excreted in milk, though only low systemic exposure is expected after the vaginal application.

Q: Are there different strengths or forms of Lomexine (e.g., 200mg, 600mg) that people use?

Lomexine is available in different forms and strengths. These commonly include a 600 mg vaginal capsule, a 200 mg vaginal capsule, and a 2% vaginal cream. The specific strength and form determine the administration schedule described in official guidelines.

Q: What is the difference between a vaginal capsule (ovule) and the cream formulation of Lomexine?

Both are designed for intravaginal use, but they differ in how they are administered. The capsule is typically part of a single-dose or three-day regimen, designed for a high concentration release. The cream is generally applied once or twice daily for a set duration, often using an applicator.

How should Lomexine be stored and disposed of?

Storage Requirements

The official regulatory labeling for Lomexine (fenticonazole) mandates specific conditions to maintain product stability and safety. The medicine must be stored out of the sight and reach of children.

Temperature constraints direct that the product generally must be stored at ambient conditions, often specified as not above 30 C. Some formulations also prohibit refrigeration or freezing. To protect the medicine from degradation, it is required to store in the original package in order to protect from light.

Disposal Instructions

To prevent environmental contamination, official instructions state: Do not throw away any medicines via wastewater or household waste. Expired or unused product must be handled as pharmaceutical waste; the official guidance is to ask your pharmacist how to throw away medicines you no longer use.

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

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