Imazol plus

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Imazol plus

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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 Imazol plus

Property Description
Active ingredients Clotrimazol and Hexamidine
Form Cream (Creme), designed for better skin tolerance
Pharmacological class Azole antifungal and antiseptic agent
General purpose Manages dermal infections with fungal and bacterial components
Origin Synthetic combination product

Imazol plus is a synthetic combination preparation formulated as a specialized cream designed exclusively for topical application on the skin. It is dually classified as an azole antifungal and an antiseptic agent due to its two distinct active compounds, representing a fixed-dose combination strategy. This medicinal product is defined by its concurrent attack on fungal pathogens and general surface cleansing capabilities, a practice recognized in dermatology for specific mixed infections.

Composition and Dual-Action Classification

The core composition involves the two principal synthetic active ingredients: Clotrimazol and Hexamidine (often utilized as diisethionate). Clotrimazol is the key antifungal component, belonging to the imidazole derivative group, a class clinically recognized for targeting the structural integrity of fungal cell membranes. Hexamidine serves as the co-active agent, classified as a potent disinfectant.

The product's key differentiation lies in its status as a single-vehicle combination product, integrating both the specific anti-fungal action of Clotrimazol and the broader disinfectant effect of Hexamidine. This dual mechanism is particularly relevant when treating skin infections where secondary bacterial colonization is a potential concern, ensuring the preparation is geared toward multifaceted microbial control.

General Purpose and Benefit of the Combination

The general purpose of Imazol plus is to provide efficient control over skin infections that involve both fungal growth (dermatomycoses) and potential microbial presence. The preparation is intended to assist in the initial management of such conditions by offering simultaneous attack and defense.

This benefit is rooted in the synergistic action where the targeted effect of the azole antifungal is complemented by the general surface cleansing provided by the antiseptic agent. This design delivers a complete approach for topical application, aiming to support the overall recovery of the affected area from challenging dermal infections.

Regulatory References

  1. Imazol Plus (clotrimazol/hexamidín) SmPC

What side effects are possible with Imazol plus?

Possible side effects and safety information

The safety profile for Imazol plus, a combination cream containing Clotrimazol and Hexamidine, is predominantly characterized by adverse reactions localized to the application site. Regulatory documents classify the vast majority of these effects as Common.


Adverse Reaction Scope

The most frequently documented effects are categorized under Skin and Subcutaneous Tissue Disorders and General Disorders and Administration Site Conditions. These may include a burning sensation, itching (pruritus), redness (erythema), and general irritation at the site of application. Less common reactions can involve blistering or contact dermatitis.

Serious adverse events are rare and primarily involve Immune System Disorders. The official label requires documentation of severe allergic reactions, known as hypersensitivity, which can manifest as angioedema (swelling beneath the skin) or, in extreme cases, anaphylaxis.


Regulatory Safety Notes

Safety notes specify important restrictions concerning the use of the cream. The product is contraindicated in individuals with a known hypersensitivity to the active ingredients or to excipients like cetostearyl alcohol.

Due to the ingredients, the cream may cause damage to latex contraceptive products (condoms and diaphragms), which could reduce their effectiveness; alternative precautions are advised for at least five days following use in the genital area. Patients are also advised to avoid contact with eyes and mucous membranes.

For specific populations, documentation notes that due to negligible systemic absorption, the risk of harmful effects during pregnancy and lactation is low, though medical supervision is recommended. Safety data is not fully established for infants under 1 month of age.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documents define the overdose profile for Imazol plus cream by establishing that overexposure resulting from topical application is unlikely to cause systemic toxicity and is not expected to lead to a life-threatening situation. This profile centers the primary risk on the possibility of accidental ingestion of the preparation.

Manifestation and Risk Profile Regulatory Requirement
Topical Overexposure Acute overdosage is unlikely; life-threatening effects are not expected.
Accidental Ingestion Primary overdose hazard; requires immediate professional guidance.
Severe Symptoms Life-threatening symptoms (e.g., struggling to breathe, unresponsiveness) require emergency services.

In cases of accidental ingestion, official guidance strictly mandates that the individual seek professional assistance or contact a Poison Control Center right away. The procedural steps described in official documents are limited to symptomatic and supportive treatment, as no specific antidote is documented in the regulatory labeling. Urgent medical attention is specifically required for severe or life-threatening symptoms. These serious manifestations may include signs of a severe allergic reaction, such as difficulty breathing or swelling of the throat or tongue, or the occurrence of unresponsiveness or fainting. Immediate contact with emergency services is necessary if these critical manifestations develop.

Therapeutic Uses of Imazol plus

What Imazol plus treats — Main Uses and Benefits

The product is commonly used for managing fungal skin infections that may be complicated by the presence of secondary bacteria, which is a common scenario in dermatology. The active antifungal component is commonly used to help with conditions such as ringworm, athlete's foot, jock itch, and yeast infections of the skin.

This cream is commonly used across conditions where a fungal disease is secondarily infected by bacteria, requiring a multifaceted approach. The combination of anti-fungal and antiseptic agents may assist with the management of such complex infections, which are often associated with distressing symptoms.

The preparation is applied in addressing symptom clusters that may become intense, including severe itching (pruritus), localized burning sensation, and painful inflammation. Eased symptoms may help patients cope more steadily with difficult episodes and assist with maintaining functional stability during symptomatic periods. Imazol plus is considered relevant for managing macerated lesions that occur in high-moisture sites like interdigital spaces and skin folds.

“Used in dermatological contexts involving both fungal activity and bacterial presence, this dual-action product may assist with supportive management for the acute symptomatic burden.”

Quick Fact: Symptom Relief
Supports Easing of Itching and Burning associated with common skin mycoses, especially when lesions are wet or weeping.

Regulatory References

  1. MedlinePlus Drug Information overview

Eligibility and Restrictions for Use

The eligibility for using Imazol plus cream is defined strictly by regulatory labeling, covering specific contraindications, age groups, and physiological states.

Eligibility Scope

Category Regulatory Rule (Official Labeling)
Contraindicated Populations Patients with known hypersensitivity to Clotrimazole, Cetyl Alcohol, Butylhydroxyanisole, or any other excipient.
Application Restrictions Must not be applied to open wounds or areas designated as mucous membranes.
Approved Age Groups Use is permitted in adults, adolescents, and children from 1 month of age.
Use Not Established Infants under 1 month of age are excluded due to insufficient data on efficacy and safety.

Conditional Use and Restrictions

Status Restriction Statement (Official Labeling)
Pregnancy Use is conditional; it should only occur after specific medical advice and assessment.
Lactation Use is restricted; the cream must not be applied to the breast or surrounding skin to prevent direct infant contact.

Connection to the overall eligibility profile: Regulatory documents establish absolute non-eligibility based on ingredient allergy and strictly limit the product to populations aged 1 month and older. Eligibility is further constrained by the anatomical application site and specific reproductive status, ensuring use only on defined dermal surfaces in approved populations.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Imazol plus, a topical cream containing Clotrimazol and Hexamidine, indicates that the incidence of systemic drug-drug interactions is minimal. This is due to the established profile of minimal systemic absorption for both active ingredients following application to the skin.

Documented Interaction Patterns

The primary interaction pattern cited in regulatory documents relates to a local chemical constraint involving the antiseptic component, Hexamidine, rather than systemic drug interactions.

Interaction Entity Official Constraint/Restriction
Other Antiseptics/Anionic Compounds Simultaneous or successive use is not recommended due to the potential for local antagonism or chemical incompatibility.
Systemic Medicines None documented. No warnings are issued for interactions involving metabolic enzymes (e.g., CYP) or drug transporters due to low systemic exposure.

Formally Contraindicated Combinations

No systemic medicinal products are classified as formally contraindicated for co-administration with Imazol plus cream in the relevant official regulatory prescribing information.

Exposure and Clearance

No interactions are officially documented that would cause a clinically relevant increase or decrease in the systemic levels of Clotrimazol or Hexamidine, consistent with the minimal systemic absorption profile.

Food, Alcohol, or Supplements

Official regulatory documents do not contain specific cautions regarding interactions between Imazol plus and food, alcohol, dietary supplements, or herbal products.

Mechanism of Action

How Imazol Plus Works

Imazol plus functions through two distinct, complementary mechanistic domains that target the microbial cells on the application surface.


Blocking Fungal Membrane Production

The primary mechanistic action against fungal structures is achieved by Clotrimazol through enzyme inhibition. It specifically blocks the fungal enzyme lanosterol 14-alpha demethylase, which is essential for synthesizing ergosterol—the primary structural sterol of fungal cell membranes. This mechanism causes a buildup of toxic intermediates and destabilizes the fungal membrane, leading to cellular leakage and the elimination of the pathogen.


Rapid Microbial Cell Disruption

The secondary mechanistic action against microbial membranes is driven by Hexamidine, which engages a membrane disruption mechanism. As a positively charged molecule, Hexamidine binds strongly to the negatively charged microbial cell membranes (bacteria and yeast), rapidly altering their permeability and structure. This non-specific binding causes the contents of the microbial cells to leak out, resulting in the rapid destruction of surface microorganisms and limiting the microbial density on the application surface.

Dosage and Administration Information

Administration Guidelines: How to Use Imazol plus

Imazol plus is a medication formulated as a cream or paste intended for Topical (Cutaneous) application only. Adherence to the official procedural steps is necessary for correct use.

Official Dosing and Frequency

The product should be applied as a thin layer to the affected skin area. The standard dosing schedule is Once or Twice Daily, typically applied in the morning and/or the evening. If a dose is missed, it should be applied as soon as it is remembered. Do not double the application to compensate for a missed dose.

Procedural Steps

The administration requires specific preparation and application steps:

  1. Preparation: The affected skin area must be cleaned and thoroughly dried before any application.
  2. Application: Apply the thin layer of cream or paste to the affected area.
  3. Massage: Gently rub the product into the skin.

Special and Population-Specific Rules

  • Duration of Course: Application must be continued for the full labeled treatment duration, which often extends for a specified time (e.g., up to two weeks) after the skin has visibly returned to normal. Treatment should not exceed the maximum duration stated in the official label.
  • Infant/Pediatric Use: When officially labeled for use in diaper rash, the paste is typically applied to the affected area underneath the diaper with each diaper change.
  • Handling: The product is strictly for external use only and contact with the eyes must be avoided.

These instructions define the standardized, required protocol for the use of this medicine, ensuring the proper route, dose, and frequency.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Imazol Plus

The following information describes the structure of scientific research and study outcomes available for Imazol plus (Clotrimazol and Hexamidine combination cream), focusing on what researchers explored.


Evidence for Use in Fungal Skin Infections with Microbial Presence

Research has explored Imazol plus in the context of conditions associated with acute or disruptive episodes, such as common skin fungal infections (dermatomycoses) where a secondary microbial component may be a factor. These conditions often involve outcomes linked to inflammatory or irritative states in moist areas like skin folds.

This combination product was studied for its application in research contexts involving fluctuating or unstable symptoms related to fungal and microbial colonization. The evidence base includes clinical trials where the combination product was evaluated in settings comparing it to the antifungal component alone.

Studies report how symptoms evolved in the observed populations over defined time intervals. Findings describe patterns observed in the studies related to mycological assessment and clinical endpoints (changes in visible signs of skin irritation). Research highlights changes measured during the study period, helping to contextualize how patients reported their experience of discomfort, such as itching and burning.


Study Design and Comparison in Clinical Research

Research supporting the antifungal component (Clotrimazol) of Imazol plus includes Randomized Controlled Trials (RCTs) and Systematic Reviews, which represent key components of the evidence base. Clotrimazol was studied for measurement of mycological cure when compared to placebo or other antifungal monotherapies.

Specific trials research examined how the dual-agent formulation was observed in comparison to the antifungal agent alone, in scenarios where secondary microbial colonization was studied for its relevance. These studies monitored short-term changes in both mycological assessment and the clinical signs of the infection.


Primary Endpoints Examined in Trials

Research examined primary and secondary endpoints defined by the study protocols. The focus was on monitoring the stability of the condition and the presence of the pathogen. A key endpoint was evaluated in studies as the clearance of the fungus, confirmed by laboratory tests. Research also monitored patient-reported outcomes describing perceived discomfort and visible signs of infection.


What Remains Unclear or Requires Further Research

The evidence is limited regarding large-scale, independent clinical trials that specifically focus on the dual-agent product compared to other established protocols for confirmed fungal and secondary microbial infections. Also, long-term effects are not fully established because follow-up durations were limited in the initial trials. This means that research provides context but not individual predictions about long-term recurrence rates. The majority of high-quality, synthesized evidence relates to the antifungal monotherapy. Data for certain groups remain insufficient regarding the specific fixed-dose combination product in children.

Key Studies & References Clotrimazole Topical Drug Information Overview

Frequently Asked Questions (FAQ)

Common questions about Imazol plus (FAQ)


Q: Is Imazol plus safe to use on sensitive skin areas?

Regulatory documents state the cream must not be applied near the eyes or on mucous membranes. It is important to know that certain ingredients, like cetostearyl alcohol, are listed as excipients and are contraindications for people with a known hypersensitivity to them.


Q: Can Imazol plus be used for general redness or irritation?

Official product information states that Imazol plus is intended for treating skin diseases caused by fungi that are also infected with bacteria. Symptoms of these infections can include redness and inflammation. However, the cream’s indication is focused on fungal skin diseases with a microbial component, not general, non-infectious redness or irritation.


Q: Is a burning sensation normal when first applying Imazol plus?

A burning sensation at the application site is listed as one of the common adverse reactions in the official product information. This indicates it is a possibility during use. If any adverse reaction, such as burning, is severe or persists, it is important to seek medical advice.


Q: Does Imazol plus have any known interactions with common skincare products?

Official warnings primarily focus on chemical incompatibility with other antiseptics, anionic compounds, and the risk of damage to latex contraceptives. Official regulatory documents do not contain specific warnings regarding common cosmetic or general moisturizing products.


Q: Can I use Imazol plus while taking oral antibiotics?

Due to the minimal systemic absorption of the active ingredients, the chance of drug-drug interactions with oral medications is minimal. Regulatory documents do not specifically list oral antibiotics as a concern. Questions about using this cream with oral medications should always be addressed to a healthcare professional.


Q: Can children use Imazol plus, and are there special considerations?

Imazol plus is generally approved for use in adults and children starting from one month of age. In children, it is used for infections such as those associated with the diaper area. The official administration instructions for children, including infants older than one month, are detailed in the patient leaflet.


Q: Why do some people report peeling skin after using this cream?

Peeling can be a symptom of the skin condition being treated. While not always listed as a common reaction, official safety information does document related adverse effects like irritation and contact dermatitis. If peeling is severe or a concern, consult a healthcare professional.


Q: What kind of skin problems is Imazol plus typically used for?

According to the official product indications, Imazol plus is used for treating fungal skin diseases (mycoses) that have a secondary microbial (bacterial) component. This includes common issues like mycoses between the toes and other fungal infections associated with itching and inflammation.


Q: Is Imazol plus the same as clotrimazole cream?

Imazol plus differs from a standard clotrimazole cream. It is a fixed-dose combination product that contains not only the antifungal agent clotrimazole but also the antiseptic agent hexamidine, providing dual-action.


Q: Can Imazol plus be used on open cuts or broken skin?

The product information states that the cream is not to be applied to open wounds or to mucous membranes. The cream is intended for application only on the affected skin area.


Q: Can Imazol plus be used to prevent recurrence of skin issues?

The product information directs that application should be continued for the full treatment duration, even after visible improvement, to ensure the course of treatment is complete. This helps support a successful outcome and reduce the risk of incomplete treatment.


Q: Is there a maximum cumulative period for using Imazol plus over a year?

The label specifies that the duration of a single course of treatment should not exceed four weeks unless otherwise advised by a healthcare professional. Official regulatory information does not generally detail a maximum cumulative period for use over an entire year.


Q: Does alcohol consumption affect the use of Imazol plus?

Official regulatory documents do not contain specific cautions or warnings regarding an interaction between Imazol plus (a topical product) and alcohol consumption.


Q: Are there any dietary considerations while using Imazol plus?

Official regulatory documents do not contain specific cautions regarding interactions between Imazol plus and food, dietary supplements, or herbal products.


Q: What happens if I miss an application of Imazol plus?

If a regular application is missed, product directions indicate applying the cream when remembered. The instructions specifically caution against doubling the application to compensate for a missed dose.


Q: What should I do if I accidentally swallow a small amount of Imazol plus?

The product is for external use only. In the event of accidental ingestion, seeking medical advice or contacting a Poison Control Center is the recommended protocol. It is important to have the product packaging available when seeking help.


Q: Does Imazol plus need a prescription in most places?

In many regions, Imazol plus is classified as a pharmacy-only medicine, meaning it is available without a doctor’s prescription but is sold under the supervision of a pharmacist. Availability and classification may differ by country.


Q: Is Imazol plus effective for jock itch or athlete's foot?

Imazol plus is indicated for fungal diseases, including mycoses between the toes (athlete’s foot), and other fungal skin infections that are concurrently infected with bacteria, which covers similar common conditions.


Q: Does Imazol plus expire quickly after opening the tube?

Like many topical products, Imazol plus has a limited shelf life once the tube is opened. The official regulatory documents specify this period, which is often limited to a defined time such as one month.

How should Imazol plus be stored and disposed of?

How to Store and Dispose of Imazol plus?

The official storage and disposal requirements for Imazol plus cream are defined by regulatory authorities to ensure the product's integrity and safety.

Storage and Protection Rules
Do not store above 25 C (77 F) and keep from freezing.
Must be protected from direct light, excessive heat, and moisture.
Always keep the product in its original container with the lid or cap tightly closed.
Keep out of the sight and reach of children.

Handling and Disposal Requirements
Fabric (e.g., clothing or bedding) that has contacted the cream burns more easily; keep it away from naked flames.
Dispose of unused or expired product and packaging according to local, state, and federal regulations.
Do not flush the cream down a toilet or throw it into wastewater to prevent environmental contamination.

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

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