Clomazol

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Medically reviewed

Marina Burgos

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 Clomazol

Property Description
Active Ingredient Clotrimazole
Pharmacological Class Azole Antifungal Agent
Common Use Control of Fungal Proliferation
Origin Synthetic Imidazole Derivative
Forms Cream, Solution, Vaginal Tablet (Pessary), Lozenge

Clomazol is a medicinal entity whose sole active component is Clotrimazole, and it is formally classified as a synthetic Azole Antifungal Agent. This product is fundamentally designed to address infections caused by pathogenic fungi and yeasts, utilizing a targeted mechanism against these microorganisms. Its composition defines it as a single-component product focused on antimycotic action. This formulation is often available over-the-counter (OTC) for its typical use in treating localized fungal conditions.


What Type of Medicine is Clomazol (Clotrimazole)?

Clomazol is an antifungal agent belonging to the imidazole derivative subgroup of the Azole pharmacological class. The active ingredient, Clotrimazole, is a chemically manufactured substance, making it a synthetic compound specifically engineered to treat fungal diseases. It serves as a first-line treatment for common surface-level fungal issues. For instance, its formulations are used for managing conditions such as dermatophyte infections, which often affect the skin's surface. As an Imidazole Derivative, its structure is defined by a specific chemical moiety that enables its precise activity against a broad spectrum of fungal strains.


Clomazol's Available Forms and Primary Action

Clomazol is prepared in multiple pharmaceutical preparations, including topical cream, solution, vaginal tablet (pessary), and oral lozenge (troche), to enable localized delivery. These diverse forms facilitate the associated route of administration, which may be Topical (Dermal), Vaginal, or Oromucosal, focusing the treatment directly on the site of infection. The general therapeutic purpose of Clomazol is achieved through its mechanism of biological control over fungal proliferation. The Clotrimazole component interferes with the biosynthesis of ergosterol, a crucial structural lipid in the fungal cell membrane. This disruption leads to the structural compromise and eventual elimination of the fungal organism, resolving the underlying fungal condition by exerting a fungistatic or fungicidal effect. This targeted delivery is a differentiating feature, allowing the compound to act directly against the source of infection.

Regulatory References

  1. Clotrimazole Drug Information

What side effects are possible with Clomazol?

Possible side effects and safety information

The safety profile of Clomazol (Clotrimazole) is primarily defined by local reactions at the application site, which are organized and classified in official regulatory documents. Serious systemic effects are documented but are generally rare following topical or vaginal use.

Adverse Reaction Scope

The most frequently documented effects are classified as Common and involve the Skin and Subcutaneous Tissue Disorders. These include local phenomena such as a burning or stinging sensation, skin irritation, erythema (redness), and pain at the site of application.

Reactions categorized as Frequency Not Known are reported, particularly through post-marketing surveillance, and include serious systemic events. These fall under Immune System Disorders and can involve hypersensitivity reactions, angioedema, syncope, hypotension, and anaphylactic reaction. The official labeling accounts for the possibility of these rare, severe adverse reactions.

Safety Considerations

Official prescribing information addresses use in specific populations. Due to the minimal systemic absorption of Clotrimazole after topical or vaginal application, harmful effects during pregnancy and lactation are considered unlikely; however, use in these circumstances is noted to require physician supervision.

Regarding physical constraints, regulatory documents include a specific safety note stating that Clomazol preparations may damage latex contraceptives (such as condoms or diaphragms), potentially reducing their effectiveness. Furthermore, a formal contraindication exists for individuals with known hypersensitivity to the active substance, Clotrimazole, or to any of the product's excipients.

Overdose and Emergency Response

Overdose and when to seek help: Official Regulatory Information for Clomazol

Official regulatory documents classify the risk of acute intoxication as unlikely following a single topical or vaginal overdose due to minimal systemic absorption. The primary scenario addressed in regulatory overdose sections is the accidental oral ingestion of the preparation, which may lead to clinical symptoms.

Overdose scope (Official Statements) Regulatory Basis
Documented Manifestations Nausea, vomiting, and dizziness are the documented symptoms following accidental oral ingestion.
Severe Outcomes Acute systemic toxicity is not expected. Management is symptomatic and supportive.
Antidote Information No specific antidote is known for this compound.

Emergency-Response Statements

Immediate medical attention is mandated if Clomazol is accidentally swallowed or if any clinical symptoms of overdose become apparent after ingestion. This instruction requires the user to seek medical advice or contact a Poison Control Center. Procedures such as gastric lavage or administering activated charcoal are rarely required and should only be considered if a potentially life-threatening amount has been ingested, and only under conditions where the airway can be adequately protected.

Connection to the overall overdose profile

The regulatory profile emphasizes that Clomazol's low systemic absorption profile dictates that severe overdose is generally not anticipated. Consequently, regulatory documents focus entirely on managing the non-specific, potentially self-limiting symptoms that follow accidental oral ingestion, without recommending an antidote or intensive medical intervention unless a large, potentially life-threatening dose has been consumed.

Therapeutic Uses of Clomazol

What Clomazol Treats: Main Uses and Benefits

Clomazol (clotrimazole) is an antifungal medication widely used to manage superficial infections caused by dermatophytes and yeasts, primarily the Candida species. Its main therapeutic benefit is in supporting the management of the underlying infection and contributing to symptom improvement.

Its common uses include treating dermal conditions such as tinea corporis (ringworm), tinea cruris (jock itch), and tinea pedis (athlete's foot). In clinical scenarios, it is also frequently used to manage vulvovaginal candidiasis (vaginal thrush) and oropharyngeal candidiasis (oral thrush). The therapeutic approach focuses on addressing the discomfort associated with these conditions, with the objective of promoting symptom relief and clinical improvement.

Quick Fact: Therapeutic focus includes addressing Itching and Scaling

Clotrimazole's role is specifically focused on addressing the fungal proliferation, which subsequently helps in managing related symptoms like redness, itching, burning, and scaling of the skin, or discharge in the case of vaginal infections.

Regulatory References

  1. Clotrimazole Topical: MedlinePlus Drug Information

Eligibility and Restrictions for Use

Eligibility and Contraindications for Clomazol (Clotrimazole)

The official population eligibility for Clomazol is strictly defined by regulatory authorities based on hypersensitivity, age, and physiological status.

Category Official Regulatory Statements
Absolute Contraindication Use is prohibited for patients with known hypersensitivity or allergy to the active substance Clotrimazole or to other Azole antifungal agents.
Disease Scope Restriction The localized formulations are not indicated for the treatment of systemic fungal infections, or for infections of the nail or scalp.

Age-Related Eligibility

Category Official Regulatory Statements
Adults Generally eligible for all labeled formulations.
Children/Adolescents (Vaginal) Not recommended or not approved for use in children under 12 to 16 years of age, depending on the formulation and region, unless specifically directed by a healthcare professional.
Children (Topical) Use in infants under 2 years of age may require medical consultation.

Special Population Status

Category Official Regulatory Statements
Pregnancy Conditional use permitted under medical supervision; use during the first trimester is generally avoided, and vaginal tablets must be inserted without an applicator.
Lactation Permitted with caution; minimal systemic absorption makes effects on the infant unlikely.
Conditional Use (Vaginal) Medical advice must be sought if the patient is under 16 or over 60, has recurrent infections, or has symptoms like irregular bleeding, sores, or pain.

These official regulatory statements define the boundaries for who is eligible to use the medicine under labeled conditions, focusing on minimizing exposure risks in vulnerable or sensitive populations.

What should I know about interactions with other medicines?

Clomazol’s official interaction profile is significantly differentiated by its specific pharmaceutical formulation, as defined by regulatory agencies.

The topical and vaginal preparations are associated with minimal systemic absorption, yet regulatory documents contain a crucial physical restriction. Vaginal Clomazol products may cause damage to latex-containing contraceptive barrier methods such as condoms, diaphragms, and cervical caps, which can lead to a loss of barrier integrity and potential contraceptive failure.

The oral lozenge (troche) formulation has measurable systemic exposure, which introduces the potential for pharmacokinetic interactions. This form may inhibit certain Cytochrome P450 (CYP) enzymes, a metabolic pathway commonly involved in the systemic clearance of other medicines. This mechanism is officially documented to result in increased plasma concentrations of specific co-administered agents, notably the immunosuppressants Tacrolimus and Sirolimus. The oral formulation also carries a population-specific caution: Periodic assessment of hepatic function is advised by regulatory agencies, particularly for patients with pre-existing hepatic impairment, due to the drug’s metabolic clearance in the liver. Finally, for the topical applications, no synergism or antagonism is officially reported in the labeling with other antifungal agents like Nystatin or Amphotericin B.

Mechanism of Action

Targeted Inhibition of Fungal Enzyme Activity

Clomazol (Clotrimazole) acts by inhibiting the fungal enzyme Lanosterol 14-alpha Demethylase (CYP51) . This specific enzyme, which is part of the fungal sterol biosynthesis pathway, is necessary to create ergosterol, the primary structural lipid of the fungal cell membrane. The drug's molecular structure allows it to bind directly to the enzyme's heme iron, blocking this necessary metabolic step.

️ Destabilization of the Fungal Cell Barrier

This enzymatic blockade results in the depletion of functional ergosterol and the accumulation of structurally abnormal sterols within the fungal cell. This profound structural disruption compromises the integrity and function of the cytoplasmic membrane, leading to increased permeability and the uncontrolled leakage of intracellular components, such as potassium ions. This disruption initiates a cascading effect that results in the complete failure of the fungal cell's physiological functions. The final physiological outcome is fungistatic (growth-inhibiting) or fungicidal (cell-killing) action, strictly dependent on the local concentration achieved at the fungal cell barrier.

Dosage and Administration Information

Clomazol (Clotrimazole) is officially administered via three approved routes: topical (skin), intravaginal, and oromucosal (mouth), each corresponding to a specific dosage form. Topical 1% cream or solution is applied as a thin layer to the affected area twice daily (morning and evening). The standard duration for dermal application ranges from 2 to 4 weeks, depending on the specific condition, and the full treatment must be completed as directed. This application regimen is approved for use in children aged 3 years and older.

Intravaginal dosing is determined by the tablet strength chosen: a single 500 mg dose, or a 200 mg tablet once daily for 3 days, or a 100 mg tablet once daily for 7 days. Regardless of the course length, the insert is typically administered at bedtime to optimize retention, and the course must be completed before the onset of menstruation.

For oromucosal use, the 10 mg lozenge is the labeled form. The official regimen requires one lozenge to be slowly dissolved in the mouth five times a day for a total course of 14 consecutive days. The lozenge must not be chewed or swallowed whole, and administration should occur after meals. If a dose is missed, it should be taken when remembered unless it is nearly time for the next scheduled dose, in which case the user must skip the missed dose and resume the regular schedule, without taking a double dose.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Clomazol


Evidence for Use in Superficial Skin Fungal Infections

Research into Clomazol's use for common skin conditions like athlete's foot (Tinea pedis) and ringworm (Tinea corporis) primarily involves short-term Randomized Controlled Trials (RCTs) and systematic reviews. The populations generally involved adults and adolescents with mycologically confirmed infections. Studies were evaluated in relation to two main outcomes: mycological endpoint (a laboratory finding confirming the elimination of the fungus) and clinical change measurement (a measured reduction in external signs and symptoms). Findings describe patterns observed related to both fungal clearance and symptom change.

Evidence quality varies across studies, and some older trials included in systematic reviews show limitations in methodology. Comparative evidence may be less consistent. Follow-up durations were limited, meaning the initial findings apply only to the specific populations and circumstances studied.


Evidence for Use in Vaginal and Oral Candidiasis

The evidence base for Vulvovaginal Candidiasis (VVC) is extensive, built upon numerous Randomized Controlled Trials (RCTs) and systematic reviews. For Oropharyngeal Candidiasis (oral thrush), the research consists mainly of specific regulatory submission trials. Studies examined specific outcomes linked to inflammatory or irritative states. For VVC, studies monitored both symptom evolution monitoring and mycological endpoint to determine a therapeutic endpoint.

For VVC, the research certainty remains low regarding the evidence for outcomes in certain complex cases, such as those with recurrent (frequent) infections. Comparative evidence is lacking for specific dosage forms against certain systemic treatments. For oral thrush, the research is highly specific to the lozenge's local action, meaning long-term effects are not fully established.


Long-Term Studies and Durability of Outcomes

The primary clinical trials that regulatory bodies reviewed for Clomazol were generally designed to observe outcomes over short, defined time intervals. Follow-up durations were limited, meaning the evidence contributes to understanding acute symptom patterns but offers limited information for long-term outcomes. The studies monitored the achievement of study endpoints but do not extensively track the durability of the observed patterns or the frequency of symptom return following the defined time intervals. The long-term patterns associated with Clomazol use are not well characterized in the core research record.

Key Studies & References

  1. Clotrimazole for Vulvovaginal Candidosis: More Than 45 Years of Clinical Experience (Systematic Review/RCT Synthesis)
  2. Treatment of Vulvovaginal Candidiasis—An Overview of Guidelines and the Latest Treatment Methods (Review mentioning limited long-term evidence)
  3. Clotrimazole - StatPearls (Review of indications, mechanism, and general evidence gaps)

Frequently Asked Questions (FAQ)

Common questions about Clomazol (FAQ)

Q: How does Clomazol compare to other medicines used for the same purpose?

A: Studies reviewed by regulatory bodies often include comparisons of Clomazol against other antifungal agents or placebo. Official documents generally state that evidence comparing Clomazol to other specific treatments may be limited or inconsistent, depending on the formulation and the specific condition studied.

Q: What is the expected timeframe before Clomazol starts to show its effects?

A: Official patient information focuses primarily on the full duration of treatment required to successfully eliminate the infection, which can range from a few days to several weeks. Specific information on the exact time when initial symptom improvement can be expected is not typically included in the official labeling.

Q: Do Clomazol's side effects usually go away on their own over time?

A: The common side effects reported for Clomazol are often local reactions, such as mild irritation or a burning sensation. Official patient information describes these effects as generally transient, which means they are considered temporary and may resolve after the use of the product is finished.

Q: Can Clomazol affect the way other prescription medicines work in the body?

A: Yes, depending on the form used. Because the oral lozenge form is absorbed into the body, it may increase the concentration of certain co-administered medicines, such as immunosuppressants like Tacrolimus and Sirolimus. The topical and vaginal forms are associated with very minimal absorption, and therefore have a lower potential for systemic drug interactions.

Q: Can Clomazol be used by children or teenagers?

A: Eligibility is determined by the specific product form. The topical cream or solution is approved for children 3 years of age and older. For vaginal applications, the product is generally not recommended or approved for use in individuals under the age of 12 to 16, depending on the regulatory guidance.

Q: What is the general conclusion from the research evidence on Clomazol?

A: Regulatory documents state that research evidence examines the use of Clomazol for superficial fungal conditions, including various skin infections and candidiasis. Studies have monitored both the lab confirmation of fungal clearance and the measured reduction in external symptoms over the defined, short treatment intervals.

Q: Can a patient stop taking Clomazol suddenly, or must it be tapered off?

A: Official patient information indicates that the full course of treatment should be completed, even if symptoms improve quickly. This is noted to be important for achieving the therapeutic goal.

Q: Does the strength of the Clomazol tablet relate to its effectiveness?

A: Regulatory guidance defines various vaginal tablet strengths as acceptable therapeutic options (e.g., single high dose versus lower doses taken daily). These different regimens are approved as alternatives intended to lead to the same therapeutic endpoint for specific conditions.

Q: What is the significance of the maximum recommended dose of Clomazol?

A: Official labeling defines set treatment regimens for each product form and duration, such as applying a cream twice daily or dissolving five lozenges per day for a specific number of days. These set regimens collectively represent the total maximum exposure allowed under the approved labeling for a complete course.

Q: Is Clomazol considered a common or specialized medication?

A: Clomazol, whose active ingredient is Clotrimazole, is classified as a synthetic Azole antifungal agent. It is widely recognized and commonly used as an initial treatment option for surface-level fungal infections.

Q: Is it possible to have an allergic reaction to Clomazol's inactive ingredients?

A: Official regulatory documents state that Clomazol is contraindicated (prohibited) for anyone with a known hypersensitivity or allergy to the active substance (Clotrimazole) or to any of the product's excipients. Excipients are the inactive ingredients that are part of the medicine's formulation.

Q: Is there a known interaction between Clomazol and alcohol consumption?

A: Official labeling does not specifically list an interaction with alcohol for Clomazol. However, because the oral lozenge form is processed in the liver, regulatory caution advises that patients with pre-existing liver impairment should have their liver function assessed periodically.

Q: Are there any over-the-counter (OTC) drugs that should be avoided while taking Clomazol?

A: Official labeling for the topical and vaginal forms generally reports a low risk of problematic interactions with co-administered medicines, though the oral form has specific documented interactions with certain prescription medicines. A key caution is the damage the vaginal form can cause to latex barrier contraceptives.

Q: Could taking Clomazol impact the effectiveness of birth control pills?

A: The vaginal preparation may cause physical damage to latex-containing barrier contraceptives, such as condoms and diaphragms, which can reduce their ability to prevent pregnancy. Official documents also contain notes regarding potential interactions with certain hormonal contraceptives.

Q: Why do official sources sometimes include rare side effects in the drug information?

A: Official regulatory processes generally require the reporting and inclusion of adverse reactions, including those reported rarely through post-marketing surveillance, to fully define the safety profile of the medication for patients and prescribers.

Q: Can Clomazol cause changes in mood or mental state?

A: The regulatory labeling documents local side effects (dermal reactions) and rare systemic effects (anaphylaxis), but mood or mental state changes are not generally listed among these reported effects.

Q: Is Clomazol known to cause sleepiness or affect the ability to drive?

A: The official labeling documents minimal systemic absorption for the topical and vaginal forms, and generally does not list drowsiness or impaired ability to drive as reported side effects.

Q: Is there a risk of becoming dependent on Clomazol?

A: Clomazol is not classified as a controlled substance by regulatory agencies, and the official safety information does not contain any warnings regarding potential for dependency, addiction, or abuse.

Q: What happens if a person takes too much Clomazol by mistake?

A: Official patient information for external-use forms advises that if the product is accidentally swallowed, a Poison Control Center should be contacted immediately, or medical help should be sought.

Q: Do generic versions of Clomazol work the same way as the brand-name version?

A: Yes, regulatory agencies require that generic versions of a drug must demonstrate bioequivalence and pharmaceutical equivalence to the brand-name drug. This means they must contain the same active ingredient, strength, dosage form, and route of administration to be approved.

Q: Can Clomazol be taken with pain relievers like ibuprofen or acetaminophen?

A: The official labeling does not explicitly list interactions with common, non-prescription pain relievers such as ibuprofen or acetaminophen. The most critical documented interactions are limited to the oral form's effects on certain immunosuppressants.

Q: Does Clomazol make a person more sensitive to sunlight?

A: The regulatory labeling lists reported side effects, and increased sensitivity to sunlight (photosensitivity) is not generally included among the common or serious effects.

Q: Is Clomazol known to cause weight gain or weight loss?

A: Weight gain or weight loss is not generally listed among the frequently reported local side effects or the serious systemic effects documented in the official safety labeling.

Q: Can Clomazol be taken if a patient has a history of stomach ulcers?

A: Contraindications or cautions related to a history of stomach ulcers or other gastrointestinal conditions are not generally listed in the regulatory labeling for the topical, vaginal, or oral lozenge forms of Clomazol.

Q: Does Clomazol cause any changes to blood pressure?

A: Changes to blood pressure are not listed as a common effect of the medication. However, hypotension (low blood pressure) has been reported as a component of rare, serious immune-system reactions, such as anaphylaxis.

How should Clomazol be stored and disposed of?

How to Store and Dispose of Clotrimazole (Clomazol)

Storage and disposal requirements for Clotrimazole are mandated by regulatory bodies to maintain the product’s quality and stability.

Official Storage Conditions

Clotrimazole must be stored at controlled room temperature, typically between 20 to 25 C (68 to 77 F). The product must be stored in its original container, kept tightly closed, and shielded from excess heat, moisture, and light. It is prohibited to freeze the medication, as this can compromise its formulation. Furthermore, all forms must be kept securely out of the sight and reach of children.

Disposal Instructions

Unused or expired Clotrimazole must be disposed of according to local regulations or through established drug take-back programs. The product must not be flushed down the toilet or poured into any drain unless specific product labeling permits this method.

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

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