Clotri

Quick links to important sections

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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

Overview of Clotri

Clotri: Definition, Active Ingredient, and Drug Classification

Property Description
Active ingredient Clotrimazol (Clotrimazole)
Forms Cream, Solution, Powder, Vaginal Tablets (Pessaries)
Pharmacological class Azole Antifungal / Antimycotic Agent
Common use Fighting Fungal and Yeast Infections
Origin Synthetic Small Molecule

Clotri is a medicinal preparation whose active pharmaceutical component is Clotrimazol (Clotrimazole). This compound is a synthetic small molecule classified as an azole antifungal agent, belonging to the broader category of antimycotic agents designed to combat infections caused by fungi and yeasts. As a broad-spectrum antimycotic agent, its primary function is to neutralize the pathogens responsible for common local infections, such as addressing athlete's foot or yeast-related skin issues. The effectiveness of Clotrimazol's mechanism applies to a variety of fungal organisms.


What Is Clotri Made Of, and How Does Its Form Factor Matter?

Clotri is typically a single-ingredient product composed of the active substance Clotrimazol combined with an appropriate pharmaceutical base or vehicle. The medication is engineered in several different high-level dosage forms, including a cream, a solution, a powder, and vaginal tablets (pessaries), which determines its intended route of administration. These various forms allow the medication to be delivered directly to the infection site on the skin or mucous membranes. For example, the non-staining nature of the cream base is often a feature highlighted for dermal applications. This variety of forms ensures the Clotrimazol component can be efficiently and directly delivered for topical or vaginal administration, maximizing its local therapeutic effect.


Clotrimazol's Core Antifungal Function

The fundamental purpose of Clotri is to eradicate or halt the growth of the fungal pathogen by disrupting its essential structure. It achieves this by acting as a broad-spectrum agent that specifically interferes with the production of ergosterol, a critical structural building block of the fungal cell membrane. Clotrimazol's activity against fungal cell structures is the basis for its effectiveness against a wide variety of fungal types. This functional breakdown of the pathogen's protective barrier results in both a fungistatic (growth-inhibiting) and a fungicidal (cell-killing) effect, thereby serving the medication’s primary objective: to eliminate or halt the proliferation of the fungal organism.

Regulatory References

  1. World Health Organization's List of Essential Medicines
  2. WHO Electronic Essential Medicines List (Clotrimazole)

What side effects are possible with Clotri?

Safety Map: Possible side effects and safety information for Clotri

Adverse reaction scope Key adverse reaction categories: Local reactions at the application site and Immune system disorders (hypersensitivity). Frequency classification (very common / common / uncommon / rare / very rare / not known): Not known (for specific, localized reactions), Common (for mild, local irritation, per some sources), and Rare (for serious hypersensitivity). System-organ classes involved (e.g., gastrointestinal, nervous system, skin): Skin and Subcutaneous Tissue Disorders (most common), and Immune System Disorders. Serious adverse reactions (as documented in regulatory sources): Serious allergic reactions (anaphylaxis) are cited as a rare potential risk in regulatory documentation. Population-specific safety considerations (if applicable): Pregnancy (use in the first trimester should be limited to clear necessity), Lactation (use with caution, avoiding application to the breast area), and Pediatric Use (safety and effectiveness established when used as indicated). Dose- or exposure-related patterns (if explicitly stated): Not explicitly stated in relation to frequency for most side effects due to poor systemic absorption. Safety-related restrictions or limitations: Contraindicated in individuals with a known hypersensitivity to the drug or its components. Not for ophthalmic use. Intravaginal formulations may damage latex contraceptive devices (condoms, diaphragms), leading to device failure.


Safety classifications (high-level) Regulatory frequency framework used (e.g., EMA / ICH frequency bands): Various (ICH/EMA/National) are utilized, resulting in the common categorization of local irritation as 'common' or 'frequency not defined' and anaphylaxis as 'rare'. Regulatory basis (EMA / FDA / other government authority): The profile is based on multiple regulatory assessments (e.g., FDA Prescribing Information, NHS/Medsafe guidelines, EMA reports). Context-of-use safety notes (as defined in official documents): If local irritation or sensitivity develops during treatment, use should be discontinued. Patients should be monitored for signs of hypersensitivity.


Resulting safety structure Regulatory safety summary:

  • The primary risks are localized reactions at the site of application, categorized as common.
  • Officially documented local adverse reactions include erythema, burning, stinging, itching (pruritus), blistering, peeling, edema, and general irritation of the skin.
  • The most significant regulatory caution is the risk of serious hypersensitivity/allergic reactions and the documented damage to latex contraceptives by vaginal formulations.

Connection to the overall safety profile (2–4 sentences): The official safety profile for Clotri is structured by focusing heavily on local reactions due to its minimal systemic absorption. Frequency classifications highlight that mild application-site issues are the most expected events, while the inclusion of specific warnings on serious allergic reactions and restrictions related to contraceptive use defines the most critical, though rare, safety considerations determined by health authorities.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information indicates that an overdose of topical or vaginal Clotrimazole is generally not expected to be dangerous due to the minimal absorption of the medicine through the skin or vaginal wall. The primary overdose concern is related to the circumstance of accidental swallowing of the topical or vaginal product.


Required Emergency Actions

If someone has accidentally swallowed the medicine, urgent guidance is required. Contact a Poison Control Center (e.g., 1-800-222-1222) immediately for professional assistance.

Immediate medical attention (e.g., calling 911 or local emergency services) is required if the person has collapsed, is not breathing, or is unresponsive. These conditions necessitate the highest level of emergency response regardless of the substance ingested.


Regulatory Overdose Profile Summary

Overdose Scope Official Regulatory Wording (FDA/MedlinePlus derived)
Documented Presentation Overdose of topical Clotrimazole is not expected to be dangerous.
Associated Factor Accidental swallowing of the medicine.
Emergency Contact Call Poison Control or the Poison Help line.
Urgent Medical Need If the victim has collapsed or is not breathing.

This profile, as defined by official labeling, focuses on accidental ingestion as the main overdose risk factor, while categorizing it as non-dangerous in the absence of severe systemic signs.

Therapeutic Uses of Clotri

What Clotri Treats: Main Uses and Benefits

Clotri is relevant for managing symptoms of superficial skin infections caused by fungi, such as athlete's foot (tinea pedis), ringworm (tinea corporis), and jock itch (tinea cruris). This medication is applied in scenarios where additional management of discomfort is required, providing supportive relief from symptoms related to inflammatory or irritative states like the intense itching, burning sensation, and the development of scaling or cracking, which are symptoms that create noticeable physiological strain.

The therapeutic relevance of Clotri extends to vulvovaginal candidiasis (yeast infection) and localized mucosal issues like oral thrush, as well as conditions characterized by episodic or fluctuating symptom patterns like Pityriasis Versicolor and cutaneous candidiasis. It may assist with addressing symptom clusters that may appear suddenly across these domains, and contributes to easing the overall symptom load.

Clotri is applicable within clinical settings that involve acute or disruptive symptom patterns, offering symptomatic relief that helps patients cope more steadily.

This supports general well-being during symptomatic phases and may assist with maintaining functional stability.


Quick Fact: Relief for Dermal Discomfort

Clotri is relevant for managing symptoms of fungal origin that involve intense itching, burning, and visible skin scaling, which helps improve day-to-day comfort during symptomatic periods.


Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Clotri — official regulatory information

Eligibility scope

Scope Element Official Regulatory Statement
Populations for whom use is allowed (as stated in label) Adults and adolescents are generally permitted for standard topical and vaginal use. Children over 2 years are permitted for topical use for tinea infections.
Populations for whom use is not recommended (if applicable) Children under 2 years for over-the-counter topical use, unless advised by a healthcare professional.
Populations for whom use is contraindicated Individuals with known hypersensitivity to Clotrimazole or to any of the specific excipients in the formulation. Individuals with known hypersensitivity to other imidazole (azole) antifungal agents.
Pregnancy and lactation eligibility status (if explicitly documented) Pregnancy: Use is restricted in the first trimester unless clearly indicated. Lactation: Application to the breast or nipple area immediately before nursing is prohibited.

Eligibility classifications (high-level)

Classification Element Regulatory Status as Defined by Official Documents
Eligibility severity classification Contraindicated (Hypersensitivity); Not Recommended (Children under 2); Use Restricted (First Trimester).

Resulting eligibility structure

Official eligibility statements:

  • Contraindicated in individuals with a known history of hypersensitivity to Clotrimazole or other azole antifungals.
  • Not recommended for over-the-counter topical use in children under 2 years of age.
  • The product must not be used for fungal nail infections (onychomycosis) or applied to the eye (ophthalmic use).

Connection to the overall eligibility profile:

Regulatory documents define who can and cannot use Clotrimazole by establishing clear contraindications based on pre-existing allergies, setting minimum age thresholds for pediatric use, and restricting use during the first trimester of pregnancy or for specific non-approved indications.

What should I know about interactions with other medicines?

Clotri Interactions with other medicines and products

The official regulatory profile for Clotrimazol is defined by its minimal systemic absorption when administered topically or vaginally, resulting in two primary categories of documented interactions.


Pharmacokinetic Interaction and Exposure Modification

Clotrimazol is documented as an inhibitor of the Cytochrome P450 3A4 (CYP3A4) enzyme pathway, which is classified as a pharmacokinetic interaction. This documented inhibition can lead to a reduction in the clearance of co-administered medicines that are substrates for this enzyme. Specifically, this interaction may cause a significant increase in the systemic exposure and blood trough concentrations of the immunosuppressant Tacrolimus. Inhibition of the P-glycoprotein (P-gp) transporter is also noted in regulatory context as a factor that may contribute to this exposure modification.


Administration Restrictions and Device Integrity

The use of Clotrimazol vaginal formulations requires adherence to a specific restriction involving certain medical devices. Excipients in the vaginal product are officially documented to cause physical damage to the latex or rubber material of barrier contraceptives (such as condoms, diaphragms, and cervical caps). This physical alteration may result in the loss of contraceptive efficacy. Consequently, the use of these barrier contraceptives must be restricted or separated from administration during and shortly following treatment with the vaginal formulation. Regulatory documents confirm no known interactions between the topical product and common foods or drinks, and the effect of alcohol is formally noted as unknown.

Mechanism of Action

Clotrimazol, the active component, exerts its effect by targeting a key regulatory enzyme within the fungal cell: lanosterol 14alpha-demethylase (14alpha-DM). This enzyme is required for the fungal ergosterol biosynthesis pathway. By acting as a specific inhibitor of this enzyme, the drug blocks the conversion of lanosterol into the structural lipid ergosterol, which ultimately leads to the pathogen's structural or functional damage.


The resulting deficiency of ergosterol and the simultaneous buildup of toxic intermediate sterols compromise the integrity of the fungal cell membrane. This mechanism causes the membrane to lose its selective permeability, resulting in the uncontrolled leakage of essential cellular components such as potassium and amino acids. This rapid loss of internal cellular material and metabolic balance results in either arrest of fungal proliferation (fungistatic effect) or irreversible cell death (fungicidal effect).

Dosage and Administration Information

Clotri administration is governed by its dosage form and the approved route of use: topical, intravaginal, or oral transmucosal. The official instructions define the precise quantity, frequency, and duration for each specific administration method.


Administration Protocols

Route Standard Dosing & Frequency Key Procedural Conditions
Topical (Cream/Solution 1%) A thin film applied twice daily (morning and evening). Duration is typically four weeks for common dermal infections, with some requiring two weeks. The affected area must be washed and thoroughly dried before application. Approved for patients 2 years of age and older.
Intravaginal (Cream/Tablets) One tablet (100 mg, 200 mg, or 500 mg) or one applicatorful of cream, used once daily. Course length is fixed at 3, 6, 7 days, or a single dose. Administration is scheduled at bedtime. Approved for patients 12 years of age and older.
Oral Transmucosal (10 mg Lozenge) Five times daily for treatment (or three times daily for prophylaxis). Course duration is typically 14 consecutive days. The lozenge must be allowed to dissolve slowly in the mouth and must not be chewed or swallowed whole. Approved for patients 3 years of age and older.

These protocols define a standardized and non-variable approach to Clotri administration, requiring strict adherence to the labeled form, dose, frequency, and time-relationship constraints to complete the required therapeutic course.

Recent Clinical Evidence

Clotri: Recent Clinical Evidence

Research has primarily examined Clotrimazol's role in conditions characterized by fluctuating or episodic manifestations, such as athlete's foot (tinea pedis), ringworm (tinea corporis), and jock itch (tinea cruris). The evidence base largely consists of short-term Randomized Controlled Trials (RCTs) and systematic reviews that synthesize the findings from these studies. This research explored both patient-reported outcomes related to perceived discomfort and mycological clearance (whether the fungal organism could still be detected) at the infection site.

Studies monitored patient experiences during periods of increased symptom activity. Research describes patterns observed in the studies, with follow-up periods typically ranging from two to four weeks. Specifically, studies monitored changes measured during the research period for endpoints like mycological status and the patient-reported severity of symptoms such as itching and scaling. The evidence for these short-term endpoints is described as High based on the consistency of the existing trials.

Evidence for Candidiasis and Research Gaps

The research for Clotrimazol's role in conditions like vulvovaginal candidiasis is also built mainly upon a foundation of RCTs. These studies were evaluated in various populations, focusing on the evaluation of acute Candida-related issues. The research explored short-term changes in both the presence of the Candida organism and patient-reported outcomes describing perceived discomfort. Trials reported on comparative measurements between different forms of the medicine.

It is important to note that follow-up durations were limited. This means that while the research provides insight into short-term changes, the frequency of recurrence over extended periods remains an area with limited data. Research has explored relapse rates, but these findings describe group patterns and do not provide individual predictions. Additionally, data for certain groups is limited, meaning the specific research exploring outcomes in older adults or individuals with certain underlying health conditions is less extensive than the general adult trial data.

Key Studies & References

  1. WHO Model List of Essential Medicines – Clotrimazole
  2. Clotrimazole Topical Drug Label - U.S. National Library of Medicine (NIH)
  3. Clotrimazole (vaginal) - MedlinePlus Drug Information (NIH)

Frequently Asked Questions (FAQ)

Common questions about Clotri (FAQ)

Q: Are there any known drug-drug interactions with common over-the-counter supplements?

Official patient information generally requires disclosure of all products currently being used to a healthcare professional. This includes all prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products. This disclosure helps support a complete assessment of potential interactions during treatment.

Q: How long does it usually take to notice the desired effects of Clotri?

Regulatory labels provide specific timelines for when lack of symptom improvement warrants seeking a medical re-evaluation. For example, a lack of improvement after two weeks for conditions like jock itch may require a re-evaluation. For athlete's foot or ringworm, that timeline is typically extended to four weeks of treatment.

Q: Can older adults (geriatric patients) use Clotri without special considerations being listed?

Official information indicates that for the topical form, the medication is not generally expected to cause different side effects or problems in older adults compared to younger adults. This is generally observed due to the topical form's limited systemic absorption.

Q: Does Clotri interact with hormonal birth control pills?

Regulatory warnings mainly focus on the risk of excipients (inactive ingredients) in vaginal formulations causing physical damage and potential failure to latex or rubber barrier contraceptives like condoms and diaphragms. Systemic interactions with hormonal pills are not typically highlighted in the same manner as the physical damage warning.

Q: Does Clotri interact with commonly used vitamin D or iron supplements?

Official patient information generally requires disclosure of all prescription and nonprescription products, including vitamins/minerals and supplements, to a healthcare provider. Providing this information supports a complete safety assessment before and during use.

Q: Why do the package instructions say to store Clotri at room temperature?

Regulatory instructions specify storing the product at controlled room temperature (generally 20 C to 25 C) and protecting it from excessive heat and freezing. These conditions are established to help preserve the product's stability and intended chemical integrity throughout its shelf life.

Q: Is Clotri described as suitable for patients with kidney issues?

Due to the minimal systemic absorption of the topical and vaginal forms, significant systemic exposure that would necessitate specific warnings or dose adjustments for kidney function is not generally noted in the labeling. The lack of extensive absorption suggests that systemic effects on the kidneys are not anticipated with these localized forms.

Q: What information exists about Clotri's use for patients with liver impairment?

For the oral lozenge formulation, regulatory documentation states that patients with pre-existing hepatic impairment (liver issues) may require specific monitoring. This monitoring includes Liver Function Tests (LFTs) during the course of treatment to assess potential effects on the liver.

Q: Does Clotri have a risk of dependence according to regulatory data?

The medication is not associated with a risk of dependence. Regulatory classification documents do not list the active ingredient Clotrimazole as a Controlled Substance under the Controlled Substances Act.

Q: Is there a generic version of Clotri available?

The active ingredient, Clotrimazole, is recognized globally by regulatory bodies and is included on the World Health Organization's List of Essential Medicines. It is widely available as an official, unbranded, generic medication.

Q: Does Clotri cause drowsiness or affect coordination based on official warnings?

Official product characteristics state that the medication has no or negligible influence on the ability to drive or use machinery. This indicates that any influence on driving or coordination is considered negligible by regulatory bodies.

Q: Is there an official patient information leaflet (PIL) available for Clotri?

Yes, official regulatory labeling and drug information sources consistently reference the availability of a Patient Information section or leaflet. This document is typically provided with the product to summarize its safe and effective use for patients.

Q: Are there any special laboratory tests required while a patient is taking Clotri?

If a lack of response occurs, the regulatory label advises that appropriate microbiological studies should be repeated to confirm the diagnosis. Additionally, patients using the oral formulation with certain underlying conditions may require monitoring of Liver Function Tests (LFTs).

Q: Does Clotri carry a Black Box Warning from the regulatory authority?

For single-ingredient Clotrimazole products, the official regulatory labeling does not include a Black Box Warning. This classification represents the strongest type of warning required by the FDA to highlight serious or life-threatening risks.

Q: What general guidance is provided if a patient misses a dose of Clotri?

Regulatory guidance includes information on applying the missed dose as soon as it is remembered. However, if it is almost time for the next scheduled dose, the missed dose should generally be skipped. The guidance also specifies that a double amount should not be used to compensate for a missed dose.

Q: Is it typically recommended that Clotri must be taken with food?

Unless otherwise directed by a healthcare provider, official regulatory sources state that a normal diet may be continued. Specific timing related to food intake is not cited as a general condition for use.

Q: Is Clotri classified as a controlled substance?

No, Clotrimazole is not classified as a controlled substance by regulatory authorities. This classification applies to drugs with a recognized potential for abuse or dependence.

Q: Why is Clotri not recommended for people with certain pre-existing conditions (e.g., specific organ issues)?

Regulatory documents define clear contraindications, which include a known hypersensitivity to the drug or its components. While the label does not widely prohibit its use for most organ issues, it notes that for the oral form, patients with hepatic (liver) impairment require specific monitoring.

Q: Is the onset of effect for Clotri different depending on the specific condition being treated?

Yes, official regulatory guidance on when patients should expect to see improvement is condition-specific. The time at which patients are advised to seek re-evaluation for lack of improvement differs between various conditions, suggesting condition-dependent efficacy timelines.

Q: How long does Clotri typically stay in the body (system)?

The drug is poorly absorbed systemically from topical and vaginal forms. Pharmacokinetic data indicates that fungicidal concentrations following a vaginal dose can persist at the site of infection for up to 3 days. The small amount of absorbed drug has a relatively short elimination half-life of about two hours.

Q: Is Clotri classified as a sedative or stimulant?

Official product characteristics confirm that the medication has no or negligible influence on the ability to drive or use machinery. This statement is used in regulatory documents to indicate that any influence on consciousness or coordination is considered negligible.

How should Clotri be stored and disposed of?

How to Store and Dispose of Clotri

Clotrimazol preparations must be stored under specific environmental constraints to maintain product stability, as detailed in regulatory documents.

Storage Requirements

Clotri should be kept at controlled room temperature, generally between 20 C and 25 C (68 F and 77 F), with permitted fluctuations. The product must be protected from excessive heat, moisture, and freezing. It must be stored in its original container, which should be kept tightly closed when not in use.

Child Safety

All Clotrimazol products must be stored out of the sight and reach of children. If the container includes a safety cap, it must be properly secured after each use.

Disposal Instructions

Unused or expired Clotri should be disposed of via a drug take-back program. If a program is unavailable, the product must be mixed with an unpalatable substance (such as dirt) and sealed in a container before being discarded in the household trash. The medication and its applicators must not be flushed down a toilet or drain.

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

Available in countries:

Equivalent of Clotri found in:

A-Z Index: