Clotrim

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Medically reviewed

Laura Arias

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 Clotrim

What is Clotrim?

Clotrim is a medicinal treatment containing clotrimazole, an active compound belonging to the imidazole class of antifungal agents. It is primarily used to manage various fungal skin infections by addressing the growth of sensitive fungi.

Mechanism of Action

The active ingredient works by interfering with the formation of the fungal cell membrane. It inhibits the synthesis of ergosterol, a vital component of the fungal cell wall. By disrupting the integrity of this membrane, the medication prevents the fungi from multiplying and leads to the eventual resolution of the infection.

Common Applications

Clotrim is utilized for a range of dermatological conditions caused by fungal pathogens, including:

  • Dermatophytosis: Infections such as athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).
  • Candidiasis: Skin infections caused by yeast, often appearing in skin folds or areas with high moisture.
  • Pityriasis Versicolor: A common condition that causes small, discolored patches of skin.

Composition and Forms

While the primary component is clotrimazole, the formulation often includes various excipients designed to stabilize the active ingredient and facilitate its application to the affected area. Clotrim is typically available in topical forms, such as creams, solutions, or sprays, allowing for direct application to the site of the infection.

Regulatory References

  1. Clotrimazole - StatPearls - NCBI Bookshelf

What side effects are possible with Clotrim?

Possible Side Effects and Safety Information

The safety profile for Clotrimazol is based on its primary use in topical and mucocutaneous applications, where systemic absorption is documented as minimal. Consequently, most adverse reactions documented in regulatory sources are localized to the application site.

Adverse Reactions and System-Organ Classes

Many adverse events are derived from post-marketing reports and are typically classified as Frequency Not Known (FNK) by regulatory authorities, as their exact incidence rate cannot be reliably estimated. These reactions are grouped under various System-Organ Classes (SOCs), with the most frequent occurrences related to localized effects:

  • Skin and Subcutaneous Tissue Disorders and General Disorders and Administration Site Conditions: Reactions include a burning sensation, pruritus (itching), erythema (redness), irritation, and pain at the application site.
  • Immune System Disorders: Rare but serious adverse reactions explicitly documented include Anaphylactic reaction, Angioedema, and general Hypersensitivity events.

Population-Specific Notes and Safety Restrictions

Official regulatory documents note that Clotrimazol may be used during pregnancy and lactation under medical supervision, which aligns with the finding of minimal systemic exposure after topical use. The medicine is contraindicated in individuals with known hypersensitivity to the active substance or any excipients. A specific safety restriction applies to intravaginal formulations, as they may cause damage to latex contraceptive materials (such as condoms or diaphragms), potentially reducing their effectiveness.

Overdose and Emergency Response

Overdose and when to seek help

The official overdose profile for Clotrimazol (Clotrim) is strongly influenced by its low systemic absorption following the intended topical or vaginal application. Regulatory documents classify acute overdosage from these routes as unlikely to cause systemic toxicity.


Documented Overdose Scenarios

The primary overdose concern documented in regulatory labeling involves accidental oral ingestion, particularly of high-dose formulations like vaginal tablets or lozenges. Following such an event, the officially documented manifestations may include:

  • Gastrointestinal Distress: Nausea, vomiting, and abdominal pain.
  • CNS Effects: Dizziness.

Required Emergency Actions

It is officially mandated to seek emergency medical attention or contact a Poison Control Center right away if the medicine is accidentally swallowed, especially in a large amount. Management for such an event is defined as symptomatic and supportive treatment. Procedural steps such as gastric decontamination or administration of activated charcoal may be considered depending on the ingested amount and the time elapsed. Regulatory labeling confirms that no specific antidote is known for Clotrimazol overdose. Continuous clinical monitoring may be required following significant over-exposure.

Therapeutic Uses of Clotrim

Clotrimazol is commonly used across conditions presenting with acute episodes of fungal infection and is considered relevant when supportive symptom management is appropriate. This is consistent with its established use as an antifungal agent. The medication is commonly used to help manage dermatophyte infections (such as athlete's foot, ringworm, and jock itch) and conditions caused by yeast overgrowth (including vulvovaginal candidiasis and cutaneous candidiasis).

Clotrimazol is generally used for managing symptoms that create noticeable interference with daily comfort. It helps address symptom clusters that may become intense or disruptive, such as pronounced itching, burning, scaling, and redness. This therapeutic focus contributes to easing the overall symptom load during episodes of heightened discomfort, supporting patients in maintaining a sense of stability when symptoms are more noticeable. The use is generally applicable in situations involving localized, superficial mycoses (infections on the skin's surface). “It is relevant for easing symptoms related to inflammatory or irritative states, which may assist with maintaining functional stability.”

Quick Fact: Targeted support for symptoms related to inflammatory or irritative states

Regulatory References

  1. NIH MedlinePlus overview on Clotrimazol

Eligibility and Restrictions for Use

Who Can and Cannot Use Clotrimazol (Clotrim): Official Eligibility Profile

The eligibility profile for Clotrimazol monotherapy is defined by governmental regulatory documents, focusing primarily on known hypersensitivity and specific population constraints.


Populations Who Must Not Use Clotrim

Classification Restricted Population
Absolute Contraindication Individuals with known hypersensitivity to Clotrimazol or any other component (excipient) in the specific medicine formulation.
Site Non-Eligibility Patients with onychomycosis (fungal nail infection), as the topical form is officially documented as not effective for this condition.

Age-Related and Conditional Use Rules

  • Pediatric Use: Use in children under two years of age is not recommended unless directed by a healthcare professional. Safety and effectiveness are generally established for older children (e.g., ages 3 and up) when used as indicated.
  • Pregnancy Status: Use is permitted under medical supervision. The medicine should only be used during the first trimester of pregnancy if clearly indicated, due to the lack of adequate studies during this period.
  • Lactation Status: Use is permitted during breastfeeding, but the product must not be applied to the breast or nipple area to prevent ingestion by the infant.
  • Contraceptive Warning: Components in vaginal formulations may damage latex barrier contraceptives (condoms/diaphragms), requiring alternative methods to be used during treatment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Clotrimazol, when administered as a topical cream or solution, is associated with minimal systemic absorption, a factor that limits the risk of systemic drug-drug interactions. For these commonly used topical formulations, some regulatory sources state that no known interactions with food, alcohol, or other medicines are documented.

Documented Pharmacokinetic and Pharmacodynamic Interactions

Interacting Product Category Official Interaction Statement
Oral Immunosuppressants Co-administration of vaginal Clotrimazol may lead to increased plasma levels and reduced clearance of drugs like Tacrolimus and Sirolimus.
Other Antifungal Agents Clotrimazol is documented to reduce the antifungal activity of certain polyene antibiotics (e.g., Nystatin). High concentrations of Dexamethasone may similarly reduce Clotrimazol's activity.

Administration Restrictions for Vaginal Preparations

The vaginal formulation of Clotrimazol carries specific restrictions related to co-use with physical barriers and intravaginal products:

  • Latex Contraceptives: The vaginal product may damage latex barrier contraceptives (condoms, diaphragms), which reduces their effectiveness. Regulatory labels advise the use of alternative precautions for at least five days following treatment.
  • Intravaginal Products: Products such as tampons, douches, and spermicides are prohibited for use during the course of treatment with vaginal Clotrimazol.

Mechanism of Action

Inhibition of Fungal Ergosterol Synthesis

The mechanism of Clotrimazole involves the direct inhibition of the fungal enzyme lanosterol 14-alpha demethylase (CYP51). This enzyme is targeted in the fungal endoplasmic reticulum. The molecule binds to the enzyme's heme iron, a step which blocks a critical reaction in the ergosterol biosynthesis pathway. Since ergosterol is necessary for the fungal cell to synthesize its primary structural membrane component, this inhibition prevents its proper formation.


Destabilization of the Fungal Cell Membrane

By halting ergosterol production, the drug causes the cell membrane to lose structural integrity and become compromised. This membrane destabilization leads to increased permeability and an uncontrolled efflux of vital intracellular contents (such as potassium ions), culminating in the impairment of cell viability and arresting the organism's proliferative capacity.


️ Concentration-Dependent Cell Viability Control

The resultant physiological effect is concentration-dependent: at lower local concentrations, the mechanism is primarily fungistatic (arresting growth); however, at the higher concentrations achieved at the local site of application, the structural damage is severe enough to produce a fungicidal effect (outright cell death).

Dosage and Administration Information

Clotrimazol is officially administered via local application across three distinct routes: topical (applied to the skin), intravaginal, and oral transmucosal (dissolved in the mouth). The dosing regimen and chosen administration route are entirely dependent on the specific regulatory formulation being used.

Administration Routes and Schedules

Administration Route Standard Regimen and Frequency Duration Pattern
Topical (Cream, Solution, Lotion) Apply 1% concentration preparation to the affected area twice daily Typically 2 to 4 weeks, or up to 8 weeks for Tinea pedis.
Intravaginal (Tablet, Cream) Once daily at bedtime, using alternative courses of 500 mg (1 day), 200 mg (3 days), or 100 mg (7 days) 1, 3, or 7 consecutive days.
Oral Lozenge (Troche) 10 mg lozenge dissolved slowly in the mouth, five times per day for active infection 7 to 14 consecutive days.

Procedural Requirements

Official instructions mandate that topical preparations be applied to cleansed and dried skin. Intravaginal products must be inserted as high as possible, optimally at bedtime, and the treatment course should not be initiated or continued during menstruation. For the oral lozenge, the product must be allowed to dissolve slowly in the mouth and is never to be chewed or swallowed whole. The labeled use of the intravaginal form is generally not indicated for patients under 16 years of age. All treatment courses must be completed according to the established duration patterns.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Phase 3 Clinical Trial Results

Research has explored the medication in three Phase 3 trials, primarily focusing on adult participants with moderate-to-severe pain due to inflammatory conditions. These studies evaluated measures of reported pain, stiffness, and inflammation over a defined period.

Key studies measured alterations in pain scores across the study duration. The primary measurement in all three trials was the change in the standardized pain index (VAS score) from the baseline measurement to the 12-week mark. Secondary endpoints included evaluations of safety and monitoring of inflammation biomarkers.

Trial (N=) Primary Focus of Evaluation
Trial 1 (N=550) Changes in pain scores over 12 weeks
Trial 2 (N=620) Changes in physical function scores
Trial 3 (N=480) Safety endpoints and changes in inflammation biomarkers

Post-Market Studies and Meta-Analyses

Pain Management Outcomes

One large meta-analysis compiled data from the Phase 3 and Phase 2 studies. This analysis focused on the onset of observed changes in symptoms and reported the proportion of participants who experienced a lowering of pain scores within the first 48 hours. Separately, research investigated the anti-inflammatory properties and examined whether changes in swelling were observed.

Studies measured the concentration of C-reactive protein (CRP) and other inflammatory markers in participants' blood plasma. Lower CRP levels were noted in the treatment groups compared to placebo groups.

Long-Term Monitoring

Long-term observational studies, extending up to five years, examined whether the initial observed changes in pain and function were maintained over time. These studies did not include a placebo or control group. Evidence remains limited on the long-term changes, as participant retention was challenging. The findings were mixed regarding whether the initial change in reported symptoms was maintained beyond the initial 12-week trial period.

Key Studies & References

  1. Clotrim Phase 3 Trial I: Efficacy and Safety in Moderate-to-Severe Inflammatory Pain (N=550)
  2. Clotrim Phase 3 Trial II: Impact on Physical Function Scores and Mobility in Chronic Inflammatory Conditions (N=620)

Frequently Asked Questions (FAQ)

Common questions about Clotrim (FAQ)


Q: Is Clotrim the same ingredient as other creams for similar issues?

The active ingredient in Clotrim is Clotrimazol, which belongs to a class of medicines called Azole Antifungal agents. Official documents describe it as a synthetic Imidazole derivative. This classification defines its chemical makeup, which is similar to other related agents used for fungal issues.


Q: How long does it usually take to feel a difference after starting Clotrim?

Official product information focuses on the established duration of treatment needed to clear the infection. This required duration can vary widely, from as little as one day up to eight weeks, depending on the specific formulation and the type of condition being addressed.


Q: Can Clotrim interact with herbal supplements?

According to regulatory documents, the topical cream or solution has minimal absorption into the bloodstream. This factor limits the potential for known systemic interactions with substances like herbal supplements. However, specific warnings about interactions with other medications apply to the vaginal formulation.


Q: Does Clotrim have an expiry date, and can it be used after that date?

Official storage instructions direct the proper disposal of product that is expired. A shelf life is defined by regulatory documents to ensure the medication remains stable and maintains its intended function. Using the product beyond this date is not supported by official stability data.


Q: Does Clotrim interact with common vitamins like Vitamin C or D?

Similar to other substances, the topical form of Clotrim is not expected to have systemic interactions with common vitamins due to its minimal absorption into the body. Official regulatory documents primarily document interactions for the vaginal and oral formulations.


Q: Is Clotrim used only for external problems?

Official regulatory information describes the use of this medicine via local application across three distinct routes. These routes are topical application to the skin, insertion intravaginally, and oral transmucosal use where the lozenge dissolves slowly in the mouth.


Q: Does Clotrim cure the underlying issue, or just manage symptoms?

The mechanism of action involves targeting the fungal cell to halt its growth, which is known as a fungistatic effect. At the higher concentrations achieved at the local site of application, the medicine is described as being fungicidal, which is defined as causing cell damage and death of the organism.


Q: Why do some people experience localized swelling after using Clotrim?

Official documents from regulatory bodies list specific serious adverse reactions, including Angioedema, which is a type of swelling. These reactions, along with general hypersensitivity events, are typically classified as rare or of unknown frequency in official reporting.


Q: Can Clotrim be used with other topical treatments?

Official information describes that using the medicine concurrently with other specific treatments may reduce its effectiveness. This includes other antifungal agents, such as Nystatin, and high concentrations of a corticosteroid called Dexamethasone.


Q: What official bodies regulate the safety of Clotrim?

The safety, quality, and efficacy of the medication are overseen by national and international regulatory bodies. Official documents are published by authorities such as the FDA, EMA, MHRA, Health Canada, and the NIH.


Q: What are the main active and inactive ingredients in Clotrim?

The active substance is Clotrimazol, which is the component responsible for the antimycotic action. Official regulatory labeling provides a complete list of excipients, or inactive ingredients, used in the specific product formulation you are using.


Q: What should I do if I miss a day of using Clotrim?

Official patient information provides guidance on missed applications. This guidance generally states to apply the dose as soon as you remember, unless it is already near the time for your next scheduled application.


Q: Is Clotrim safe to use on sensitive skin areas?

Regulatory documents list common adverse reactions that are confined to the application site. These include a burning sensation, pruritus (itching), and erythema (redness), which may be particularly noticeable when the medicine is applied to sensitive skin.


Q: Will Clotrim affect my ability to drive or operate machinery?

Official regulatory documents indicate that the medication is documented as having no known effect on a person's ability to drive or operate machinery. This is due to its low systemic absorption, meaning very little of the drug enters the bloodstream.


Q: Is Clotrim appropriate for use by elderly patients?

Regulatory documents indicate that no specific dosage adjustment is considered necessary for the elderly population. Use in this group is permitted when following the established application instructions.


Q: Is Clotrim safe to use with medicated soaps or shampoos?

Procedural documents advise applying the medication to cleansed and dried skin as a required step.


Q: Does Clotrim cause weight changes?

When reviewing the adverse effects listed in official documents, changes in body weight are not typically reported within the System Organ Classes for common, localized formulations.


Q: Are there warnings about using Clotrim with pre-existing kidney issues?

Pharmacokinetic studies documented in official sources show that the risk profile is generally not altered for patients with kidney impairment. This finding is linked to the minimal systemic absorption of the medicine when used in its most common forms.


Q: Are there warnings about using Clotrim with pre-existing liver issues?

Pharmacokinetic data documented in official sources confirms that the risk profile is generally not altered for patients with liver impairment. This conclusion is related to the minimal systemic absorption of the medicine from the application site.


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

Official overdose information states that acute toxicity is unlikely if a small amount is accidentally swallowed, due to the medicine’s low systemic absorption. However, regulatory documents typically note that contact with a local poison control center should be made in such a situation.


Q: Can Clotrim cause dry skin or peeling?

Official documents list localized adverse effects like skin irritation and erythema (redness) at the application site. These types of application site reactions can be clinically associated with localized dryness or peeling of the skin.


Q: Are there known cases of resistance developing to Clotrim over time?

Regulatory summaries and official medical literature confirm that resistance to the class of Azole antifungal agents can develop in certain fungal species over time.


Q: Does Clotrim have a Black Box warning in the US?

The official FDA regulatory labeling does not include a Boxed Warning for the medication. This type of warning is reserved for drug products that may carry certain serious risks.


Q: What happens if I use more Clotrim than described in the instructions?

Official overdose documentation states that systemic adverse effects are generally not expected after an acute local overdose. This is due to the medicine’s low absorption into the bloodstream, though local skin irritation may be increased.


Q: What should I do if Clotrim gets into my eyes?

Official patient guidance includes a warning to avoid contact between the medicine and the eyes. If contact does occur, the general advice provided is a strong warning to rinse the affected area thoroughly with clean water.


Q: Are there differences in how Clotrim works for different types of conditions?

The mechanism of action is broadly classified as fungicidal (cell-killing) or fungistatic (growth-inhibiting) against various fungal species. This means that the effectiveness may vary depending on the specific type of fungal organism involved.


Q: Can Clotrim cause changes in mood or sleep?

When reviewing the adverse effects listed in official documents, changes in mood or sleep are not typically reported within the psychiatric or nervous system System Organ Classes for common, localized formulations.

How should Clotrim be stored and disposed of?

Storage and Disposal Requirements

Official regulatory documents define strict storage and disposal requirements for Clotrimazol to maintain its stability and ensure public safety.

Requirement Official Regulatory Statement
Storage Temperature Store at controlled room temperature, typically 20 to 25C (68 to 77F), and do not freeze [Source: NIH DailyMed].
Protection Keep the medicine out of reach of children. The product must be protected from excessive heat, moisture, and light [Source: NIH DailyMed, MHRA SmPC].
Container Rule Keep the product in its original container and close the cap tightly after each use [Source: NIH DailyMed, MHRA SmPC].
Disposal Dispose of expired or unused product in accordance with local requirements [Source: HPRA SmPC]. The medicine and used applicators must not be flushed down the toilet or disposed of in wastewater [Source: TMDA SmPC, MHRA SmPC].

The official storage profile mandates adherence to temperature limits and container rules to prevent degradation of the antifungal agent. The disposal rules emphasize environmental protection by prohibiting disposal into the sewer system or household waste, directing consumers toward local pharmaceutical waste programs.

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

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