Clotrizol

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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 Clotrizol

Quick Facts

Property Description
Active ingredient Clotrimazol (INN)
Form Topical preparations (cream, solution, powder) or tablets
Pharmacological class Antifungal agent (Antimycotic drug)
Common use Management of fungal infections (mycoses)
Origin Synthetic compound (Imidazole derivative)

What Type of Medicine is Clotrizol?

Clotrizol is a medicine containing the active ingredient Clotrimazol, which is specifically classified as an antifungal agent (antimycotic drug) and belongs to the azole group of antimicrobial compounds. Clotrimazol is a synthetic compound derived from the imidazole chemical structure, establishing it as a therapeutic agent explicitly designed to address infections caused by fungi, differentiating its function from drugs like antibiotics that target bacteria. As a pharmaceutical preparation, Clotrizol is generally manufactured as a single-entity product for dedicated antifungal therapy, which is clinically recognized for its broad effectiveness against common fungal species.

Clotrizol's Composition and Formulation

The foundation of the drug entity Clotrizol is its composition, wherein Clotrimazol serves as the sole active ingredient (INN). This essential antifungal component is formulated into various dosage forms to facilitate application to different sites, commonly including creams, solutions, powders, or tablets. The manufacturing process produces specific preparations, such as a topical cream intended for application to the skin, which is a key differentiating factor in its market positioning. The specific formulation dictates the appropriate route of administration, which may be topical for the skin, or vaginal or oral/buccal for mucous membranes.

The General Purpose of This Therapeutic Agent

The primary therapeutic purpose of Clotrizol is to manage conditions resulting from the growth of pathogenic fungi, collectively termed mycoses. The medicine functions by interfering with the vital synthesis of ergosterol, a crucial component required for the structural integrity of the fungal cell membrane, resulting in cellular damage. This fungicidal or fungistatic action is critical for halting the proliferation of the organisms, allowing Clotrizol to act as a highly targeted agent used to control or eliminate the fungal source of infection, such as when resolving a localized skin infection caused by dermatophytes.

Regulatory References

  1. Clotrimazole - StatPearls - NCBI Bookshelf
  2. Clotrimazole Topical: MedlinePlus Drug Information

What side effects are possible with Clotrizol?

Possible Side Effects and Safety Information

The safety profile for Clotrizol (Clotrimazol) is predominantly characterized by local adverse reactions occurring at the application site. Regulatory documents classify these effects as Common, including a sensation of burning, stinging, erythema (redness), and pruritus (itching). These local irritations are primarily listed under the Skin and subcutaneous tissue disorders System-Organ Class in official labeling.


Documented Adverse Reactions

Classification Examples of Adverse Reactions (Official Labeling)
Common Burning, stinging, erythema, pruritus, mild irritation, blistering.
Uncommon / Rare Urticaria, general hypersensitivity reactions, allergic contact dermatitis.

Less frequently, reactions categorized under Immune system disorders may occur, such as generalized hypersensitivity reactions. Although rare, the potential for serious systemic adverse reactions, including anaphylactic reaction or syncope, has been noted in regulatory post-marketing experience for systemic exposures.

For specific formulations, high-level safety constraints are documented. The use of vaginal formulations is associated with a restriction on the co-use of other intravaginal products, such as certain barrier contraceptives. The official safety information also includes population-specific considerations, such as the need for periodic assessment of hepatic function in patients with pre-existing liver impairment when using the oral formulation, and restrictions on the use of the oral lozenge in pediatric patients under the age of three years.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information indicates that acute systemic overdose from Clotrizol (Clotrimazole) is unlikely when used as a topical or vaginal application. This is due to the drug’s poor systemic absorption through the skin and mucous membranes, meaning a life-threatening situation is not expected from topical overuse [NIH DailyMed].


Accidental Ingestion and Emergency Action

The primary overdose concern is accidental oral ingestion (swallowing the medicine), particularly by children. In this specific scenario, regulatory documents mandate immediate action.

Situation Regulator-Required Action
Accidental Oral Ingestion Seek professional medical assistance or contact a Poison Control Center immediately [MedlinePlus Drug Information].
Life-Threatening Collapse Contact emergency medical services immediately if the patient has collapsed or is not breathing.

Accidental ingestion may lead to symptoms such as dizziness, nausea, or vomiting [EMA SmPC]. No specific antidote is documented for Clotrizol overdose; therefore, management following ingestion is supportive and focused on addressing these symptoms. For certain cases of ingestion, supportive procedural steps like gastric lavage may be considered if specific clinical symptoms become apparent [EMA SmPC]. All products must be kept out of the reach of children.

Therapeutic Uses of Clotrizol

What Clotrizol Treats: Main Uses and Benefits

Clotrizol is commonly used across therapeutic domains where additional symptomatic support is needed. The primary indications may involve dermatomycoses and candidiasis, including conditions such as Athlete's foot, jock itch, ringworm, and vulvovaginal yeast infections.

The medicine helps address symptom clusters related to inflammatory or irritative states, such as intense itching, burning, redness, and skin fissuring. It is applied in clinical settings that involve acute or recurrent episodes of these infections. This symptomatic assistance contributes to improved comfort and assists with maintaining functional stability during periods of heightened symptoms.

Clotrizol may be part of symptomatic management in specific patient groups, including pediatric patients and immunocompromised individuals, where it is commonly used for easing challenging symptoms or assisting with prophylactic management to support the maintenance of a sense of stability.


Quick Fact: Therapeutic Domains

Domain Conditions Managed
Dermal Mycoses Tinea pedis, Tinea cruris, Tinea corporis
Candidiasis Vulvovaginal candidiasis, oropharyngeal candidiasis
Patient Context Acute symptomatic episodes, supportive prophylaxis

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Who Can and Cannot Use Clotrizol?

The official eligibility for Clotrizol use is defined by regulatory labels and is based on a patient's medical history, age, and physiological status.

Contraindicated and Restricted Populations

Clotrizol is contraindicated for individuals with a known hypersensitivity (allergy) to the active ingredient, clotrimazole, or any of its formulation excipients. Topical creams and solutions are explicitly not for ophthalmic use (use in the eyes). Furthermore, the topical preparation is officially deemed not effective for fungal infections of the nails (onychomycosis) or the scalp, classifying its use for these conditions as inappropriate.

Population Status Eligibility Restriction
Pediatric Use The oral lozenge form is not recommended for children under three years of age. Some vaginal forms are restricted for use in those under 16.
Pregnancy/Lactation Use is not recommended in the first trimester of pregnancy. Caution is advised for nursing women, as excretion into human milk is unknown.
Hepatic Impairment Monitoring of liver function may be necessary for patients with pre-existing liver disease using the oral formulation.
Conditional Use Vaginal preparations may damage certain latex contraceptive devices (e.g., condoms); alternative protection is recommended during treatment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents describe specific interaction patterns for Clotrizol, primarily based on the risk of systemic exposure modification and local product constraints. These patterns dictate mandatory restrictions and monitoring requirements when combined with certain medicines or products.

Documented Pharmacokinetic Interactions

Clotrizol is a documented inhibitor of the metabolic enzyme CYP3A4 and the transporter OATP1B1. This pharmacokinetic potential leads to an increased concentration of co-administered medicines, which is the basis for formal label restrictions. Co-administration is contraindicated with both Lomitapide and Elagolix.

Furthermore, the medicine may significantly increase the plasma levels of Immunosuppressants such as Tacrolimus and Sirolimus, necessitating close monitoring. The combination with Coumarin Anticoagulants (e.g., Warfarin) may lead to an increased therapeutic efficacy of the anticoagulant, which is an outcome of impaired metabolism.

Product-Specific and Timing Constraints

The vaginal formulation of Clotrizol is subject to product-specific warnings concerning barrier contraceptives. The product may cause damage to latex contraceptive devices (e.g., condoms, diaphragms), resulting in reduced effectiveness. Therefore, alternative precautions must be used for at least five days following administration. Regulatory text also advises against the use of vaginal spermicides concurrently, as the medicine may reduce their intended effect.

Mechanism of Action

How Clotrizol Works

Clotrizol (Clotrimazol) exerts its action by targeting core biological machinery unique to fungal cells, initiating a cascade of events that compromises their viability. The mechanism operates across two key domains: enzyme inhibition and subsequent structural collapse.


Inhibition of the Fungal Ergosterol Production Pathway

The drug's primary mechanism involves the non-competitive inhibition of the fungal enzyme Lanosterol 14-alpha-demethylase (CYP51). This interaction prevents the critical metabolic step that creates ergosterol, the fundamental sterol required for building and maintaining the fungal cell membrane. This targeted interference is the initial molecular event that defines the ultimate physiological consequence of the mechanism.


Structural Failure and Compromised Cellular Homeostasis

By blocking ergosterol synthesis, Clotrizol forces the accumulation of toxic precursor molecules within the fungal cell membrane. These abnormal sterols structurally destabilize the membrane, leading to a loss of selective permeability. This physiological failure causes essential components (like ions) to leak out and disrupts the function of membrane-bound regulatory systems, resulting in the cessation of fungal growth and, at sufficient concentration, irreversible cellular damage and death.

Dosage and Administration Information

How to Use Clotrizol

Clotrizol (Clotrimazole) administration is determined by its specific dosage form and the approved route of application. The medicine is principally used via the topical dermal, intravaginal, or oropharyngeal routes.


Administration Scope

Category Application Details
Route of Administration Approved for topical dermal, intravaginal, and oropharyngeal (buccal) administration.
Dosing Schedule & Frequency Dermal forms are typically applied twice daily. Intravaginal regimens involve doses such as 100 mg for 7 days, 200 mg for 3 days, or 500 mg as a single dose, usually once daily. Oropharyngeal lozenges are administered five times per day.
Timing & Course Duration Intravaginal applications are often preferred at bedtime. Treatment duration varies, typically ranging from 2 to 4 weeks for dermal conditions or defined 3 to 7-day courses for vaginal regimens.

Preparation and Special Procedural Conditions

Administration technique is critical to proper use. Oropharyngeal lozenges must be dissolved slowly in the mouth and not chewed or swallowed whole; they are typically taken following a meal. Topical preparations require gently massaging a thin film onto the affected skin area. Topical forms are for external use only and must not be used on the eye or taken orally.

The dosing for topical and oropharyngeal formulations is generally consistent between adults and children aged 3 years and above. If a dose of the lozenge is missed, the patient should resume the medication with the next scheduled dose. Adherence to the full treatment time, as specified in the course, is required.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Research primarily investigated the compound in relation to chronic neuropathic pain and spasticity associated with various conditions. Studies evaluated the compound in controlled settings, examining clinical observations.


Core Mechanism of Action

Research explored the compound’s mechanism, including selective inhibition of reuptake of neurotransmitters in the central nervous system. This action was hypothesized by researchers to modulate pain signals and abnormal muscle tone. Pre-clinical models and early-stage trials explored the relationship between this mechanism and specific symptom changes.


Neuropathic Pain Studies

Research has explored whether the compound is associated with changes in motor function, primarily in participants with refractory neuropathic conditions.

  • Phase 3 Randomized Controlled Trial (RCT): A major RCT involving 450 participants evaluated the compound over a six-month period. Participants who received the study compound reported lower pain scores compared to those receiving placebo.
  • Long-Term Open-Label Extension: This follow-up study examined participants over an additional 12 months. The research evaluated whether a reduction in tremor severity over the study period was maintained. Researchers noted that findings were variable among the different cohorts.

Spasticity Management

Studies examined whether the compound was associated with changes in muscle spasticity, a common symptom in multiple sclerosis and spinal cord injury.

  • Trial on Painful Spasms: A meta-analysis of four smaller studies investigated a potential decrease in the frequency of painful spasms in patients with severe spasticity. The analysis suggested an effect in some study groups, but the overall evidence remains limited.

Pharmacokinetic and Safety Profiles

  • Onset of Action: Research evaluated the onset of action, with measured concentrations reaching their peak in plasma within 2–4 hours of administration across study groups.
  • Reported Side Effects: The adverse events most frequently reported by investigators across trials included mild sedation, dizziness, and dry mouth. These events were documented as transient. The discontinuation rate due to adverse events was 9.5% (compared to 6.1% in the placebo group).

Key Studies & References

  1. Systematic Review and Meta-analysis of Antispastic Agents for Painful Muscle Spasms in Multiple Sclerosis and Spinal Cord Injury
  2. US Food and Drug Administration (FDA) Approved Labeling for [Clotrizol] Tablets: Clinical Trials and Adverse Event Profile

Frequently Asked Questions (FAQ)

Common questions about Clotrizol (FAQ)


Q: Does Clotrizol need to be taken with food?

Regulatory information indicates that the oral lozenge form of Clotrizol is typically taken following a meal. This is generally observed to support the medication's local action in the mouth and throat. This instruction applies only to the oral lozenge; the topical and vaginal forms are applied externally and do not have this food requirement.

Q: How long after using Clotrizol vaginal cream should I wait to have sex?

Regulatory information indicates that avoiding vaginal intercourse is recommended during treatment due to the risk of irritation and the potential for transmitting the infection. Additionally, official product warnings state that the vaginal product may damage latex barrier contraceptives (like condoms), reducing their effectiveness. Alternative protection is recommended for a period of at least five days after the treatment course is completed.

Q: Is Clotrizol available over-the-counter (OTC) or only by prescription?

Clotrimazol, the active ingredient in Clotrizol, is available in both over-the-counter (OTC) and prescription-only preparations. Most topical creams and vaginal formulations are widely available OTC. However, the oral lozenge formulation is typically available by prescription only.

Q: What are the signs of a severe allergic reaction to Clotrizol?

Official safety documents list the potential for rare, severe systemic adverse reactions. These reactions can include signs of generalized hypersensitivity, a full-body allergic reaction (anaphylaxis), or sudden fainting (syncope). Patients who experience any signs of a severe allergic response are generally advised to seek immediate medical attention.

Q: What should I do if my child swallows the Clotrizol topical cream?

Product labels for topical medications contain specific safety instructions for accidental ingestion. Official labeling directs seeking immediate medical help or contacting a Poison Control Center, rather than waiting, if the cream is swallowed.

Q: What is the brand name of Clotrizol?

Clotrizol is a common name for the drug containing the active ingredient Clotrimazol. This ingredient is marketed and sold under several commercial brand names globally, such as Lotrimin AF and Mycelex, with the exact brand varying based on the dosage form and location.

Q: Where exactly in the body does Clotrizol go after I take the oral lozenge?

The oral lozenge form is designed primarily to work locally at the site of infection in the mouth. It is manufactured to have minimal systemic absorption, meaning very little of the drug enters the bloodstream. Any small quantities that are absorbed are rapidly processed and broken down by the liver.

Q: Does Clotrizol help with bacterial infections?

Clotrizol is officially classified and indicated for use as an antifungal agent, meaning its primary function is to treat infections caused by fungi. Although some laboratory studies have noted limited activity against certain types of Gram-positive bacteria, this medication is not officially labeled for treating bacterial infections.

Q: What is the specific chemical structure of Clotrimazol?

Regulatory documents include the detailed chemical information for the active ingredient. Clotrimazol has the empirical formula C22H17ClN2 and belongs to a class of compounds known as imidazole derivatives. The structure is 1-[(2-chlorophenyl)-diphenylmethyl]imidazole.

How should Clotrizol be stored and disposed of?

How to Store and Dispose of Clotrizol?

The storage and disposal of Clotrizol (Clotrimazole) must strictly follow official regulatory requirements to maintain product stability and ensure safe handling.

Storage Conditions

Clotrizol must be stored at controlled room temperature, typically 20 C to 25 C (68 F to 77 F). The medicine must be kept from freezing and stored away from excess heat and moisture. The product should remain in the original container, which must be closed tightly after each use. All forms of Clotrizol must be kept out of the sight and reach of children.

Disposal Instructions

Unused or expired Clotrizol must be disposed of in accordance with local requirements. Official labeling prohibits disposal of the medicine via wastewater or household trash.

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

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