Ketoconazol Cinfa

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

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

Overview of Ketoconazol Cinfa

Property Description
Active Ingredient Ketoconazole (INN)
Form Topical Gel or Viscous Solution
Pharmacological Class Azole Antifungal Agent
Route of Administration Dermatological (Topical)
Origin Synthetic Compound (Imidazole Derivative)

Ketoconazol Cinfa is a medicinal entity defined by the single active ingredient Ketoconazole, a synthetic Azole antifungal agent used for topical administration. This product is manufactured by Cinfa, a pharmaceutical company based in Spain, and is clinically recognized for its role in superficial fungal management.

What Type of Medicine is Ketoconazol Cinfa?

Ketoconazol Cinfa is classified pharmacologically as an Azole antifungal agent and chemically as an Imidazole derivative, placing it within the category of antimycotic medicines. The active substance, Ketoconazole, is a synthetic compound specifically designed to combat infections caused by fungi and yeasts. This classification is vital for understanding its narrow therapeutic scope: the product is solely intended to neutralize fungal threats and is not utilized as a general antibacterial or anti-inflammatory drug.

Composition and Physical Form of the Product

The product is a single-active-ingredient formulation, with Ketoconazole as the sole therapeutic component, typically manufactured as a topical gel or viscous solution. The preparation is intended for dermatological administration, meaning it is applied directly to the skin or scalp. This formulation ensures that the active substance is concentrated locally at the site of infection.

General Purpose of Azole Antifungal Agents

The fundamental purpose of Ketoconazole is to disrupt the essential processes of fungal organisms. It achieves this by acting as a highly targeted inhibitor, blocking the enzyme system necessary for the synthesis of ergosterol, a crucial structural component of the fungal cell membrane. This action compromises the integrity of the fungal cell barrier. Research confirms that this mechanism successfully stops the growth of common fungi, ensuring the general therapeutic goal of eliminating the source of fungal proliferation on the skin or scalp.

Regulatory References

  1. DailyMed: Ketoconazole Topical
  2. EMA Public Assessment Report: Ketoconazole

What side effects are possible with Ketoconazol Cinfa?

Ketoconazole, the active substance in Ketoconazol Cinfa, can cause side effects, though not everyone experiences them. It is important to be aware of the potential for serious, though rare, adverse effects on the liver and heart.

Serious Side Effects (Require Immediate Medical Attention)

Consult a doctor or seek emergency medical help immediately if you experience signs of:

  • Liver Damage (Hepatotoxicity): Symptoms include severe stomach pain, unusual tiredness, loss of appetite, dark urine, light-colored stools, or yellowing of the skin or whites of the eyes (jaundice).
  • Severe Allergic Reaction (Anaphylaxis): Symptoms such as a rash, itching, hives, swelling of the face, lips, tongue, or throat, or difficulty breathing/swallowing.
  • Heart Rhythm Changes (QT Prolongation): Symptoms like fainting, dizziness, or a fast, pounding, or irregular heartbeat. This risk is increased when taken with certain other medications.

Other Common and Less Common Side Effects

These side effects are generally less severe, but you should inform your doctor if they persist or are bothersome. Frequencies are approximated based on clinical data:

Frequency Side Effects
Common (1% to 10%) Nausea, vomiting, diarrhea, abdominal pain, headache, abnormal liver function test results, itching, and rash.
Less Common/Rare Dizziness, sleepiness, loss of hair (alopecia), menstrual abnormalities, impotence, breast enlargement in males (gynecomastia), or low adrenal function.

Safety Precautions

Ketoconazol Cinfa is generally reserved for treating serious fungal infections when other treatments are unavailable or not tolerated, due to the risk of severe side effects. Your doctor may perform blood tests to monitor your liver function before and during treatment. Alcohol consumption should be avoided while taking this medication as it may increase the risk of liver damage. Always inform your healthcare provider of all other medications, supplements, and herbal products you are taking to prevent dangerous drug interactions.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information describes two distinct scenarios regarding overdose for topical ketoconazole.

Documented Manifestations and Actions

Overdose Scenario Documented Manifestations Required Action (Regulatory)
Excessive Topical Use Local effects such as erythema (redness), oedema (swelling), and a burning sensation. Symptoms typically disappear upon discontinuation of the product.
Accidental Ingestion Severe outcomes are associated with ingestion, triggering emergency action if signs like collapse, seizure, or trouble breathing occur. Seek immediate medical attention and contact a poison control center.

Emergency Response Guidance

For any suspected accidental ingestion, immediate medical help must be sought. Call emergency services if the person experiences severe, life-threatening symptoms. Following ingestion, management requires symptomatic and supportive treatment. Official labeling explicitly states that procedures such as induced emesis or gastric lavage should not be performed due to the risk of pulmonary aspiration.

Regulatory documents confirm that no specific antidote is known. A population-specific consideration notes that detectable systemic plasma levels may occur in infants when the product is applied over a large body surface area.

Therapeutic Uses of Ketoconazol Cinfa

What Ketoconazol Cinfa Treats: Main Uses and Benefits

The therapeutic relevance of Ketoconazol Cinfa is centered on the treatment of specific superficial fungal and yeast infections. This medicine is commonly used to help manage conditions characterized by periods of heightened symptoms arising from fungal proliferation. The product is applied in contexts marked by increased discomfort and flaking associated with Malassezia yeast and dermatophyte overgrowth.

This is used for managing the visible manifestations of conditions such as Ringworm (Tinea corporis), Jock Itch (Tinea cruris), and Athlete's Foot (Tinea pedis), as well as the persistent scaling and itching in Seborrheic dermatitis and common dandruff. The primary benefit involves assistance with managing the microbial cause, which may assist with easing the visible manifestations of the red, scaly rash and uncomfortable skin lesions typical of these infections.

The treatment provides supportive relief when symptoms interfere with routine activities. It is also considered relevant for easing the recurrent or episodic manifestations of conditions like Pityriasis versicolor. The focus remains on providing supportive relief when symptoms interfere with routine activities, and may support improved comfort during periods of heightened symptoms.

“This medicine is commonly used to address symptom clusters that may become disruptive, such as persistent scaling and itching in often-recurrent conditions.”


Quick Fact: Relief for Pruritus
This product provides supportive relief for persistent itching (pruritus) and excessive scaling, which are two common and noticeable symptoms linked to fungal and yeast skin conditions.

Regulatory References

  1. NIH MedlinePlus overview on topical Ketoconazole

Eligibility and Restrictions for Use

The regulatory eligibility profile for Ketoconazol Cinfa defines who can and cannot use the medicine through specific population restrictions and official contraindications.

Eligibility Scope

Populations for whom use is contraindicated: Use is absolutely prohibited for any person with a known hypersensitivity to the active ingredient, Ketoconazole, or to any of the product's excipients. Regulatory information also states that the product should not be used on areas of the skin that are severely broken or inflamed.

Age and Status: Eligibility is established for adults and adolescents 12 years of age and older. The safety and effectiveness of the topical product have not been established in children younger than 12 years. Furthermore, the medicine is indicated for use in immunocompetent individuals.

Pregnancy and Lactation Eligibility: Use during pregnancy is conditional (Category C), and should occur only if the potential benefit justifies the potential risk to the fetus, with some official regulatory labels advising it is preferable to avoid use. Similarly, caution should be exercised during lactation, with the official label advising avoidance on the breast/nipple area.

What should I know about interactions with other medicines?

Interaction Map: Interactions with other medicines and products — official regulatory information for Ketoconazol Cinfa

Category Official Regulatory Statement/Entity (Topical Formulation)
Medicinal product categories with documented interactions Topical Corticosteroids (Subject to administration timing rule). No systemic medicinal product categories are officially listed.
Specific interacting medicines (if explicitly listed) None with systemic medicines.
Mechanistic basis of interactions (only if stated in label) None documented. Formal drug interaction studies have not been performed due to minimal systemic absorption.
Timing-based interaction rules (if applicable) Co-administration with topical corticosteroids requires a timing separation, advising application at separate times or at least 30 minutes apart.
Population-specific interaction notes (if applicable) None documented regarding an altered interaction profile in specific patient populations.
Interaction-related restrictions None with systemic medicinal products based on interaction risk. No known interactions with food or drink.

Interaction Classifications (High-Level)

Category Regulatory Statement/Classification
Interaction severity classification (as defined in official documents) No documented systemic interactions are classified as contraindicated, severe, or moderate. The only official constraint is an administration timing rule for co-applied topical agents.
Regulatory basis (EMA / FDA / etc.) Information derived from government drug labels which state that the topical formulation has not been associated with drug interactions.
Interaction-context constraints (as defined in official documents) The lack of systemic absorption is the primary constraint defining the interaction profile, removing the need for systemic drug-drug interaction warnings.

Resulting Interaction Structure

Official interaction statements:

  • Formal drug interaction studies with the topical formulation have not been performed.
  • Minimal to undetectable systemic plasma concentrations mean the product is not expected to cause or be subject to clinically relevant systemic drug-drug interactions.
  • No known interactions are documented with food or drinks.
  • Co-application of topical Ketoconazole and topical corticosteroids requires a temporal separation (e.g., at least 30 minutes) as an administration rule.

Connection to the overall interaction profile (2–4 sentences):

The regulatory documents define the product's interaction structure primarily by the absence of systemic risk. This is explicitly stated through the lack of formal studies and the finding of negligible plasma concentrations. The only mandatory interaction-related condition documented in official guidance is a required timing separation when co-administering the solution with topical corticosteroids.

Mechanism of Action

How Ketoconazol Cinfa Works

Ketoconazole's action is defined by its ability to inhibit fungal enzymes necessary for structural integrity. The molecule functions as an inhibitor targeting the fungal enzyme cytochrome P450 14alpha-demethylase (CYP51A1). This enzyme is indispensable to the ergosterol biosynthesis pathway in fungal cells . By binding to the enzyme, the drug immediately blocks the conversion of lanosterol to ergosterol, the primary sterol required for fungal cell membrane structure.

This molecular blockade initiates a cascade leading to a critical depletion of functional ergosterol and a simultaneous accumulation of abnormal, toxic 14alpha-methylated sterols. This defect in the lipid bilayer causes the fungal cell membrane to lose its structural integrity and selective permeability. The resulting cellular dysfunction leads directly to the arrest of fungal growth (fungistatic) or irreversible cell death (fungicidal). The molecule also exhibits affinity for certain mammalian P450 enzymes, inhibiting steroidogenesis (e.g., cortisol and testosterone synthesis), which is a key physiological constraint on its mechanistic specificity.

Dosage and Administration Information

How to Use Ketoconazol Cinfa

Ketoconazol Cinfa is a product designated for Topical administration, meaning it is applied directly to the skin or scalp and is strictly for external use. It is supplied as a 2% Gel or viscous solution. The usage protocol is defined by specific administration steps, schedules, and duration.


Official Administration Guidelines

Usage Parameter Description
Route of Administration Topical (Dermatological Use Only)
Standard Dosing Apply an amount sufficient to cover the affected area and a wide margin of surrounding skin/scalp.
Age Restriction Indicated for adults and adolescents (generally 12 years of age and older); safety and efficacy are not established below 12 years.
Special Condition Must avoid contact with the eyes; if contact occurs, the area should be rinsed immediately with water.

Frequency and Duration Protocols

Administration schedules vary based on the clinical context:

  • For Seborrheic Dermatitis: Treatment typically requires application twice weekly or once daily for 2 weeks, often for a total course duration of 2 to 4 consecutive weeks. The maintenance phase to prevent recurrence may involve application once per week or once every two weeks.
  • For Pityriasis Versicolor: The standard treatment regimen is application once daily for 5 consecutive days.

Treatment should generally continue until a few days after all physical signs have disappeared. The product is not intended for oral, ophthalmic, or intravaginal application.


Procedural Steps

The product's efficacy is tied to a specific contact time during administration. The 2% Gel must be applied to the affected area of the skin or scalp and allowed to act for 3 to 5 minutes before being rinsed off thoroughly with water.

Recent Clinical Evidence

Recent Clinical Evidence Overview

Ketoconazole is an antifungal agent primarily studied for topical use in treating superficial fungal infections. Recent research focuses on optimizing its delivery and assessing its application in various dermatological conditions.


Topical Efficacy and Comparison

Clinical trials have examined topical ketoconazole in conditions such as tinea pedis (athlete's foot) and seborrheic dermatitis. Studies comparing new formulations of ketoconazole 2% cream to existing formulations and placebo have focused on the primary efficacy endpoint of mycological cure (negative fungal culture and microscopic examination) in tinea pedis, demonstrating its established role against dermatophytes.

Research involving ketoconazole 2% shampoo has also been assessed for use in Malassezia-related conditions, including seborrheic dermatitis. In one study, response rates for both three-day and single-day regimens of the 2% shampoo were significantly greater than those observed with placebo.


Safety and Systemic Risk

It is important to note the distinction between the topical and oral forms of the medication. Regulatory bodies have advised against the use of oral ketoconazole for fungal infections due to a risk of serious liver injury (hepatotoxicity) that was found to be greater than the benefits. Studies indicated that the incidence and seriousness of this risk were higher compared to other oral antifungals.

However, topical formulations (creams, shampoos, gels) are generally associated with very low systemic absorption, meaning the amount of drug entering the bloodstream is minimal. Consequently, these topical forms have not been linked to the same risk of fatal liver injury or adrenal gland problems associated with the oral tablets.

Frequently Asked Questions (FAQ)

Common questions about Ketoconazol Cinfa (FAQ)

Q: Is Ketoconazol Cinfa the same as regular Ketoconazole?

Ketoconazole is the active substance, known as the International Nonproprietary Name (INN), which is the component responsible for the drug’s antifungal action. Cinfa is the specific manufacturer or brand name for this particular product formulation that contains ketoconazole.

Therefore, Ketoconazol Cinfa is the specific commercial product containing the active drug ketoconazole.

Q: Why does this medication come in different strengths?

Official documents indicate that this medication is manufactured in different concentrations, such as 1% and 2%. These varying strengths are used to address different levels of infection severity or type of fungal condition.

For instance, the 2% concentration is often provided with a prescription for treating more defined infections.

Q: Does Ketoconazol Cinfa have an impact on the body's natural balance of yeast?

As an antifungal agent, ketoconazole functions by inhibiting the growth of yeasts and fungi like Malassezia and Candida that are associated with skin infections. Since Ketoconazol Cinfa is a topical treatment, the amount of the drug that enters the bloodstream (systemic absorption) is minimal.

This method of administration focuses the drug's action locally on the affected area.

Q: How long does it usually take for Ketoconazol Cinfa to start working?

Symptomatic improvement, such as relief from associated itching, often begins relatively quickly, even before physical signs of healing are clearly visible.

Clinical improvement for conditions like seborrheic dermatitis may be noted fairly soon after the start of therapy. Following the course as described by a healthcare provider is generally recommended for optimal outcomes.

Q: Is it possible to stop using Ketoconazol Cinfa once symptoms improve?

Official treatment guidelines advise against stopping the medicine as soon as symptoms get better, as this can potentially lead to the symptoms returning (a relapse).

Continuing the treatment until a few days after all physical signs of the infection have fully disappeared is generally taken to support the complete resolution of the underlying condition.

Q: Is it normal to feel a mild burning sensation when starting this treatment?

Yes, official product information lists a skin burning sensation at the application site as a common adverse reaction, affecting 1% to 10% of users.

This sensation may also occur with excessive topical application. Regulatory documents indicate that such effects are expected to diminish with proper usage or after discontinuation.

Q: What non-prescription medications might interact with Ketoconazol Cinfa?

Formal drug interaction studies have not been performed for the topical formulation due to its minimal systemic absorption. Systemic interactions with non-prescription drugs are therefore not expected.

Co-administration of multiple skin products in the same area is typically advised to be discussed with a healthcare provider.

Q: Does Ketoconazol Cinfa interact with birth control pills?

Because the topical formulation results in minimal or undetectable plasma concentrations, clinically relevant systemic drug-drug interactions are not expected.

This principle applies to hormonal contraceptives like birth control pills, as the amount of drug entering the bloodstream is negligible.

Q: Can Ketoconazol Cinfa be used by older adults?

The topical formulation is indicated for use in adults, and official regulatory documents do not specify separate dosage adjustments or precautions for geriatric patients.

No specific precautions are generally outlined regarding the use of topical ketoconazole solely based on advanced age.

Q: Is it described in research whether Ketoconazol Cinfa builds up in the body over time?

Clinical pharmacology studies indicate that plasma concentrations of ketoconazole are generally not detectable following topical application to the skin of non-pregnant humans.

This finding suggests that clinically significant systemic build-up or accumulation in the body is not expected with appropriate use of the topical product.

Q: Does alcohol consumption affect how Ketoconazol Cinfa works?

Regulatory documents state that no known interactions are documented between the topical formulation and food or drink.

While the oral form of ketoconazole has strict warnings against alcohol use due to an increased risk of severe liver damage, this specific interaction risk is not associated with topical application.

Q: Are there any known interactions between Ketoconazol Cinfa and herbal supplements?

Due to the topical formulation's minimal systemic absorption, clinically relevant systemic interactions with herbal supplements are not expected.

The disclosure of all current medications and herbal products to a healthcare provider is an established safety precaution.

Q: What is the information regarding the use of Ketoconazol Cinfa for dandruff?

Official product labeling indicates that the active ingredient, ketoconazole, is indicated for the topical treatment of seborrheic dermatitis, which is a common underlying cause of severe dandruff.

The product is often specifically labeled to help control the flaking, scaling, and itching that accompanies dandruff.

Q: Are there certain medical conditions that might prevent a person from using Ketoconazol Cinfa?

Use is officially contraindicated in persons with a known hypersensitivity (allergic reaction) to the active ingredient, ketoconazole, or any of the inactive ingredients (excipients) in the product.

Additionally, the product should not be applied to areas of the skin that are severely broken or inflamed.

Q: Are patients typically informed about the active component’s effect on hormones?

While the molecule is noted to inhibit the synthesis of steroids (hormones) in mammals when taken in high doses, this is only a theoretical concern with topical use.

The topical formulation of Ketoconazol Cinfa has minimal systemic absorption, meaning this potential hormonal effect is not relevant to its clinical use on the skin.

Q: What is the difference between a systemic and a topical antifungal treatment?

A topical treatment, such as Ketoconazol Cinfa, is applied directly to the surface of the skin or scalp and only acts locally, with very little drug entering the bloodstream.

A systemic treatment, however, is typically taken by mouth or injection and enters the bloodstream to treat infections throughout the entire body.

Q: Does Ketoconazol Cinfa contain any ingredients known to cause sensitivity?

Yes, official documents list several excipients (inactive ingredients) in the cream or gel formulations. Ingredients such as cetyl alcohol, stearyl alcohol, propylene glycol, and sodium sulfite are present.

These excipients may cause local skin reactions like contact dermatitis or allergic-type reactions in sensitive individuals.

Q: Is there a list of active ingredients besides ketoconazole in this product?

Ketoconazole is the sole active, therapeutic component. However, the product contains other inactive ingredients, known as excipients, which are listed in the official documents.

Examples of excipients include propylene glycol, stearyl alcohol, and cetyl alcohol, which help form the product's base.

Q: What are the official restrictions on who can use the oral tablets?

The oral (tablet) form of ketoconazole has significant restrictions, mainly due to the risk of serious liver damage and adrenal gland problems.

Official regulatory bodies restrict its use to only when other effective antifungal therapies are unavailable or not tolerated.

Q: What is the current regulatory standing of Ketoconazol Cinfa in major health bodies?

Topical ketoconazole is a licensed and approved treatment for various superficial fungal infections across major global jurisdictions.

Its approval and inclusion in regulatory documentation from bodies like the FDA and EMA confirm its established role in fungal management.

Q: What happens if another person accidentally uses my prescribed Ketoconazol Cinfa?

In the event of excessive topical application or accidental ingestion, official guidelines indicate that supportive and symptomatic measures may be required.

Regulatory guidance includes storing the product securely out of the sight and reach of children as a standard safety measure to prevent accidental use.

Q: Can sun exposure be an issue while using Ketoconazol Cinfa?

Official information regarding some specific foam formulations of ketoconazole indicates that they may increase skin sensitivity to sunlight (photosensitivity).

Standard patient instructions for such formulations may include precautions such as using sunscreen and avoiding sunlamps or tanning beds.

Q: What are the known signs that the medication may not be working?

If no visible clinical improvement is observed after the recommended course of treatment, usually a period of 2 to 4 weeks, consultation with a healthcare professional for diagnosis review is typically indicated.

The lack of improvement suggests the need to reconsider the treatment strategy.

Q: Is there any evidence concerning the long-term use of Ketoconazol Cinfa?

While continuous daily use is generally not advised, regulatory documents allow for intermittent maintenance therapy for chronic conditions like seborrheic dermatitis.

This maintenance phase may involve application once per week or less often for an extended period to prevent the recurrence of symptoms.

Q: What information is available about the potential for drug resistance with Ketoconazol Cinfa?

Authoritative clinical pharmacology data on topical ketoconazole generally indicate that the development of resistance has not been reported in patients using the cream or gel formulation.

The active ingredient remains effective against common dermatophytes and yeasts.

Q: Does Ketoconazol Cinfa affect driving or operating machinery?

Official product information for the topical formulation confirms that this medication has no known influence on a person's ability to drive vehicles or operate heavy machinery.

Q: Is Ketoconazol Cinfa used for ringworm (tinea corporis)?

Yes. Official regulatory indications state that ketoconazole 2% cream is used for the topical treatment of tinea corporis, which is the medical term for ringworm.

It is effective against common fungal species that cause this condition.

Q: Why is this drug sometimes used for conditions that aren't fungal?

While ketoconazole is primarily an antifungal agent, official information indicates it also exhibits anti-inflammatory properties.

This dual action helps to reduce the accompanying redness and irritation, which is beneficial in treating conditions like seborrheic dermatitis that have both a fungal and inflammatory component.

Q: What happens if a scheduled application or dose is missed?

If a scheduled application is missed, official patient information often indicates that the dose may be applied as soon as the user remembers.

However, if it is almost time for the next scheduled dose, the missed one should be skipped, and using a double application to compensate for a missed one is generally advised against in regulatory instructions.

Q: Is Ketoconazol Cinfa considered a broad-spectrum antifungal?

Yes. According to authoritative clinical pharmacology data, ketoconazole is generally described as a broad-spectrum synthetic antifungal agent.

This means it is effective at inhibiting the growth of a wide range of common dermatophytes (fungi) and yeasts in laboratory settings.

How should Ketoconazol Cinfa be stored and disposed of?

How to Store and Dispose of Ketoconazol Cinfa?

Ketoconazol Cinfa (topical ketoconazole) must be stored and handled according to official regulatory specifications to maintain its stability and effectiveness.


Storage Requirements

Condition Requirement
Temperature Store at Controlled Room Temperature (20^circ to 25 C) and do not freeze the product.
Protection Protect from excessive heat and moisture.
Container Keep the topical solution or gel in its original container and ensure the cap is tightly closed.

Disposal and Safety

Ketoconazol Cinfa must be stored out of the sight and reach of children.

Disposal of any unused or expired product must be carried out in accordance with local regulations for pharmaceutical waste. The medication should not be disposed of via wastewater or household waste to protect the environment.

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

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