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Clotrimazole usage. Clotrimazole Topical: Uses, Application, and Precautions for Fungal Skin Infections

How is clotrimazole used topically. What conditions does topical clotrimazole treat. How long does it take for clotrimazole to work. What are the potential side effects of clotrimazole. How should clotrimazole be stored and disposed of.

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Understanding Clotrimazole and Its Antifungal Properties

Clotrimazole is a powerful antifungal medication belonging to the imidazole class. Its primary function is to halt the growth of fungi responsible for various skin infections. This topical treatment is available in cream and liquid forms, making it versatile for different applications.

The effectiveness of clotrimazole lies in its ability to target specific fungal infections:

  • Tinea corporis (ringworm)
  • Tinea cruris (jock itch)
  • Tinea pedis (athlete’s foot)

These conditions are characterized by red, scaly rashes that can cause discomfort and irritation. Clotrimazole works by disrupting the fungal cell membranes, ultimately preventing their growth and spread.

Proper Application Techniques for Topical Clotrimazole

To maximize the efficacy of clotrimazole, proper application is crucial. How should you apply clotrimazole topically? Follow these steps:

  1. Thoroughly wash and dry the affected area.
  2. Apply a thin layer of cream or liquid to cover the infected skin.
  3. Gently massage the medication into the skin.
  4. Repeat the application twice daily, typically in the morning and evening.

When treating athlete’s foot, pay special attention to the spaces between your toes. This area is particularly prone to fungal growth due to moisture and warmth. Additionally, ensure you wear well-fitting shoes that allow air circulation and change your socks at least once a day to maintain a dry environment.

Special Considerations for Different Fungal Infections

The duration of treatment can vary depending on the specific fungal infection:

  • Jock itch: Symptoms should improve within 2 weeks of treatment.
  • Athlete’s foot and ringworm: Expect symptom improvement over 4 weeks of treatment.

If you don’t notice any improvement or if symptoms worsen during treatment, consult your healthcare provider promptly.

Exploring Off-Label Uses of Clotrimazole

While clotrimazole is primarily prescribed for the aforementioned fungal infections, it may also be used to treat other conditions. Can clotrimazole be used for other skin issues? Indeed, it can. Off-label uses of topical clotrimazole include:

  • Tinea versicolor: A fungal infection causing discolored patches on the skin
  • Yeast infections of the skin

Always consult with your healthcare provider before using clotrimazole for these conditions, as they can assess the potential risks and benefits specific to your situation.

Essential Precautions and Considerations

Before using clotrimazole, it’s crucial to be aware of certain precautions. What should you tell your doctor before using clotrimazole?

  • Inform your healthcare provider about any allergies to clotrimazole or its ingredients.
  • Disclose all medications, supplements, and herbal products you’re currently taking.
  • Mention if you’re pregnant, planning to become pregnant, or breastfeeding.

Remember, clotrimazole is for external use only. Avoid contact with eyes and never ingest the medication. It’s not effective for treating scalp or nail fungal infections.

Potential Side Effects and When to Seek Medical Attention

While clotrimazole is generally well-tolerated, some individuals may experience side effects. What are the common side effects of topical clotrimazole?

  • Blistering
  • Redness
  • Swelling
  • Itching
  • Burning or stinging sensation
  • Peeling
  • Hives
  • Skin cracking

If you experience any of these symptoms, discontinue use and contact your healthcare provider immediately. In rare cases, more serious side effects may occur. If you notice any unusual reactions, don’t hesitate to seek medical attention.

Proper Storage and Disposal of Clotrimazole

To maintain the effectiveness of clotrimazole and ensure safety, proper storage is essential. How should you store clotrimazole?

  • Keep the medication in its original container, tightly closed.
  • Store at room temperature, away from excess heat and moisture.
  • Avoid storing in the bathroom, as humidity can affect the product.
  • Keep out of reach of children and pets.

When it’s time to dispose of unused or expired clotrimazole, follow local guidelines for medication disposal. Many pharmacies offer take-back programs for safe disposal of medications.

Interactions and Special Populations

While topical clotrimazole has minimal systemic absorption, it’s still important to be aware of potential interactions. Are there any known drug interactions with topical clotrimazole?

Generally, topical clotrimazole has few drug interactions due to its limited absorption into the bloodstream. However, it’s always best to inform your healthcare provider about all medications you’re taking, including over-the-counter drugs and supplements.

Use in Pregnancy and Breastfeeding

For pregnant or breastfeeding individuals, the use of clotrimazole should be discussed with a healthcare provider. While topical clotrimazole is generally considered safe during pregnancy, it’s important to weigh the potential benefits against any risks.

Pediatric Use

Clotrimazole can be used in children, but the dosage and application may differ. Always consult a pediatrician before using clotrimazole on a child’s skin.

Enhancing Treatment Efficacy: Lifestyle and Hygiene Tips

To maximize the effectiveness of clotrimazole treatment, consider implementing these lifestyle and hygiene practices:

  • Keep the affected area clean and dry
  • Wear breathable, moisture-wicking fabrics
  • Change socks and underwear daily, or more frequently if sweating
  • Avoid sharing personal items like towels or shoes
  • Use antifungal powders in shoes to prevent recurrence

These measures can help create an environment less conducive to fungal growth, supporting the healing process and preventing reinfection.

Duration of Treatment and Follow-up Care

The duration of clotrimazole treatment can vary depending on the specific infection and its severity. How long should you use clotrimazole?

Typically, treatment lasts for 2-4 weeks, but your healthcare provider may recommend a different duration based on your individual case. It’s crucial to complete the full course of treatment, even if symptoms improve earlier, to ensure complete eradication of the fungal infection.

After completing the treatment, schedule a follow-up appointment with your healthcare provider to assess the effectiveness and determine if any additional measures are necessary.

Alternative Treatments and Complementary Approaches

While clotrimazole is highly effective for many fungal skin infections, there may be cases where alternative treatments are considered. What other options are available for treating fungal skin infections?

  • Other topical antifungals (e.g., miconazole, terbinafine)
  • Oral antifungal medications for severe or resistant infections
  • Natural remedies like tea tree oil or garlic (though efficacy may vary)

Always consult with a healthcare professional before trying alternative treatments, as they can advise on the most appropriate option for your specific condition.

Preventive Measures for Recurrent Infections

For individuals prone to recurrent fungal infections, implementing preventive strategies is crucial. How can you prevent fungal skin infections from recurring?

  • Maintain good hygiene practices
  • Keep skin dry, especially in areas prone to sweating
  • Use antifungal powders or sprays in shoes and on feet regularly
  • Avoid walking barefoot in public areas like locker rooms or swimming pools
  • Choose breathable, moisture-wicking fabrics for clothing and footwear

By incorporating these habits into your daily routine, you can significantly reduce the risk of future fungal infections.

Understanding the Broader Impact of Fungal Skin Infections

Fungal skin infections, while often considered minor ailments, can have a significant impact on quality of life. How do fungal skin infections affect daily life and well-being?

  • Physical discomfort and itching
  • Embarrassment and self-consciousness
  • Limitations in physical activities or clothing choices
  • Potential spread to other body parts or individuals

Recognizing the broader implications of these infections underscores the importance of prompt and effective treatment with medications like clotrimazole.

The Role of Immune System in Fungal Infections

The body’s immune system plays a crucial role in fighting fungal infections. Individuals with compromised immune systems may be more susceptible to fungal skin infections and may require more aggressive treatment approaches. In such cases, topical clotrimazole may be used in conjunction with other medications or therapies to enhance effectiveness.

Advances in Antifungal Research and Future Treatments

The field of antifungal research is continually evolving, with scientists exploring new treatment options and delivery methods. What advancements are being made in antifungal treatments?

  • Development of new antifungal compounds with broader spectrum activity
  • Exploration of nanotechnology for improved drug delivery
  • Investigation of combination therapies for enhanced efficacy
  • Research into probiotic approaches to prevent fungal overgrowth

While clotrimazole remains a highly effective treatment for many fungal skin infections, these ongoing research efforts promise to expand the arsenal of antifungal therapies in the future.

The Importance of Proper Diagnosis

Accurate diagnosis is crucial for effective treatment of fungal skin infections. Some conditions may mimic the appearance of fungal infections but require different treatments. How can you ensure proper diagnosis of a fungal skin infection?

  • Consult a healthcare professional for evaluation
  • Provide a detailed history of symptoms and potential exposures
  • Undergo skin scrapings or cultures if necessary
  • Be open to alternative diagnoses if initial treatment is ineffective

By working closely with your healthcare provider, you can ensure that you receive the most appropriate treatment, whether it’s clotrimazole or an alternative therapy.

Clotrimazole in the Context of Global Health

Fungal skin infections are a global health concern, affecting millions of people worldwide. How does clotrimazole contribute to global health efforts?

  • Provides an accessible and cost-effective treatment option
  • Reduces the burden of fungal infections in resource-limited settings
  • Helps prevent the spread of contagious fungal infections in communities
  • Supports overall skin health and well-being on a global scale

The availability of effective antifungal treatments like clotrimazole plays a crucial role in managing fungal skin infections and improving public health outcomes worldwide.

Environmental Factors and Fungal Infections

Environmental conditions can significantly influence the prevalence and severity of fungal skin infections. How do environmental factors impact fungal infections, and how can clotrimazole help?

  • Hot and humid climates promote fungal growth
  • Occupational exposures (e.g., in agriculture or healthcare) can increase risk
  • Shared facilities like gyms or swimming pools can facilitate transmission

Clotrimazole provides an effective treatment option regardless of environmental factors, helping individuals manage fungal infections even in challenging conditions. By combining proper hygiene practices with clotrimazole treatment, individuals can effectively combat fungal infections in various environments.

As we continue to navigate the complexities of fungal skin infections and their treatment, clotrimazole remains a cornerstone of antifungal therapy. Its proven efficacy, ease of use, and wide availability make it an invaluable tool in the management of common fungal skin conditions. By understanding its proper use, potential side effects, and the broader context of fungal infections, individuals can make informed decisions about their skin health and work effectively with healthcare providers to achieve optimal outcomes.

Clotrimazole Topical: MedlinePlus Drug Information


pronounced as (kloe trim’ a zole)

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Topical clotrimazole is used to treat tinea corporis (ringworm; fungal skin infection that causes a red scaly rash on different parts of the body), tinea cruris (jock itch; fungal infection of the skin in the groin or buttocks), and tinea pedis (athlete’s foot; fungal infection of the skin on the feet and between the toes). Clotrimazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection.

Topical clotrimazole comes as a cream and liquid to apply to the skin. It is usually applied twice a day (morning and night). Follow the directions on the package label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use clotrimazole exactly as directed. Do not use more or less of it or use it more often than directed on the package or as directed by your doctor.

Topical clotrimazole is only for use on the skin. Do not let clotrimazole get into your eyes and do not swallow the medication. Clotrimazole does not work on the scalp or nails.

If you are using clotrimazole to treat jock itch, your symptoms should improve over 2 weeks of treatment. If you are using clotrimazole to treat athlete’s foot or ringworm, your symptoms should improve over 4 weeks of treatment. Call your doctor if your symptoms do not improve during this time or if your symptoms get worse at any time during your treatment.

To use topical clotrimazole, wash the affected area and dry thoroughly. Then apply a small amount of cream or liquid to cover the affected area of skin with a thin layer.

If you are treating athlete’s foot, pay special attention to the spaces between the toes when applying clotrimazole. Also, be sure to wear well-fitting shoes that allow for air circulation, and change shoes and socks at least once a day.

If you are using the liquid, do not apply it to any severely cracked or irritated areas.

Topical clotrimazole may be used to treat tinea versicolor (fungal infection of the skin that causes brown or light colored spots on the chest, back, arms, legs, or neck) or yeast infections of the skin. Talk to your doctor about the risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using topical clotrimazole,

  • tell your doctor and pharmacist if you are allergic to clotrimazole, any other medications, or any of the ingredients in clotrimazole cream or liquid. Ask your pharmacist for a list of the ingredients.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using clotrimazole, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply a double amount to make up for a missed dose.

Clotrimazole may cause side effects. If you experience any of these symptoms, stop using clotrimazole and call your doctor:

  • blistering, redness, swelling, itching, burning, stinging, peeling, hives, or skin cracks

Clotrimazole may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

If someone swallows clotrimazole topical, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

  • Lotrimin® AF Athlete’s Foot Cream
  • Lotrimin® AF Jock Itch Cream
  • Lotrimin® AF Ringworm Cream
  • Lotrimin® Solution
  • Lotrisone® Cream (containing Betamethasone, Clotrimazole)
  • Lotrisone® Lotion (containing Betamethasone, Clotrimazole)

This branded product is no longer on the market. Generic alternatives may be available.

Last Revised – 11/15/2018

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Clotrimazole Topical: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Uses

Clotrimazole is used to treat skin infections such as athlete’s foot, jock itch, ringworm, and other fungal skin infections (candidiasis). This medication is also used to treat a skin condition known as pityriasis (tinea versicolor), a fungal infection that causes a lightening or darkening of the skin of the neck, chest, arms, or legs. Clotrimazole is an azole antifungal that works by preventing the growth of fungus.

How to use Clotrimazole Solution, Non-

Use this medication on the skin only. Clean and thoroughly dry the area to be treated. Apply this medication to the affected skin, usually twice a day or as directed by your doctor. Dosage and length of treatment depends on the type of infection being treated. Do not apply this more often than prescribed. Your condition will not clear faster, but side effects may be increased.

Apply enough medication to cover the affected area and some of the surrounding skin. After applying this medication, wash your hands. Do not wrap, cover or bandage the area unless directed to do so by your doctor.

Do not apply this medication in the eyes, nose, mouth, or vagina.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same times each day.

Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after starting clotrimazole. Stopping the medication too early may allow the fungus to continue to grow, which may result in a relapse of the infection.

Inform your doctor if your condition lasts after 4 weeks of treatment or gets worse at any time.

Side Effects

Burning, stinging, swelling, irritation, redness, pimple-like bumps, tenderness, or flaking of the treated skin may occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: blistering, oozing, open sores.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using clotrimazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungals such as econazole, ketoconazole, or miconazole; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This medication should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

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Overdose

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Do not share this medication with others.

If your doctor has directed you to use this medication, use it for your current condition only. Do not use it later for another infection unless your doctor tells you to.

When treating pityriasis, this medication may not cause an immediate return to normal skin color. It may take several months after treatment is completed for your natural skin color to return.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Different brands/strengths of this medication may have different storage requirements. Read the package labeling or ask your pharmacist for the storage requirements for the product you are using. Protect from light. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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Color: whiteShape: Imprint:

This medicine is a clear, clear, solution

clotrimazole 1 % topical cream

Color: whiteShape: Imprint:

This medicine is a clear, clear, solution

clotrimazole 1 % topical solution

Color: Shape: Imprint:

This medicine is a clear, clear, solution

clotrimazole 1 % topical cream

Color: whiteShape: Imprint:

This medicine is a clear, clear, solution

clotrimazole 1 % topical cream

Color: whiteShape: Imprint:

This medicine is a clear, clear, solution

clotrimazole 1 % topical cream

Color: Shape: Imprint:

This medicine is a clear, clear, solution

clotrimazole 1 % topical solution

Color: clearShape: Imprint:

This medicine is a clear, clear, solution

clotrimazole 1 % topical cream

Color: whiteShape: Imprint:

This medicine is a clear, clear, solution

clotrimazole 1 % topical cream

Color: whiteShape: Imprint:

This medicine is a clear, clear, solution

clotrimazole 1 % topical cream

Color: whiteShape: Imprint:

This medicine is a clear, clear, solution

clotrimazole 1 % topical cream

Color: whiteShape: Imprint:

This medicine is a clear, clear, solution

clotrimazole 1 % topical solution

Color: colorlessShape: Imprint:

This medicine is a clear, clear, solution

clotrimazole 1 % topical cream

Color: whiteShape: Imprint:

This medicine is a clear, clear, solution

clotrimazole 1 % topical solution

Color: clearShape: Imprint:

This medicine is a clear, clear, solution

clotrimazole 1 % topical cream

Color: whiteShape: Imprint:

This medicine is a clear, clear, solution

clotrimazole 1 % topical cream

Color: whiteShape: Imprint:

This medicine is a clear, clear, solution

clotrimazole 1 % topical cream

Color: whiteShape: Imprint:

This medicine is a clear, clear, solution

clotrimazole 1 % topical cream

Color: whiteShape: Imprint:

This medicine is a clear, clear, solution

clotrimazole 1 % topical solution

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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Clotrimazole instructions for use: indications, contraindications, side effects – description of Clotrimazole ointment for external use. approx. 1%: tube 30 g (18636)

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✅ Use of the drug Clotrimazole

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Product description

clotrimazole
(Clotrimazole)

Based on the approved instructions for use of the drug and prepared for the electronic edition of the 2008 Vidal guide, updated on 2020. 07.23

Marketing authorization holder:

SYNTHESIS, PAO
(Russia)

ATX code:

D01AC01

(Clotrimazole)

Active substance:
clotrimazole
(clotrimazole)

Rec.INN

WHO registered

Dosage form

clotrimazole

Ointment for external use approx. 1%: tube 30 g

reg. No.: P N003228/01
dated 18.08.09
– Replaced by

Re-registration date: 08/06/19

Release form, packaging and composition
drug Clotrimazole

Ointment for external use 1% white or almost white, uniform.

Excipients : propylene glycol, polyethylene oxide 1500, polyethylene oxide 400, nipagin (methyl parahydroxybenzoate) or methyl paraben.

30 g – aluminum tubes (1) – packs of cardboard.

Clinical and pharmacological group:

Antifungal drug for external use

Pharmacotherapeutic group:

Antifungal agent

Pharmacological action

Clotrimazole is a broad spectrum topical antifungal agent. The antimycotic effect of the active active substance (imidazole derivative) is associated with a violation of the synthesis of ergosterol, which is part of the cell membrane of fungi, which changes the permeability of the membrane and causes subsequent cell lysis. In small concentrations, it acts fungistatically, and in large concentrations, it is fungicidal, and not only on proliferating cells. In fungicidal concentrations, it interacts with mitochondrial and peroxidase enzymes, resulting in an increase in the concentration of hydrogen peroxide to a toxic level, which also contributes to the destruction of fungal cells.

Effective against dermatophytes, yeast-like and mold fungi, as well as the causative agent Pityriasis versicolor (Malazessia furfur) and the causative agent of erythrasma. It has an antimicrobial effect against gram-positive (staphylococci, streptococci) and gram-negative bacteria (Bacteroides, Gardnerella vaginalis), as well as against Trichomonas vaginalis.

Pharmacokinetics

Clotrimazole is poorly absorbed through the skin and mucous membranes and has practically no systemic effect. The concentration in the deep layers of the epidermis is higher than the minimum inhibitory concentration for dermatophytes. When applied externally, the concentration of clotrimazole in the epidermis is higher than in the dermis and subcutaneous tissue.

Indications of the drug

clotrimazole

  • fungal diseases of the skin, mycosis of skin folds, feet;
  • pityriasis versicolor, erythrasma, superficial candidiasis caused by dermatophytes, yeasts (including the genus Candida), molds and other fungi and pathogens sensitive to clotrimazole;
  • mycoses complicated by secondary pyoderma.

Open list of ICD-10 codes

B35.2 Mycosis of the hands
B35.3 Foot mycosis
B35.4 Trunk mycosis
B35.6 Athlete’s groin
B36.0 versicolor
B37.2 Skin and nail candidiasis
L08.0 Pyoderma
L08.1 Erythrasma

Dosing regimen

The ointment is applied in a thin layer 2-3 times a day on pre-cleaned (using soap with a neutral pH value) and dry affected areas of the skin and gently rubbed.

The duration of treatment depends on the severity of the disease, the localization of pathological changes and the effectiveness of therapy.

Treatment of dermatomycosis is carried out for at least 4 weeks, pityriasis versicolor – 1-3 weeks.

For fungal diseases of the skin of the legs , therapy is recommended to continue for at least 2 weeks after the symptoms of the disease have disappeared.

Side effects

Itching, burning, tingling at the site of application of the ointment, the appearance of erythema, blisters, swelling, irritation and peeling of the skin. Allergic reactions (itching, urticaria).

Contraindications for use

  • hypersensitivity to clotrimazole or excipients;
  • I trimester of pregnancy.

Caution: lactation period.

Use during pregnancy and lactation

Contraindication – I trimester of pregnancy.

In clinical and experimental studies, it has not been established that the use of the drug during pregnancy or lactation has a negative effect on the health of the woman or the fetus (child). However, the question of the advisability of prescribing the drug should be decided individually after consulting a doctor.

Applying the drug directly to a lactating breast is contraindicated.

Use for violations of liver function

In patients with liver failure, the functional state of the liver should be periodically monitored.

Special instructions

It is not recommended to apply the drug to the skin in the eye area. When treating onychomycosis, it is necessary to ensure that the treated nail plates are cut short or have a rough surface for better penetration of the active substance. In these cases, a solution should be preferred due to better penetrating properties. In patients with hepatic insufficiency, the functional state of the liver should be periodically monitored.

Stop treatment if signs of hypersensitivity or irritation appear. If there is no effect within 4 weeks, the diagnosis should be confirmed.

Overdose

The use of the ointment in high doses does not cause any reactions and conditions that are life-threatening.

Drug interactions

Amphotericin B, nystatin, natamycin reduce the effectiveness of clotrimazole when used simultaneously.

When using the ointment, negative interactions with other agents are unknown and should not be expected, because. the resorption capacity of clotrimazole is very low.

Storage conditions of the drug Clotrimazole

At a temperature not exceeding 20°C, in a dry, dark place and out of the reach of children. Freezing is not allowed.

Shelf life of Clotrimazole

Shelf life – 2 years. Do not use after the expiration date.

Terms of sale

The drug is approved for use as an over-the-counter drug.

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Clotrimazole . Description of the drug in the reference book Vidal.

Clotrimazole instructions for use: indications, contraindications, side effects – description of Clotrimazole cream for external use.

approx. 1%: tube 20 g (7002)

📜 Instructions for use Clotrimazole

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Product description

clotrimazole
(Clotrimazole)

Based on the official instructions for use of the drug, approved by the manufacturer
and prepared for the electronic edition of the Vidal Handbook 2014
year, updated date: 2018.07.18

Marketing authorization holder:

GlaxoSmithKline Trading JSC
(Russia)

Manufactured:

GlaxoSmithKline Pharmaceuticals, S. A.

(Poland)

Contacts for inquiries:

GlaxoSmithKline Trading JSC
(Russia)

ATX code:

D01AC01

(Clotrimazole)

Active substance:
clotrimazole
(clotrimazole)

Rec.INN

WHO registered

Dosage form

clotrimazole

Cream for external approx. 1%: tube 20 g

reg. No.: P N011413/02
dated 11.06.10
– Indefinitely

Re-registration date: 11/16/16

Release form, packaging and composition
drug Clotrimazole

Cream for external use 1% in the form of a homogeneous white mass.

Excipients : benzyl alcohol – 1 g, cetostearyl alcohol – 11.5 g, octyldodecanol – 10 g, polysorbate 60 – 1.5 g, sorbitan stearate – 2 g, synthetic spermaceti – 3 g, water – 71 g.

20 g – aluminum tubes (1) – packs of cardboard.

Clinical and pharmacological group:

Antifungal drug for external use

Pharmacotherapeutic group:

Antifungal agent

Pharmacological action

Clotrimazole inhibits the growth and division of microorganisms and, depending on the concentration, may have a fungistatic (delaying and stopping the growth of fungal cells) or fungicidal (leading to the death of fungi) action. Clotrimazole inhibits the synthesis of ergosterol and binds to the phospholipids of the cell membrane of the fungus, which leads to a change in the permeability of cell membranes.

At higher concentrations, clotrimazole causes damage to cell membranes through mechanisms independent of sterol synthesis.

Clotrimazole also disrupts the vital processes in the fungal cell, inhibiting the formation of components necessary for building vital cellular structures (proteins, fats, DNA, polysaccharides), damages nucleic acids and increases the excretion of potassium.

Ultimately, the action of clotrimazole on fungal cells leads to their death.

Clotrimazole is characterized by a wide spectrum of antifungal and antibacterial activity : dermatophytes (Epidermophyton floccosum, Microsporum canis, Trichophyton mentagrophytes, Trichophyton rubrum), yeasts (Candida spp., Cryptococcus neoformans), dimorphic fungi (Coccidioides immitis, Histoplasma cap sulatum, Paracoccidioides brasiliensis), protozoa (Trichomonas vaginalis).

It is also active against certain Gram-positive bacteria .

When studying the effectiveness of clotrimazole in laboratory conditions outside the human body (in vitro), a wide range of its fungistatic and fungicidal activity was revealed. It acts on the mycelium of dermatophytes (Trichophyton, Microsporum, Epidermophyton) similarly to griseofulvin, and its effect on budding fungi (Candida) is similar to that of polyenes (amphotericin B and nystatin).

At concentrations less than 1 μg / ml, clotrimazole inhibits the development of most strains of pathogenic fungi related to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis.

At a concentration of 3 μg / ml, clotrimazole inhibits the development of most other bacteria: Pityrosporum orbiculare, Aspergillus fumigatus, Candida genus, incl. Candida albicans, some strains of Staphylococcus aureus, Streptococcus pyogenes, and some strains of Proteus vulgaris and Salmonella. Clotrimazole is active against Sporothrix, Cryptococcus, Cephalosporium, Fusarium.

At concentrations greater than 100 µg/ml it is effective against Trichomonas vaginalis.

Clotrimazole-resistant fungi are extremely rare; there are data only for individual strains of Candida guilliermondii.

No development of resistance has been reported in clotrimazole-sensitive fungi after passage of Candida albicans and Trichophyton mentagrophytes. No cases of development of resistance to clotrimazole in strains of Candida albicans resistant to polyene antibiotics due to a chemical mutation have been described.

Pharmacokinetics

Absorption and distribution

Pharmacokinetic studies have shown that clotrimazole is practically not absorbed into the systemic circulation when the drug is applied to intact or inflamed skin areas. Serum concentrations of clotrimazole were below the detection limit (0.001 µg/mL), confirming that topical clotrimazole does not cause clinically significant systemic effects or side effects.

Metabolism and excretion

Clotrimazole is degraded in the liver to inactive substances that are excreted from the body through the kidneys and intestines.

Indications of the drug

clotrimazole

For the external treatment of fungal skin diseases caused by dermatophytes, yeast-like fungi, fungi, and pathogens sensitive to clotrimazole:

  • mycoses of the feet, hands, trunk, skin folds;
  • candidal vulvitis, candidal balanitis;
  • versicolor, erythrasma;
  • fungal infections of the outer ear.

Open list of ICD-10 codes

B35.2 Mycosis of the hands
B35.3 Foot mycosis
B35.4 Trunk mycosis
B35.6 Athlete’s groin
B36.0 versicolor
B37.2 Skin and nail candidiasis
B37.3 Vulvar and vaginal candidiasis
B37.4 Candidiasis of other urogenital sites
H62.2 Otitis externa in mycoses
L08. 1 Erythrasma

Dosing regimen

For external use. The cream should be applied to the affected areas of the skin 2-3 times / day.

For prevention of recurrence treatment should be continued for at least two weeks after the disappearance of all symptoms of infection.

The cream should be applied to clean, dry areas of the affected skin (washed with neutral pH soap), on the feet, the cream should be applied between the toes.

The duration of treatment depends on the severity of the disease, its localization, and the effectiveness of the treatment.

Duration of treatment: dermatomycosis – 3-4 weeks; erythrasma – 2-4 weeks; multi-colored lichen – 1-3 weeks; candidal vulvitis and balanitis – 1-2 weeks.

The duration of treatment may vary according to the individual, but a duration of treatment of less than 3 weeks is not recommended. To prevent recurrence of infection, you should continue using the drug for 1-2 weeks after the disappearance of all symptoms of the disease. If after 7 days of treatment there is no improvement in symptoms, it is necessary to consult a doctor.

Side effects

The adverse events listed below are listed according to the damage to organs and organ systems and the frequency of occurrence. The frequency of occurrence is defined as follows: very often (≥1/10), often (≥1/100 and < 1/10), infrequently (≥1/1000 and < 1/100), rare (≥1/10,000 and < 1/1,000), very rare (< 1/10,000, including isolated cases), unknown (frequency cannot be estimated from currently available data). Frequency categories were formed on the basis of post-registration observation.

From the immune system: unknown – allergic reaction (manifested by urticaria, fainting, arterial hypotension, shortness of breath).

From the skin and subcutaneous tissues: unknown – rash, itching, blisters, peeling, pain or discomfort, swelling, burning, irritation.

Contraindications for use

  • hypersensitivity to clotrimazole or other components of the drug.

Pregnancy and lactation

The use of the drug Clotrimazole during pregnancy is allowed only if, in the opinion of the doctor, the potential benefit of using the cream for the mother outweighs the possible risk to the fetus.

In the conducted epidemiological studies, no adverse events in relation to pregnancy or fetal health have been identified with the use of the drug Clotrimazole.

The use of the drug Clotrimazole in women during breastfeeding is allowed only if, in the opinion of the doctor, the potential benefit of using the cream for the mother outweighs the possible risk to the child.

Fertility

No data available.

Special instructions

Avoid getting the cream on the mucous membrane of the eyes. Do not swallow.

All infected areas should be treated at the same time.

Clotrimazole contains cetostearyl alcohol, which may cause local skin reactions (eg, contact dermatitis).

Discontinue treatment if symptoms of hypersensitivity or irritation occur.

Laboratory data suggest that the use of contraceptives containing latex may cause damage when used together with clotrimazole. Therefore, the effectiveness of such contraceptives may decrease. Patients should be advised to use alternative methods of contraception for at least 5 days after using clotrimazole.

Influence on the ability to drive vehicles and mechanisms

No effect of clotrimazole on the ability to drive vehicles and mechanisms has been reported.

Overdose

Symptoms: in case of accidental ingestion of the drug, dizziness, nausea, vomiting may occur.

Treatment: in case of accidental ingestion of the cream, symptomatic treatment should be carried out. With external use of the drug, an overdose is unlikely.

Drug interactions

Not studied.

Storage conditions of the drug Clotrimazole

The drug should be kept out of the reach of children at a temperature not exceeding 25 °C.

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