Clotrimazole cream - instructions for use. Clotrimazole ointment - instructions for use, composition, what helps, review of analogues and reviews

Clotrimazole 1 is an antifungal drug with a 1% concentration of the active ingredient clotrimazole. It is widely used in various diseases associated with bacterial or fungal microflora.

Release form and composition

Clotrimazole is produced in several dosage forms - a solution for external use, ointment, cream, vaginal tablets, suppositories, etc. All of them have the main active ingredient - clotrimazole and auxiliary components that differ for each dosage form of the drug.

Clotrimazole belongs to the group of antifungal drugs and actively fights many types of pathogens - viruses, bacteria, mold fungi, dermatophytes. In addition to disinfection, the substance relieves inflammation, itching, redness and pain, accelerates tissue regeneration at the cellular level, which contributes to the rapid healing of skin lesions.

Clotrimazole 1 is an antifungal drug with a 1% concentration of the active ingredient clotrimazole.

Vaginal tablets

Used for intravaginal use. In addition to clotrimazole, the composition includes:

  • lactose;
  • microcrystalline cellulose;
  • potato starch;
  • magnesium stearate;
  • lemon acid.

Candles vaginal

As part of the candles, in addition to the main component, solid fat of vegetable or animal origin is used to form a suppository.

Cream

The cream contains clotrimazole and excipients - benzyl alcohol, cetasteryl alcohol, polysorbate 60, synthetic olbrot (synthetic spermaceti), purified water.

Gel

The gel is available in tubes of 20 and 40 g. It differs from cream or ointment in its light and watery structure. That is, it is not greasy, because it consists of clotrimazole, water and starch, and does not leave marks on the skin or clothing.

Ointment

The ointment consists of clotrimazole and is available in tubes of 20 g. As additional components, sodium benzoate, castor oil, paraffin, water, propylene glycol are used. The ointment is a white, oily substance without a characteristic odor.

Solution

Solution for external use is available in glass bottles of 25 mg. The main component is clotrimazole, the additional ones are medical alcohol, propylene glycol and propylene glycol.

Pharmacological action

Clotrimazole belongs to the group of broad-spectrum antifungal drugs. The active substance clotrimazole is a derivative of imidazole and is used for the topical treatment of fungal, viral, bacterial infections. It has an antimicrobial effect.

Upon contact with a pathogenic microorganism, clotrimazole penetrates into its structure and destroys the cells of the membranes, due to which the organisms cannot reproduce and die in whole colonies. For effectiveness, the course of treatment should last at least 5 days to avoid relapse.

When applied topically, the drug is practically not absorbed into the blood, and if absorbed, then its concentration is negligible.

Indications for use

Clotrimazole in any of the dosage forms is used for the following pathologies:

  • all types of mycoses, lichen, lichen color, eczema (it is recommended to use a solution, cream, ointment);
  • genital infections and inflammations, for example, herpes, thrush and other pathologies caused by the pathogen candida albicans (vaginal suppositories and tablets are used);
  • candles are used before and after childbirth to cleanse and disinfect the birth canal;
  • erythrasma;
  • bacvaginosis.

Clotrimazole alone is not always enough for a complete treatment. It will be more effective to take oral antifungal tablets, and apply a solution, ointment, cream, etc. to the damage.

With a complex effect, the chances of a quick recovery without relapse and consequences increase.

Contraindications

The use of this drug has some contraindications:

  • individual sensitivity to the components of the composition;
  • menstruation (for using suppositories or tablets);
  • during lactation - only as directed by a doctor;
  • 1 trimester of pregnancy;
  • liver failure.

Method of application and dosing regimen

Gel, ointment and cream are used 1-3 times a day for 7-10 days for skin lesions. Apply to cleansed skin with gentle movements.

The solution is used for nail fungus and mycoses. It is applied with a cotton swab to the affected areas 2 times a day - in the morning and in the evening.

For thrush or other sexually transmitted diseases, the partner should use suppositories or tablets 1-2 times a day for a week. A man needs to use the form of a cream or ointment to treat the genitals. With such pathologies, both partners should be treated, even if one of them does not develop any symptoms.

After unprotected intercourse, you can use the drug for both partners as a prophylaxis.

Side effects

In case of intolerance or misuse of the drug, it can provoke adverse reactions:

  • allergic reactions are manifested in the form of itching and rash, swelling, irritation, redness of the eyes, shortness of breath may occur;
  • on the part of the subcutaneous tissue, reddening of the skin may occur, in men there is a strong burning sensation in the penis, a feeling of dryness.

If these symptoms occur, discontinue use of this medicinal product and seek medical advice.

Overdose

In case of excessive external use, an allergy may occur, which will disappear when the dose is restored or the drug is discontinued.

Influence on the ability to drive vehicles and complex mechanisms

The substance is not absorbed into the blood and does not affect the organs of vision or the functioning of the central nervous system. Therefore, you can drive or operate automatic mechanisms.

Drug interaction Clotrimazole 1

Before taking, you need to carefully read the instructions for drug interactions of drugs, so as not to harm your health.

With other drugs

Alcohol compatibility

With local use of a solution, gel, cream or ointment, Clotrimazole does not penetrate into the blood and does not interact with ethyl alcohol. When using suppositories or vaginal tablets for the duration of treatment, it is better to refrain from alcohol.

Features of the use of Clotrimazole 1

  • you can use the medicine only after consulting a doctor;
  • with prolonged use, it is recommended to monitor hepatic and renal activity;
  • if a side effect occurs, discontinue use;
  • do not apply under the eyes;
  • with long-term therapy (6 months, 1 year), you need to take breaks of 1-2 weeks;
  • do not use orally.

During pregnancy and lactation

Only under the supervision of a doctor from the II trimester. When used during lactation, do not apply the product to the nipples.

In childhood

Studies on children have not been conducted on the subject of contraindications and adverse reactions, therefore, in pediatrics, this drug is used only as directed by a doctor, when the possible benefits outweigh the risks.

Terms of dispensing from pharmacies

You don't need a prescription from a doctor to buy an antifungal. Clotrimazole is sold in every pharmacy, because. it is a popular and effective drug.

Are they sold without a prescription?

Price

The cost of the drug depends on the form of release:

  • cream (Akrikhin) 30 g - 170-190 rubles;
  • ointment 15 gr - 50 rubles;
  • solution 15 ml - 250 rubles;
  • tablets number 6 - 60 rubles;
  • gel 20 gr - 40 rubles.

Conditions and terms of storage of Clotrimazole 1

The drug can be stored at room temperature, suppositories - in the refrigerator. Shelf life - 3 years from the date of production. Do not use the drug after the expiration date. For safety reasons, keep away from children.

Fungal diseases of the skin, skin folds, feet. Pityriasis versicolor, erythrasma, superficial candidiasis caused by dermatophytes, yeasts (including the Candida genus), molds and other fungi and pathogens sensitive to clotrimazole. Mycoses complicated by secondary pyoderma.

Contraindications Clotrimazole solution 1% 15ml

Hypersensitivity to clotrimazole or excipients of the drug. I trimester of pregnancy. With caution: lactation period. Use during pregnancy and lactation: in clinical and experimental studies, it has not been established that the use of clotrimazole during pregnancy or during lactation has a negative effect on the health of a woman or fetus (child). However, the question of the advisability of prescribing the drug in the II and III trimesters of pregnancy should be decided individually after consulting a doctor. Application of the drug directly to the mammary gland during breastfeeding is not recommended.

Method of application and dosage Clotrimazole solution 1% 15ml

The solution is applied in a thin layer on previously cleansed (using soap with a neutral pH value) and dry affected areas of the skin 2 times a day (morning and evening) 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 ringworm is carried out for at least 4 weeks, pityriasis versicolor - 1-3 weeks. In case of fungal diseases of the skin of the legs, it is recommended to continue therapy for at least 2 weeks after the symptoms of the disease have disappeared.

Antifungal agents - derivatives of imidazole and triazole.

Compound

The active substance is clotrimazole.

Manufacturers

Glaxo Wellcome Poznan (Poland), GlaxoSmithKline Pharmaceuticals S.A. (Poland), Hyperion S. A. (Romania), Shreya Life Sciences Pvt. Ltd (India)

pharmachologic effect

Clotrimazole is an imidazole derivative.

Broad spectrum antifungal agent.

The effect of the drug is associated with a violation of the synthesis of ergosterol, which is part of the cell membrane of fungi, which causes a change in its structure and properties, and leads to cell lysis.

At concentrations of 1 μg / ml in vitro and more than 6 μg / ml in vivo, clotrimazole acts fungistatically.

At concentrations of more than 10 μg / ml, it has a fungicidal effect on most types of fungi, and not only on proliferating cells.

In relation to Candida, it has a fungicidal effect at concentrations of 2 μg / ml and above.

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.

Active against pathogenic dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis), yeast and mold fungi (Candida spp., Torulopsis glabrata, Rhodotorula genus, Pityrosporum orbiculare), as well as the pathogen Pityriasis versicolor (lichen versicolor) 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, Malazessia furfur (pathogen Pityriasis versicolor) and Corynebacterium minussimum (pathogen erythrasma).

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 in the dermis and subcutaneous tissue, and exceeds the minimum inhibitory concentration for dermatophytes.

Side effect

In rare cases, there are local reactions - itching, burning, tingling at the site of application of the cream, the appearance of erythema, blisters, swelling, irritation and peeling of the skin.

Allergic reactions (itching, urticaria).

Indications for use

Fungal diseases of the skin, mycoses 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.

Contraindications

Hypersensitivity to clotrimazole or other components of the drug, I trimester of pregnancy.

Method of application and dosage

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

A single dose on a surface area the size of a palm - a column of cream 5 mm long.

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.

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

Overdose

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

Interaction

Amphotericin B, nystatin, natamycin reduce the effectiveness of clotrimazole with simultaneous use.

special instructions

With caution - lactation.

Use during pregnancy and lactation.

In clinical and experimental studies, it has not been established that the use of the drug during pregnancy or during lactation has a negative effect on the health of a woman or a fetus (child).

However, the question of the advisability of prescribing the drug should be decided individually after consulting a doctor.

Application of the drug directly to the lactating mammary gland is contraindicated.

The drug is not intended for use in ophthalmic practice.

Contact with eyes must be avoided.

After applying the cream, do not apply occlusive dressings.

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.

If signs of hypersensitivity or irritation appear, treatment is stopped.

If there is no effect within 3 days, the diagnosis should be confirmed.

In liver failure, liver function should be monitored periodically.

In the case of an unintended method of using the drug (orally), the following symptoms are possible:

  • anorexia, nausea, vomiting, abdominal pain, liver dysfunction;
  • rarely: drowsiness, hallucinations, frequent urination, allergic skin reactions.

In these cases, it is necessary to take activated charcoal and consult a doctor.

Keep away from children.

Storage conditions

Do not freeze.

Store in a dry, dark place, out of the reach of children, at a temperature of 15-25 C.

Antifungal, antibacterial, antiprotozoal, trichomonacid. Dermatomycosis, versicolor, erythrasma, vulvovaginal candidiasis or balanitis. Apply a thin layer 2-3 times a day on pre-cleaned (using soap with a neutral pH value) and dry affected skin areas.

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 by 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 potassium excretion. Ultimately, the effect of clotrimazole on fungal cells leads to their death. Clotrimazole is characterized by a wide spectrum antifungal and antibacterial activity: dermatophytes (Epidermophyton floccosum, Microsporum canis, Trichophyton mentagrophytes, Trichophyton rubrum), yeasts (Candida spp., Cryptococcus neoformans), dimorphic fungi (Coccidioides immitis, Histoplasma capsulatum, Paracoccidioides brasiliensis), protozoa (Trichomonas vaginalis). He also active against some 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. Mushrooms resistant to clotrimazole are extremely rare; there are data only for individual strains of Candida guilliermondii. No resistance development 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.

For external treatment of fungal skin diseases caused by dermatophytes, yeast-like fungi, mold fungi, as well as pathogens sensitive to clotrimazole: - mycosis of the feet, hands, trunk, skin folds; - candidal vulvitis, candidal balanitis; - versicolor versicolor, erythrasma; - fungal infections of the external ear.

For outdoor use. The cream should be applied to the affected areas of the skin 2-3 times / day. For relapse prevention 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 treatment. Duration of treatment: ringworm - 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 individual characteristics, 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.

The adverse events presented 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), нечасто (≥1/1000 и < 1/100), редко (≥1/10 000 и < 1/1 000), очень редко (< 1/10 000, включая отдельные случаи), неизвестно (частота не может быть оценена по имеющимся на настоящий момент данным). Категории частоты были сформированы на основании пострегистрационного наблюдения. From the immune system: unknown - an 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.

- hypersensitivity to clotrimazole or other components of the drug.

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.

It is necessary to avoid getting the cream on the mucous membrane of the eyes. Do not swallow. All infected areas should be treated at the same time. The composition of the drug Clotrimazole contains cetostearyl alcohol, which can cause local skin reactions (for example, contact dermatitis). If symptoms of hypersensitivity or irritation appear, treatment is stopped. Laboratory data indicate that the use of contraceptives containing latex can 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 control mechanisms No effect of clotrimazole on the ability to drive vehicles and mechanisms has been reported.

Not studied.

The drug should be kept out of the reach of children at a temperature not exceeding 25 ° C. Do not freeze. Shelf life - 3 years.

Instructions for use

Clotrimazole instructions for use

Dosage form

Homogeneous cream of soft consistency, emulsion type, from white to almost white.

Compound

Active substance - clotrimazole 1%

Excipients - liquid paraffin, ketosteryl alcohol, white soft paraffin, ketomacrogol 1000, purified water, chlorocresol, disodium edetate, citric acid, dibasic sodium phosphate (anhydrous), propipengpicope, sodium metabisulfite.

Pharmacodynamics

Clotrimazole is a broad-spectrum antifungal agent for topical use. The antimycotic effect of the active ingredient kpotrimazole (an 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. Clotrimazole is effective against dermatophytes, yeast-like and mold fungi, as well as the causative agent of multi-colored lichen (Pityriasis versicolor) and the causative agent of erythrasma. Clotrimazole has an antimicrobial effect against gram-positive (staphylococci, streptococci) and gram-negative bacteria (Bacteroides, Gardnerella vaginalis), as well as against Trichomonas vaginalis, Corynebacterium minutissimum.

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 in the dermis and subcutaneous tissue, and exceeds the minimum inhibitory concentration for dermatophytes.

Side effects

In rare cases, there are local allergic reactions (redness, burning, itching, tingling at the site of application of the drug).

Selling Features

Released without a prescription

Special conditions

If after 4 weeks from the start of treatment there is no clinical improvement, it is necessary to conduct a microbiological study to confirm the diagnosis and exclude another cause of the disease.

If hypersensitivity or irritation develops when using the drug, treatment should be stopped and another therapy should be selected.

Indications

Fungal lesions of the skin and mucous membranes caused by dermatophytes, yeast-like and mold fungi, as well as pathogens sensitive to clotrimazole;

Pityriasis versicolor, erythrasma;

Mycoses complicated by secondary pyoderma.

Contraindications

Clotrimazole should not be used in the presence of hypersensitivity to clotrimazole or excipients.

I trimester of pregnancy.

Carefully:

With caution - lactation.

Use during pregnancy and lactation

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

The application of clotrimazole directly to the mammary gland during breastfeeding is contraindicated.

drug interaction

With topical application of the drug, negative interactions with other drugs are not: known.

With simultaneous use with nystatin, the activity of clotrimazole may decrease.

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Mode of application

Dosage

It is recommended to apply the cream 2-3 times a day with a thin layer on previously cleansed and dry affected skin areas.

For successful treatment, regular use of the cream is important.

The duration of therapy is individual and depends on the severity and localization of the disease. To achieve complete recovery, you should not stop treatment with the cream immediately after the disappearance of acute symptoms of inflammation or subjective complaints. The duration of therapy should be, on average, about 4 weeks.

Pityriasis versicolor usually heals within 1-3 weeks, and erythrasma within 2-4 weeks. For fungal diseases of the skin of the legs, it is recommended to continue therapy for about 2 weeks after the symptoms of the disease have stopped.

Overdose

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