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

Antifungal drug for external use

Active substance

Release form, composition and packaging

◊ 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) - cardboard packs.

pharmachologic effect

Clotrimazole inhibits the growth and division of microorganisms and, depending on the concentration, can have a fungistatic (delaying and stopping the growth of fungal cells) or fungicidal (leading to the death of fungi) effect. Clotrimazole inhibits the synthesis of ergosterol and binds to phospholipids of the fungal cell membrane, 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, suppressing the formation of components necessary for the construction of vital cellular structures (proteins, fats, DNA, polysaccharides), damages nucleic acids and increases the excretion of potassium.

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), yeast (Candida spp., Cryptococcus neoformans), dimorphic fungi (Coccidioides immitis, Histoplasma capsulatum, Paracoccidioides brasiliensis), protozoa (Trichomonas vaginalis).

He also active regarding 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) in a similar way to griseofulvin, and its effect on budding fungi (Candida) is similar to the effect of polyenes (amphotericin B and nystatin).

At concentrations less than 1 mcg/ml, clotrimazole inhibits the development of most strains of pathogenic fungi belonging 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, the genus Candida, incl. Candida albicans, some strains of Staphylococcus aureus, Streptococcus pyogenes, as well as 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.

Fungi resistant to clotrimazole are extremely rare; There is data only on individual strains of Candida guilliermondii.

The development of resistance in clotrimazole-sensitive fungi following passage of Candida albicans and Trichophyton mentagrophytes has not been reported. There have been no cases of the development of resistance to clotrimazole in Candida albicans strains resistant to polyene antibiotics due to a chemical mutation.

Pharmacokinetics

Suction 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 areas of the skin. Clotrimazole serum concentrations were below the detection limit (0.001 μg/ml), confirming that topical clotrimazole does not lead to clinically significant systemic effects or side effects.

Metabolism and excretion

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

Indications

For external treatment of fungal infections caused by dermatophytes, yeast-like fungi, molds, as well as pathogens sensitive to clotrimazole:

— mycoses of the feet, hands, torso, skin folds;

— candidal vulvitis, candidal balanitis;

- lichen versicolor, erythrasma;

- fungal infections of the outer ear.

Contraindications

- hypersensitivity to clotrimazole or other components of the drug.

Dosage

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

For relapse prevention Treatment should be continued for at least two weeks after all symptoms of infection have disappeared.

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

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

Duration of treatment: ringworm - 3-4 weeks; erythrasma - 2-4 weeks; pityriasis versicolor - 1-3 weeks; candidal vulvitis and balanitis - 1-2 weeks.

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

Side effects

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 - allergic reaction (manifested by urticaria, fainting, arterial hypotension, shortness of breath).

For the skin and subcutaneous tissues: unknown - rash, itching, blistering rashes, peeling, pain or discomfort, swelling, burning, irritation.

Overdose

Symptoms: If the drug is accidentally taken orally, nausea and vomiting may occur.

Treatment: In case of accidental ingestion of the cream, symptomatic treatment should be carried out. When using the drug externally, an overdose is unlikely.

Drug interactions

Not studied.

special instructions

Avoid contact of the cream with the mucous membrane of the eyes. Do not swallow.

All infected areas should be treated at the same time.

The drug Clotrimazole contains cetostearyl alcohol, which can cause local skin reactions (for example, contact reactions).

If symptoms of hypersensitivity or irritation appear, stop treatment.

Laboratory data indicate that the use of latex-containing contraceptives may cause contraceptive damage when used concomitantly with clotrimazole. Consequently, the effectiveness of such contraceptives may be reduced. Patients should be advised to use alternative methods for at least 5 days after using clotrimazole.

Impact on the ability to drive vehicles and operate machinery

The effect of clotrimazole on the ability to drive vehicles and machines has not been reported.

Pregnancy and lactation

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

Epidemiological studies have not revealed any adverse events related to pregnancy or fetal health when using 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 for the child.

Fertility

No data available.

Conditions for dispensing from pharmacies

The drug is available without a prescription.

Storage conditions and periods

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.

Clotrimazole instructions

Instructions for Clotrimazole give a complete description of the drug Clotrimazole, presenting it as an antifungal drug for external use.

Clotrimazole release form

The drug Clotrimazole has several forms of release. On pharmacy shelves it can be found in the form of ointments, creams, suppositories and solutions.

Clotrimazole composition

Clotrimazole ointment composition

Ointment for external use. It is a white mass of uniform consistency.

The active ingredient is clotrimazole. Excipients in the required proportions of propylene glycol, polyethylene oxide 1500, polyethylene oxide 400, nipagin or methylparaben.

Clotrimazole cream composition

Cream for external use. It is a homogeneous mass of white color.

The active ingredient is clotrimazole. Excipients in the required proportions: benzyl alcohol, cetostearyl alcohol, octyldodecanol, polysorbate, sorbitan stearate, synthetic spermaceti, as well as water.

Clotrimazole suppositories composition

The drug is in the form of vaginal suppositories having a cylindrical-conical shape. The color is white or with a yellow tint.

The active ingredient is clotrimazole. Excipients in the required proportions of semi-synthetic glyceride.

Clotrimazole solution composition

The drug has a soft emulsion-type consistency. White color.

The active ingredient is clotrimazole. Excipients in the required proportions: liquid paraffin, ketosteryl alcohol, white soft paraffin, ketomacrogol 1000, purified water, chlorocresol, disodium edetate, citric acid, dibasic sodium phosphate, propylene glycol, sodium metabisulfite.

Storage conditions

The drug should not be frozen. Can be stored for three years from the date of manufacture. The storage room must be inaccessible to children with an air temperature not exceeding 25 degrees.

Pharmacology

The drug Clotrimazole is an antifungal agent that has a wide spectrum of action. Apply topically. The effectiveness of its antifungal action is based on the ability to disrupt the synthesis of ergosterol, which is part of the fungal cell membrane.

The activity of Clotrimazole applies to dermatophytes, yeast-like and mold fungi, as well as to the causative agent of pityriasis versicolor (Pityriasis versicolor) and the causative agent of erythrasma. Clotrimazole is capable of exerting an antimicrobial effect against gram-positive (Staphylococcus, Streptococcus) and gram-negative bacteria (Bacteroides, Gardnerella vaginalis), as well as against vaginal Trichomonas.

Indications for use Clotrimazole

Clotrimazole indications for use (ointment)

Clotrimazole ointment is indicated for external use in the following cases:

• For fungal skin diseases;
• For mycoses of the foot or skin folds;
• With pityriasis versicolor;
• With erythrasma;
• For superficial candidiasis that is caused by dermatophyte, yeast (Candida), mold and other fungus or pathogen that is sensitive to clotrimazole;
• For mycoses that are complicated by secondary pyoderma.

Suppositories (tablets) Clotrimazole indications for use

The drug Clotrimazole in the form of vaginal suppositories and tablets is intended for the treatment of vaginal infections in girls and women caused by a yeast-like fungus of the genus Candida. The indications also apply to superinfections that can be caused by microorganisms sensitive to the drug.

Clotrimazole cream indications

The drug Clotrimazole in the form of a cream is used to treat skin fungus and is indicated for use in the following conditions:

• For mycoses of the foot, hand, torso, skin folds;
• With candidal vulvitis,
• With candidal balanitis;
• If you have multicolored lichen,
• With erythrasma;
• For a fungal infection in the outer ear.

Clotrimazole solution indications

The drug Clotrimazole in the form of a solution is used to treat fungal-affected skin and mucous membranes. The drug is indicated for use:

• For mycoses of the foot, hand, torso, lower extremities, skin folds, as well as the area where the beard and mustache, scalp,
• With pityriasis versicolor;
• With erythrasma;
• For candidiasis of the skin, mucous membranes and genitals;
• With paronychia.

Clotrimazole contraindications

The use of the drug Clotrimazole is contraindicated in the first three months of pregnancy, as well as in case of sensitivity to the components that make up the drug.

Clotrimazole instructions for use

Clotrimazole instructions for use ointment/cream

1. The drug is used exclusively externally.
2. After preliminary cleaning, the ointment/cream is applied to the affected area of ​​the skin in a thin layer and rubbed in with caution. This should be done three times a day.
3. The duration of the course depends on the severity of the disease and the effectiveness of treatment.
4. Dermatomycosis should be treated with ointment for at least a month.
5. Pityriasis versicolor must be treated for at least three weeks.
6. Fungal infections on the feet should be treated within two weeks after the symptoms of the disease have disappeared.

Clotrimazole instructions for use of suppositories/tablets

1. The drug in the form of suppositories or vaginal tablets is used exclusively topically.
2. Only women use the drug intravaginally.
3. In the evening, while the patient is lying down, 1 suppository is inserted into the vagina.
4. Duration of treatment – ​​six days, 1 suppository/tablet.
5. The course of treatment can be repeated only as prescribed by a doctor.

Clotrimazole solution instructions for use

• The drug Clotrimazole in the form of a solution is used for external treatment in both adults and children.
• Apply a small amount of Clotrimazole solution to previously cleaned dry affected areas and gently rub into the skin. Apply twice daily. After eliminating severe symptoms, use the drug for another month.
• Treat tinea pedis for at least two weeks after the symptoms of the lesion disappear. It is advisable to use the solution after each water procedure.

Clotrimazole for children

The drug Clotrimazole is not prohibited for use in children. However, basic caution should be exercised when applying the drug to the baby’s delicate skin. In addition, large areas of skin should also not be covered with the drug, since it also performs a respiratory function for the child.

Clotrimazole during pregnancy

Since it is not advisable for a pregnant woman to insert an applicator into the vagina, it is not advisable to use the drug during the second half of pregnancy, although it does not adversely affect the fetus. But the use of the drug is prohibited for the first three months of pregnancy.

There is no information about the penetration of the drug into breast milk. Therefore, it is better not to use it during breastfeeding.

Clotrimazole side effects

As a rule, there are no side effects associated with the use of the drug, but sometimes local irritation in the form of itching or burning, as well as allergic reactions, may occur.

Additional instructions

Do not apply the drug to the skin around the eyes.

If after a month the treatment does not give any positive results, then it should be stopped and examined to clarify the diagnosis.

If an allergic reaction or local irritation develops, treatment should be stopped and replaced with another.

Drug interactions

A high concentration of para-hydroxybenzoic acid propyl ester can enhance the effect of Clotrimazole.

High doses of Dexamethasone can inhibit the effect of Clotrimazole.

The drug itself is capable of reducing the effect of polyene antibiotics (nystatin, natamycin, amphotericin) when used simultaneously.

Clotrimazole analogues

The drug Clotrimazole has analogues in all its release forms.

Clotrimazole price

The drug has a low price, which ranges from 50 to 100 rubles, depending on the form of the drug.

Being one of the most effective antifungal drugs, Clotrimazole is prescribed for the complex treatment of various skin infections that are caused by excessive proliferation of Corynebacterium minutissimum and Malassezia furfur. Having a simple method of administration and a significant content of active substance in the composition of the drug, Clotrimazole is well tolerated by patients even with high sensitivity and has a small number of contraindications for use.

In the article we will review the instructions for use, price, analogs of Clotrimazole and reviews of doctors and patients about it.

Features of the drug

This drug has the greatest effect in the development of diseases caused by molds, yeasts, as well as dermatophytes and other pathogens that are sensitive to the effects of clotrimazole, the active substance of the drug.

To see what the drug Clotrimazole is, watch the video below:

Composition of Clotrimazole

The main active ingredient is clotrimazole, of which 1 g of the product contains 10 mg (meaning 100% dry matter). Auxiliary components include the following:

• polyethylene glycol cetostearyl ether;
• propylene glycol;
• cetostearyl alcohol;
• polyethylene glycol 400;
• proxanol 268.

Externally, the drug is an ointment that is white in color, has a uniform consistency, and has a slight specific medicinal odor.

Dosage forms

The drug is offered for sale in the form of aluminum tubes with bouchons, which have an internal varnish coating that is approved for use. The tube with a leaflet describing the composition and method of use is contained in a cardboard package.

Clotrimazole is also sold in the following forms:

• vaginal tablets, having the appearance of a parallelepiped with slightly rounded corners. They contain 100 mg of active substance. There are 6 pieces in the blister;
• ointment (cream), having a white color and uniform consistency, for external use. The active substance in the ointment is 10 mg per 1 g of ointment. The ointment is packaged in tubes of 30 g, 20 g. Vaginal cream 2% is offered in tubes of 50 g;
• solution, also used for outdoor use. The solution (1%) is packaged in orange bottles and their volume can be 15 or 30 ml.

The cost of the drug may vary: vaginal pharmacies offer tablets at prices ranging from 35 to 60 rubles. A solution of various volumes costs from 96 to 123 rubles per bottle, and ointment, also depending on the volume of the tube, costs 180-215 rubles.

pharmachologic effect

A special feature of Clotrimazole is its rapid penetration into the upper layer of the epidermis and the immediate onset of action on yeast fungi. At the same time, the rate of reproduction of fungi is sharply limited, the possibility for their further spread is reduced, and improvements in the condition of the skin appear.

Pharmacodynamics

Clotrimazole, penetrating the skin within 30-45 minutes after its application, destroys the cell membranes of fungi, preventing the absorption of nutrients from the environment. Without a negative effect on the composition of the blood, the drug penetrates into all layers of the epidermis and has a detrimental effect on the colonies of Corynebacterium minutissimum and Malassezia furfur.

Pharmacokinetics

Due to the rapid rate of absorption of the active substance of the drug into the skin, the fastest possible effect on the cause of the disease occurs: the skin is cleansed, its surface is smoothed and functions are restored.

The breakdown products of the drug are eliminated by the kidneys. No negative effects on the body when the product is absorbed in the absence of increased sensitivity of the skin to the components of Clotrimazole.

The active substance can penetrate the tissues of the placenta and enter the fetus; for this reason, careful administration of Clotrimazole is required during pregnancy or when pregnancy is suspected. The drug can be used by pregnant women in cases where its benefits outweigh the likely negative consequences for the fetus. When breastfeeding, Clotrimazole is prescribed as needed; Before feeding, the mammary glands should be thoroughly wiped to avoid the drug entering the newborn’s body.

What, besides fungus, does Clotrimazole help with, this video will tell you:

Indications

Clotrimazole is prescribed for many lesions of the upper layer of skin. Due to the high activity of the active substance, it has a rapid effect on the foci of infection and a noticeable improvement in the condition of the skin within 1.5-2 weeks from the start of use of the product.

The drug is prescribed in the presence of the following diseases and conditions:

• skin infections that are caused by mold, yeast and other fungi, as well as dermatophytes and other types of pathogens;
• diseases that arise in the layers of the skin under the influence of excessively active reproduction of Corynebacterium minutissimum (erythrasma) and Malassezia furfur (variegated);
• for the treatment of inflammation;
• during treatment.

Usually the drug is recommended by a dermatologist, who, when drawing up a treatment regimen, takes into account the general condition of the body, the presence of hypersensitivity to the components of the drug, however, Clotrimazole is sold in pharmacies without the need to present a prescription, which allows it to be used independently in the presence of severe skin lesions. In this case, it is mandatory to carefully study the attached instructions.

Instructions

Before using the antifungal drug in question, you should thoroughly clean the surface of the affected skin using soap and plenty of water. The pH value should be neutral. After this, dry the skin and apply ointment (cream) to the affected areas, which is distributed evenly over it. The amount of ointment depends on the area of ​​the lesion.

After application, the ointment should be lightly rubbed in: this will allow it to be absorbed faster and increase the effect of the active substance. The first signs of improvement in skin condition usually begin to appear after 1.5-2 weeks from the start of treatment. Also, the final effect depends on the degree of skin damage and its sensitivity to the active substance.

After the first signs of improvement appear, it is recommended to continue using the drug for another two weeks to consolidate the effect.

Depending on the type of disease, the duration of treatment is prescribed:

• for lichen versicolor, the ointment is used for 1-3 weeks;
• for dermatomycosis of various origins - 3-4 weeks;
• When treating erythrasma, 2.5-4 weeks of using Clotrimazole is usually sufficient.

If a pronounced improvement in the condition of the skin has not occurred after 4 weeks of continuous use of the drug, you should inform your dermatologist about this and make adjustments to the proposed treatment regimen.

In the presence of liver or kidney dysfunction, the dose of the drug used does not change.

Contraindications

• Excessive sensitivity to the active substance of the drug or to its other components should be considered a contraindication to the use of Clotrimazole.
• Some caution should also be exercised when prescribing the drug during pregnancy and breastfeeding.

Side effects

The most common side effects when using Clotrimazole usually include:

special instructions

Pregnancy and breastfeeding are special cases in which special caution should be exercised when prescribing Clotrimazole. If there is greater benefit for the pregnant woman than the negative effect of the drug on the fetus, Clotrimazole can be prescribed, but it should be constantly monitored by a doctor.

Interaction with other drugs

Enhancing the antifungal effect of increased concentrations of propyl ester of hydroxybenzoic acid allows the use of these substances together without reducing the effect. However, Clotrimazole reduces the degree of exposure to nystatin, amphotericin, and natamycin.

When using Clotrimazole in significant concentrations on the affected areas of the skin, the degree of its effectiveness increases.

Clotrimazole

International nonproprietary name

Clotrimazole

Dosage form

Compound

100 g of cream contain

active substance - clotrimazole 1 g,

Excipients: cetostearyl alcohol, octyldodecanol, polysorbate 60, sorbitan stearate, synthetic spermaceti, benzyl alcohol, purified water.

Description

Homogeneous white mass

Pharmacotherapeutic group

Antifungal drugs for external use. Imidazole and triazole derivatives. Clotrimazole.

ATX code D01AC01

Pharmacological properties

Pharmacokinetics

After applying Clotrimazole cream to the skin, clotrimazole is absorbed by the epidermis. Higher concentrations of clotrimazole are found in the stratum corneum and spinosum of the epidermis, as well as in the papillae and reticular layer of the dermis. Clotrimazole is poorly absorbed through the skin and mucous membranes and has virtually no systemic effect.

Clotrimazole is metabolized in the liver to inactive substances excreted in urine and feces.

Pharmacodynamics

Mechanism of action

Clotrimazole inhibits cell growth and division. In small concentrations it acts fungistatically, in large concentrations it is fungicidal. The antimycotic effect of clotrimazole is associated with disruption of the synthesis of ergosterol, which is part of the cell membrane of fungi, and binding to phospholipids of the fungal cell wall.

Clinical studies have shown that the effect of using clotrimazole is similar to the effect of using imidazole derivatives - econazole and ketoconazole.

In the fungal cell, Clotrimazole also inhibits the biosynthesis of protein, fats, DNA and polysaccharides, destroys cellular nucleic acids and increases potassium loss. May inhibit enzyme activity and biosynthesis of triglycerides and phospholipids in the cell wall. At high concentrations, clotrimazole causes cell membrane damage through mechanisms independent of sterol synthesis.

Clotrimazole, used to treat infections caused by C. albicans, suppresses the transformation of the blastophore into its invasive form. Changes in the structure of the cell membrane lead to cell death. The degree of influence of the drug depends on the degree of susceptibility of the microorganism to clotrimazole.

Activity spectrum

Clotrimazole is characterized by a wide spectrum of antifungal and antimicrobial action, inhibits the growth and leads to the death of dermatophytes (Epidermophyton floccosum, Microsporum canis, Trichophyton mentagrophytes, Trichophyton rubrum), yeast-like fungi (Candida sp., Cryptococcus neoformans), dimorphic fungi ( Coccidioides immitis, Histoplasma capsulatum, Paracoccidicides brasiliensis) and protozoa (Trichomonas vaginalis).

Clotrimazole has an antimicrobial effect against gram-positive microorganisms: Streptococcus, Staphylococcus, Gardnerella vagiinalis and gram-negative microorganisms ( Bacteroides). Has no effect on lactic acid bacteria ( Lactobacilli).

In vitro clotrimazole inhibits reproduction Corynebacteria and gram-positive cocci - with the exception of enterococci - at a concentration of 0.5-10 μg/ml of substrate.

In vitro Clotrimazole has a broad fungistatic and fungicidal effect. Its effect on dermatophytes is similar to that of griseofulvin, and on organisms of the genus Candida - polyenes (amphothecin B and nystatin).

At concentrations below 1 μg/ml, clotrimazole inhibits most strains Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum And Microsporum canis.

At a concentration of 3 mcg/ml, clotrimazole inhibits the growth of most bacteria: Pitorosporum orbiculare, Aspergillus fumigatus, Candida species, including Candida albicans, some strains Staphylococcus aureus, Streptococcus pyogenis, and also some strains Proteus vulgaris And Salmonella. Clotrimazole is active against Sporotrix, Cryptococcus, Cephalosporium And Fusarium. Concentrations above 100 μg/ml are effective against Trichomonas vaginalis.

Clotrimazole-resistant strains are extremely rare; the only described strain with characteristic resistance is Candida guilliermondi.

No reports of resistance among clotrimazole-susceptible strains after culture Candida albicans And Trichophyton mentagrophytes. No resistance to clotrimazole was observed in strains C. albicans with resistance to polyene antibiotics.

Indications for use

Topical treatment of skin infections of the hands, feet, body, legs and legs caused by dermatophytes ( Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum And Microsporum canis)

Pityriasis versicolor caused by Malassezia furfur (Pityrosporum orbiculare or Pityrosporum ovale)

Yeast infections (including genus Candida And balanitis) skin and mucous membranes of the external genitalia (labia, foreskin)

Directions for use and doses

For external use only.

The cream is applied in a thin layer to the affected areas of the skin 2-3 times a day and gently rubbed in (the skin is first cleaned with neutral pH soap and blotted with a dry towel).

The duration of treatment is from 2 to 4 weeks and depends on the severity of the disease, the location of pathological changes and the effectiveness of therapy.

All infected areas should be treated at the same time.

To avoid relapses, it is recommended to continue therapy with Clotrimazole cream for at least 2 weeks after the symptoms of the disease disappear.

Duration of therapy

Treatment of dermatomycosis is carried out for at least 4 weeks.

Treatment of infections caused by Candida- at least 2 weeks.

Pityriasis versicolor is effectively treated when applied topically for 1-3 weeks.

If the symptoms of the disease do not decrease after 7 days of use, you should consult your doctor.

Side effects

The frequency of side effects of the drug is determined as follows:

Very often (≥1/10), often (≥1/100 and<1/10), нечасто (≥1/1000 и <1/100), редко (≥1/10000 и <1/1000), очень редко (<1/10000), неизвестно (недостаточно сведений для оценки).

Rarely

Allergic contact dermatitis, erythema

Allergic reactions (urticaria, shortness of breath, hypotension, fainting)

Itching, rash, blisters, peeling skin, discomfort/pain at the application site, burning, swelling, irritation

Contraindications

Hypersensitivity to the active substance or any component of the drug

Drug interactions

The drug may have a negative effect on latex contraceptives, damaging them and reducing their contraceptive ability. Patients should use alternative methods of contraception for at least five days after completion of therapy with Clotrimazole.

Intravaginal use of the drug Clotrimazole and the drug tacrolimus for oral administration (FK-506, an immunosuppressant) may lead to an increase in the level of tacrolimus in the blood plasma, and therefore patients should be closely monitored by a physician for symptoms of tacrolimus overdose and, if necessary, determination its concentration in plasma.

special instructions

The drug contains cetostearyl alcohol, which can cause local skin irritation (contact dermatitis).

Fertility

There have been no studies on the effect on human fertility, and data from animal studies have shown no effect on fertility.

Pregnancy

There is limited data on the use of clotrimazole in pregnant women. Animal studies do not indicate direct or indirect harmful effects associated with reproductive toxicity. As a precaution, it is preferable to avoid the use of clotrimazole during the first trimester of pregnancy.

Lactation period

Available pharmacodynamic/toxicological data in animals have shown the release of clotrimazole/metabolites into milk. Breastfeeding is not recommended during treatment with clotrimazole.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

Clotrimazole cream has no or negligible effect on the ability to drive a vehicle or operate potentially dangerous machinery.

Overdose

An overdose of the drug is unlikely due to the dosage form, the form of administration and the low absorption of clotrimazole.

Symptoms: In case of unintended oral use of the drug, dizziness, nausea, and vomiting may occur.

Treatment: there is no specific antidote. If necessary, symptomatic treatment.

Release form and packaging

20 g of cream are placed in aluminum tubes with an internal varnish coating, sealed with membranes and closed with screw-on plastic caps.

1 tube, along with instructions for use in the state and Russian languages, is placed in a cardboard pack.

Storage conditions

Store at a temperature not exceeding 25 ºС. Do not freeze.

Keep out of the reach of children!

Shelf life

Do not use after the expiration date.

Conditions for dispensing from pharmacies

Over the counter

Manufacturer/Packager

Registration Certificate Holder

GlaxoSmithKline Pharmaceuticals S.A., Poland

(189 Grunwaldzka Street, 60-322 Poznan)

Address of the organization that receives claims from consumers on the quality of products (goods) in the territory of the Republic of Kazakhstan and is responsible for post-registration monitoring of the safety of the medicinal product

Representative office of GlaxoSmithKline Export Ltd in Kazakhstan

050059, Almaty, Furmanov st., 273

Phone number: +7 727 258 28 92, +7 727 259 09 96

Fax number: + 7 727 258 28 90

E-mail address: [email protected]

Approved instructionsYuFor medical use, see also on the website www.dari.kz

A drug with a pronounced antifungal effect is Clotrimazole. Instructions for use indicate that suppositories, vaginal tablets, ointment, cream, gel and 1% solution are widely used in gynecology. Reviews from patients and recommendations from doctors report that this drug helps in the treatment of thrush (candidiasis) and other fungal and genital infections in men and women.

Release form and composition

Clotrimazole is available in the following forms:

• Vaginal tablets (Clotrimazole suppositories) containing 100 mg of the active substance - clotrimazole. 6 pieces in a blister.
• Antifungal ointment for external use. 1 g of ointment contains 10 mg of active substance. In tubes of 30 g.
• 1% Clotrimazole cream, applied externally, in tubes of 20 g.
• 2% vaginal cream, in tubes of 50 g; 1% solution for external use in orange bottles, 15 ml and 30 ml.

pharmachologic effect

The main active ingredient of the drug produces an antifungal effect against the following harmful bacteria:

• Sporothrix schenckii.

The drug has the highest penetrating ability. In addition to the antifungal effect, the drug produces antitrichomoniacal, antiamoebic and antibacterial effects.

What does Clotrimazole help with (ointment, suppositories, cream, gel)?

Indications for use of the drug include fungal diseases of the mucous membranes and skin and for mycoses of the skin folds and feet:

• Mycoses complicated by secondary pyoderma.
• Pityriasis versicolor.
• Microscopy.
• Dermatomycosis.
• Dermatophytosis.
• Athlete's foot.
• Erythrasma.

Superficial candidiasis, initiated by various types of fungi that are sensitive to clotrimazole.

• Candidiasis.
• Stomatitis.
• Genital infections and superinfections (in particular trichomoniasis and vulvovaginal candidiasis).
• Vaginal tablets (suppositories) are used to sanitize the birth canal before childbirth. Often, before operations on the genital organs, suppositories are used for prophylactic purposes to prevent infection.

Instructions for use

Vaginal tablets Clotrimazole instructions for use require inserting 1 vaginal tablet into the vagina as deeply as possible in the evening, lying on your back with slightly bent legs, daily for 6 days. A repeated course of treatment is possible after consulting a doctor.

In the presence of candidal vulvitis or candidal balanitis, it is recommended to simultaneously prescribe Clotrimazole in the form of a cream, applying it externally 2-3 times a day for 6-12 days to the affected areas.

Candles

For women and teenage girls (after the onset of sexual activity), vaginal suppositories are administered in the evening into the vagina, as deep as possible, in a supine position with slightly bent legs, 1 vaginal suppository of 100 mg daily for 6 days. A repeated course of treatment is possible after consulting a doctor.

Cream, ointment or gel

Apply a thin layer 2-3 times a day to previously cleansed (using soap with a neutral pH value) and dry affected skin areas and rub in gently. The duration of treatment depends on the severity of the disease, the location 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, it is recommended to continue therapy for at least 2 weeks after the symptoms of the disease have resolved.

Solution (can be used in adults and children). A few drops of the solution are applied in a thin layer to cleansed and dry affected and surrounding areas of skin 2 (morning and evening) and rub in thoroughly. After eliminating the acute symptoms of the disease, treatment should be continued for an average of about 4 weeks.

For tinea pedis, the drug should be used for another 2 weeks after all symptoms of the disease have resolved. It is recommended to use the solution after each foot wash.

Contraindications

The drug is not used if you are hypersensitive to its components. The drug is also not used to treat women in the first trimester of pregnancy. The drug can be used with extreme caution and only according to medical indications in the second and third trimesters of pregnancy and during breastfeeding.

Side effects

Allergic reactions.

When applied to the skin, the following side effects are possible:

• peeling;
• the appearance of blisters;
• burning;
• edema;
• skin irritation;
• erythema;
• tingling sensation.

Local use for urogenital mycoses may be accompanied by burning, itching, swelling and hyperemia of the mucous membrane, intercurrent cystitis, the appearance of vaginal discharge, increased urination, pain during sexual intercourse.

When applied topically for mycoses of the oral cavity, redness of the mucous membrane, tingling and burning sensation at the site of application of the drug, and irritation may be observed.

Children, pregnancy and breastfeeding

The use of the drug 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.

The use of 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 for the child.

Used externally in adults and children.

special instructions

To prevent urogenital reinfection, simultaneous treatment of sexual partners is necessary (can be used in the form of a solution in men). For trichomoniasis, for more successful treatment, other drugs with systemic effects (for example, metronidazole orally) should be used together with clotrimazole.

Drug interactions

When using vaginal suppositories, it is not recommended to douche the vagina, as this may suppress the effect of Clotrimazole.

The drug should not be prescribed to patients simultaneously with Nystatin or Natamycin, since this drug interaction significantly reduces the therapeutic effect of the drug.

Analogues of the drug Clotrimazole

Analogues are determined by structure:

1. Kanesten.
2. Imidyl.
3. Gine-Lotrimin.
4. Clotrimazole-Acri.
5. Yenamazole.
6. Amyclone.
7. Kandibene.
8. Lotrimin.
9. Faktodin.
10. Kanizon.
11. Antifungol.
12. Candizol.

Vacation conditions and price

The average price of Clotrimazole (vaginal tablets 100 mg No. 6) in Moscow is 24 rubles. The cost of ointment or cream is 95 rubles. Available without a prescription.

Store out of the reach of children at a temperature not exceeding +25 °C. Do not freeze. Shelf life: 3 years.

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