Clotrimazole vaginal tablets 100 mg No. 6, Glaxo-Wellcome


Compound

Gel 1% contains clotrimazole at a concentration of 10 mg/g, propylene glycol, macrogol 400, carbomer , rectified ethyl alcohol 96% from food raw materials, glycerol , sage ethereal extract.
Cream composition 1%: clotrimazole at a concentration of 10 mg/g, cetostearyl and benzyl alcohols, polysorbate 60, synthetic spermaceti, octyldodecanol, sorbitan stearate, water.

Composition of the ointment 1%: clotrimazole at a concentration of 10 mg/g, polyethylene oxides 400 and 1500, propylene glycol, methylparaben, nipagin.

Composition of the 1% solution: clotrimazole at a concentration of 10 mg/ml (in terms of dry matter), polyethylene glycol 400, propylene glycol, ethanol 96%.

Composition of suppositories: one suppository contains 100 mg of active substance and base in the volume necessary to obtain a suppository weighing 2 g. Clotrimazole suppositories contain semi-synthetic glycerides as a base.

Composition of tablets: 100, 200 or 500 mg of clotrimazole, lactose in the form of monohydrate, potato starch, adipic acid, sodium bicarbonate, silicon dioxide in colloidal form, sodium lauryl sulfate.

Release form

  • gel 1% (pack of 20 and 40 g);
  • cream 1% (tubes 15, 20, 30 and 50 g);
  • ointment 1% (tubes 15, 20, 30 and 40 g);
  • 1% solution (15 ml bottles);
  • vaginal suppositories 0.1 g (package No. 6);
  • vaginal tablets 0.1, 0.2 or 0.5 g (packaging No. 1, No. 3, No. 6; tablets are equipped with an applicator).

Clotrimazole tablets and vaginal suppositories have an ATC code different from other dosage forms of the drug - G01AF02.

Clotrimazole can also be produced in the form of granules, powder for external use, or spray.

The drug is intended for local (including intravaginal) and external use; tablets for oral administration are not available.

Pharmacodynamics and pharmacokinetics

Clotrimazole is an imidazole .

In vitro, exhibits high activity against the most pathogenic fungi , which can cause serious infectious complications, namely:

  • dermatophytes (Microsporum sp., Epidermophyton floccosum, Trichophyton sp.);
  • yeast-like fungi (Cryptococcus neoformans, Candida sp.);
  • dimorphic fungi (Histoplasma capsulatum, Paracoccidicides brasiliensis, Coccidiodes immitis).

The mechanism of action of clotrimazole is based on its ability to block the synthesis of proteins, nucleic acids and ergosterol, which is necessary for the construction of cell membranes of fungi. As a result, the cell membranes of the fungi are damaged and the cells die.

At low concentrations, clotrimazole has a fungistatic effect. If the dose exceeds 20 mcg/ml, the drug has a fungicidal effect, and not only on proliferating cells.

When used in high doses, it helps to increase the concentration of hydrogen peroxide in the fungal cell to a toxic value and, as a result, destroys the fungal cells

When applied topically, the drug is absorbed by the epidermis . The highest concentration of the substance is determined in the reticuloderm . It is also able to penetrate the keratin of nails.

Clotrimazole enters the systemic circulation in very small quantities. Metabolized in the liver to inactive substances that are excreted from the body in feces and urine.

When administered intravaginally, 5 to 10% of clotrimazole is absorbed. The absorbed substance is metabolized in the liver. Metabolic products are excreted in bile.

Pharmacological properties of the drug Clotrimazole

Clotrimazole belongs to the group of imidazole antifungal drugs. The antimycotic effect is due to a disruption in the composition of the fungal cell membrane, a change in its permeability and subsequent cell lysis. Has a wide spectrum of action. Effective against dermatophytes and yeast fungi. In addition, it has an antimicrobial effect against gram-positive (staphylococci and streptococci) and gram-negative bacteria ( Bacteroides spp. , Gardnerella vaginalis ), as well as against Trichomonas vaginalis , Malassezia furfur , Corynebacterium minutissimum. Dosage forms of clotrimazole do not have a resorptive effect. When administered intravaginally, approximately 5–10% of clotrimazole is absorbed. The fungicidal concentration in the vagina remains for 3 days after application. The absorbed substance is metabolized in the liver and excreted in the bile.

Indications for use: what is Clotrimazole ointment, cream, gel, suppositories and tablets for?

What do Clotrimazole ointment, gel, cream and solution help with?

The drug is prescribed for the treatment of fungal infections of the skin , which are caused by molds and yeasts , dermatophytes and other pathogens sensitive to clotrimazole.

They are also used as remedies for lichen caused by Malassezia furfur and erythrasma (caused by Corynebacterium minutissimum).

Clotrimazole ointment, cream, gel and solution help: against nail fungus ( onychomycosis , fungal paronychia ), trichophytosis , dermatophytosis , fungal erosion and diaper rash, candidiasis , microsporia , athlete's foot , dermatomycosis , complicated by secondary pyoderma mycoses .

Indications for the use of ointment, gel, cream and solution include infectious diseases, pathogens that are resistant to nystatin and a number of other antifungal agents.

for the treatment of pityriasis rosea , since this disease is most likely of viral or infectious-allergic origin , and may also be the body’s response to a severe shock or nervous breakdown. Clotrimazole is effective against fungal infections .

The use of Clotrimazole ointment, gel and cream with Clotrimazole in gynecology is indicated:

  • for the treatment and prevention of thrush ;
  • for the prevention of repeated fungal infections of the female reproductive system , which develop during long-term treatment with antibiotics or against the background of immunodeficiency conditions.

Also, solution, gel, cream and ointment in gynecology are used to sanitize the genital tract before delivery.

Candles - what are they for?

The indication for the use of vaginal suppositories is vaginal candidiasis and genital superinfections caused by microorganisms sensitive to clotrimazole. The drug is prescribed to women and, after the onset of sexual activity, to teenage girls.

What are Clotrimazole tablets for?

Clotrimazole tablets are used to treat blastomycotic infections of the vulva and vagina . In particular, the drug is prescribed for vaginitis caused by fungi of the genus Candida (including diseases caused by strains resistant to nystatin ), caused by other pathogens sensitive to clotrimazole, superinfections of the genital organs , for sanitization of the genital tract before delivery.

Use of the drug

Clotrimazole cream is prescribed for the topical treatment of the following skin infections:

  • Tinea pedis, tinea cruris and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Floccosum Epidermophyton;
  • Candidiasis caused by Candida albicans;
  • Herpes zoster caused by Malassezia furfur;
  • Diaper rash infected with Candida Albicans;

In some drugs, clotrimazole can be combined with betamethasone dipropionate and corticosteroids.

The oral formulation is indicated as a prophylactic drug to reduce the incidence of oral and pharyngeal candidiasis in immunocompromised patients receiving chemotherapy, radiation therapy, or steroid therapy used to treat leukemia, cancer, or kidney transplantation. The drug is not indicated for the treatment of any systemic mycoses.

Side effects

Allergic reactions.

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

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

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.

Clotrimazole solution

Release form, composition and packaging

Cream 1% homogeneous, soft consistency, emulsion type, from white to almost white.

1 g clotrimazole 10 mg.

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

Clinical and pharmacological group

Antifungal drug for external use

pharmachologic effect

Clotrimazole is a broad-spectrum antifungal agent for topical use.

The antifungal effect is due to a disruption in the synthesis of ergosterol, which is part of the cell membrane of the fungus.

Has a wide spectrum of action. Fungistatic or fungicidal activity depends on the strains of microorganisms. Clotrimazole is active against dermatophytes, yeast-like and mold fungi, as well as the causative agent of pityriasis versicolor (Pityriasis versicolor) and the causative agent of erythrasma. Clotrimazole has an antimicrobial effect against gram-positive (Staphylococcus, Streptococcus) and gram-negative bacteria (Bacteroides, Gardnerella vaginalis), as well as against Trichomonas vaginalis.

Pharmacokinetics

Clotrimazole has penetrating ability and accumulates in the stratum corneum of the epidermis. When applied to nails, it is found in keratin.

When applied externally, clotrimazole is practically not absorbed into the systemic circulation through the skin, is absorbed to a small extent from the mucous membranes, the concentration of the drug in the lower layers of the epidermis significantly exceeds the minimum inhibitory concentrations of clotrimazole established in vitro for dermatophytes.

Indications for use of the drug

Treatment of fungal infections of the skin and mucous membranes caused by dermatophytes, molds and yeast-like fungi, including:

  • mycoses of the feet/hands, smooth skin of the torso, limbs, folds, beard area, mustache, scalp, caused by dermatophytes;
  • pityriasis versicolor;
  • erythrasma;
  • candidiasis of the skin, genital mucosa;
  • paronychia.

Dosage regimen

Clotrimazole is used externally 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.

Side effect

In rare cases, allergic reactions (urticaria, swelling, rash, erythema) and local reactions (burning, itching, irritation at the sites of application of the drug) are observed.

Contraindications to the use of the drug

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

Pregnancy and lactation

The use of the drug in the first trimester of pregnancy is not recommended.

Clinical and experimental studies have not found that the use of clotrimazole during pregnancy or breastfeeding has a negative effect on the health of the woman or fetus (child). However, the question of the advisability of prescribing the drug in the second and third trimesters of pregnancy should be decided individually after consulting a doctor.

Applying clotrimazole directly to the mammary gland during breastfeeding is not recommended.

special instructions

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.

It is not recommended to apply the drug to the skin in the eye area.

Drug interactions

Clotrimazole reduces the effect of polyene antibiotics (amphotericin, nystatin, natamycin, etc.).

Propyl ester of para-hydroxybenzoic acid in high concentrations enhances the antifungal effect of clotrimazole.

Dexamethasone in high doses inhibits the antifungal effect of clotrimazole.

Conditions for dispensing from pharmacies

The drug is approved for use as a means of OTC.

Storage conditions and periods

Store out of reach of children at temperatures from 2° to 30°C. Shelf life: 2 years.

Instructions for use of Clotrimazole: Clotrimazole for women and men

Clotrimazole ointment: instructions for use. How to apply Clotrimazole ointment for men?

Before applying Clotrimazole ointment (Acri or other manufacturers), the affected areas of the body are first washed with soapy water and dried thoroughly.

The drug is applied to the affected areas (covering small areas of healthy skin around the lesion) in a thin layer from 1 to 3 r./day. and rub lightly.

For 1 treatment of an area the size of a palm, a 5-mm strip of ointment is sufficient.

Regardless of what pathogen causes the disease, treatment after relief of subjective symptoms is recommended to continue for another 2 weeks.

For dermatomycosis, the course of treatment lasts from 3 to 4, for erythrasma - from 2 to 4, for lichen versicolor - from 1 to 3 weeks.

If there is no clinical improvement after 4 weeks of regular use of the drug, the patient is sent for a repeat microbiological study and the treatment regimen is revised.

The use of ointment for thrush in women helps block the spread of fungal cells and, when higher doses are prescribed, ensures their complete destruction. For therapeutic purposes, Clotrimazole for thrush is used 2 times a day, rubbing the ointment into the affected areas of the perineum.

Until the drug is absorbed, it is recommended not to wear underwear.

For men, the method of use for thrush and other fungal infections of the genital organs ( candidal balanoposthitis , urogenital candidiasis ) is the same as for women.

The ointment is applied to the foreskin and glans penis and gently rubbed into the skin and mucous membrane. Frequency of applications - 2 times/day.

The drug is poorly absorbed into the skin, and its active substance is characterized by the ability to gradually accumulate in the upper layer of the skin. Thanks to these properties, Clotrimazole ointment is highly effective for thrush in men and women.

Clotrimazole cream: instructions for use

The cream is intended for topical use. For thrush and other fungal diseases , apply it to the affected areas twice or thrice during the day and rub in lightly.

If mycoparasites affect the genitals, to treat thrush , the cream is prescribed simultaneously to both partners. For candidal balanitis or balanoposthitis, clotrimazole cream for men is used in the same way as ointment.

The duration of the course depends on the indications for use and ranges from 1-2 (for candidal balanitis/vulvitis ) to 3-4 weeks (for dermatomycosis ).

To prevent relapse of the disease, it is very important not to stop treatment for another 2 weeks after the subjective symptoms of infection disappear. If there is no improvement after 4 weeks of therapy, the patient should consult a doctor.

Vaginal cream Clotrimazole is administered into the vagina in portions of 5 grams 1 time per day. within 3 days.

Instructions for the solution

Before applying Clotrimazole, the skin should be washed with warm soapy water (especially the areas between the fingers) and dried well. The affected areas are treated 2-3 times a day. The amount of solution should be sufficient for uniform application to the entire affected surface.

If the skin of the feet is affected, liquid Clotrimazole solution must be applied after each wash.

The solution is the most preferred dosage form for onychomycosis . This is due to the fact that it has the best penetrating properties.

For fungal infections of the oral cavity, the affected areas of the mucous membrane are treated with a cotton swab or swab, onto which drops are first applied (10 to 20 drops are enough to treat each ear). Frequency of procedures - 3-4 rubles/day.

After applying Clotrimazole, you should refrain from eating and drinking for an hour.

Clotrimazole drops are also effective against onomycosis caused by yeast fungi. Drops are administered into the ear using turundas: a twisted cotton ball is moistened in the solution and 3-4 times a day. Place it in the ear canal for 5-10 minutes. Treatment lasts from 3 to 4 weeks.

Instructions for the gel

The method of using the gel is similar to the method of using the ointment. The product is applied to the epidermis affected by mycoparasites 2-3 times a day. and rub in with light movements.

The peculiarity of this dosage form is that the gel is well distributed on the skin and is also well absorbed into it. This allows the drug to be used for treating hard-to-reach areas of the body.

The gel is used intravaginally in the same way as clotrimazole cream: 1 r./day. 5 grams each. The course of treatment is 3 days.

Clotrimazole vaginal tablets: instructions for use

In the absence of other prescriptions, Clotrimazole Acri tablets and synonymous drugs for thrush and other fungal infections of the genital organs are used:

  • for 3 days, 1 tablet 2 times a day;
  • for 6 days, 1 tablet 1 time per day.

How to administer Clotrimazole vaginal tablets? Before administration, the tablet is removed from the package and moistened with chilled boiled water. The drug should be administered in the “lying on your back” position with your knees bent.

In order for the tablet to completely dissolve and clotrimazole to work, a moist environment is necessary (otherwise, undissolved particles may spill out). Therefore, the tablet is inserted into the vagina as deeply as possible. It is optimal to carry out the procedure before bedtime.

Treatment must be stopped before menstruation begins. Menstrual flow will wash away the drug and it will not have the desired effect. During treatment with vaginal tablets, you should not use tampons, spermicides, intravaginal douching or any other vaginal products.

To sanitize the genital tract before delivery, a woman is given a single dose of 200 mg of clotrimazole.

During pregnancy , the drug is contraindicated in the 1st trimester. At later stages, clotrimazole does not have an adverse effect on the development of the fetus, however, the use of the applicator may be associated with certain risks.

Instructions for candles

Suppositories for thrush are used intravaginally. The drug should be injected deep into the vagina, one dose daily for 6 days. A repeat course is possible after consulting a doctor.

Clotrimazole suppositories for thrush and other urogenital mycoses are not used during menstrual bleeding. Treatment must be completed before it begins.

During pregnancy, the drug in this dosage form is used from the 2nd trimester and in situations where the expected benefit to the mother outweighs the possible risks to the fetus.

Reviews allow us to conclude that the drug quickly destroys fungal colonies and eliminates the unpleasant symptoms of mycoses. Its other advantages include low price and a large selection of dosage forms.

Clotrimazole

Clotrimazole

(Latin
Clotrimazolum
, English
clotrimazole
) is a broad-spectrum antifungal drug, an imidazole derivative. Acts mainly on microorganisms in the stage of division and growth. Clotrimazole is poorly absorbed when taken orally, it cannot be administered parenterally and is used almost exclusively for the local treatment of diseases of the oral cavity, skin and gynecological diseases.

Clotrimazole is a chemical compound

The chemical name of clotrimazole is 1-[(2-chlorophenyl)diphenylmethyl]-1H-imidazole.
The empirical formula of clotrimazole is C22H17ClN2. Molecular weight 345 g/mol. White crystalline substance, odorless. Almost insoluble in water, slightly soluble in ether, very soluble in ethanol and polyethylene glycol 400.

Microorganisms against which clotrimazole is active or inactive

Mushrooms:

  • Clotrimazole is active against yeast fungi: Candida spp.
    (including
    Candida albicans
    and
    Candida glabrata
    (
    Torulopsis glabrata
    ) and excluding
    Candida guillermondii
    ),
    Rhodotorula spp., Malassezia furfur (Pityrosporum orbiculare), Blastomyces dermatitidis
  • active against dermatophytes: Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Arthroderma otae (Microsporum canis)
  • Clotrimazole resistant: Candida guillermondii

Bacteria:

  • clotrimazole has antibacterial activity in vitro against strains of gram-positive bacteria: Staphylococcus spp.
    (including
    Staphylococcus aureus), Streptococcus spp
    .
    (including Streptococcus pyogenes), Proteus vulgaris, Corynebacterium minutissimum, Salmonella spp.
  • clotrimazole is active against gram-negative (gram-variable) bacteria: Bacteroides spp., Gardnerella vaginalis
  • resistant to clotrimazole: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis
    and
    Pseudomonas aeruginosa

Protists: Clotrimazole in high concentrations is active against Trichomonas vaginalis
.

Clotrimazole in ATC

Clotrimazole is the international nonproprietary name (INN) of the drug. In ATC, clotrimazole is included in a number of different groups, each of which has its own code, in particular:

  • "A01 Dental preparations", "A01AB Antimicrobial preparations for local treatment of diseases of the oral cavity", code A01AB18
  • "D01 Antifungal drugs for the treatment of skin diseases", "D01AC Imidazole and triazole derivatives", code D01AC01
  • “G01 Antiseptics and antimicrobials for the treatment of gynecological diseases”, “G01AF Imidazole derivatives”, code G01AF02
Indications for use of clotrimazole

Clotrimazole is indicated for diseases of the skin, oral cavity, mucous membranes of the female and male genital organs with microorganisms sensitive to it:

  • fungal infections of the skin and mucous membranes: dermatomycosis, dermatophytosis, trichophytosis, epidermophytosis, microsporia, candidiasis, stomatitis, interdigital fungal erosion, fungal paronychia
  • candidiasis vulvitis, vulvovaginitis
  • balanitis, balanoposthitis
  • trichomoniasis
  • lichen: pityriasis versicolor or versicolor
  • erythrasma
  • mycoses complicated by secondary pyoderma
Order of use of clotrimazole and dose

Fungal skin infections, erythrasma, lichen
. Clotrimazole ointment, cream or solution is applied in a thin layer to the affected areas of the skin and mucous membranes 2-4 times a day and rubbed in gently. The duration of therapy is about 4 weeks, or until the clinical manifestations disappear and another 2 weeks (for fungal infections of the legs - 2-3 weeks).

In the treatment of oral

: 0.5–1 ml (10–20 drops) of clotrimazole solution, using, for example, a cotton swab, is applied to the affected areas of the oral mucosa 3-4 times a day.
At least 3-5 days of treatment; Duration of treatment: from 3 or more days until complete recovery.
Mild balanoposthitis

Balanitis, vulvitis

. 2-3 times a day for 1-2 weeks - clotrimazole ointment, cream or solution.

Vaginitis, trichomoniasis

. Vaginal tablets are inserted deep into the vagina, once a day, in the evening: either 6-7 days, 100 mg of clotrimazole, or 3 days, 200 mg of clotrimazole, or 1 day, 500 mg of clotrimazole. The cream, a full applicator, is inserted into the vagina as deeply as possible once a day, before bedtime.

Candidal esophagitis

. Clotrimazole 10 mg tablets, sucked every 6 hours (Harrison's Handbook of Internal Medicine).

Sanitation of the birth canal

- 1 tablet of clotrimazole once.

In the absence of clinical effect

within 4 weeks, a repeated study is required to determine the infectious agent.

Use of clotrimazole in pregnant and nursing mothers

The FDA risk category for the use of clotrimazole in pregnant women is B (animal studies have not revealed a risk of adverse effects on the fetus; there have been no adequate studies in pregnant women).
It is not recommended to use clotrimazole in the first trimester of pregnancy. In the II-III trimesters, it is not recommended to use intravaginal applicators. Since there are no reliable studies confirming or refuting the excretion of clotrimazole into breast milk, therapy with clotrimazole for nursing mothers is not recommended.

Trade names of drugs with the active substance clotrimazole

The following drugs with the active substance clotrimazole are (have been) registered in Russia: Amyclone, Antifungol, Gine-Lotrimin, Imidil, Yenamazol 100, Candibene, Candid, Candid-B6, Candizol, Kanesten, Kanizon, Clotrimazole, Clotrimazole-Acri, Clotrimazole-Teva , Lotrimin, Faktodin.
See also (pdf): “Instructions for use of the drug for medical use Clotrimazole-Teva.”

Clotrimazole has contraindications and side effects; before use, consultation with a specialist is necessary.

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Overdose

When applied to the skin and intravaginally, there is no risk of acute intoxication, since clotrimazole enters the systemic circulation in very small quantities.

In case of accidental ingestion of Clotrimazole, nausea, anorexia, vomiting, gastralgia, and liver dysfunction are possible. In rare cases, pollakiuria, hallucinations, drowsiness, and allergic skin reactions are observed.

In this case, the patient is prescribed enterosorbents and symptomatic treatment. Gastric lavage is performed in situations where a life-threatening dose was taken within the previous hour, as well as in the presence of visible symptoms of an overdose (nausea, dizziness, vomiting).

Clotrimazole cream 1% 20g No. 1

Name

Clotrimazole.

Release forms

Cream.

INN

Clotrimazole.

FTG

Antifungal agent.

Compound

1 g of cream contains: active substance: clotrimazole 0.01 g. excipients: benzyl alcohol, cetostearyl alcohol, octyldodecanol, polysorbate 60, sorbitan stearate, synthetic cetaceum (cetyl ester), purified water.

Description

Homogeneous mass of white color.

Pharmacotherapeutic group

Antifungal agents for external use. Imidazole and triazole derivatives. ATX code:

D01AC01

.

pharmachologic effect

Clotrimazole inhibits cell growth and division and, depending on the concentration, may have a fungistatic or fungicidal effect. Clotrimazole changes the permeability of cell membranes by disrupting the synthesis of ergosterol and binding to phospholipids of the fungal cell wall. Clinical studies have shown that topical treatment of infections with clotrimazole is as effective as the use of other imidazole derivatives, econazole and ketoconazole. Clotrimazole inhibits the synthesis of proteins, fats, DNA and polysaccharides, damages cellular nucleic acids and accelerates the excretion of potassium. It can also inhibit the activity of oxidases and peroxidases and the biosynthesis of triglycerides and phospholipids in fungi. At higher concentrations, clotrimazole causes damage to cell membranes through mechanisms independent of sterol synthesis. Clotrimazole prevents the transformation of Candida albicans blastospores into an invasive form of mycelium. A change in the activity of the cell membrane leads to cell death and depends on the degree of exposure of the drug to microbial organisms. Spectrum of activity Clotrimazole is characterized by a wide spectrum of activity. Clotrimazole inhibits the development and destroys dermatophytes (Epidermophyton floccosum, Microsporum canis, Trichophyton mentagrophytes, Trichophyton rubrum), yeast (Candida spp., Cryptococcus neoformans) and dimorphic fungi (Coccidioides immitis, Histoplasma capsulatum, Paracoccidioides brasiliensis). Clotrimazole is also active against some gram-positive (Streptococcus, Staphylococcus, Gardnerella vaginalis) and gram-negative (Bacteroides) microorganisms. In vitro, clotrimazole inhibits the proliferation of Corynebacterium and gram-positive cocci (except enterococci) at concentrations of 0.5-10 μg/ml. Clotrimazole has a wide spectrum of fungistatic and fungicidal activity in vitro. Its effect on the mycelium of dermatophytes (Trichophyton, Microsporum, Epidermophyton) is similar to the effect of griseofulvin, and its effect on budding fungi (Candida) is similar to the activity of polyenes (amphotericin B and nystatin). Clotrimazole at concentrations below 1 mcg/ml inhibits the development of most strains of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum and Microsporum canis. Clotrimazole at a concentration of 3 mcg/ml inhibits the development of most pathogens Pityrosporum orbiculare, Aspergillus fumigatus, Candida species, including Candida albicans, some strains of Staphylococcus aureus and Streptococcus pyogenes, as well as some strains of Proteus vulgaris and Salmonella. Clotrimazole is active against Sporothrix, Cryptococcus, Cefalosporium and Fusarium. Concentrations above 100 µg/ml are 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 development of resistance to clotrimazole in C. albicans strains resistant to polyene antibiotics due to chemical mutation.

Pharmacokinetics

When applied topically 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 papillary and reticular layers of the dermis, but clotrimazole enters the systemic circulation in small quantities. Clotrimazole is metabolized in the liver to inactive substances that are excreted from the body through the kidneys and intestines.

Indications for use

Clotrimazole cream is used for the local treatment of fungal skin diseases: arms and legs, trunk, legs and feet caused by the dermatophytes Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum and Microsporum canis; pityriasis versicolor caused by Malassezia furfur (Pityrosporum orbiculare or Pityrosporum ovale); - fungal infections of the skin and mucous membranes of the external genitalia (labia, foreskin and glans penis) caused by Candida vulvitis or Candida balanitis.

Contraindications

Hypersensitivity to clotrimazole or excipients of the drug.

Use during pregnancy and lactation

Pregnancy There are limited data on the use of clotrimazole during pregnancy. Animal studies have shown no direct or indirect effects on reproductive toxicity. As a precaution, the use of clotrimazole should be avoided during the first trimester of pregnancy. Lactation Available pharmacodynamic/pharmacokinetic data in animals indicate the release of clotrimazole/metabolites into milk. Breastfeeding should be discontinued during treatment with clotrimazole. Fertility No studies have been conducted on the effects of clotrimazole on human fertility. Animal studies show no effect on fertility

Directions for use and doses

For external use. The cream should be applied in a thin layer 2-3 times a day to previously cleansed (using soap with a neutral pH value) and dry affected areas for 2-4 weeks. The cream should be applied simultaneously to all affected areas. When applying the cream to the feet, they must be thoroughly washed, dried, and then applied to the areas between the toes. Patients should contact their doctor again if symptoms do not improve after 7 days of treatment.

Side effect

The frequency of occurrence of adverse reactions is determined as follows: very often (≥ 1/10), often (from ≥ 1/100 to

Overdose

When using the drug externally, an overdose is unlikely. The use of clotrimazole in high doses does not cause any reactions or life-threatening conditions. The drug is not intended for oral administration. If the cream is accidentally taken orally, anorexia, nausea, vomiting, abdominal pain, and impaired liver function are possible; rarely drowsiness, hallucinations, frequent urination, allergic skin reactions. In this case, it is necessary to perform gastric lavage and prescribe activated charcoal. If you accidentally get the cream into your eyes or mouth, rinse them immediately with water and consult a doctor as soon as possible. If you swallow the cream, you should immediately consult a doctor.

Interaction with other drugs

Clotrimazole applied topically to the mucous membranes of the external genitalia may damage contraceptives made from latex (condoms and pessaries), and thereby reduce their effectiveness. Therefore, patients should use an alternative means of contraception during treatment with clotrimazole and for at least 5 days after its completion.

Impact on the ability to drive a car and operate machinery

Clotrimazole does not have or has an extremely insignificant effect on the ability to drive a car and use machinery.

Precautionary measures

Avoid applying the drug to the skin in the eye area. Do not swallow. All potentially infected skin areas must be treated at the same time. Propylene glycol contained in the cream may cause skin irritation. Due to the presence of cetostearyl alcohol in the composition of the drug, the drug may cause local skin reactions (for example, contact dermatitis).

Package

Cream for external use 1%. 20 g of cream in an aluminum tube coated with varnish on the inside. 1 tube along with instructions for use in a cardboard box.

Best before date

3 years. Do not use after expiration date.

Storage conditions

At temperatures below 25 °C, out of the reach of children. Do not freeze.

Release from pharmacies

Over the counter.

Buy Clotrimazole cream 1% 20g No. 1 in the pharmacy

Price for Clotrimazole cream 1% 20g No. 1

Instructions for use for Clotrimazole cream 1% 20g No. 1

special instructions

Avoid ingestion and contact with eyes.

For mycoses, all affected areas of the body should be treated simultaneously.

The use of vaginal tablets, unless otherwise advised by a doctor, is contraindicated in the presence of any of the following symptoms:

  • acyclic vaginal bleeding;
  • bloody discharge or pathological bleeding from the vagina, uterine hemorrhages;
  • dysuria;
  • lower abdominal pain;
  • open sores, blisters, or sores of the vagina or vulva;
  • any unpleasant symptoms that are associated with the use of Clotrimazole (irritation, redness, burning, swelling, etc.);
  • chills or fever with a temperature above 38°C;
  • nausea and/or vomiting;
  • vaginal discharge with an unpleasant odor;
  • diarrhea;
  • pain in the shoulder or back.

To prevent reinfection, treatment is prescribed to both partners simultaneously. The optimal dosage form for men is cream.

For trichomoniasis, in addition to the drug, chemotherapeutic agents are prescribed for systemic treatment ( metronidazole orally).

Which is better, Clotrimazole ointment or cream?

The choice in favor of one or another dosage form is made depending on the indications. Clotrimazole ointment for women and men is prescribed for diseases that are accompanied by increased dryness and flaking of the skin.

As a rule, these are skin mycoses caused by dermatophytes ( trichopytosis , microsporia ), athlete's foot inguinal , erythrasma , pityriasis versicolor , isolated cases of smooth skin candidiasis , mixed bacterial-fungal infections .

For weeping inflammatory processes, it is more advisable to use a cream that has a drying effect.

Clotrimazole vaginal tablets 100 mg No. 6, Glaxo-Wellcome

A country

Poland
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.

Active substance

Clotrimazole

Compound

lactose monohydrate - 1122.2 mg, potato starch - 180 mg, adipic acid - 140 mg, sodium bicarbonate - 110 mg, magnesium stearate - 31.3 mg, colloidal silicon dioxide - 12.3 mg, sodium lauryl sulfate - 4.2 mg.

pharmachologic effect

Clotrimazole inhibits the growth and division of microorganisms and, depending on the concentration, can have a fungistatic or fungicidal effect. The mechanism of action of clotrimazole is associated with a change in the permeability of cell membranes due to the effect on the synthesis of ergosterol and binding to phospholipids of the fungal cell wall. Clotrimazole inhibits the synthesis of proteins, fats, DNA, polysaccharides, damages nucleic acids in fungal cells and accelerates the excretion of potassium. It can also inhibit the activity of oxidative and peroxidant enzymes and the biosynthesis of triglycerides and phospholipids in fungal cells. At higher concentrations, clotrimazole causes damage to cell membranes by mechanisms independent of sterol synthesis. Clotrimazole prevents the transformation of Candida albicans blastospores into invasive forms of mycelium. A change in the activity of the cell membrane leads to cell death, and this process depends on the contact of the drug with microbes. Clotrimazole is characterized by a wide spectrum of antifungal and antibacterial activity. It is active against: 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). Clotrimazole is also active against some gram-positive bacteria. In vitro, clotrimazole is characterized by a wide spectrum of fungistatic and fungicidal activity. It affects the mycelium of dermatophytes (Trichophyton, Microsporum, Epidermophyton) similarly to griseofulvin, its effect on budding yeast-like 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.

Indications for use

- vaginitis caused by fungi of the genus Candida; - infections of the genital organs caused by fungi of the genus Candida, incl. infections caused by strains resistant to nystatin; - superinfections of the genital organs caused by other pathogens sensitive to clot

Mode of application

For intravaginal use. Prescribe 1 tablet. 2 times a day for 3 days or 1 tablet. 1 time/day for 6-7 days, preferably before bedtime. If there is no effect within 3 days, the diagnosis should be confirmed. If symptoms persist for more than 7 days, medical supervision is necessary. Treatment can be repeated if necessary, but recurrent infections may indicate an underlying pathology, including diabetes mellitus or HIV infection. If symptoms recur within 2 months, the patient should consult a doctor. In case of simultaneous infection of the vulva and adjacent areas, external treatment using a cream is necessary. For complete dissolution of vaginal tablets, normal humidity of the vaginal mucosa is required. In women with vaginal dryness, undissolved parts of the tablet may come out. To prevent this, it is necessary to insert the tablet as deeply as possible into the vagina before bed. Treatment during menstruation is not recommended due to the risk of tablet washout and should be completed before menstruation. To sanitize the birth canal, take 1 tablet once immediately before childbirth. For children over 12 years of age, the method of application is the same as for adults. Clotrimazole vaginal tablets are not recommended for use in children under 12 years of age. A repeated course of therapy is possible in accordance with medical indications. The use of clotrimazole during pregnancy is allowed only if the expected benefit to the mother outweighs the potential risk to the fetus. In the conducted epidemiological studies, which included a retrospective analysis, the use of clotrimazole during pregnancy (even in the first trimester) did not reveal any undesirable effects on the pregnant woman’s body, as well as birth defects and undesirable effects in the fetus. The use of clotrimazole in women during breastfeeding is allowed only if the expected benefit to the mother outweighs the potential risk to the child. Fertility No data available.

Interaction

Laboratory data indicate that the use of contraceptives containing latex may cause damage when used together with Clotrimazole. Consequently, the effectiveness of such contraceptives may be reduced. Patients should be advised to use alternative methods of contraception for at least five days after using Clotrimazole. Concomitant use of vaginal clotrimazole and oral tacrolimus (FK-506; an immunosuppressant) may result in increased tacrolimus plasma concentrations. Patients should be closely monitored for symptoms of tacrolimus overdose, with drug concentrations measured if necessary. Amphotericin B, nystatin, natamycin reduce the effectiveness of clotrimazole when used simultaneously.

Side effect

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 determined as follows: very often (≥1/10), often (≥1/100 and From the immune system: unknown - allergic reactions (urticaria, fainting, arterial hypotension, shortness of breath). From the gastrointestinal tract: unknown - pain in abdomen. From the genital organs and mammary gland: unknown - discomfort in the vulva and vagina, hyperemia and swelling of the vaginal mucosa, vaginal discharge, burning, peeling, irritation, itching, pain in the pelvic area, burning sensation in the penis sexual partner, pain during intercourse, rash. If these symptoms appear, clotrimazole therapy should be stopped. From the nervous system: unknown - headache. From the kidneys and urinary tract: unknown - frequent urination, intercurrent cystitis.

Contraindications

- hypersensitivity to clotrimazole or other components of the drug; - age up to 12 years; - period of menstruation. With caution At the first case of candidal vaginitis, you should consult your doctor. If any of the following factors are detected before prescribing Clotrimazole vaginal tablets, you should consult your doctor: - more than two episodes of candidal vaginitis in the previous 6 months; - a history of sexually transmitted diseases or contact with a partner with a sexually transmitted disease; - proven or suspected pregnancy; — age over 60 years; - a history of hypersensitivity to imidazoles or other antifungal drugs for vaginal use.

Overdose

Symptoms: dizziness, nausea, vomiting. Treatment: In case of accidental ingestion, symptomatic treatment should be carried out.

special instructions

Avoid contact with eyes and ingestion. It is recommended to treat all affected areas of the body simultaneously. Clotrimazole vaginal tablets should not be used if you have any of the following symptoms unless otherwise advised by your doctor: - irregular vaginal bleeding; - abnormal vaginal bleeding, uterine hemorrhages or bloody vaginal discharge; - sores, blisters or open wounds of the vulva or vagina; - pain in the lower abdomen or dysuria; - any undesirable effects, such as redness, irritation, swelling associated with treatment; - fever (temperature 38°C or higher) or chills; - nausea or vomiting; - diarrhea; - vaginal discharge with an unpleasant odor; - backache; - pain in the shoulder area. To prevent reinfection, simultaneous treatment of sexual partners is necessary. The effect on the ability to drive vehicles and operate machinery has not been studied.

Storage conditions

Room temperature

Clotrimazole analogs

Level 4 ATC code matches:
Daktarin

Oronazole

Isoconazole

Kandibene

Miconazole

Candide B

Nizoral

Kanesten

Mifungar

Ecodax

Econazole

Travogen

Bifonazole

Sebozol

Mycozolon

Mycozoral

Travocort

Mycospor

Mycospor Set

Dermazol

Synonyms of dosage forms for external use: Clotrimazole -Acri , Amyclone , Imidil , Candibene , Candizol Candide , Kanesten , Kanizon , Funginal , Funugitsip .

Vag analogues. tab.: Candide , Imidil , Candizol , Candibene , Funginal , Candide-B6 , Kanizon , Fungitsip .

Which is better: Candide or Clotrimazole?

Candida is synonymous with Clotrimazole. The basis of both drugs is the same substance, so there are no fundamental differences between them.

Clotrimazole or Pimafucin - which is better?

The main component of Pimafucin is the antimycotic antibiotic nitamicin . Sensitivity to the drug is predominantly caused by molds and yeasts (including the genera Penicillium, Candida, Cephalosporium, Aspergillus and Fusarium).

Less sensitive to Pimafucin are Pseudoallescheria boydii and dermatophytes . That is, in situations where the cause of the disease is fungi of the genus Epidermophyton, Trichophyton or Microsporum, the choice should be made in favor of the drug Clotrimazole.

The use of Clotrimazole is less often accompanied by hypersensitivity reactions. In addition, it is less likely than Pimafucin to provoke imbalances in the microflora of the genital organs.

Clotrimazole during pregnancy and lactation

Cream, gel, ointment, solution, suppositories and vag. tablets during pregnancy can be used from the 2nd trimester.

Strictly controlled studies regarding the safety of use during pregnancy; therefore, Clotrimazole is not prescribed in the 1st trimester.

Clinical studies regarding the effect of the drug on fertility in women have not been conducted; no adverse effects were detected in animal experiments.

Clotrimazole tablets and suppositories during pregnancy (in the 2nd and 3rd trimesters) do not have a negative effect on the fetus, but using the applicator can be dangerous.

When breastfeeding, the drug is used with caution, since it is unknown whether it passes into milk.

Gel, solution, cream and ointment Clotrimazole during pregnancy is applied to the skin affected by mycoparasites 2-3 times a day. If vaginal tablets are prescribed, they should be administered without an applicator. The duration of the course depends on the localization of pathological changes, the severity of the disease and the effectiveness of treatment.

Reviews indicate that in most cases the drug is well tolerated, and adverse reactions due to its use occur very rarely.

Reviews of Clotrimazole

Solution, ointment, cream, gel, suppositories and vaginal tablets Clotrimazole - reviews are eloquent confirmation of this - this is a time-tested, inexpensive and very effective remedy for nail and skin , as well as for urogenital mycoses .

In addition, the drug is effective against age spots .

Reviews of Clotrimazole suppositories on the forums are mostly as follows: “It’s the only thing I use to treat thrush . The product is cheap, but it helps a lot. No side effects.”

Important features of Clotrimazole, which are taken into account when prescribing it, are the possibility of:

  • the use of suppositories, tablets, ointments, solutions, gels and creams for thrush during pregnancy;
  • prescribing creams and ointments for the preventive treatment of a woman’s sexual partner.

No less good reviews from men about Clotrimazole ointment and reviews about the cream. The only drawback of the drug, men sometimes note, is that it should be used for a long time.

Clotrimazole price

The price of Clotrimazole in suppositories in Ukraine is 14 UAH for package No. 6, while the price in different cities - Kharkov, Kyiv or Odessa - is practically the same. In Russia, the price of suppositories with clotrimazole starts from 35 rubles.

The price of Clotrimazole ointment in Ukraine is from 7 UAH, in Russia you can buy ointment for 65-72 rubles. For Clotrimazole vaginal tablets, the price varies from 12 to 17 UAH in Ukrainian, and from 17 to 75 rubles. in Russian pharmacies (how much the drug costs depends on which company produces it).

The average price of the solution is 13.5 UAH. In Russia, drops can be bought for 12-140 rubles. The cost of the spray is about 28 UAH.

  • Online pharmacies in RussiaRussia
  • Online pharmacies in UkraineUkraine
  • Online pharmacies in KazakhstanKazakhstan

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