Phenobarbital without prescription. Medicinal reference book geotar. Release form, composition and packaging

P N001917/02

Trade name of the drug:

Clotrimazole-Akrikhin

International nonproprietary name:

clotrimazole

Dosage form:

ointment for external use

Compound

100 g ointment contains:
active substance: clotrimazole in terms of 100% substance - 1 g;
Excipients: propylene glycol - 12.5 g, methyl parahydroxybenzoate (nipagin) - 0.2 g, succinic acid - 0.5 g, sodium benzoate - 6 g, emulsion wax - 3 g, castor oil - 14 g, methylcellulose - 3 g, distilled monoglycerides -1.5 g, purified water - up to 100 g.

Description

Ointment white or almost white with a weak specific odor.

Pharmacotherapeutic group:

antifungal agent

ATX code:

D01AC01

Pharmacological properties

Pharmacodynamics.
An antifungal agent from the group of imidazole derivatives for external use, reduces the synthesis of ergosterol, which is integral part cell membrane of the microbial wall, and leads to a change in its structure and properties.

In small concentrations it acts fungistatically, and in large concentrations (more than 20 μg/ml) it is fungicidal, and not only on proliferating cells. At 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 spp., Pityrosporum orbiculare).

Pharmacokinetics.
It is poorly absorbed through the skin and mucous membranes and has virtually no systemic effect. Accumulates in the stratum corneum of the epidermis and penetrates the keratin of the nails. The concentration in the deep layers of the epidermis is higher than the minimum inhibitory concentration for dermatophytes.

Indications for use:

  • fungal diseases of the skin, including skin folds and feet, caused by dermatophytes, yeast (Candida spp.), mold and other fungi and pathogens sensitive to clotrimazole: dermatomycosis, dermatophytosis, trichophytosis, epidermophytosis, microsporia, candidiasis, interdigital fungal erosion, fungal paronychia;
  • mycoses complicated by secondary pyoderma, as part of complex therapy;
  • pityriasis versicolor, pityriasis versicolor, erythrasma.
  • Contraindications:

    Hypersensitivity to cpotrimazole or excipients, pregnancy (first trimester), children under 2 years of age.

    Carefully

    Lactation period, pregnancy (II and III trimester).

    Directions for use and doses

    Externally. For adults, in the absence of other prescriptions, it is recommended to apply the ointment 2-3 times a day in a thin layer to previously cleansed and dry affected areas of the skin. A single dose for a palm-sized surface area is a column of ointment 5 mm long. Regular use of the ointment is important for successful treatment.

    The duration of therapy is individual and depends on the severity and location of the disease. To achieve complete recovery, you should not stop treatment with ointment immediately after the disappearance of symptoms. acute symptoms inflammation or subjective complaints.

    The duration of therapy should average about 4 weeks.

    Pityriasis versicolor is usually cured within 1-3 weeks, and erythrasma within 2-4 weeks.

    In children over 2 years of age, the drug is used in the doses indicated above.

    Side effects

    Local reactions: burning, swelling, irritation and peeling of the skin, paresthesia, erythematous rashes, blistering.
    Allergic reactions: itching, urticaria.

    Overdose

    Low systemic absorption of the active component of the drug when applied externally makes overdose almost impossible.

    Interaction with other drugs

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

    special instructions

    Contact with the mucous membrane of the eyes should be avoided.
    In patients with liver failure, the functional state of the liver should be periodically monitored.
    If signs of hypersensitivity or irritation appear, treatment is stopped.
    If there is no effect within 4 weeks, the diagnosis should be confirmed.
    In children, avoid application to large surfaces.

    Release form:

    Ointment for external use 1%.
    20 g per aluminum tube. Each tube, along with instructions for use, is placed in a cardboard pack.

    Storage conditions

    In a dry place, protected from light, at a temperature not exceeding 15°C.
    Keep out of the reach of children.

    Best before date

    2 years. Do not use after the expiration date.

    Release from pharmacies:

    Over the counter.

    Manufacturer/Organization accepting consumer complaints:

    Open Joint Stock Company "Chemical and Pharmaceutical Plant "AKRIKHIN" (JSC "AKRIKHIN"), Russia
    142450, Moscow region, Noginsky district, Staraya Kupavna, st. Kirova, 29.

    Clotrimazole-Akrikhin (form - ointment) belongs to the pharmacological group of antifungal drugs for the treatment of skin diseases. Important features of the medicine from the instructions for use:

    • During pregnancy: contraindicated
    • When breastfeeding: with caution

    Package

    Clotrimazole-Akrikhin is a broad-spectrum antifungal drug.

    Release form and composition

    Clotrimazole-Akrikhin is available in two dosage forms:

    • vaginal tablets: almost white or white, biconvex, oval (in contour cell packs of 6 pcs., 1 pack in a cardboard pack);
    • ointment for external use 1%: almost white or white, with a weak specific odor (in aluminum tubes of 20 g, 1 tube in a cardboard box).

    1 vaginal tablet contains:

    • active substance: clotrimazole – 0.1 g;
    • auxiliary components: magnesium stearate, lemon acid, microcrystalline cellulose, potato starch, lactose (milk sugar).

    The composition of 1 g of ointment includes:

    • active substance: clotrimazole – 0.01 g;
    • auxiliary components: purified water – up to 1 g; distilled monoglycerides – 0.015 g; methylcellulose – 0.03 g; castor oil – 0.14 g; emulsion wax – 0.03 g; sodium benzoate – 0.06 g; succinic acid – 0.005 g; methyl parahydroxybenzoate (nipagin) – 0.002 g; propylene glycol – 0.125 g.

    Pharmacological properties

    Pharmacodynamics

    The effects of the drug Clotrimazole-Akrikhin, due to its constituent active substance(clotrimazole):

    • has an antimycotic effect associated with disruption of the synthesis of ergosterol contained in the cell membranes of fungi, which changes the permeability of the membrane and serves subsequent cell lysis;
    • has a fungistatic effect when used in small concentrations and a fungicidal effect when used in large doses, and not only in proliferating cells;
    • increases hydrogen peroxide concentrations to toxic levels (which also contributes to the destruction of fungal cells) through interaction with mitochondrial and peroxidase enzymes at fungicidal concentrations;
    • is active against the causative agent of erythrasma, pityriasis versicolor (Malassezia furfur), mold and yeast-like fungi, dermatophytes;
    • has antimicrobial activity against Trichomonas vaginalis, staphylococci and streptococci (Gram-positive bacteria), Bacteroides and Gardnerella vaginalis (Gram-negative bacteria).

    Pharmacokinetics

    Characteristics of clotrimazole:

    • absorption: absorption for intravaginal use is 3–10%; when used externally, it is poorly absorbed into the skin and mucous membranes, and has virtually no systemic effect;
    • distribution: for 48–72 hours its low concentrations in the blood and high concentrations in the vaginal secretion remain; when used externally, penetrates the keratin of nails and accumulates in the stratum corneum of the epidermis; in the deep layers of the epidermis its concentration is higher than the minimum inhibitory concentration for dermatophytes;
    • Metabolism: Rapidly metabolized in the liver to inactive metabolites.

    Indications for use

    Vaginal tablets

    • genital superinfections caused by clotrimazole-sensitive microorganisms;
    • genital infections caused by yeast-like fungi of the genus Candida and/or Trichomonas vaginalis (trichomoniasis, vulvovaginal candidiasis);
    • sanitation of the birth canal before childbirth.

    Ointment for external use

    • fungal paronychia, interdigital fungal erosion, candidiasis, microsporia, epidermophytosis, trichophytosis, dermatophytosis, dermatomycosis (caused by mold, yeast and other fungi, dermatophytes and pathogens sensitive to clotrimazole, fungal pathologies of the skin, including the feet and skin folds);
    • mycoses complicated by secondary pyoderma (as part of complex treatment);
    • pityriasis versicolor, erythrasma, pityriasis versicolor.

    Contraindications

    • menstruation period (for vaginal tablets);
    • age under 2 years (for ointment);
    • I trimester of pregnancy;
    • individual intolerance to the components contained in the drug.

    According to the instructions, Clotrimazole-Akrikhin is prescribed with caution in the following cases:

    • vaginal tablets: period breastfeeding;
    • ointment: II and III trimesters of pregnancy, lactation period.

    Instructions for use Clotrimazole-Akrikhin: method and dosage

    Vaginal tablets

    Clotrimazole-Akrikhin tablets are administered intravaginally, as deep as possible into the vagina, in a supine position with legs slightly bent at the knees, in the evening.

    Daily dose – 1 pc. Duration of therapy is 6 days, with possible repetition of the course as prescribed by the doctor.

    For the purpose of sanitizing the birth canal, 1 piece is administered once.

    Ointment for external use

    Clotrimazole-Akrikhin ointment is used externally: applied in a thin layer to previously cleansed and dried affected areas of the skin. Frequency of application – 2–3 times a day.

    A single dose of the drug when applied to an affected area the size of a palm is a column of ointment 5 mm long.

    To obtain a therapeutic effect, it is important to use the ointment regularly.

    The duration of treatment is determined by the doctor individually, taking into account the severity and location of the pathology.

    On average, Clotrimazole-Akrikhin is used for about 28 days.

    With pityriasis versicolor, 7–21 days of therapy are usually sufficient for recovery, with erythrasma – 14–28 days.

    In cases of fungal diseases of the skin of the legs, Clotrimazole-Akrikhin ointment is used for another 14 days after the symptoms have stopped.

    Side effects

    Vaginal tablets

    During the period of use of Clotrimazole-Akrikhin tablets, pain may occur during sexual intercourse, vaginal discharge, the development of intercurrent cystitis, frequent urination, gastralgia, headache, swelling, burning or itching of the vaginal mucosa, and in the sexual partner - a burning sensation in the penis.

    Ointment for external use

    • allergic reactions: urticaria, itching;
    • local reactions: blisters, erythematous rashes, paresthesia, peeling/irritation of the skin, swelling, burning.

    Overdose

    Vaginal tablets

    Main symptoms: in case of accidental oral ingestion - impaired liver function, gastralgia, vomiting, nausea, anorexia; rarely - allergic skin reactions, pollakiuria, hallucinations, drowsiness.

    Therapy: there is no specific antidote. Recommended admission activated carbon, symptomatic treatment (if necessary).

    Ointment for external use

    Since clotrimazole has low systemic absorption when used externally, overdose is practically impossible.

    special instructions

    In case of liver failure, the functional state of the liver is periodically monitored.

    Clotrimazole-Akrikhin is discontinued if signs of hypersensitivity develop.

    If there is no effect of therapy within 28 days, it is recommended to clarify the diagnosis.

    Vaginal tablets

    In order to prevent urogenital reinfection, simultaneous therapy of sexual partners is important.

    For trichomoniasis, for more successful treatment, the drug is used in combination with other systemic agents (for example, metronidazole for oral administration).

    In cases of simultaneous candidal vulvitis, local treatment with a cream containing clotrimazole is additionally carried out.

    During pregnancy, vaginal tablets are administered without an applicator.

    Ointment for external use

    When applying the ointment, it is important to avoid getting it into your eyes.

    In children, Clotrimazole-Akrikhin should not be applied to large areas.

    Use during pregnancy and lactation

    The drug is contraindicated for use in the first trimester of pregnancy.

    In the second and third trimesters of pregnancy, ointment for external use Clotrimazole-Akrikhin is used, observing precautions.

    Use the drug with caution during lactation.

    Use in childhood

    Clotrimazole-Akrikhin ointment is contraindicated in children under 2 years of age.

    Drug interactions

    Vaginal tablets

    Clotrimazole, when administered vaginally, reduces the activity of amphotericin B and other polyene antibacterial agents.

    The activity of clotrimazole may reduce nystatin.

    Ointment for external use

    The effectiveness of clotrimazole is reduced by natamycin, nystatin, and amphotericin B.

    Analogues

    Analogues of Clotrimazole-Akrikhin are: Exifin, Terbinox, Antifungol, Mikozolon.

    Terms and conditions of storage

    Store in a place protected from light and moisture, vaginal tablets - at temperatures up to 25 °C, ointment - up to 15 °C. Keep away from children.

    Best before date:

    • tablets – 3.5 years;
    • ointment – ​​2 years.
    Dosage form:  vaginal tablets Compound:

    1 vaginal tablet contains:

    active substance: clotrimazole in terms of 100% substance 100 mg;

    Excipients: lactose monohydrate, potato starch, microcrystalline cellulose, citric acid, magnesium stearate.

    Description: Tablets are white or almost white, oval, biconvex. Pharmacotherapeutic group:Antifungal agent ATX:  

    G.01.A.F.02 Clotrimazole

    Pharmacodynamics:

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

    Effective against dermatophytes, yeast-like and mold fungi, as well as the causative agent of lichen versicolor Pityriasis versicolor (Malazessia furfur) and the causative agent of erythrasma. Has an antimicrobial effect against gram-positive (staphylococci, streptococci) and gram-negative bacteria(Bacteroides, Gardnerella vaginalis), and also in relation to Trichomonas vaginalis.
    Pharmacokinetics:When using Clotrimazole-Akrikhin intravaginally, absorption is 3-10% administeredno dose. High concentrations in vaginal secretions and low concentrations in blood persist for 48-72 hours. In the liver it is quickly metabolized to inactive metabolites. Indications:

    Genital infections caused by yeast-like fungi of the genus Candida and/or Trichomonas vaginalis (vulvovaginal candidiasis, trichomoniasis);

    Genital superinfections caused by microorganisms sensitive to clotrimazole;

    WITH anation of the birth canal before childbirth.

    Contraindications:Hypersensitivity to clotrimazole or excipients in the first trimester of pregnancy. The use of tablets should be avoided during menstruation. Carefully:

    Lactation period.

    Pregnancy and lactation:In clinical and experimental studies, it was not found that the use of the drug during pregnancy or breastfeeding has bad influence 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. Directions for use and dosage:

    Locally.

    For intravaginal use only. Vaginal tablets are administered in the evening into the vagina, as deep as possible, in a supine position with slightly bent legs, daily for 6 days, 1 vaginal tablet of 100 mg. A repeated course of treatment is possible after consulting a doctor.

    For sanitization of the birth canal, a single administration of one tablet is recommended. Side effects:

    Itching, burning and swelling of the vaginal mucosa, vaginal discharge, headache, gastralgia, frequent urination, intercurrent cystitis, burning sensation in the penis of the sexual partner, pain during sexual intercourse.

    Overdose:

    The use of the drug in high doses does not cause any reactions or life-threatening conditions.

    In case of unintended use of the drug (orally), the following symptoms are possible: anorexia, nausea, vomiting, gastralgia, liver dysfunction; rarely - drowsiness, hallucinations, pollakiuria, allergic skin reactions.

    There is no specific antidote. Must be administered orally. If necessary, treatment is symptomatic.

    Interaction:

    When administered vaginally, Clotrimazole-Akrikhin reduces the activity of amphotericin B and other polyene antibiotics. At simultaneous use with nystatin, the activity of Clotrimazole-Akrikhin may decrease.

    Special instructions:

    To prevent urogenital reinfection, simultaneous treatment of sexual partners is necessary.

    For trichomoniasis, for more successful treatment, other drugs with systemic effects should be used in conjunction with Clotrimazole-Akrikhin (for example,metronidazole orally).

    In case of simultaneous infection of the labia and adjacent areas (candidal vulvitis), additional local treatment with a cream should be carried out.

    During pregnancy, treatment with vaginal tablets should be carried out without an applicator.

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

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

    If there is no effect within 4 weeks, the diagnosis should be confirmed. Release form/dosage:

    Vaginal tablets 100 mg.

    Package:

    6 tablets per blister pack.

    1 blister pack along with instructions for use is placed in a cardboard pack.

    Storage conditions:

    In a place protected from light, at a temperature not exceeding 25 ° C. Keep out of the reach of children.

    Clotrimazole-Acri ointment is an antifungal and antimicrobial agent. It is widely used for the treatment of gynecological, urological, and dermatological diseases. The active substance included in the product is active against various types bacteria and fungi. The drug is available in several forms, which is why it has a wide range of applications.

    Composition and release form

    "Clotrimazole-Acri" is available in various dosage forms, namely:

    • white vaginal tablets;
    • antifungal ointment;
    • cream for external use;
    • vaginal cream;
    • solution.

    This product contains the substance clotrimazole, as well as other auxiliary components that facilitate the process of applying the product to the mucous membranes and skin.

    What is it prescribed for?

    According to the instructions, Clotrimazole-Acri ointment destroys pathogenic cells. This remedy is especially effective against dermatophytes, mold and yeast-like fungi, as well as lichen. The ointment has an antimicrobial effect against various bacteria.

    According to the instructions, "Clotrimazole-Acri" is used in the presence of fungal diseases of the skin, mucous membranes and feet. This is very effective remedy, which begins to act almost immediately after application.

    Vaginal suppositories are used to cleanse the birth canal and prevent infection before surgery on the genitals.

    You can independently diagnose fungal damage by the presence of non-inflamed flaky spots on the skin that are pink, red, Brown accompanied by severe itching. On nail plates white stripes or spots appear. Over time, the nail becomes thinner and begins to crumble heavily. Candidiasis diaper rash is characterized by the presence of weeping areas on the surface of the skin with the appearance of a characteristic cheesy coating.

    Features of application

    According to the instructions for use, "Clotrimazole-Acri" in the form of a cream, solution or lotion is applied in a very thin layer to the skin and mucous membranes 2-3 times a day. The duration of therapy is approximately 4 weeks. After completing the course and eliminating the main symptoms of the disease, it is advisable to continue treatment for another 14 days.

    For fungal diseases, after obtaining the proper therapeutic effect, it is recommended to extend therapy for another 2-3 weeks.

    Vaginal cream or gel is administered in small portions of 5 grams into the vagina once a day for 3 days. The instructions for Clotrimazole-Acri tablets warn that they must be inserted deep into the vagina. The course of treatment depends on the dosage of the active substance. Additionally, you need to treat the external genitalia with a cream, solution or ointment. If necessary, the course of therapy can be repeated.

    In the case of systematic use of the drug, recovery occurs literally within a month from the start of treatment. Since the product acts exclusively on growing and dividing microorganisms, its use should be continued for another 2 weeks after the existing symptoms have disappeared.

    Features of use in men and women

    As written in the instructions, Clotrimazole-Acri ointment has a strong effect on yeast fungi, slowing down their growth and stopping reproduction. This drug is prescribed to women with thrush and helps eliminate:

    • burning;
    • redness in the genital area;
    • discharge.

    The product can be used during complex therapy to achieve a better result. The drug can be used during pregnancy and breastfeeding. Before using the ointment, it is advisable to douche with herbal infusions of chamomile, oak bark or calendula.

    The male body is more resistant to yeast fungi, so there are often no symptoms of the pathological process. However, if thrush is detected in a regular sexual partner, then both need to undergo treatment. Clotrimazole-Acri ointment is applied to the head of the penis and foreskin.

    In the presence of fungal diseases, this remedy is used externally in prescribed dosages. Gender differences do not affect the course of therapy. The therapeutic regimen will be the same for men and women.

    For lichen versicolor, the course of treatment is 5-7 days. For foot fungus, it is continued until the symptoms are completely eliminated. If there is severe peeling of the skin at the site of the lesion, it is initially recommended to remove the stratum corneum. Various ointments are used for this purpose.

    Application for children

    According to the instructions, "Clotrimazole-Acri" can be used in the form of an ointment, gel or solution in the treatment of diseases in children. This remedy is applied to the site of diaper rash or fungal infection. If the affected area is in skin folds, it is better to use the medicine in the form of a solution. The ointment contains sage oil, which acts as an antiseptic and helps eliminate severe itching and burning.

    The drug is applied at least 3 times a day for a month, including after the disappearance of the main signs of the disease. Treatment of diaper rash or fungal diseases in a child should be carried out under the strict supervision of a doctor to prevent relapses. It is important to remember that during the treatment of fungal diseases, the child’s skin folds must be dry at all times.

    Side effects and contraindications

    "Clotrimazole-Acri" has virtually no contraindications. This remedy should not be used in case of hypersensitivity to individual components, as well as in the first trimester of pregnancy. In the 2-3 trimesters and during breastfeeding, the drug is used with extreme caution and according to doctor’s indications.

    This remedy may cause various side effects, in particular:

    • with vaginal administration: itching, burning, swelling of the mucous membrane, vaginal discharge;
    • for external use: swelling, burning, peeling of the skin, rashes;
    • allergic reactions.

    To prevent re-infection with a urogenital infection, it is recommended that both partners undergo treatment at the same time. For trichomoniasis, together with the ointment, you need to take other medications that have a systemic effect.

    Analogues of the drug, reviews, price

    The price of Clotrimazole-Acri in the form of an ointment is 75 rubles, and the cost of vaginal tablets is 32 rubles. Since this remedy is not suitable for everyone, there are its analogues that have the same principle of action. Among them are:

    1. "Kanizon".
    2. "Candide".
    3. "Imidil."
    4. "Amiclone".
    5. "Canesten."

    Assign medicine only the doctor should. Reviews about "Clotrimazole-Acri" are only positive. According to consumers, this is a fairly effective remedy that helps quickly get rid of the manifestations of fungal diseases.

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