Clotrimazole 20 g 1% ointment for external use


How to take Clotrimazole

Recommended dose:

Clotrimazole cream is injected as deep as possible into the vagina once a day (preferably before bedtime) for 3 days without a break. A sufficient course of treatment with the cream is 3 intravaginal applications, according to the procedure described below. Additionally, a cream may be needed to relieve the external itching and burning sometimes associated with a vaginal yeast infection. Clotrimazole is for vaginal use only and should never be taken orally. The treatment course should not be carried out during the menstrual cycle. Treatment should be completed before the onset of menstruation. Although it is possible that sexual relations may occur during treatment with Clotrimazole, it is preferable for couples to wait until the end of the treatment course to prevent infecting your partner.

Applicator filling:

Remove the cap from the Clotrimazole tube, press and pierce the aluminum foil with the tube cap. To refill the applicator, screw the open end of the applicator barrel onto the threaded neck of the tube. Carefully begin squeezing the cream out of the tube. After this, the upward movement of the piston draws the required amount of cream into the applicator cylinder. As the applicator fills, the piston moves outward. When the plunger reaches its stop and stops, the proper amount of Clotrimazole has already been filled into the applicator and the applicator can be unscrewed from the tip of the tube. Close the cap and reserve the tube for the next use.

Insertion of the cream: Clotrimazole cream is inserted into the vagina in the same way as a tampon, standing, crouching or lying on your back, in a position convenient for you. Insert the filled applicator into the vagina. The depth of insertion depends on how comfortable you feel during insertion. Hold the applicator cylinder steady and insert the cream into the vagina, gently pressing the applicator piston until it stops. Inject the cream as deep into the vagina as possible, which will ensure the maximum effect of the drug. Remove the applicator.

Use for each procedure .

External use of the cream:

A small amount of Clotrimazole cream may be applied to the external opening of the vagina to provide additional relief from external symptoms. Squeeze a small amount of cream onto your finger and gently spread over the irritated vaginal area. The cream should be used once or twice a day and only during the period when external symptoms are present, no more than 7 days.

If you use more Clotrimazole than recommended

If you have used more Clotrimazole than recommended, consult your doctor immediately, contact the emergency and emergency department at your nearest hospital, even if there are no symptoms.

Possible side effects

If you develop a rash or new irritation while using the drug, stop using the drug and contact your doctor.

This is not a complete list of side effects. If unexpected side effects occur while using Clotrimazole, consult your doctor or pharmacist.

Side Effect Reporting:

If you notice any side effects, tell your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects by going to the website www.arpimed.com and filling out the appropriate form “Report a side effect or ineffectiveness of a drug” and to the Scientific Center for Expertise of Medicines and Medical Technologies named after. Academician E. Gabrielyan by going to the website www.pharm.am to the “Report a side effect of a drug” section and fill out the form “Card of reporting a side effect of a drug.” Scientific center hotline phone number: +37410237665; +37498773368

How to store Clotrimazole

Store at room temperature, dry and out of reach of children.

Shelf life – 3 years.

Package contents and additional information

What Clotrimazole contains

Each gram of Clotrimazole 2% vaginal cream contains:

active substance: clotrimazole – 20 mg;

other components: ceteareth-12, ceteareth-20, liquid paraffin, cetostearyl alcohol, methylparaben, propylparaben, propylene glycol, dimethicone, purified water.

What Clotrimazole looks like and contents of the pack

Homogeneous cream of smooth white color, odorless.

Description of packaging

50 g of vaginal cream in an aluminum tube along with 3 vaginal applicators and a leaflet in a cardboard pack. The capacity of one applicator is 6 g Clotrimazole 2% vaginal cream.

Vacation conditions

Dispensed by prescription.

Clotrimazole 20 g 1% ointment for external use

Instructions for use Clotrimazole 1% 20 g ointment for external use

Description of the dosage form

A homogeneous ointment of white or almost white color.

pharmachologic effect

Antifungal agent.

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, penetrates into the keratin of the nails. The concentration in the deep layers of the epidermis is higher than the minimum inhibitory concentration for dermatophytes.

Pharmacodynamics

An antifungal agent from the group of imidazole derivatives for external use. Clotrimazole reduces the synthesis of ergosterol, which is an integral part of the 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).

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.

Lichen versicolor, erythrasma.

Contraindications for use

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

With caution: lactation period, pregnancy (II and III trimester).

Use during pregnancy and children

The use of the drug in the first trimester of pregnancy is contraindicated. Clinical and experimental studies have not found that the use of the drug during pregnancy (II and III trimester) or during breastfeeding has a negative effect on the health of the woman or fetus (child). The question of the advisability of prescribing the drug should be decided individually after consulting a doctor.

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

Side effects

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

Allergic reactions: itching, urticaria.

If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Drug interactions

Nystatin, natamycin and amphotericin B reduce the effectiveness of clotrimazole when used simultaneously.

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

Dosage

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 and rub in gently. 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 the ointment immediately after the disappearance of acute symptoms or subjective complaints. The duration of therapy should average about 4 weeks.

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

For fungal diseases of the skin of the feet, it is recommended to continue therapy for about 2 weeks after the symptoms of the disease have subsided.

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

Overdose

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

Precautionary measures

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.

Impact on the ability to drive vehicles and operate machinery

The drug does not affect the ability to drive vehicles, operate machinery or engage in other hazardous activities that require special attention and quick reactions.

Clotrimazole

Read the instructions for use carefully before you start using the drug. Save the instructions, you may need them again. If you have any questions, consult your doctor. The medicine you are using is intended for you personally and should not be given to others as it may cause harm even if you have the same symptoms as you.

If allergic reactions or irritation occur at the injection site, treatment should be discontinued.

The drug should not be used during menstruation; it is advisable to start treatment after menstruation.

In case of simultaneous infection of the labia and adjacent areas (candidal vulvitis), additional local treatment with the drug clotrimazole in the dosage form of a cream, ointment, or gel should be carried out.

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

To prevent infection, simultaneous treatment of sexual partners is necessary. During the treatment period it is necessary to abstain from sexual intercourse. To prevent reinfection, hygiene rules should be observed.

If clinical signs of infection persist after completion of treatment, a repeat microbiological examination should be performed to clarify the diagnosis.

It is not recommended to use the drug if the following phenomena are observed:

  • Irregular bleeding from the genital tract, ulceration of the mucous membrane of the vulva and/or vagina, pain, irritation, swelling, rash, burning, itching, discomfort in the vagina;
  • Vaginal discharge with an unpleasant odor;
  • Fever (temperature 38° or higher) or chills;
  • Nausea, vomiting, diarrhea;
  • Lower abdominal pain;
  • Backache.

Before vaginal tablets are completely dissolved, normal humidity of the vaginal mucosa is required, otherwise undissolved parts of the tablet may crumble and come out. With vaginal dryness, women may notice the passage of undissolved pieces of pills. To prevent this, you should insert the tablet as deep into the vagina as possible before going to bed.

You should not use tampons, douche, use spermicides or other drugs for intravaginal use during treatment with this drug.

During treatment, it is recommended to use contraception. The risk of condom or diaphragm rupture increases when used simultaneously with the drug. It is necessary to use reliable methods of contraception.

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