Clotrimazole, Vaginal tablets 100mg, 6pcs

Composition

Composition for 1 tablet:

Name of components Quantity, mg

Active Subtractionclotrimazole 100.0

Excipients Galactose monohydrate 1122.2 Potato starch 180.0 Adipic acid 140.0 Sodium bicarbonate 110.0 Magnesium stearate 31.3 Colloidal silicon dioxide 12.3 Sodium lauryl sulfate 4.2 Total mass of the dosage unit 1700.0

Pharmacological action

Antifungal agent.

ATX code:

G01AF02.

Pharmacological properties

Pharmacodynamics

Clotrimazole is a broad-spectrum antifungal agent for topical use. The antifungal effect of clotrimazole (a derivative of imidazole) is associated with a violation of the synthesis of ergosterol, which is part of the fungal cell membrane, which changes the membrane permeability and causes subsequent cell lysis. In low concentrations, it acts fungistatically, in high concentrations-fungicidal, and not only on proliferating cells. In fungicidal concentrations, it interacts with mitochondrial and peroxidase enzymes, resulting in an increase in the concentration of hydrogen peroxide to a toxic level, which also contributes to the destruction of fungal cells.

It is effective against dermatophytes, yeasts, molds and protozoa. It has an antimicrobial effect against gram-positive bacteria (Streptococcus spp., Staphylococcus spp. ) and anaerobes (Bacteroides spp., Gardnerella vaginalis). Clotrimazole has no effect on lactobacilli.

Under in vitro conditions, clotrimazole at a concentration of 0.5-10 mcg/ml suppresses the reproduction of Corinebacteria bacteria and gram-positive cocci (with the exception of enterococci); at a concentration of 100 mcg/ml, it has a trichomonacid effect.

Pharmacokinetics

Suction

With vaginal use of clotrimazole, absorption is 3-10% of the administered dose. High concentrations in the vaginal secretions and low concentrations in the blood persist for 48-72 hours.

Metabolism

Clotrimazole is metabolized in the liver to inactive substances that are excreted from the body by the kidneys and through the intestines.

Indications

• genital infections caused by yeast-like fungi of the genus Candida (candida vulvovaginitis).

If necessary, please consult your doctor before using the medicine.

Use during pregnancy and lactation

Fertility

Studies of the effect of clotrimazole on fertility in humans have not been conducted, in animal studies, the effect of the drug on fertility was not found.

Pregnancy

Data on the use of the drug in pregnant women are limited. In the course of clinical and experimental studies, it was not established that the use of the drug during pregnancy has a negative effect on the health of the woman or fetus. Clotrimazole in the form of vaginal tablets is contraindicated for use in the first trimester of pregnancy. The question of whether to use the drug in the second and third trimesters of pregnancy should be decided individually after consulting a doctor.

Breast-feeding period

Available data from pharmacodynamic and toxicological studies in animals indicate the excretion of clotrimazole and its metabolites in milk. Breast-feeding should be discontinued during clotrimazole treatment.

Contraindications

• Hypersensitivity to clotrimazole or other components of the drug;
• age up to 12 years;
• period of menstruation;
• first trimester of pregnancy.

With caution

• , the period of breastfeeding.

Side effects

The frequency of occurrence is determined as follows:  very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10000 and <1/1000), very rare (<1/10000, including isolated cases), unknown (cannot be estimated from available data).

Immune system disorders

Unknown: allergic reactions with symptoms such as hives, syncope, hypotension, shortness of breath.

Disorders of the gastrointestinal tract

Unknown: abdominal pain.

Genital and breast disorders

Unknown: itching, burning, hyperemia and swelling of the vaginal mucosa, ulceration of the vaginal mucosa, rash, pelvic pain.

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

Interaction

When administered vaginally, clotrimazole reduces the activity of amphotericin B and other polyene antibiotics. When used concomitantly with nystatin, clotrimazole activity may decrease. Concomitant use of clotrimazole intravaginally and tacrolimus, sirolimus orally may lead to an increase in the concentration of the latter in the blood plasma, so patients should be monitored for the development of symptoms of their overdose and, if necessary, measure their plasma concentrations.

How to take, course of use and dosage

Adults and children over 12 years of age

For intravaginal use. Vaginal tablets are inserted into the vagina, as deep as possible, in a supine position with slightly bent legs, daily 1 tablet 2 times a day for 3 days or 1 tablet 1 time a day for 6-7 days (in the evening before going to bed).

If symptoms persist for more than 7 days, it is recommended to consult a doctor. A second course of treatment is possible after consulting a doctor.

If symptoms recur within 2 months, the patient should consult a doctor.

Use the drug only according to the method of application and in the doses indicated in the instructions for use. If necessary, please consult your doctor before using the medicine.

Special patient groups

Children

For children over 12 years of age, the method of use and dosage are the same as for adults. The drug Clotrimazole, vaginal tablets should not be used in children under 12 years of age.

Elderly patients

Insufficient data.

Patients with impaired renal function

Insufficient data.

Patients with impaired liver function

Insufficient data.

Overdose

Symptoms

Dizziness, nausea, vomiting.

Treatment

There is no specific antidote. In case of accidental ingestion, symptomatic treatment should be carried out

Description

White biconvex tablets with a chamfer, oblong shape, rounded at one end and flat at the other.

Special instructions

Please 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, contact your doctor. The medicine you are being treated with is intended for you personally, and it should not be passed on to others, as it can cause harm to them even if you have the same symptoms as you do.

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 (candida vulvitis), local treatment with clotrimazole in the dosage form of cream, ointment, gel should be additionally 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 recommended to refrain from sexual contact. To prevent reinfection, follow good hygiene practices.

If clinical signs of infection persist after treatment is completed, a second 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, rashes, burning, itching, discomfort in the vagina;
• a vaginal discharge with an unpleasant odor;
• fever (temperature of 38° C or higher) or chills;
• nausea, vomiting, diarrhea;
• abdominal pain;
• back pain.

For complete dissolution of vaginal tablets, normal moisture of the vaginal mucosa is required, otherwise the undissolved parts of the tablet may crumble and stand out. With vaginal dryness, women may notice the excretion of undissolved pieces of pills. To prevent this, it is necessary to inject the tablet deep into the vagina, as far as possible, before going to bed.

Do not use tampons, douching, spermicides or other intravaginal medications during treatment with this drug.

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

Influence on the ability to drive vehicles and mechanisms

There are no data on the negative effect of the drug on the ability to perform potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions (driving vehicles, working with moving mechanisms).

Form of production

Vaginal tablets,100 mg. 6 tablets in a blister of PVC / aluminum foil,1 blister together with the instructions for use in a cardboard pack with the control of the first opening.

Storage conditions

Store at a temperature not exceeding 25°C. Keep out of reach of children.

Shelf

life is 3 years. Do not use after the expiration date indicated on the package.

Active ingredient

Clotrimazole

Dosage form

vaginal tablets

Purpose

Adults, For women, Pregnant women in the second and third trimester as prescribed by a doctor, Nursing mothers

Indications

From inflammation of the female genital organs, From thrush