Clotrimazole vaginal tablets 100mg, No. 6 Akrihin

- 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;
- sanitation of the birth canal before childbirth.

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

For the sanitation of the birth canal, a single administration of one tablet is recommended.

1 vaginal tablet contains:
active substance: clotrimazole 100 mg,
excipients: milk sugar (lactose), potato starch, microcrystalline cellulose, citric acid, magnesium stearate.

Hypersensitivity to clotrimazole or excipients,

In the first trimester of pregnancy.

The use of tablets during menstruation should be avoided.

With care - lactation period.

Trade name of the drug:

Clotrimazole-Akrikhin

International Non-Proprietary Name (INN):

clotrimazole

Dosage form:

vaginal pills

Composition.

1 vaginal tablet contains:
active substance: clotrimazole 100 mg,
excipients: milk sugar (lactose), potato starch, microcrystalline cellulose, citric acid, magnesium stearate.

Description.

Tablets are white or almost white, oval, biconvex.

Pharmacotherapeutic group:

antifungal agent.

ATX code:

G01AF02

pharmachologic effect

Clotrimazole-Akrikhin is a broad-spectrum antifungal agent for topical use. The antimycotic effect of the active active substance clotrimazole (an imidazole derivative) is associated with a violation of the synthesis of ergosterol, which is part of the cell membrane of fungi, which changes the membrane permeability and causes subsequent cell lysis. In small concentrations it acts fungistatically, and in large concentrations it is 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.

Effective against dermatophytes, yeast-like and mold fungi, as well as the causative agent of pityriasis versicolor (Malazessia furfur) and the causative agent of erythrasma. It has an antimicrobial effect against gram-positive (staphylococci, streptococci) and gram-negative bacteria (Bacteroides, Cardnerella vaginalis), as well as against Trichomonas vaginalis.

Pharmacokinetics
When using Clotrimazole-Akrikhin intravaginally, absorption is 3-10% of the administered dose. High concentrations in vaginal secretions and low concentrations in blood persist for 48-72 hours. In the liver, they are rapidly metabolized to inactive metabolites.

Indications for use:

- 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;
- sanitation of the birth canal before childbirth.

Contraindications:

Hypersensitivity to clotrimazole or excipients,

In the first trimester of pregnancy.

The use of tablets during menstruation should be avoided.

With care - lactation period.

Application during pregnancy and lactation

In clinical and experimental studies, it was not found that the use of the drug during pregnancy or during lactation has a negative effect 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.

Method of administration and dosage

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

For the sanitation of the birth canal, a single administration of one tablet is recommended.

Side effect

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

Overdose

The use of the drug in high doses does not cause any reactions and conditions that are life-threatening. In case of unintended use of the drug (inside), the following symptoms are possible: anorexia, nausea, vomiting, gastralgia, liver dysfunction; rarely, drowsiness, hallucinations, pollakiuria, skin allergic reactions. There is no specific antidote. It is necessary to appoint activated carbon internally. If necessary, treatment is symptomatic.

Interaction with other medicinal products

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

special instructions

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

In case of trichomoniasis, for more successful treatment, other drugs with a systemic effect should be used in conjunction with Clotrimazole-Akrikhin (for example, metronidazole orally).

With a simultaneous infection of the labia and adjacent areas (vulvitis candidiasis), additional local treatment with Clotrimazole cream should be carried out. During pregnancy, treatment with vaginal tablets should be carried out without an applicator.

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

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

If there is no effect within 4 weeks, the diagnosis should be confirmed.

Release form:

Vaginal tablets 100 mg.
6 tablets in a blister strip packaging. 1 blister strip along with instructions for use is placed in a cardboard box.

Shelf life

3 years 6 months Do not use after the expiration date!

Storage conditions

Store in a dry, dark place and out of reach of children, at a temperature not exceeding 25 ? C.

Dispensing from pharmacies:

Dispensed without a doctor's prescription.

Manufacturer / Organization accepting customer claims:

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