Clotrimazole vaginal tablets 100mg, No. 6

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

Adults and children over 12 years old

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

If symptoms persist for more than 7 days, it is recommended to see 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 administration and in those doses indicated in the instructions for use. If necessary, please consult your doctor before using this medication.

Special patient groups

Children

For children over 12 years of age, the method of administration 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.

Active substance:

Clotrimazole - 100.0

Excipients:

Lactose 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

The total mass of the dosage unit is 1700.0

• Hypersensitivity to clotrimazole or other components of the drug;

• age up to 12 years;

• period of menstruation;

• first trimester of pregnancy.

Carefully

• period of breastfeeding.

Trade name of the drug:

Clotrimazole / Clotrimazole.

International non-proprietary name:

clotrimazole / Clotrimazole.

Dosage form:

vaginal tablets.

Composition for 1 tablet:

Active substance:

Clotrimazole - 100.0

Excipients:

Lactose 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

The total mass of the dosage unit is 1700.0

Description

White, biconvex beveled tablets, oblong in shape, rounded at one end and flat at the other.

Pharmacotherapeutic group

Antifungal agent.

Pharmacological properties

Pharmacodynamics

Clotrimazole is a broad-spectrum, topical antifungal agent. The antifungal effect of 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 low concentrations it acts fungistatically, in high 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, yeasts, molds and protozoa. Has 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 ?g / ml inhibits the multiplication of bacteria of the Corinebacteria family and gram-positive cocci (with the exception of enterococci); at a concentration of 100 ?g / ml has a trichomonacid effect.

Pharmacokinetics

Suction

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

Metabolism

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

Indications for use

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

If necessary, please consult your doctor before using this medication.

Contraindications

• Hypersensitivity to clotrimazole or other components of the drug;

• age up to 12 years;

• period of menstruation;

• first trimester of pregnancy.

Carefully

• period of breastfeeding.

Use during pregnancy and breastfeeding, effects on fertility

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 has not been 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 found that the use of the drug during pregnancy has a negative effect on the health of a woman or fetus. Clotrimazole in the form of vaginal tablets is contraindicated for use in the first trimester of pregnancy. The question of the advisability of using the drug in the second and third trimesters of pregnancy should be decided individually after consulting a doctor.

Breastfeeding period

The available data from pharmacodynamic and toxicological studies in animals indicate the excretion of clotrimazole and its metabolites in milk. During the period of treatment with clotrimazole, breastfeeding should be discontinued.

Method of administration and dosage

Adults and children over 12 years old

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

If symptoms persist for more than 7 days, it is recommended to see 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 administration and in those doses indicated in the instructions for use. If necessary, please consult your doctor before using this medication.

Special patient groups

Children

For children over 12 years of age, the method of administration 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.

Side effect

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

Immune system disorders

Not known: allergic reactions with symptoms such as urticaria, fainting, arterial hypotension, shortness of breath.

Gastrointestinal disorders

Unknown: abdominal pain.

Genital and Breast Disorders

Not known: itching, burning, hyperemia and edema of the vaginal mucosa, ulceration of the vaginal mucosa, rash, pain in the pelvic region.

If any of these side effects are aggravated or you notice any other side effects not listed in the instructions, inform your doctor.

Overdose

Symptoms

Dizziness, nausea, vomiting.

Treatment

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

Interaction with other medicinal products

When administered vaginally, clotrimazole reduces the activity of amphotericin B and other polyene antibiotics. With simultaneous use with nystatin, the activity of clotrimazole may decrease. The simultaneous use of clotrimazole intravaginally and tacrolimus, orally sirolimus can lead to an increase in the concentration of the latter in the blood plasma, therefore, patients should be monitored for the development of symptoms of their overdose and, if necessary, their concentration in the blood plasma should be measured.

special instructions

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, see your doctor. The medicine you are treating is intended for you personally and should not be passed on to others, as it can harm them even if they have the same symptoms as you.

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

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

With a simultaneous infection of the labia and adjacent areas (vulvitis candidiasis), additional local treatment with clotrimazole in the dosage form cream, ointment, 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 recommended to refrain from sexual intercourse. Hygiene rules should be followed to prevent reinfection.

If clinical signs of infection persist after completion of treatment, a second microbiological study 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, soreness, irritation, swelling, rash, burning, itching, vaginal discomfort;

• foul-smelling vaginal discharge;

• fever (temperature 38 ? or higher) or chills;

• nausea, vomiting, diarrhea;

• lower abdominal pain;

• backache.

?л¤ полного растворени¤ вагинальных таблеток требуетс¤ нормальна¤ влажность слизистой влагалища, в противном случае нерастворенные части таблетки могут крошитьс¤ и выдел¤тьс¤ наружу. ѕри сухости влагалища женщины могут замечать выведение нерастворенных кусочков таблеток. ?л¤ предотвращени¤ этого необходимо вводить таблетку глубоко во влагалище, насколько это возможно, перед сном.

Ќе следует использовать тампоны, проводить спринцевани¤, примен¤ть спермициды или другие препараты дл¤ интравагинального применени¤ в период лечени¤ данным препаратом.

¬о врем¤ лечени¤ рекомендуетс¤ пользоватьс¤ средствами контрацепции. –иск разрыва презерватива или диафрагмы увеличиваетс¤ при их применении одновременно с препаратом. Ќеобходимо использовать надежные методы контрацепции.

¬ли¤ние на способность управл¤ть транспортными средствами, механизмами

There is no data on the negative effect of the drug on the ability to perform potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions (driving, working with moving mechanisms).

Release form

Vaginal tablets, 100 mg.

6 tablets in a PVC / aluminum foil blister, 1 blister with instructions for use in a cardboard box with first opening control.

Shelf life

3 years.

Do not use after the expiration date printed on the package.

Storage conditions

Store at a temperature not exceeding 25 ? C.

Keep out of the reach of children.

Vacation conditions

Without recipe.