Clotrimazole, vaginal tablets 100 mg 6 pcs

Antifungal agent.

ATX code:

G01AF02.

Pharmacological properties

Pharmacodynamics

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

It is effective against dermatophytes, yeast-like, mold fungi and protozoa. It has antimicrobial action against Gram-positive bacteria (Streptococcus spp., Staphylococcus spp.) and anaerobes (Bacteroides spp, Gardnerella vaginalis). Clotrimazole has no effect on lactobacilli.

In vitro clotrimazole at a concentration of 0.5-10 µg/ml inhibits the reproduction of bacteria of the family Corinebacteria and Gram-positive cocci (except enterococci); at a concentration of 100 µg/ml has a trichomonacid effect.

Pharmacokinetics

absorption

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

Metabolism

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

Indications

Inflammation of the female genitalia, Itching and dryness in the genital area, thrush (candidiasis)

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

If necessary, please consult a physician before using the medication.

Active ingredient

Clotrimazole

Composition

Composition per tablet:

Component Name Quantity, mg

The active ingredient
Clotrimazole 100.0

/p>

Supplementary substances
Lactose monohydrate 1122.2
Potato starch 180.0Adipic acid 140,0
Sodium hydrogen carbonate 110,0
Magnesium stearate 31,3
Colloidal silicon dioxide 12,3
Sodium lauryl sulfate 4,2
General weight of 1,700,0

How to take, the dosage

Adults and children over 12 years

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

If symptoms persist longer than 7 days, it is recommended that a doctor be consulted. You can only repeat treatment after consulting a doctor.

If symptoms persist for 2 months, you should talk to your doctor.

Perform the drug only in the way and at the doses mentioned in the instructions for use. If necessary, please talk to your doctor before using the medicine.

Patient Special Groups

Children

For children over 12 years of age, the route of administration and doses are the same as for adults. Clotrimazole, vaginal tablets should not be used in children younger than 12 years.

Elderly patients

Lack of data.

Patients with impaired renal function

Not enough data.

Patients with impaired liver function

There is insufficient data.

Interaction

When administered vaginally, clotrimazole reduces the activity of amphotericin B and other polyene antibiotics. When concomitant use with nystatin activity of clotrimazole may decrease. Concomitant use of clotrimazole intravaginally and oral tacrolimus, sirolimus may lead to increased plasma concentrations of the latter, so patients should be monitored for the development of symptoms of their overdose and if necessary their plasma concentrations should be measured.

Special Instructions

Read the instructions for use carefully before using this medicine. Keep the instructions; you may need them again. If you have any questions, ask your doctor. The medicine you are taking is for your own personal use, and should not be given to others, as it could cause harm to them, even if you have the same symptoms as you do.

If you have any allergic reaction or irritation where the medicine was given, stop treatment.

In case of simultaneous infection of the labia and adjacent areas (candidal vulvitis), clotrimazole in a dosage form of cream, ointment or gel should be given topically.

In pregnancy, treatment with the vaginal pills is carried out without an applicator.

To prevent infection, simultaneous treatment of sexual partners is necessary.

At the time of treatment, it is recommended to refrain from sexual contact. Follow good hygiene practices to prevent reinfection.

If clinical signs of infection persist after treatment has been completed, repeat microbiological testing to confirm the diagnosis.

The product is not recommended if the following conditions are present:

• irregular bleeding from the genital tract, vulvar and/or vaginal mucosal ulceration, soreness, irritation, swelling, rash, burning, itching, vaginal discomfort;
• vaginal discharge with foul odor;
• fever (fever 38° or higher) or chills;
• nausea, vomiting, diarrhea;
• pain in the lower abdomen;
• back pain.

Vaginal pills require normal vaginal mucosal moisture to dissolve completely, otherwise the undissolved parts of the pill may crumble and leak out. When the vagina is dry, women may notice undissolved pieces of the pills coming out. To prevent this, the pill should be inserted as deeply into the vagina as possible before bedtime.

Do not use tampons, perform douches, use spermicides or other intravaginal medications during treatment with this medication.

With contraception is recommended during treatment. The risk of condom or diaphragm rupture increases if used at the same time as the drug. Reliable methods of contraception should be used.

Influence on the ability to drive vehicles, machinery

There are no data on adverse effects of the drug on the ability to perform potentially hazardous activities requiring increased concentration and rapid psychomotor reactions (driving, operating moving machinery).

Synopsis

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

Contraindications

• Hypersensitivity to clotrimazole or other ingredients of the drug
• under 12 years of age
• menstruation period
• first trimester of pregnancy.

Cautious

• period of breastfeeding

Side effects

Frequency of occurrence is defined as follows: very often (≥1/10), frequently (≥1/100 and <1/10), (≥1/1000 and <1/100), frequently (≥1/10000 and <1/1000), very rarely (<1/10000, including isolated cases), unknown (cannot be estimated from data available).

Immune system disorders

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

Gastrointestinal tract disorders

Unknown: abdominal pain.

Genital and breast disorders

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

If any of these side effects worsen, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Symptoms

Dizziness, nausea, vomiting.

Treatment

There is no specific antidote. Symptomatic treatment should be administered if ingested accidentally

There is no specific antidote.

Pregnancy use

Fertility

There have been no studies of the effect of clotrimazole on fertility in humans, in animal studies no effect of the drug on fertility was found.

Pregnancy

The data on the use of the drug in pregnant women are limited. Clinical and experimental studies have not found that the use of the drug during pregnancy has adverse effects on the health of the woman or the fetus. Clotrimazole in the form of vaginal tablets is contraindicated for use in the first trimester of pregnancy. The advisability of using the drug in the second and third trimesters of pregnancy should be decided individually after consultation with the doctor.

Breast-feeding period

The available data of pharmacodynamic and toxicological studies in animals indicate the excretion of clotrimazole and its metabolites with milk. Breastfeeding should be discontinued during treatment with clotrimazole.

Similarities

Candide, Clotrimazol-Acrihin, Clotrimazol, Clotrimazol-Teva