Clotrimazole vaginal cream 2%, 20g

Composition

100 g of cream contains:

Active ingredient:  

• clotrimazole – 2.0 g;

Auxiliary substances:

• sorbitan stearate-2.0 g,

• cetyl palmitate-3.0 g,

• cetostearyl alcohol [cetyl alcohol 60% and stearyl alcohol 40%] – 10.0 g,

• polysorbate-60-1.5 g,

• octyldodecanol-13.5 g,

• benzyl alcohol-1.0 g,

• purified water-67.0 g

Pharmacological action

Pharmacotherapy group:

antifungal agent.

ATX Code: G01AF02

Pharmacological properties Pharmacodynamics

Clotrimazole is a broad-spectrum antifungal agent for topical use. The antimycotic effect of the active ingredient clotrimazole (imidazole derivative) 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 small concentrations, it acts fungistatically, and in large ones it acts as a fungicide, 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. In vitro, at a concentration of 0.5-10 mcg/ml, clotrimazole suppresses the reproduction of Corinebacteria bacteria and gram-positive cocci (with the exception of enterococci); it has a trichomonacid effect at a concentration of 100 mcg/ml.

Pharmacokinetics

When using clotrimazole intravaginally, 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. In the liver, it is metabolized to inactive metabolites 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

Use in the first trimester of pregnancy is contraindicated. The question of the feasibility of using the drug in the II-III trimesters of pregnancy should be decided individually after consulting a doctor.

The use of the drug during breastfeeding is allowed only if, in the opinion of the doctor, the potential benefit of using the cream for the mother exceeds the possible risk to the child.

Contraindications

• Hypersensitivity to clotrimazole or other components of the drug, especially to cetostearyl alcohol;

• menstruation period;

• I trimester of pregnancy.

With caution

Breast-feeding period.

Side effects

According to the World Health Organization (WHO), adverse events are classified according to their frequency as follows: very common (≥ 1/10), common (≥1/100,1/10), uncommon (≥1/1000,1/100), rare (≥1/10000,1/1000) and very rare (1/10000); the frequency is unknown (the frequency of events cannot be determined based on available data).

Immune system disorders:

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

Disorders of the gastrointestinal tract:

frequency unknown: abdominal pain.

Skin and subcutaneous tissue disorders:

frequency unknown: allergic reactions may occur in case of hypersensitivity to the Active ingredient or other component of the drug, such as cetostearyl alcohol.

Kidney and urinary tract disorders:

frequency unknown: frequent urination, intercurrent cystitis.

Genital disorders:

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

Other services:

frequency unknown: headache, gastralgia.

If any of the side effects listed in the instructions get worse or you notice any other side effects 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 natamycin and 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, if necessary, with measurement of plasma concentrations.

How to take, course of use and dosage

Locally. For intravaginal use only.

For 6 consecutive days, once a day in the evening before going to bed, insert the contents of the filled applicator (approximately 5 g) as deep as possible into the vagina, lying on your back, with your legs slightly bent.

Application of vaginal cream with a disposable applicator:

1. Open the tube and fasten the disposable applicator.

2. Gently squeeze the tube and fill the disposable applicator until the plunger is completely squeezed out.

3. Unscrew the applicator from the tube. Insert the applicator as far as possible into the vagina (preferably in a supine position) and squeeze out the contents of the applicator by pressing the plunger.

4. Remove the disposable applicator after use and discard it.

Use the drug only according to the method of application and in the doses indicated in the instructions for use.

A second course of treatment is possible after consultation with the attending physician.

If there is no improvement after treatment or new symptoms appear, you should consult your doctor.

Overdose

In case of overdose, the following symptoms may occur: dizziness, nausea, vomiting.

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

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 is 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 should also be carried out.

During pregnancy, treatment with vaginal cream 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.

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.

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 confirm the diagnosis.

Influence on the ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles and engage in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Vaginal cream 2%.

20 g each in aluminum tubes. The tube together with disposable applicators (3 pcs. ) for intravaginal use and instructions for use are placed in a cardboard pack.

Storage conditions

At a temperature not exceeding 25 °C.

Keep out of reach of children.

Shelf

life is 3 years.

Active ingredient

Clotrimazole

Dosage Form

Cream vaginal