Clotrimazole - instructions for use, dose, side effects, contraindications

Excipients: sorbigane stearate 2.0 g, cetyl palmitate 3.0 g, cetostearyl alcohol [cetyl alcohol 60% and stearic alcohol 40%] 10.0 g, polysorbate 60 grams 1.5 grams, octyl dodecanol 13.5 grams, gasoline alcohol - 1.0 g, purified water -67.0 g.

Description:Homogeneous cream of white color, odorless.

Pharmacotherapeutic group:Antifungal agent

ATX: & nbsp

G.01.A.F.02 Clotrimazole

Pharmacodynamics:

Clotrimazole is a broad-spectrum antifungal agent for topical application. The antimycotic effect of the active active agent clotrimazole (imidazole derivative) is associated with a disruption in the synthesis of ergosterol, which is part of the cell membrane of fungi, which changes the permeability of the membrane and causes subsequent cell lysis. In small concentrations acts fungistatically, and in large fungicidal, 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, molds and protozoa. Has antimicrobial effect against Gram-positive (Streptococcus spp., Staphylococcus spp.) and anaerobes (Bacteroides spp., Gardnerella vaginalis). Clotrimazole does not affect lactobacilli. In vitro in a concentration of 0.5-10 μg / ml clotrimazole suppresses the reproduction of the bacteria of the family Corinebacteria and Gram-positive cocci (with the exception of enterococci); has a trichomonaside action at a concentration of 100 μg / ml.

Pharmacokinetics:

When clotrimazole is administered intravaginally, the absorption is 3-10% of the dose administered. High concentrations in the vaginal secretion and low concentrations in the blood persist for 48-72 hours. In the liver, it is metabolized to inactive metabolites, excreted from the body by the kidneys and through the intestine.

Indications:

- Genital infections caused by yeast-like fungi of the genus Candida (candidiasis vulvovaginitis).

If necessary, please consult with your doctor before using the medication.

Contraindications:

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

- the period of menstruation;

- I trimester of pregnancy.

Carefully:

Breastfeeding period.

Pregnancy and lactation:

Application in the first trimester of pregnancy is contraindicated. The question of the expediency of using the drug in II-III trimesters of pregnancy should be addressed individually after a doctor's consultation.

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

Dosing and Administration:

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 (about 5 grams) as deep as possible into the vagina, in the supine position, with slightly bent legs.

Use of a vaginal cream with a disposable applicator:

- Open the tube and attach the disposable applicator.

- Gently squeeze the tube, fill the disposable applicator until the piston is completely squeezed out.

- Unbolt the applicator from the lip. Insert the applicator as deep as possible into the vagina (preferably in the supine position on the back) and squeeze out the contents of the applicator by pressing the plunger.

- Remove the disposable applicator after use and discard.

Use the drug only according to the method of administration and at the doses specified 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, it is necessary to consult a doctor.

Side effects:

According to the World Health Organization (WHO), unwanted effects are classified according to their frequency of development as follows: very often (≥ 1/10), often (≥ 1/100, <1/10) infrequently (≥ 1/1000, < 1/100), rarely (≥ 1/10000, <1/1000) and very rarely (<1/10000); frequency is unknown (the frequency of occurrence of phenomena can not be determined on the basis of available data).

Immune system disorders:

frequency is unknown: allergic reactions with symptoms such as urticaria, fainting, arterial hypotension, dyspnea.

Disorders from the gastrointestinal tract:

frequency is unknown: abdominal pain.

Disturbances from the skin and subcutaneous tissues:

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

Disorders from the kidneys and urinary tract:

frequency is unknown: frequent urination, incubation cystitis.

Violations of the genitals:

frequency is unknown: itching, burning, flushing and edema of the vaginal mucosa, ulceration of the vaginal mucosa, rash, pain in the pelvic region.

Other:

frequency unknown: headache, gastralgia.

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

Overdose:

In case of an overdose, the following symptoms are possible: dizziness, nausea, vomiting. Treatment. There is no specific antidote.In case of accidental ingestion, symptomatic treatment should be performed.

Interaction:

With vaginal administration clotrimazole reduces the activity of amphotericin B and other polyene antibiotics.

When used simultaneously with natamycin and nystatin, the activity of clotrimazole may decrease.

Simultaneous use of clotrimazole intravaginally and tacrolimus, sirolimus orally may 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, if necessary with the measurement of concentrations in the blood plasma.

Special instructions:

Read the instructions for use carefully before using the product. Keep the manual, it may be needed again. If you have any questions, contact your doctor.

The medicinal product that you are treated is intended for you personally, and it should not be passed on to others, as it can harm them even if you have the same symptoms as you.

When allergic reactions or irritation occur at the site of the drug, treatment is stopped.

The drug can not be used during menstruation, it is advisable to start treatment after menstruation.

With a simultaneous infection of the labia and adjacent areas (candidiasis vulvitis), additional local treatment with the drug clotrimazole.

During pregnancy, vaginal cream is administered without an applicator.

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

During treatment it is recommended to abstain from sexual intercourse.

It is recommended to use contraception during treatment. The risk of rupture of the condom or diaphragm increases with their simultaneous use with the drug. It is necessary to use reliable methods of contraception.

To prevent re-infection, hygiene rules should be followed.

If clinical signs of infection persist after completion of treatment, a second microbiological study should be conducted to confirm the diagnosis.

Effect on the ability to drive transp. cf. and fur:The drug does not affect the ability to drive vehicles and engage in other potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:Vaginal cream 2%.

Packaging:

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

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-004092

Date of registration:23.01.2017

Expiration Date:23.01.2022

The owner of the registration certificate:Esparma GmbHEsparma GmbH Germany

Manufacturer: & nbsp

PHARMA WERNIGERODE, GmbH Germany

Representation: & nbspESPARMA GmbH ESPARMA GmbH Germany

Information update date: & nbsp06.02.2017

Illustrated instructions

Instructions

Clotrimazole (Clotrimazole)