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

Name of components	Amount, g
Active substance
Clotrimazole	1,00
Excipients
Cetostearyl alcohol	11,50
Octyldodecanol	10,00
Polysorbate-60	1,50
Sorbitan Stearate	2,00
Spermaceti synthetic	3,00
Benzyl alcohol	1,00
Purified water*	70,00
Total mass of the dosing unit	100,00

* Water is injected with an excess of 1.5%, which is removed during the process.

Description:The mass of white color is of uniform consistency.

Pharmacotherapeutic group:Antifungal agent.

ATX: & nbsp

G.01.A.F.02 Clotrimazole

Pharmacodynamics:Mechanism of action

Clotrimazole suppresses the growth and division of microorganisms and can exert fungistatic (retarding and stopping the growth of fungal cells) or fungicidal (leading to the death of fungi) action. Clotrimazole inhibits the synthesis of ergosterol and binds to the phospholipids of the cell membrane of the fungus, which leads to a change in the permeability of cell membranes.

Clotrimazole can cause damage to cell membranes by mechanisms not dependent on the synthesis of sterols.

Clotrimazole also disrupts vital processes in the fungal cell, suppressing the formation of components necessary for the construction of vital cellular structures (proteins, fats, DNA, polysaccharides), damages nucleic acids and increases the excretion of potassium.

Ultimately, the effect of clotrimazole on fungal cells leads to their death.

Activity spectrum

Clotrimazole is characterized by a wide range of antifungal and antibacterial activity:

- dermatophytes ( Epidermophyton floccosum, Microsporum canis, Trichophyton mentagrophytes, Trichophyton rubrum),

- yeast (Candida spp., Cryptococcus neoformans),

- dimorphic fungi (Coccidioides immitis, Histoplasma capsulatum, Paracoccidioides brasiliensis),

- the simplest (Trichomonas vaginalis).

It is also active against certain gram-positive bacteria.

Mushrooms that are resistant to clotrimazole are extremely rare; there is data only for individual strains Candida guilliermondii.

There was no reported development of resistance in clotrimazole-sensitive fungi after passage Candida albicans and Trichophyton mentagrophytes. The cases of development of resistance to clotrimazole in strains C. albicans, resistant to polyene antibiotics due to chemical mutation.

Pharmacokinetics:Suction and distribution

Pharmacokinetic studies have shown that clotrimazole It is not practically absorbed into the systemic blood stream when the preparation is applied to undamaged or inflamed skin areas. The concentrations of clotrimazole in the serum were below the detection limit (0.001 μg / ml), confirming the fact that clotrimazole with external application does not lead to clinically significant systemic effects or side effects.

Metabolism and excretion

Clotrimazole dissolves in the liver to inactive substances that are excreted from the body through the kidneys and intestines.

Indications:For external treatment of fungal skin diseases caused by dermatophytes, yeast-like fungi, mold fungi, and pathogens sensitive to clotrimazole: mycoses of feet, brushes, trunk, skin folds; candidiasis vulvitis, candida balanitis; colored lichen, erythrasms; fungal infections of the external ear.

Contraindications:

Hypersensitivity to clotrimazole or other components of the drug.

Carefully:

Pregnancy and lactation:Fertility

Data is not available.

Pregnancy

Application of the drug Clotrimazole when pregnancy is allowed only if, in the opinion of the doctor, the potential benefit of the cream for the mother exceeds the possible risk to the fetus.

In the epidemiological studies conducted, there were no undesirable effects on pregnancy or fetal health when the drug was used Clotrimazole.

Breastfeeding period

Application of the drug Clotrimazole women in the period of breastfeeding are 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.

Dosing and Administration:

For external use. The cream should be applied to the affected skin 2-3 times a day.

To prevent relapse, treatment should be continued for at least two weeks after all symptoms of the infection have disappeared.

The cream should be applied to clean dry areas of the affected skin (washed with soap with a neutral pH), on the feet, the cream should be applied between the fingers.

The duration of treatment depends on the severity of the disease, its location, the effectiveness of treatment.

Duration of treatment:

- dermatomycosis - within 3-4 weeks;

- erythrasma - 2-4 weeks;

- multi-colored lichen - 1-3 weeks;

- Candidiasis vulvitis and balanitis -1-2 weeks.

Duration of treatment can vary according to individual characteristics, but not recommended treatment duration less than 3 weeksspruce. To prevent recurrence of infection should continue to use the drug within 1-2 weeks after the disappearance of all symptoms of the disease. If after 7 days of treatment there is no improvement in symptoms, it is necessary to consult a doctor.

Special patient groups

There are no data on dose adjustment for children, elderly patients, patients with impaired renal and hepatic function.

Side effects:The adverse events presented below are listed in accordance with the damage to organs and organ systems and frequency of occurrence. Frequency of occurrence is defined as follows: Often (> 1/10), often (> 1/100 and <1/10), infrequently (> 1/1 000 and <1/100), rarely (> 1/10 000 and <1/1 000), rarely (<1/10 000, including individual cases), unknown (the frequency can not be estimated from the currently available data). Frequency categories were formed on the basis of post-registration observation.

Frequency of occurrence of undesirable phenomena

Immune system disorders

Unknown: an allergic reaction (manifested by urticaria, syncope, arterial hypotension, dyspnea).

Disturbances from the skin and subcutaneous tissuesUnknown: rash, itching, bubble rashes, peeling, pain or discomfort, swelling, burning, irritation.

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

Overdose:

Symptoms

At casual reception of a preparation inside the following symptoms are possible: a giddiness, a nausea, vomiting.

Treatment

If you accidentally take the cream inside should be symptomatic treatment. With external application of the drug, an overdose is unlikely.

Interaction:

Not studied.

Special instructions:

It is necessary to avoid getting the cream on the mucous membrane of the eyes. Do not swallow.

All infected areas should be treated at the same time.

The composition of the drug Clotrimazole includes cetostearyl alcohol, which can cause local skin reactions (eg, contact dermatitis).

When there are symptoms of hypersensitivity or irritation, the treatment is stopped.

Laboratory test data indicate that the use of contraceptives containing latex can cause damage to them when combined with clotrimazole. Consequently, the effectiveness of such contraceptives can be reduced. Patients should be encouraged to use alternative methods contraception for at least five days after the application of clotrimazole.

Effect on the ability to drive transp. cf. and fur:

It was not reported on the influence of clotrimazole on the ability to drive vehicles and mechanisms.

Form release / dosage:

Cream for external use 1%.

For 20 grams in an aluminum tube, coated internally with a varnish sealed with a membrane, sealed with a screwed polyethylene or polypropylene cap. One tube with instructions for medical use is placed in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:

3 years.

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

Terms of leave from pharmacies:Without recipe

Registration number:П N011413 / 02

Date of registration:10.06.2010 / 16.11.2016

Expiration Date:Unlimited

The owner of the registration certificate:GlaxoSmithKline Trading, ZAO GlaxoSmithKline Trading, ZAO Russia

Manufacturer: & nbsp

GlaxoSmithKline Pharmaceuticals, S.A. Poland

Representation: & nbspGlaxoSmithKline group of companies GlaxoSmithKline group of companies Unknown

Information update date: & nbsp18.10.2013

Illustrated instructions

Instructions

Clotrimazole (Clotrimazole)