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

Excipients: propylene glycol 7.0 g, macrogol-1500 (polyethylene glycol 1500, polyethylene oxide-1500) 27.0 g, macrogol 400 (polyethylene glycol 400, polyethylene oxide-400) 64.9 g, methyl parahydroxybenzoate (nipagine, methylparaben ) - 0.1 g.

Description:Homogeneous ointment is white or almost white.

Pharmacotherapeutic group:Antifungal agent

ATX: & nbsp

G.01.A.F.02 Clotrimazole

Pharmacodynamics:

Antifungal agent from the group of imidazole derivatives for external use. Clotrimazole reduces the synthesis of ergosterol, which is an integral part of the cell membrane of the microbial wall, and leads to a change in its structure and properties. In small concentrations, it acts fungistatically, and in large concentrations (more than 20 μg / ml) it is 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. Active against pathogenic dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis); yeast and mold fungi (Candida spp., Torulopsis glabrata, Rhodotorula spp., Pityrosporum orbiculare).

Pharmacokinetics:Poorly absorbed through the skin and mucous membranes and practically does not have a systemic effect. It accumulates in the stratum corneum of the epidermis, penetrates into the nail keratin The concentration in the deep layers of the epidermis is higher than the minimum suppressing concentration for dermatophytes.

Indications:

- Fungal skin diseases, including skin folds and feet caused by dermatophytes, yeast (Candida spp.), mold and other fungi and pathogens sensitive to clotrimazole: dermatomycosis, dermatophytosis, trichophytosis, epidermophytosis, microsporia, candidamycosis, interdigital fungal erosion, fungal paronychia;

- mycoses complicated by secondary pyoderma, as part of complex therapy;

- multicolored lichen, erythrasma.

Contraindications:Hypersensitivity to clotrimazole or excipients, pregnancy (I trimester), children under 2 years.

Carefully:

Lactation period, pregnancy (II and III trimester).

Pregnancy and lactation:

The use of the drug in the first trimester of pregnancy is contraindicated. In clinical and experimental studies it has not been established that the use of the drug during pregnancy (II and III trimester) or during breastfeeding has a negative effect on the health of a woman or fetus (child). The question of the expediency of prescribing the drug should be decided individually after consultation of the doctor.

The application of the drug directly to the lactating mammary gland is contraindicated.

Dosing and Administration:

Outwardly.

Adults in the absence of other prescriptions are advised to apply the ointment 2-3 times a day with a thin layer on the previously cleaned and dry affected areas of the skin and gently rub. A single dose for a palm-sized surface area is a 5 mm ointment column. For successful treatment it is important to regularly apply the ointment. The duration of therapy is individual and depends on the severity and localization of the disease. To achieve full recovery, do not stop treatment with ointment immediately after the disappearance of acute symptoms or subjective complaints. The duration of therapy should be about 4 weeks on average.

Multicolored lichen is cured, mainly for 1-3 weeks, and erythrasma for 2-4 weeks.

In fungal diseases of the skin of the legs, it is recommended to continue therapy for about 2 weeks after the relief of the symptoms of the disease.

In children from 2 years, the drug is used in the above doses.

Side effects:

Local reactions: burning, swelling, irritation and peeling of the skin, paresthesia, the appearance of blisters, erythematous rashes.

Allergic reactions: itching, hives.

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:

Low systemic absorption of the active component of the drug with external application makes an overdose almost impossible.

Interaction:

Nystatin, natamycin and amphotericin B reduce the effectiveness of clotrimazole while simultaneously using them.

When using ointment, negative interactions with other agents are unknown and should not be expected, since the resorptive capacity of clotrimazole is very low.

Special instructions:

It is necessary to avoid getting on the mucous membrane of the eyes.

Patients with hepatic insufficiency should periodically monitor the functional state of the liver.

When signs of hypersensitivity or irritation appear, the treatment is stopped. If there is no effect within 4 weeks, you should confirm the diagnosis. Children should avoid applying to large surfaces.

Effect on the ability to drive transp. cf. and fur:The drug has no effect on the ability to drive vehicles, mechanisms and engage in other hazardous activities requiring special attention and quick reactions.

Form release / dosage:

Ointment for external use 1%.

Packaging:By 10, 15, 20, 30 g in tube aluminum or laminate. Each tube with instruction for use is placed in a pack of cardboard.

Storage conditions:In the dark place at a temperature of 2 to 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years. Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:P N003228 / 01

Date of registration:18.08.2009 / 15.07.2014

Expiration Date:Unlimited

The owner of the registration certificate:SYNTHESIS, JSC Joint-stock Kurgan Society of Medical Preparations and Products SYNTHESIS, JSC Joint-stock Kurgan Society of Medical Preparations and Products Russia

Manufacturer: & nbsp

SYNTHESIS, OJSC Russia

Information update date: & nbsp29.01.2018

Illustrated instructions

Instructions

Clotrimazole (Clotrimazole)