Termikon - instructions for use, doses, side effects, contraindications

Excipients: cetyl alcohol (lanet 16), stearyl alcohol or cetostearyl alcohol (lanet "O" nibs), an alcohol gasoline, cetyl palmitate (Cutina CP), polysorbate 60, isopropyl myristate, sorbitan stearate, sodium hydroxide, purified water.

Description:White homogeneous cream with a weak specific odor.

Pharmacotherapeutic group:Antifungal agent

ATX: & nbsp

D.01.A.E.15 Terbinafine

Pharmacodynamics:

Antifungal agent for topical use, with a wide range of antifungal activity. In low concentrations terbinafine has a fungicidal action against dermatophytes (Trychophyton rubrum, T.mentagrophytes, T.verrucosum, T.violaceum, T.tonsurans, Microsporum canis, Epidermophyton Jloccosum), molds (for example, Aspergillus, Cladosporium, Scorpulariopsis brevicalius), certain dimorphic (Pityrosporum orbiculare) and yeast fungi (mainly Candida albicans). Activity in relation to other yeast fungi Candida spp., depending on their type, can be fungicidal or fungistatic.

Terbinafine specifically changes the early stage of sterol biosynthesis occurring in fungi. This leads to a deficit of ergosterol and to intracellular accumulation of squalene, which causes death of the fungal cell. The action of terbinafine is carried out by inhibiting the enzyme squalene epoxidase located on the cell membrane of the fungus.

Terbinafine has no effect on the cytochrome P450 system in humans and, accordingly, on the metabolism of hormones or other medications.

Pharmacokinetics:With topical application, absorption - less than 5%, has a minor systemic effect.

Indications:

Prevention and treatment of fungal infections of the skin, including:

- mycosis of the feet ("fungus" of the foot);

- inguinal epidermophyte;

- fungal lesions of the smooth skin of the body;

- infections caused by yeast-like fungi of the genus Candida (candidiasis), in particular diaper rash;

- multi-colored (pitybearing) lichen.

Contraindications:

Hypersensitivity to terbinafine or any of the inactive ingredients that make up the drug.

Carefully:hepatic and / or renal failure, alcoholism, oppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive diseases of the extremities, children under 12 years of age (for this dosage form) due to lack of sufficient clinical experience, lactation period.

Pregnancy and lactation:

Use during pregnancy is possible if the intended benefit to the mother exceeds the potential risk to the fetus.

It is known that when ingested, terbinafine excreted in breast milk. However, with external use of the cream by the nursing mother,any negative impact on the baby is unlikely, since the systemic absorption of the cream through the skin is very small.

Use with caution during lactation.

Dosing and Administration:

Outwardly.

Adults and children over 12 years of age: Before applying the cream, clean and dry the affected areas. The cream is applied once or twice a day with a thin layer on the affected skin and adjacent areas and lightly rubbed. In infections accompanied by intertrigo (under the mammary glands, in the interdigital spaces, between the buttocks, in the groin area), the places of application of the cream can be covered with gauze, especially at night.

Average duration and frequency of application

Dermatomycosis of feet	1 week 1 time per day
Dermatomycosis of the trunk, tibia, folds	1 week 1 time per day
Candidiasis of the skin	1-2 weeks 1 or 2 times a day
Multicolored lichen	2 weeks 1 or 2 times a day

Reducing the severity of cellsandmanifestations are usually observed in the first days of treatment. In the case of irregular treatment or premature termination, there is a risk of renewal of infection.

Dosage regimen in elderly people does not differ from the above.

Side effects:

In places where the product is applied, redness, itching or burning sensation may appear. Allergic reactions.

Overdose:

No cases of drug overdose have been reported. If, by chance, Thermicone® cream is taken internally, you can expect the development of the same side effects as in the case of an overdose of Termicon® tablets (headache, nausea, epigastric pain and dizziness).

Treatment: Activated carbon, if necessary, symptomatic maintenance therapy.

Interaction:

Any drug interactions for Termicon® cream are not known.

Special instructions:

Reduction in the severity of clinical manifestations is usually noted in the first days treatment. In the case of irregular treatment or premature termination, there is a risk of renewal of infection.

Thermicone® cream is for external use only. Avoid contact with eyes, as it can cause irritation. In case of accidental ingestion of the drug into the eyes, they should be washed immediately with running water, and in case of persistent irritation, consult a physician.

When developing allergic reactions, it is necessary to cancel the drug.

Form release / dosage:

Cream for external use 1% in tubes of aluminum for 10 g or 15 g. Each tube with instruction for use is placed in a pack of cardboard.

Packaging:tubes, aluminum (1) - packs, cardboard

Storage conditions:Store at a temperature not exceeding 30 ° C. Keep out of the reach of children.

Shelf life:3 years. Do not use after expiration date, specified package.

Terms of leave from pharmacies:Without recipe

Registration number:LS-002394

Date of registration:02.04.2009

The owner of the registration certificate:OTISIFARM, OJSC OTISIFARM, OJSC Russia

Manufacturer: & nbsp

PHARMSTANDART-TOMSKHIMFARM, OJSC Russia

Information update date: & nbsp21.09.2015

Illustrated instructions

Instructions

Thermicon® (Termicon®)