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

Excipients: alcohol gasoline - 1.0 g, polysorbate 60 (tvni 60) - 5.0 g, sorbitan monostearate - 2.4 g, cetyl alcohol - 6.0 g, isonropyl myristate - 6.0 g, cetyl palmitate - 3.0 g, sodium Hydroxide-0.12 g, purified water - 75.48 g.

Description:Homogeneous cream of white color with a weak characteristic odor.

Pharmacotherapeutic group:Antifungal agent.

ATX: & nbsp

D.01.A.E.15 Terbinafine

Pharmacodynamics:

Terbinafine is an allylamine with a broad spectrum of antifungal activity. Terbipafin is active against dermatophags (Trichophyton rubrum, T. mentagrophytes, T. verrucosum, T. violaceum, T. tonsurans, Microsporum canis, Epidermophyton floccosum), yeast fungi of the genus Candida (mainly C. albicans) and certain dimorphic fungi (Pityrosporum orbiculare). Activity with respect to yeast fungi, depending on their type, may be fungicidal or fungistatic.

Terbinafine specifically changes the early stage of biosynthesis of sterols occurring in fungi. This leads to a deficit of ergostrotal and to intracellular accumulation of equalene, 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 external application, absorption is less than 5%. has a minor systemic effect.

Indications:

- prevention and treatment of fungal infections of the skin, including foot mycoses (foot fungus), hornfels, cracks, itching and flaking of the skin caused by foot fungus, inguinal epidermophytosis (tinea cruris), fungal lesions of smooth skin of the body (tinea corporis), caused by dermatophytes, such as Trichophyton (e.g., T. rubrum, 'I', mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum;

- yeast skin infections, mainly caused by the genus Candida (eg. Candida albicans), in particular, diaper rash;

- colored lichen (Pityriasis versicolor), called Pityrosporum orbiculare (also known as Malassezia furfur).

Contraindications:

- hypersensitivity to terbinafine or any other component of the drug;

- the period of breastfeeding;

- children's age (up to 12 years).

Carefully:

- hepatic and / or renal insufficiency;

- alcoholism;

- oppression of bone marrow hematopoiesis;

- tumors;

- metabolic diseases;

- occlusive diseases of the vessels of the extremities.

Pregnancy and lactation:

In experimental studies teratogenic properties of terbinafine were not revealed. Until now, there have been no reports of any developmental defects in the use of cream Terbinafine. However, since the experience of applying cream Terbinafine in pregnant women is very limited, it should not be used, except in cases of extreme necessity.When pregnancy is used only if the intended benefit for the mother exceeds the potential risk to the fetus. It is necessary to consult a doctor.

Terbinafine excreted in breast milk, so the drug should not be prescribed during breastfeeding. If it is necessary to use terbinafine, breastfeeding should be discontinued.

Do not allow the baby to contact any skin surface treated with cream Terbinafine.

Dosing and Administration:

Outwardly.

Adults and children from 12 years.

Before applying the cream, it is necessary to clean and dry the affected areas of the skin. The cream is applied once or twice a day with a thin layer on the affected areas of the skin and adjacent areas, lightly rubbing.

In infections accompanied by intertrigo (iodine breasts, 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.

The duration of the treatment depends on the indications and the severity of the course of the disease.

Average duration of treatment:

- dermatomycosis of the trunk, legs: I once a day for 1 week;

- dermatomycosis of the feet: 1 time per day for 1 week;

- stiffness, cracks, itching and flaking caused by foot fungus - 1-2 times a day for 2 weeks;

- Candidiasis of the skin: 1 -2 times a day for 1 -2 weeks;

- multi-colored lichen: 1-2 times a day for 2 weeks.

Reducing the severity of clinical manifestations is usually noted in the first days of treatment. In the case of irregular treatment or premature termination, there is a risk of renewal of infection. If there are no signs of improvement after 1-2 weeks of treatment, the diagnosis should be verified.

Elderly age

The mode of dosing of terbinafine in elderly people does not differ from the above.

Use of the drug in children

The use of this drug in children under 12 years is not recommended.

If you forgot to apply the drug

If you forget to apply the drug again, you should apply it as soon as possible. But if the time of application of the next dose of the drug is approaching, skip the forgotten dose and continue applying in accordance with the recommendations. Do not use a double dose instead of a forgotten dose or more than 2 times a day.

Side effects:

Classification of the incidence of adverse events according to recommendations

World Health Organization (WHO):

very often> 1/10;

often from> 1/100 to <1/10;

infrequently from> 1/1000 to <1/100;

rarely from> 1/10000 to <1/1000;

very rarely <1/10000. including individual messages;

the frequency is unknown - it is not possible to establish the frequency of occurrence from the available data.

From the immune system:

very rarely - hypersensitivity reactions (rash).

From the side of the organ of vision: rarely - eye irritation.

From the skin: often - itching, scaling of the skin;

infrequently - skin damage, crusting, skin damage, impairment

pigmentation, erythema, burning sensation of the skin;

rarely - dry skin sensation, contact dermatitis, eczema;

very rarely - a rash.

Local reactions:

infrequently - pain, pain in the place of application, irritation in the place of application; rarely - exacerbation of the symptoms of the disease.

In places where the product is applied, itching, skin flaking, pain, irritation, skin pigmentation change, burning, erythema, and cortex can be observed. These minor symptoms should be distinguished from hypersensitivity reactions such as rashes that occur in rare cases and require the withdrawal of therapy.

If any of the side effects indicated in the manual are aggravated, or any other side effects not indicated in the instruction are noted,Immediately notify your doctor immediately.

Overdose:

On cases of drug overdose ns was reported.

At casual reception of a preparation inside there can be systemic by-effects from a gastrointestinal tract (a nausea, a gastralgia, absence of appetite, a diarrhea), and also a headache, dizziness, frequent urination, an eruption.

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

Interaction:

Currently, the drug interaction of terbinafine in a medicinal form of the cream for external use is not known.

Special instructions:

Reducing the severity of clinical manifestations is usually noted in the first days of treatment. AT If there is irregular treatment or premature termination, there is a risk of recurrence of the infection.

Terbinafine cream is for external use only. Avoid contact with the eyes, nose, mouth, 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.

The drug contains cetyl alcohol, which can cause local allergic reactions (contact dermatitis) in the places of application.

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 that require increased concentration and speed of psychomotor reactions.

Form release / dosage:

Cream for external use I%.

For 15 or 30 grams of aluminum tubes. Each lip together with the instruction is placed in a pack of cardboard.

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

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:LSR-003723/07

Date of registration:09.11.2007

The owner of the registration certificate:VERTEKS, AO VERTEKS, AO Russia

Manufacturer: & nbsp

VERTEKS, AO Russia

Information update date: & nbsp22.09.2015

Illustrated instructions

Instructions

Terbinafine (Terbinafine)