Terbized-Adzhio - instructions for use, dose, side effects, contraindications

Excipients: sodium hydroxide, benzyl alcohol, sorbitan stearate, cetyl palmitate, cetyl alcohol, stearic alcohol, polysorbate-60, isopropyl myristate, purified water.

Description:Homogeneous cream white or almost white.

Pharmacotherapeutic group:antifungal agent.

ATX: & nbsp

D.01.A.E.15 Terbinafine

Pharmacodynamics:

Antifungal drug for external use. At low concentrations has fungicidal activityYu at attitudesdermatophytes (Trychophyton rubrum, Trychophyton mentagrophytes, Trychophyton verrucosum, Trychophyton violaceum, Trychophyton tonsurans, Microsporum canis, Epidermophyton floccosum), yeast fungi (at mostly Candida albicans), yeast-like fungi - Pityrosporum orbiculare.

Activity with respect to yeast is fungicidal or fungistatic in nature depending on the type of fungi.

Terbinafine inhibiting squalene epoxidase in the cell membrane of the fungus (not related to cytochrome P450) specifically inhibits the early stage of the synthesis of sterols in fungal cell, resulting in ergosterol deficiency, intracellular accumulation of squalene and destruction of the fungus cells.

Pharmacokinetics:

At external application absorption - 5%, renders insignificant system action.

Indications:Fungal skin diseases caused by sensitive pathogens (trichophytosis, microsporia, epidermophytia, rubrophytic, skin candidiasis), multicolored lichen.

Contraindications:

Hypersensitivity to terbinafine or any other component in the cream, children under 12 years.

Carefully:

Renal and / or hepatic insufficiency, alcoholism, oppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive diseases of the extremities, pregnancy, lactation period (lack of sufficient clinical experience of use).

Pregnancy and lactation:Carefully.

Dosing and Administration:

Adults and children over 12 years of age:

The drug is applied to the skin 1 or 2 times a day. Before applying the cream, it is necessary to clean and dry the affected areas. The cream is applied 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 of treatment:

Dermatomycosis of the trunk, drumsticks: 1 week 1 time per day Dermatomycosis stop: 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 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.In the event that after two weeks of treatment there are no signs of improvement, the diagnosis should be verified.

Side effects:

In the place of application of the preparation in rare cases, redness of the skin, sensation of itching or burning, was noted, but these phenomena rarely led to the necessity of cessation of treatment. These above symptoms should be distinguished from allergic reactions, for example, urticaria, which occur rarely, however, when they appear, you must stop treatment and consult a doctor.

Overdose:

No cases of drug overdose with external application have been reported. If the drug is accidentally taken internally, it is possible to expect the development of the same side effects as in the case of an overdose of terbinafine tablets: headache, nausea, gastralgia, dizziness, frequent urination, rash.

Treatment (with accidental ingestion): activated charcoal, if necessary symptomatic and supportive therapy.

Interaction:Currently, drug interactions are not known.

Special instructions:

The cream is for external use only. Avoid contact with eyes.If the product gets into the eyes, rinse it with plenty of water.

It is known that terbinafine excreted with breast milk. Nevertheless, when using the drug by a nursing mother, any negative effect on the baby is unlikely, since systemic absorption of the cream through the skin is very small. Do not apply to the area of the mammary glands.

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

Form release / dosage:

Cream for outdoor use1%.

10 grams of cream in an aluminum tube. One tube together with the instruction for use is placed in a cardboard box.

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

Storage conditions:

At a temperature of no higher than 30 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the date shown on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-004404/10

Date of registration:18.05.2010

The owner of the registration certificate:Agio Pharmaceuticals Ltd.Agio Pharmaceuticals Ltd. India

Manufacturer: & nbsp

Agio Pharmaceuticals Ltd. India

Representation: & nbspAgio Pharmaceuticals Ltd.Agio Pharmaceuticals Ltd.

Information update date: & nbsp20.09.2015

Illustrated instructions

Instructions

Terbized-Ajio (Terbizede-Agio)