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

Sodium hydroxide, benzyl alcohol, sorbitan stearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate, purified water.

Description:Homogenous cream is white or almost white.

Pharmacotherapeutic group:Antifungal agent

ATX: & nbsp

D.01.A.E.15 Terbinafine

Pharmacodynamics:

Antifungal drug for external use, which has a wide range of antifungal activity. In small concentrations terbinafine has a fungicidal action against dermatophytes (Trichophyton rubrum,

T.mentagrophytes, T.verrucosum, T. violaceum, T.tonsurans, Microsporum canis, Epidermophyton floccosum), molds (for example, Scopulariopsis brevicaulis) and certain dimorphic fungi (Pityrosporum orbiculare). Activity with respect to yeast fungi (mainly Candida albicans), depending on their type, can be fungicidal or fungistatic.

Terbinafine specifically changes the early stage of biosynthesis of sterols occurring in fungi. This leads to a deficit of ergosterol and 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 isoenzyme 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 skin infections caused by sensitive pathogens, including foot mycoses (foot fungus),inguinal epidermophytes (tinea cruris), fungal lesions of smooth skin of the body (tinea corporis), caused by such dermatophytes as Trichophyton (including, T. rubrum, T. mentagrophytes, T.verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum.

Yeast infections of the skin, mainly those that are caused by the genus Candida (eg, Candida albicans), in particular, diaper rash.

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

Contraindications:Hypersensitivity to terbinafine or other components of the drug, children under 12 years of age (lack of sufficient experience).

Carefully:Hepatic and / or renal failure, alcoholism, oppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive diseases of the vessels of the extremities.

Pregnancy and lactation:

In experimental studies on animals teratogenic properties of terbinafine were not revealed. Until now, there have been no reports of any malformations of the fetus against the background of the use of the drug Atifin®.

The use of the drug Atifin® in pregnancy is possible if the potential benefit to the mother exceeds the possible risk to the fetus / child.

Terbinafine penetrates into breast milk in a very small amount.

The cream should not be applied to the mammary glands during breastfeeding.

Dosing and Administration:

Outwardly.

Adults and children from 12 years.

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

Disease	Dosage	Duration treatment
Skin diseases
Dermatomycosis of smooth skin and inguinal dermatomycosis (including dermatomycosis of the trunk, dermatomycosis of the shins)	2 times a day (morning and evening)	1 Week
Dermatomycosis of feet	- 2 times a day between the toes (morning and evening),	- 1 Week
	- 1 time per day (upper and lateral parts of the foot)	- 2 weeks
Fungal skin infections caused by yeast (skin candidiasis)	1 per day	1 Week
Multicolored lichen	1 per day	2 weeks

If there are no signs of improvement after 1-2 weeks of treatment, the diagnosis should be verified.

Elderly patients - correction of the dose is not required.

Side effects:

In places of terbinafine application, redness, itching or burning sensation may appear. There may be allergic reactions.

Overdose:

ABOUT cases of drug overdose Atifin® cream was not reported. If the drug is accidentally taken inside (despite the dosage form), the following symptoms are possible: headache, nausea, abdominal pain, dizziness.

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

Interaction:

When topical application of terbinafine on its interaction with other drugs has not been reported.

Special instructions:

The drug Atifin® Cream is for external use only.

Reducing the severity of clinical manifestations is usually noted in the early days of the drug Atifin®. In case of irregular application or premature termination of it, there is a risk of recurrence of the infection.

During the period of application of Atifin® it is necessary to observe general hygiene rules for the prevention of reinfection (through underwear, shoes).

In case of accidental ingestion of the drug into the eyes, they should be washed immediately with running water,and in case of development of persistent phenomena of irritation it is necessary to consult a doctor.

When developing allergic reactions, use of Atifin® should be discontinued.

Effect on the ability to drive transp. cf. and fur:The drug Atifin® does not affect the management of vehicles and other technical devices that require a high concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Cream for external use, 1%.

Packaging:

15 g of cream in an aluminum tube.

1 Tubu together with instructions for use are placed in a cardboard pack.

Storage conditions:

At a temperature of no higher than 25 ° C, in the original packaging.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-001799/07

Date of registration:11.10.2011 / 04.08.2016

Expiration Date:Unlimited

The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Manufacturer: & nbsp

KRKA, dd, Novo mesto, AO Slovenia

Representation: & nbspKRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Information update date: & nbsp08.10.2017

Illustrated instructions

Instructions

Atifin® (Atifin®)