Terbinafine-Asteria cream for external use

Nazione: Armenia

Lingua: inglese

Fonte: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Principio attivo:

terbinafine (terbinafine hydrochloride)

Commercializzato da:

Hankook Korus Pharm Co.

Codice ATC:

D01AE15

INN (Nome Internazionale):

terbinafine (terbinafine hydrochloride)

Dosaggio:

10mg/g

Forma farmaceutica:

cream for external use

Confezione:

30g aluminium tube

Tipo di ricetta:

OTC

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2015-09-04

Foglio illustrativo

[ COMPOSITION ]
Each 1g cream contains :
ACTIVE INGREDIENT
Terbinane Hydrochloride
--------------------------------------------------
10.0 mg (8.888 mg as Terbinane)
EXCIPIENTS : Stearyl Alcohol, Cetyl Alcohol, Paran Liquid, Propylene
Glycol, Puried Water, Sorbitan Monostearate, Polysorbate 60, Sodium
Hydroxide, Methyl
Parahydroxybenzoate, Propyl Parahydroxybenzoate
[ INDICATION ]
The treatment of tinea pedis (athlete's foot) and tinea cruris (dhobie
itch/jock itch) caused by Trichophyton (e.g. T. rubrum, T.
mentagrophytes, T. verrucosum, T.
violaceum) and Epidermophyton occosum.
[ DOSAGE AND ADMINISTRATION ]
Adults and children over 16 years of age
Terbinane Hydrochloride Cream is applied once daily.
Duration and frequency of treatment
Duration of treatment is one week for tinea pedis and tinea cruris.
Relief of clinical symptoms usually occurs within a few days.
Irregular use or premature
discontinuation of treatment carries the risk of recurrence. If there
are no signs of improvement after two weeks, the diagnosis should be
veried by a physician.
Dosing in special populations:
Paediatric population
The experience with topical Terbinane Hydrochloride Cream in children
is still limited and its use in children under 16 years cannot
therefore be recommended.
Elderly patients
There is no evidence to suggest that elderly patients require dierent
dosages or experience side-eects dierent to those of younger patients.
Method of administration
For cutaneous use.
The aected area should be cleaned and dried thoroughly before
application of Terbinane Hydrochloride Cream. The cream should be
applied to the aected skin
and surrounding area in a thin layer and rubbed in lightly. In the
case of intertriginous infections (interdigital, intergluteal,
inguinal) the application may be covered
with a gauze strip, especially at night.
[ CONTRAINDICATIONS ]
Hypersensitivity to terbinane or to any of the excipients contained in
the cream.Hypersensitivity to terbinane or to any of the excipients
contained in the cream.
[ INTERACTION ]