Ketoconazole cream for external use

Nazione: Armenia

Lingua: inglese

Fonte: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Principio attivo:

ketoconazole

Commercializzato da:

Arpimed LLC

Codice ATC:

D01AC08

INN (Nome Internazionale):

ketoconazole

Dosaggio:

20mg/g

Forma farmaceutica:

cream for external use

Confezione:

aluminium tube 15g, aluminium tube 25g

Tipo di ricetta:

OTC

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2021-07-12

Scheda tecnica

SUMMARY PRODUCT CHARACTERISTIC (SPC)
KETOCONAZOLE
2% CREAM FOR EXTERNAL USE
1.
NAME OF THE MEDICINAL PRODUCT
1.1
TRADE NAME
– Ketoconazole
1.2
INTERNATIONAL NON-PROPERTY NAME
– Ketoconazole
2.
CUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
_ _
_ACTIVE INGREDIENT:_
ketoconazole - 20 mg;
_FOR A FULL LIST OF EXCIPIENTS, see section 6.1._
_ _
3.
PHARMACEUTICAL FORM
Cream for external use
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For topical application in the treatment of dermatophyte infections of
the skin such as tinea
corporis, tinea cruris, tinea manus and tinea pedis infections due to
Trichophyton spp,
Microsporon spp and Epidermophyton spp. Ketokonazole 2% cream is also
indicated for the
treatment
of
cutaneous
candidosis
(including
vulvitis),
tinea
(pityriasis)
versicolor
and
seborrhoeic dermatitis caused by Malassezia (previously called
Pityrosporum) spp.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Ketoconazole cream is for use in adults.
TINEA PEDIS:
Ketoconazole 2% cream should be applied to the affected areas twice
daily. The usual
duration of treatment for mild infections is 1 week. For more severe
or extensive infections
(eg involving the sole or sides of the feet) treatment should be
continued until a few days
after all signs and symptoms have disappeared in order to prevent
relapse.
FOR OTHER INFECTIONS:
Ketoconazole 2%
cream should be applied to the affected areas once or twice daily,
depending on the severity of the infection.
The treatment should be continued until a few days after the
disappearance of all signs and
symptoms. The usual duration of treatment is: tinea versicolor 2–3
weeks, tinea corporis 3–4
weeks.
The diagnosis should be reconsidered if no clinical improvement is
noted after 4 weeks.
General measures in regard to hygiene should be observed to control
sources of infection or
reinfection.
Seborrheic dermatitis is a chronic condition and relapse is highly
likely.
Method of administration: Cutaneous administration.
PEDIATRICS:
There are limited data on the u