Ketoconazole shampoo

Maa: Armenia

Kieli: englanti

Lähde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiivinen ainesosa:

ketoconazole

Saatavilla:

Arpimed LLC

ATC-koodi:

D01AC08

INN (Kansainvälinen yleisnimi):

ketoconazole

Annos:

20mg/ml

Lääkemuoto:

shampoo

Kpl paketissa:

100ml plastic container

Prescription tyyppi:

OTC

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2015-09-24

Valmisteyhteenveto

SUMMARY PRODUCT CHARACTERISTIC (SPC)
KETOCONAZOLE
2% SHAMPOO
BRAND NAME
– Ketoconazole
INTERNATIONAL NON-PROPERTY NAME
– Ketoconazole
COMPOSITION
Each ml of shampoo contains:
_ACTIVE INGREDIENT:_
ketoconazole – 20mg;
_INACTIVE INGREDIENTS:_
cocamide DEA, cocamidopropyl betaine, sodium laureth
sulfate, diazolidinyl urea, hydrochloric acid(conc), triethanolamine
98 %, sodium
chloride, flavor apple,color red E-129, water deionized
DOSAGE FORM
Shampoo
A red, transparent, viscous liquid.
PHARMACOLOGICAL GROUP AND ATC CODE
Antifungal; D01AC08.
PHARMACOLOGICAL ACTION
MECHANISM OF ACTION
Ketoconazole usually is fungistatic in action, but may be fungicidal
at high
concentrations after prolonged incubation or against very susceptible
organisms.
Like other azole antifungal agents, ketoconazole presumably exerts its
antifungal
activity by altering and damaging cellular membranes, resulting in
increased
membrane permeability, secondary metabolic effects, and growth
inhibition of
fungal cells. Although the exact mechanism of action of ketoconazole
has not been
fully determined, it has been suggested that the fungistatic activity
of the drug may
result from interference with ergosterol synthesis, probably via
inhibition of C-14
demethylation of sterol intermediates (e.g., lanosterol). The
fungicidal activity of
ketoconazole at high concentrations may result from a direct
physiochemical effect
of the drug on the fungal cell membrane.
Ketoconazole 2% shampoo is an imidazole antifungal administered
topically for
scale washing. It is given in candidiasis and dermatophyte infections
of the scalp
for prophylaxis and treatment. It indicated for treatment of dandruff
and seborrheic
dermatitis.
It
has
been
given
for
the
prophylaxis
of
fungal
infections
in
immunocompromised patients, although fluconazole or itraconazole are
usually
preferred. It has been recommended that, because of its erratic
absorption and slow
therapeutic response, ketoconazole should not be used for the
treatment of life-
threatening fungal infections, includi