NIZORAL

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

Ketoconazole

Tilgængelig fra:

Janssen-Cilag Pty Ltd

Klasse:

Medicine Registered

Indlægsseddel

 
CCDS100526 1 
NIZORALTABS(110523)ACI 

NIZORAL
®
 TABLETS 
_Ketoconazole _
CONSUMER MEDICINE INFORMATION 
WHAT IS IN THIS LEAFLET  
This leaflet answers some of the common questions 
about NIZORAL tablets.  It does not contain all the 
available information.  It does not take the place of 
talking to your doctor or pharmacist. 
All medicines have risks and benefits.  Your doctor has 
weighed the risks of you taking NIZORAL tablets 
against the benefits this medicine is expected to have 
for you. 
If you have any concerns about using NIZORAL 
tablets, ask your doctor or pharmacist. 
Keep this leaflet with your medicine.  You may need 
to read it again. 
WHAT NIZORAL TABLETS ARE USED FOR 
NIZORAL tablets are used to treat: 
•  fungal infections of the skin, hair and mucous 
membrane that cannot be treated by applying a 
medicine directly to the infected area 
•  persistent fungal infections of the vagina 
•  fungal infections of the mouth, throat and stomach, 
intestines or other internal organs. 
NIZORAL contains ketoconazole which belongs to a 
group of medicine called antifungals.  It works by 
killing or stopping the growth of certain types of fungi 
or yeasts that cause the infection. 
Your doctor may have prescribed NIZORAL tablets 
for another reason.  Ask your doctor if you have any 
questions about why this medicine has been prescribed 
for you.  
BEFORE YOU TAKE NIZORAL TABLETS 
WHEN YOU MUST NOT TAKE IT 
Do not take NIZORAL tablets if: 
•  you have an allergy to NIZORAL or any of the 
ingredients.  See PRODUCT DESCRIPTION at the end of 
this leaflet for a list of ingredients  
•  you have liver diseases or are recovering from 
hepatitis 
•  you are pregnant. 
Do not use NIZORAL tablets with any of the 
following: 
•  certain medicines for allergy or hay fever 
(terfenadine, mizolastine or astemizole) 
•  cisapride or domperidone(used for certa

Produktets egenskaber

 
1 
NIZORALTAB(110523)API 
CCDS 100528

NIZORAL
®
 TABLETS 
PRODUCT INFORMATION 
NAME OF THE MEDICINE 
Ketoconazole 
The chemical name for ketoconazole
is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-
imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy] phenyl] piperazine. 

Ketoconazole has the following chemical structure: 

CAS 
65277-42-1 
  C
26
H
28
CI
2
N
4
O
4
    MW:531.44 
DESCRIPTION

Ketoconazole is a synthetic antifungal for oral administration. It is
a white or almost white 
powder, practically insoluble in water, freely soluble
in methylene chloride, soluble in 
methanol and sparingly soluble in alcohol. The inactive ingredients
are maize starch, 
lactose, povidone, microcrystalline cellulose, colloidal anhydrous
silica and magnesium 
stearate.  
PHARMACOLOGY

Ketoconazole exerts a fungistatic effect at plasma levels (mean
approx. 3.5 micrograms/mL) 
achieved following an oral dose of 200 mg.   
_In vitro _antifungal activity of ketoconazole against a number
of organisms has been 
determined using an agar dilution procedure (Table 1).  The clinical
significance of these 
_in _
_vitro_ observations is not known.  Despite the fact that some
common fungi do not appear to be 
inhibited 
_in vitro_ by a concentration of 4 micrograms/mL,
ketoconazole has been shown to be 
clinically effective against them (see below). 

NIZORALTAB(110523)API 
CCDS 100528

2
Clinical efficacy of varying degrees has been demonstrated in
patients with the following 
species of fungi (see DOSAGE AND ADMINISTRATION): 
_Trichophyton rubrum_,  _T. _
_mentagrophytes_,  _Microsporum canis_,  _Epidermophyton
floccosum_,  _Candida albicans_,  _C. _
_tropicalis_,  _C. stellatoidea_,  _Candida_ spp., _Malassezia
furfur_,  _Paracoccidioides brasiliensis_, 
_Histoplasma capsulatum_,  _Coccidioides
immitis_ and _Phialaphora_ sppThe mode of action of 
ketoconazole appears to be simi