SW ECONAZOLE CREAM 1% WW

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

ECONAZOLE NITRATE

Boleh didapati daripada:

SUNWARD PHARMACEUTICAL SDN. BHD.

INN (Nama Antarabangsa):

ECONAZOLE NITRATE

Unit dalam pakej:

400 gm; 400 gm; 30 gm mcg/mL; 15 gm mcg/mL; 10 gm mcg/mL

Dikeluarkan oleh:

SUNWARD PHARMACEUTICAL SDN. BHD.

Risalah maklumat

_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
ECONAZOLE CREAM 1% W/W
Econazole Nitrate ( 1%w/w)
WHAT IS IN THIS LEAFLET
1. What SW Econazole cream is used for
2. How SW Econazole cream works
3. Before you use SW Econazole cream
4. How to use SW Econazole cream
5. While you are using it
6. Side effects
7. Storage & Disposal of SW Econazole cream
8. Product Description
9. Manufacturer and Product Registration
Holder
10.Date of revision
WHAT SW ECONAZOLE CREAM IS USED FOR
It is used for the treatment of Tinea Pedis (foot
fungal infection), Tinea Cruris (jock itch) , and
Tinea Corporis (ringworm infection) caused
by fungus such as Trichophyton Rubrum,
Trichophyton
Mentagrophytes,
Trichophyton
Tonsurans, Microsporum Canis, Microsporum
Audouini,
Microsporum
Gypseum
and
Epidermophyton Foccosum, in the
treatment
of skin fungal infection such as Cutaneous
Candidiasis and also for Tinea Versicolor.
HOW SW ECONAZOLE CREAM WORKS
The active ingredient in the medicine is Econa-
zole nitrate. Econazole nitrate exhibits broad
spectrum anti-fungal activity. It may act by
interfering with the permeability of the fungal
cell membrane. It also possesses some anti-
bacterial activity.
BEFORE YOU USE SW ECONAZOLE CREAM
_- When you must not use it _
•
If
you
have
exhibited
hypersensitivity
to
Econazole or other ingredients listed at the
end of this leaflet.
_-Before you start to use it _
You should check with your doctor:-
•
If you are pregnant
_- Taking Other Medicines _
Avoid introduction of cream into the eyes. If a
reaction
suggesting
sensitivity
or
chemical
irritation should occur, use of the medication
should be discontinued. No known drug inter-
action. Econazole has shown undesired effects
on the fetus. Therefore, Econazole should be
used during pregnancy and lactation only if the
potential benefit outweighs the potential risk.
HOW TO USE SW ECONAZOLE CREAM
_- How much to use_
Topical application.
Sufficient cream should be applied to cover
affected areas twice daily (morning and even-
ing) in people with tinea pedis,

Ciri produk

Composition:
Econazole nitrate 1%w/w
PHARMACOLOGY
Econazole nitrate exhibits broad spectrum anti-fungal activity against
the dermatophytes, Trichophyton
rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans,
Microsporum canis, Microsporum audouini,
Microsporum gypseum and Epidermophyton floccosum, the yeasts, Candida
albicans and Pityrosporum
orbiculare.It may act by interfering with the permeability of the
fungal cell membrane.
It also posseses some anti-bacterial activity. The sensitive bacteria
include staphylococci, streptococci,
bacillus anthracis and bacteroides fragilis.After topical application
to the skin of norm.al subjects, systemic
absorption of econazole nitrate is extremely low. Although most of the
applied drug remains on the skin
surface, drug concentrations were found in the stratum corneum which,
by far, exceeded the minimum
inhibitory concentrations for dermatophytes. Inhibitory concentrations
were achieved in the epidermis and as
deep as the middle region of the dermis. Less than 1% of the applied
dose was recovered in the urine and
faeces
INDICATIONS:
It is indicated for topical application in the treatment of tinea
pedis, tinea cruris, and tinea corporis caused by
Trichophyton
rubrum,
Trichophyton
mentagrophytes,
Trichophyton
tonsurans,
Microsporum
canis,
Microsporum audouini, Microsporum gypseum and Epidermophyton
floccosum, in the treatment of cutaneous
candidiasis and tinea versicolor.
CONTRAINDICATIONS:
It is contraindicated in individuals who have shown hypersensitivity
to it.
SIDE EFFECTS:
The reported side effects consist mainly of itching, burning, stinging
and erythema.
PRECAUTIONS/WARNINGS:
If a reaction suggesting sensitivity or chemical irritation should
occur, use of the medication should be
discontinued.
Avoid introduction of cream into the eyes.
PREGNANCY & LACTATION
Pregnancy Category C : In animal studies after high oral dose (10 –
40 times human topical dose), Econazole
has shown undesired effects on the fetus. Therefore, Econazole should
be used during pregnancy an