TRICONAZOLE CREAM

Country: Malaysia

Language: English

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

Active ingredient:

ECONAZOLE NITRATE; TRIAMCINOLONE

Available from:

SUNWARD PHARMACEUTICAL SDN. BHD.

INN (International Name):

ECONAZOLE NITRATE; TRIAMCINOLONE

Units in package:

400 gm; 50x15 gm; 15 gm

Manufactured by:

SUNWARD PHARMACEUTICAL SDN. BHD.

Patient Information leaflet

NOT APPLICABLE

Summary of Product characteristics

TRICONAZOLE CREAM
Composition:
Triamcinolone Acetonide BP
0.1% w/w
Econazole Nitrate BP
1.0% w/w
PHARMACOLOGY:
Triamcinolone
acetonide
and
econazole
nitrate
combination
has
anti-inflammatory, anti-pruritic, anti-fungal and anti-bacterial
action.
Econazole acts by damaging cell membranes. The permeability of the
fungal
cell is increased. Subcellular membranes in the cytoplasm are damaged.
The
site
action
is
most
probably
the
unsaturated
fatty
acid
acyl
moiety
of
membrane phospholipids.
Triamcinolone acetonide is a more potent form of the naturally
occurring
adrenocorticol hormone. The mechanism of anti-inflammatory activity of
the
corticosteroids is unclear, but there is some evidence to suggest that
a
recognizable
correlation
exists
between
vasoconstrictor
potency
and
therapeutic efficacy in man.
When applied topically, particularly to large areas, the triamcinolone
acetonide
may be absorbed in sufficient amount to cause systemic effect. It is
slowly
metabolized in the skin and thus tend to be systemically absorbed to a
greater extend.
After topical application to the skin of normal subjects, systemic
absorption of
econazole nitrate in 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 concentration
for
dermatophytes. Inhibitory concentrations are 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:
Inflammatory dermatoses with mycotic or bacterial infection.
Inflammatory
dermatomycoses caused by dermatophytes, yeasts and molds.
CONTRAINDICATIONS:
It is contraindicated in patient who are hypersensitive to econazole
nitrate,
triamcinolone or other corticosteriods.
WARNING AND PRECAUTIONS:
The medication should be discontinued if irritation occurred.
Do not use in and around eyes.
Special precaution should be taken when medication is used in
children.
USE IN PREGNANCY AND LACTATION: