FUNGI-STAT CREAM

Country: Malaysia

Language: English

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

Active ingredient:

ECONAZOLE NITRATE; TRIAMCINOLONE ACETONIDE

Available from:

SM PHARMACEUTICALS SDN. BHD.

INN (International Name):

ECONAZOLE NITRATE; TRIAMCINOLONE ACETONIDE

Units in package:

15gm mcg/mL; 15gm mcg/mL; 450gm mcg/mL; 30 gm mcg/mL; 450 gm mcg/mL

Manufactured by:

SM PHARMACEUTICALS SDN. BHD.

Patient Information leaflet

CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)
FUNGI-STAT CREAM
_(ECONAZOLE NITRATE AND TRIAMCINOLONE ACETONIDE CREAM)_
_______________________________________________________________________________________________________________
___________________________________________________________________________________________________________
1
WHAT IN THIS LEAFLET WHAT IS FUNGI STAT USED FOR
HOW FUNGI STAT WORKS
BEFORE YOU USE FUNGI STAT
HOW TO TAKE FUNGI STAT
WHILE YOU ARE USING FUNGI STAT SIDE EFFECTS STORAGE AND DISPOSAL OF FUNGI STAT
PRODUCTS DESCRIPTIONS
MANUFACTURER AND PRODUCT REGISTRATION
HOLDER
DATE OF REVISION WHAT IS FUNGI STAT USED FOR
•
Eczema
•
Inflammatory dermatomycoses caused
by dermatophytes, yeasts and moulds.
•
Mycotic infections in the body folds
.
HOW FUNGI STAT WORKS
Econazole works by killing the fungus or
yeast or preventing its growth.
Triamcinolone works by reducing skin
inflammation (redness, swelling, itching, and
irritation). The emollient moisturizes the
skin.
BEFORE YOU USE FUNGI STAT
When you must not take it
•
If you are hypersensitive to active
ingredients or any other ingredients of the
cream.
•
If you have tubecular of the skin
including vaccini, varicella and herpes
simplex.
Before you start take it
Tell doctor our medical condition,if you are
pregnant,planning to get pregnant or breast
feeding
Taking other medicine
No records
HOW TO TAKE FUNGI STAT
How much to take
Should be rubbed into the affected area.
When to take it
Follow doctor’s advice
How long to take it
Follow doctor’s advice
If you forget to take it
Take the missed dose as soon as possible as
you remember it. However if it is almost for
the next dose, skip the missed dose and
continue your regular doing schedule. Do not
take a double dose to make up for a missed
one.
If you take too much (overdose) Get medical help as soon as possible
WHILE YOU ARE USING FUNGI STAT
Things you must do
Follow doctors advice
Things you must not do
Do not stop taking without consulting
doctor first.Do not give you medicine

Summary of Product characteristics

Package Insert
Page 1 of 4
SM PHARMACEUTICALS SDN. BHD.
FUNGI-STAT CREAM
(ECONAZOLE NITRATE AND TRIAMCINOLONE ACETONIDE CREAM)
DESCRIPTION:
A smooth, soft, white, homogenous cream.
COMPOSITION:
Econazole Nitrate 10 mg / gram (1% w/w)
Triamcinolone Acetonide 1 mg / gram (0.1% w/w)
ACTIONS AND MODE OR MECHANISMS OF ACTION:
Econazole Nitrate
Fungistatic; may be fungicidal, depending on concentration; inhibits
biosynthesis of
ergosterol or other sterols, damaging the fungal cell wall membrane
and altering its
permeability; as a result, loss of essential intracellular elements
may occur; also inhibits
biosynthesis of triglycerides and phospholipids by fungi; in addition
inhibits oxidative
and
peroxidative
enzyme
activity,
resulting
in
intracellular
buildup
of
toxic
concentration of hydrogen peroxide which may contribute to
deterioration of subcellular
organelles
and
cellular
necrosis.
In
Candida
albicans,
inhibits
transformation
of
blastospores into invasive mycelial form.
Also have some activity against Gram-positive bacteria.
Triamconolone Acetonide
Triamcinolone diffuse across cell membranes and complex with specific
cytoplasmic
receptors. These complexes then enter the cell nucleuc, bind to DNA
(chromatin), and
stimulate transcription of messenger RNA (mRNA) and subsequent protein
synthesis of
various enzymes thought to be ultimately responsible for
anti-inflammatory effects of
topical application of adrenocorticoids.
PHARMACOLOGY
(SUMMARY
OF
PHARMACODYNAMICS
AND
PHARMACOKINETICS):
Absorption: Minimal systemic absorption following topical application
to normal skin.
Stratum corneum concentration
Far exceeded minimum inhibitory concentrations (MICs) for
dermatophytes; inhibitory
concentrations found in epidermis and as deep as middle region of
dermis.
Elimination:
Renal and fecal; <1% of applied dose recovered in urine and feces.
Absorption: Dermal penetration, minimal systemic absorption.
TRIAMCINOLONE ACETONIDE
Absorbed systemically across the stratum corneum; occlusion, use over
extensive areas,
or prolonged use