MYCORIL SPRAY 1%

Country: Malaysia

Language: English

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

Active ingredient:

CLOTRIMAZOLE

Available from:

EUCOGEN SDN BHD

INN (International Name):

CLOTRIMAZOLE

Units in package:

75 gm

Manufactured by:

REMEDICA LTD

Summary of Product characteristics

my-pi-mycoril-spray-a1 page 1 of 4
PACKAGE INSERT
1. PRODUCT NAME
Mycoril 1% w/v cutaneous spray, solution.
2. NAME AND STRENGTH OF ACTIVE INGREDIENT
Mycoril cutaneous spray, solution contains 1% w/v clotrimazole.
3. PRODUCT DESCRIPTION
Cutaneous spray, solution.
Clear to pale yellow liquid with characteristic odour.
4. PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMICS
ATC code: D01AC01
Clotrimazole is an imidazole derivative with a broad spectrum
antimycotic activity. It
also exhibits activity against
_Trichomonas_
, staphylococci, streptococci and
_Bacteroides_
.
It has no effect on lactobacilli.
Mechanism of action
Clotrimazole acts against fungi by inhibiting ergosterol synthesis.
Inhibition synthesis
leads to structural and functional impairment of the cytoplasmic
membrane.
Phannacodynamic Effects:
Clotrimazole has a broad antimycotic spectrum of action in vitro and
in vivo, which
includes dermatophytes, yeast, moulds, etc.
The
mode
of
action
of
clotrimazole
is
fungistatic
or
fungicidal
depending
on
the
concentration of clotrimazole at the site of infection. In-vitro
activity is limited to
proliferating fungal elements; fungal spores are only slightly
sensitive.
Primarily resistant variants of sensitive fungal species are very
rare; the development of
secondary resistance by sensitive fungi has been observed in very
isolated cases under
therapeutic conditions.
PHARMACOKINETICS
my-pi-mycoril-spray-a1 page 2 of 4
Pharmacokinetic investigations after dermal application have shown
that clotrimazole is
practically
not
absorbed
from
the
intact
or
inflamed
skin
into
the
human
blood
circulation. The resulting peak serum concentrations of clotrimazole
were below the
detection limit of 0.001 ug/ml, reflecting that clotrimazole applied
topically
does
not
lead
to
measurable
systemic
effects
or
side
effects.
Absorption
bioavailability in skin, topical: Less than 0.5%
_(Anon, 1975)_
.
Distribution:
Skin
a)
1.53
to
100
mcg/ml
(
_Duhm _
_et _
_al, _
_1974)_
.
Following
topical
application to the skin, clotrimazole was distributed