CANDID EAR DROPS 1%

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CLOTRIMAZOLE

Boleh didapati daripada:

Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.

INN (Nama Antarabangsa):

CLOTRIMAZOLE

Unit dalam pakej:

15 ml

Dikeluarkan oleh:

GLENMARK PHARMACEUTICALS LTD

Risalah maklumat

Consumer Medication Information Leaflet (RiMUP)
1
CANDID EAR DROPS
Clotrimazole USP 1% w/v
WHAT IS IN THIS LEAFLET
1. What Candid Ear Drops is
used for
2. How Candid Ear Drops works
3. Before you use Candid Ear
Drops
4. How to use Candid Ear
Drops
5. While you are using it
6. Side effects
7. Storage and Disposal of
Candid Ear Drops
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
WHAT CANDID EAR DROPS IS
USED FOR
The active substance in Candid
1% Ear Drops is clotrimazole.
Clotrimazole belongs to a
group of medicines called
imidazoles and is an antifungal
agent which fights the cause of
fungal ear infections.
HOW CANDID EAR DROPS
WORKS
Clotrimazole acts against fungi
by inhibiting ergosterol
synthesis. Inhibition of
ergosterol synthesis leads to
structural and functional
impairment of the fungal
cytoplasmic membrane.
Clotrimazole has a broad
antimycotic spectrum of action
in vitro and in vivo, which
includes dermatophytes, yeasts,
moulds, etc. Under appropriate
test conditions, the MIC values
for these types of fungi are in
the region of less than 0.062-
8.0 µg/ml substrate. The mode
of action of clotrimazole is
primarily 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.
In addition to its antimycotic
action, clotrimazole also acts
on gram-positive
microorganisms (Streptococci /
Staphylococci / Gardnerella
vaginalis), and gram-negative
microorganisms (Bacteroides).
In vitro clotrimazole inhibits
the multiplication of
Corynebacteria and gram-
positive cocci - with the
exception of Enterococci - in
concentrations of 0.5-10 µg/ml
substrate. Primarily resistant
variants of sensitive fungal
species are very rare; the
development of secondary
resistance by sensitive fungi
has so far only been observed
in very isolated cases under
therapeutic conditions.
BEFORE YOU USE CANDID EAR
DROPS
_When you must not use it _
If you are

Ciri produk

PANTONE
BLACK PROCESS C
SUPERSEDES
ARTWORK CODE:
PE
19364
PANTONE SHADE
ICONGRAPHICS CODE:
PHARMACODE:
Clotrimazole also has antibacterial action and some strains of
Staphylococcus aureus and Streptococcus pyogenes have
been reported to be sensitive. Clotrimazole is believed to exert
its activity on the cell membrane of the fungus. It appears that
the drug inhibits protein synthesis and so influences the
utilisation and the incorporation of the acylated amino acids
essential for fungi.
PHARMACOKINETICS
Clotrimazole appears to be well absorbed in humans following
oral administration and is eliminated
mainly as inactive metabolites. Following topical and vaginal
administration, however, Clotrimazole appears to be minimally
absorbed.
Six
hours
after
the
application
of
radioactive
Clotrimazole 1% cream and 1% solution onto intact and acutely
inflamed skin, the concentration of Clotrimazole varied from
3
3
100 mcg / cm in the stratum corneum to 0.5 to 1 mcg / cm in
3
the stratum reticulare, and 0.1 mcg / cm in the subcutis. No
measurable amount of radioactivity (
£
0.001 mcg/ml) was
found in the serum within 48 hours after application under
occlusive dressing of 0.5 ml of the solution or 0.8 g of the
cream. Only 0.5% or less of the applied radioactivity was
excreted in the urine.
INDICATIONS
lOtomycosis.
lConcomitant therapy with Antibiotic and Corticosteroid
Ear Drops.
lProphylaxis for swimmers.
CONTRAINDICATIONS
Except for possible hypersensitivity reactions, there are no
contraindications to CANDID Ear Drops.
SIDE EFFECTS / ADVERSE REACTIONS
The local tolerance of CANDID Ear Drops is excellent and no
systemic effects are seen with topical use. Rarely patients may
experience
local
irritation.This
generally
disappears
on
continuing the therapy.
PE00000 MY
SAME SIZE ARTWORK
LEAFLET SIZE: 130 mm x 100 mm
DRUG INTERACTIONS
None reported.
PRECAUTIONS / WARNINGS
When the ear drum is perforated, CANDID Ear Drops should
be used with caution. This in accordance with the general
directions for the use of all ear drops.
This