OttoZole Ear Drops (Clotrimazole 1% wv)

Ülke: Malezya

Dil: İngilizce

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

Aktif bileşen:

CLOTRIMAZOLE

Mevcut itibaren:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (International Adı):

CLOTRIMAZOLE

Paketteki üniteler:

10 ml

Tarafından üretildi:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

Bilgilendirme broşürü

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
OTTOZOLE EAR DROPS (CLOTRIMAZOLE 1% W/V)
Clotrimazole (1% w/v)
1
WHAT IS IN THIS LEAFLET
1.
What OttoZole is used for
2.
How OttoZole works
3.
Before you use OttoZole
4.
How to use OttoZole
5.
While you are using OttoZole
6.
Side effects
7.
Storage and disposal of OttoZole
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT OTTOZOLE IS USED FOR
Fungal
infection
that
affects
ears,
combination treatment of antibiotics and
steroids and prevention for swimmer’s
ears.
HOW OTTOZOLE WORKS
Clotrimazole is an imidazole antifungal
agent and is effective against a
wide
variety of fungi.
It also has antibacterial action and some
microorganism have been reported to be
sensitive.
Clotrimazole also exert its activity on the
cell membrane of the fungus and inhibits
protein
synthesis
and
influences
the
usage
of
the
acylated
amino
acids
essential for fungi.
BEFORE YOU USE OTTOZOLE
_- When you must not use it _
Do not use it when you have sensitivity
to Clotrimazole.
_-Before you start to use it_
To be used under medical advice and as
directed by the attending physician.
_-Taking other medicines _
Tell your doctor if you are taking any
other medicines, including any that you
buy
without
a
prescription
from
a
pharmacy, supermarket or health food
shop.
No known drug interaction.
HOW TO USE OTTOZOLE
_-How much to use _
4 to 5 drops are instilled in the ear 3-4
times
daily
or
as
directed
by
the
physician.
_-When to use it _
Use
as
directed
by
your
doctor
or
pharmacist.
Apply 3-4 times daily.
_-How long to use it _
Continue taking OttoZole as your doctor
recommended.
_ _
_-If you forget to use it _
Consult your doctor or pharmacist on
what you should do if you forget to use
it.
_ _
_-If you use too much (overdose) _
Acute overdose with topical application
of Clotrimazole is unlikely and would
not
be
expected
to
lead
to
a
life-
threatening situation.
WHILE YOU ARE USING OTTOZOLE
_-Things you must do _
•
Tell
all
the
doctors,
dentists
and
p

Ürün özellikleri

OTTOZOLE EAR DROPS (CLOTRIMAZOLE 1% W/V)
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Clotrimazole.……………………………… 1% w/v
Preservatives:
Sodium Methyl Paraben ……………. 0.05% w/v
Propyl Paraben ……………………... 0.01% w/v
_ _
PRODUCT DESCRIPTION
Clear, colourless viscous liquid.
PHARMACODYNAMICS
Clotrimazole is an imidazole antifungal agent and is effective against
a wide variety of fungi
including.
Epidermophyton,
Microsporum
and
Trichophyton
spp,
Coccidioides
immitis,
Histoplasma capsulatum, Aspergillus and Candida spp. Other fungi
responding to Clotrimazole
include
Crytococcus
neoformans,
Malassezia
furfur
[Pityrosporum
orbiculare],
Paracoccidioides
brasilliensis,
Sporothrix
schenckii,
Psedallescheria,
Medurella
and
and
Phialophora spp.
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 utilisations
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 to intact
acutely inflamed skin, the
concentration of clotrimazole varied from 100 mcg / cm 3 in the
stratum corneum to 0.5 to 1
mcg / cm3 in the stratum reticulare, and 0.1 mcg / cm3 in the
subcutis. No measurable amount
of radioactivity [ <0.0001 mcg/ml ] was found in the serum within 48
hours after application
under occlusive dressing of 0.5ml 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
. Otomycosis
. Concomitant therapy with Antibiotic and Corti