资料单张
LOCACORTEN
®
-VIOFORM
®
V 4.0
1
LOCACORTEN®-VIOFORM®
_flumethasone pivalate / clioquinol _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common
questions about
Locacorten-Vioform ear drops.
It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits.
Your doctor has
weighed the risks of you using
this medicine against the benefits
they expect it will provide.
IF YOU HAVE ANY CONCERNS ABOUT
THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT LOCACORTEN-
VIOFORM IS USED FOR
Locacorten-Vioform ear drops
contain flumethasone pivalate
and clioquinol.
Flumethasone pivalate belongs to
a group of medicines called
corticosteroids. It is used to
relieve symptoms of ear infection
such as itching, redness and
swelling.
Clioquinol is an anti-infective
medicine. It is used to fight the
germs which are causing the ear
infection.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed
it for another purpose.
Locacorten-Vioform is only
available
with a doctor's
prescription. It is not addictive.
BEFORE YOU USE
LOCACORTEN- VIOFORM
_WHEN YOU MUST NOT USE IT _
DO NOT USE LOCACORTEN-VIOFORM
IF YOU HAVE AN ALLERGY TO:
• flumethasone or clioquinol,
the
active ingredients of
Locacorten- Vioform
• macrogol, the other ingredient
of Locacorten- Vioform
• other quinoline medicines
which are similar to clioquinol
• iodine or other medicines that
contain iodine
IF YOU ARE NOT SURE ABOUT ANY OF
THE ABOVE MEDICIN
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产品特点
LOCACORTEN-VIOFORM EAR DROPS
DESCRIPTION
Locacorten-Vioform ear drops are presented in polyethylene bottles containing 7.5 mL solution
containing 0.02% Flumethasone pivalate and 1% Clioquinol.
Flumethasone pivalate
Chemical Formula: C
27
H
36
F
2
O
6
(
6
α, 9-Difluouro-11ß,17,21-trihydroxy-16α-methyl- pregna-1,4-
diene-3,20-dione 21-pivalate)
MW: 494.571
CAS Number: 2002-29-1
Flumethasone is a synthetic difluorinated glucocorticoid.
Clioquinol
Chemical Formula: C
9
H
5
ClINO (5-chloro-7-iodo-8-quinolinol) MW: 305.5
CAS Number: _130-26-7_
Clioquinol is an halogenated hydroxyquinoline derivative.
Polyethylene glycol 300
ACTIONS
PHARMACOLOGY
Flumethasone pivalate is a moderately potent glucocorticoid
designed for local application. It exerts
an anti-inflammatory, anti-allergic, vasoconstrictive, and anti- proliferative
effect.
In inflammatory skin diseases of the external
auditory meatus it affords prompt relief and eliminates
symptoms such as pruritus while at
the same time reducing swelling.
Clioquinol, the antimicrobial component of Locacorten-Vioform ear drops, is active against a
broad spectrum of pathogenic micro-organisms, including fungi (e.g. Candida, Microsporum,
Trichophyton) and Gram-positive bacteria (e.g. staphylococci). Clioquinol has only a moderate
inhibitory effect on Gram-negative bacteria.
Clioquinol exerts a bacteriostatic, rather than a bactericidal action.
PHARMACOKINETICS
No pharmacokinetic data on Locacorten-Vioform ear-drops are available.
Trials (including treatment under occlusive dressings) with different formulations of Locacorten-
Vioform for topical application have shown that no demonstrable percutaneous absorption of
flumethasone pivalate occurs, while clioquinol was absorbed to an extent of about 1.5% to 4%, as
judged by the urinary excretion.
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