Locorten-Vioform

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Clioquinol 1%{relative};  ; Flumetasone pivalate 0.02%{relative}

Available from:

AFT Pharmaceuticals Ltd

INN (International Name):

Clioquinol 1% w/v

Pharmaceutical form:

Ear drops

Composition:

Active: Clioquinol 1%{relative}   Flumetasone pivalate 0.02%{relative} Excipient: Macrogol 300

Units in package:

Bottle, plastic, 7.5 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Synthexim

Therapeutic indications:

Eczema of the external auditory meatus in which secondary infection with micro-organisms sensitive to clioquinol has occurred. · Otis externa · Otomycosis

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, - 7.5 mL - 18 months from date of manufacture stored at or below 25°C

Authorization date:

1969-12-31

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Page 1 of 9
1.
LOCORTEN-VIOFORM
®
(1%
CLIOQUINOL
AND
0.02%
FLUMETASONE
PIVALATE EAR DROPS)
LOCORTEN-VIOFORM
®
1% clioquinol and 0.02% flumetasone pivalate ear drops
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
LOCORTEN-VIOFORM
®
contains
1% clioquinol and 0.02% flumetasone pivalate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ear drops.
A clear yellowish solution with a volume of 7.5ml (32 ± 3 drops per
1ml). Flumetasone is a synthetic
difluorinated glucocorticoid.
Clioquinol is a halogenated hydroxyquinolone derivative.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Eczema of the external auditory meatus in which secondary infection
with micro-organisms sensitive
to clioquinol has occurred.
•
Otitis externa
•
Otomycosis.
4.2
DOSE AND METHOD OF ADMINISTRATION
Before application, the auditory meatus should be cleansed and dried
carefully.
Instill 2 or 3 drops twice daily into the auditory meatus by gently
squeezing the plastic bottle. The
patient should be either sitting or lying down with the treated ear
turned upwards during application.
This position should be maintained for at least 1-2 minutes following
the application.
Alternatively, a gauze or cotton wick saturated with the solution may
be inserted into the ear canal.
Keep the wick moistened by adding further solution. It should be
replaced at least once every 24 hours.
The solution may be warmed to body temperature prior to each
application (e.g. by holding the bottle
in the hands). Heating above body temperature should be avoided.
Contamination of the dropper with
material from the ear, fingers, or other sources should be avoided.
Treatment should normally not
exceed 10 days.
NEW ZEALAND DATA SHEET
Page 2 of 9
LOCORTEN-VIOFORM
®
is dissolved in a polyethylene glycol vehicle which forms an inert,
non-
irritant, rather viscous medium. This medium has a softening effect on
the cerumen and does not prevent
drainage, thus ensures prolonged contact of the active ingredients
with the surface of the e