Otosporin ear drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydrocortisone; Neomycin sulfate; Polymyxin B sulfate

Available from:

Stephar (U.K.) Ltd

ATC code:

S02CA03

INN (International Name):

Hydrocortisone; Neomycin sulfate; Polymyxin B sulfate

Dosage:

10mg/1ml ; 3400unit/1ml ; 10000unit/1ml

Pharmaceutical form:

Ear drops

Administration route:

Auricular

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 12010100

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
OTOSPORIN
® EAR DROPS
(POLYMYXIN B SULPHATE, NEOMYCIN SULPHATE
AND HYDROCORTISONE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START USING THIS MEDICINE
BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it
again.
•
If you have any further questions, ask your
doctor or pharmacist.
•
This medicine has been prescribed for you.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
•
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
The name of your medicine is Otosporin Ear
Drops but will be referred to as Otosporin
throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Otosporin is and what it is used for
2.
What you need to know before you use
Otosporin
3.
How to use Otosporin
4.
Possible side effects
5.
How to store Otosporin
6.
Contents of the pack and other information
The name of your ear drops is Otosporin. It is
used to treat ear infections.
•
Otosporin contains three medicines called:
polymyxin B sulphate, neomycin sulphate and
hydrocortisone.
•
Polymyxin B sulphate and neomycin sulphate
belong to a group of medicines called
antibiotics. They kill the germs that can cause
ear infections.
•
Hydrocortisone belongs to a group of
medicines called steroids. It helps to reduce
the swelling and irritation caused by the
infection.
DO NOT USE OTOSPORIN:
•
if you are allergic (hypersensitive) to
polymyxin B sulphate, neomycin sulphate,
hydrocortisone or any of the other ingredients
of this medicine (see section 6)
•
if you are allergic (hypersensitive) to
aminoglycoside antibiotics such as
framycetin, kanamycin or gentamicin
•
if you have a perforated ear drum
•
if you have either a viral, fungal or tubercular
(TB) infection
•
for a child under 3 years old.
Do not use if any of the above apply to you. If
you are not sure, talk to your doctor or
pharmacist before using Oto

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Otosporin Ear Drops.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Polymyxin B Sulphate 10,000 units per ml
Neomycin Sulphate 3,400 units per ml
Hydrocortisone 1.0% w/v
Excipient(s) with known effect:
Also contains cetostearyl alcohol and methyl hydroxybenzoate E218
For a full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Liquid for topical application to humans.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Otosporin Ear Drops are indicated for the treatment of otitis externa
due to, or
complicated by, bacterial infection.
Route of Administration
Topical
IN VITRO ACTIVITY
Otosporin Ear Drops are active against a wide range of bacterial
pathogens.
The range of activity includes:-
GRAM-POSITIVE ORGANISMS:
_Staphylococcus epidermis_ and _Staphylococcus aureus_:
GRAM-NEGATIVE ORGANISMS:
_Enterobacter_ Spp.
_Escherichia_ Spp.
_Haemophilus_ Spp.
_Klebsiella_ Spp.
_Proteus_ Spp.
_Pseudomonas aeruginosa _
Otosporin Ear Drops are not expected to be active against
streptococci,
including _Streptococcus_ _pyogenes_.
Hydrocortisone possesses anti-inflammatory, anti-allergic and
antipruritic
activity.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Otosporin ear drops are for topical administration into the ear only.
Adults
Following cleansing and drying of the external auditory meatus and
canal as
appropriate, three drops should be instilled into the affected ear
three or four
times daily. Alternatively, a gauze wick may be introduced into the
external
auditory canal and kept saturated with the solution; the wick may be
left in
place for 24 to 48 hours.
Treatment should not be continued for more than 7 days without medical
supervision.
Soap should not be used for cleansing of the external auditory meatus
and
canal as it may inactivate the antibiotics.
Children
Otosporin Ear Drops are suitable for use in children ( 3 years and
over) at the
same dose as adults. A possibility of increased absorption exists in
very
young children, thus Otosporin Ear Dro