Chloramphenicol 10% ear drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Chloramphenicol

Available from:

A A H Pharmaceuticals Ltd

ATC code:

S02AA01

INN (International Name):

Chloramphenicol

Dosage:

100mg/1ml

Pharmaceutical form:

Ear drops

Administration route:

Auricular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 12010100; GTIN: 5037562203186

Patient Information leaflet

5. HOW TO STORE
CHLORAMPHENICOL EAR DROPS
Keep out of the sight and reach of
children.
Do not use Chloramphenicol Ear Drops
after the expiry date printed on the
bottle label. The expiry date refers to
the last day of that month.
This medicine needs to be stored
upright between 2-8°C (in a
refrigerator). Protect from light. Do not
allow it to freeze.
Once you have opened the bottle it
should not be used after four weeks.
Do not throw away any medicines via
wastewater or household waste. Ask
your pharmacist how to dispose of
medicines no longer required. These
measures will help to protect the
environment.
6. CONTENTS OF THE PACK AND
OTHER INFORMATION
WHAT CHLORAMPHENICOL EAR DROPS
CONTAIN
The active ingredient is
Chloramphenicol 10% w/v.
The other ingredient is Propylene
Glycol (90%).
WHAT CHLORAMPHENICOL EAR DROPS
LOOK LIKE AND CONTENTS OF THE PACK
Chloramphenicol Ear Drops are
supplied in plastic bottles, each bottle
containing 10ml of solution.
MARKETING AUTHORISATION HOLDER AND
MANUFACTURER
Martindale Pharmaceuticals Ltd.
Bampton Road,
Romford, RM3 8UG, England
IF YOU WOULD LIKE ANY MORE
INFORMATION, OR WOULD LIKE THE LEAFLET
IN A DIFFERENT FORMAT, PLEASE CONTACT
MEDICAL INFORMATION AT THE ABOVE
ADDRESS.
PRODUCT LICENCE NUMBER:
PL 00156/0051
This leaflet was last revised in:
June 2018
This medicine will be referred to as
Chloramphenicol ear drops in the rest of
this leaflet.
WHAT IS IN THIS LEAFLET
1. What Chloramphenicol Ear Drops are
and what they are used for
2. What you need to know before you
use Chloramphenicol Ear Drops
3. How to use Chloramphenicol Ear
Drops
4. Possible side effects
5. How to store Chloramphenicol
Ear Drops
6. Contents of the pack and other
information
1. WHAT CHLORAMPHENICOL EAR
DROPS ARE AND WHAT THEY ARE
USED FOR
Chloramphenicol belongs to a group
of medicines called antibiotics. An
antibiotic is a medicine which is used for
the treatment of a variety of infections
caused by bacteria. Chloramphenicol
Ear Drops are used in the treatment of a
wide range of bacterial infections of the

Summary of Product characteristics

1
NAME OF THE MEDICINAL PRODUCT
Chloramphenicol 10% w/v Ear Drops
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chloramphenicol 10% w/v
Excipient with known effect
1ml contains 0.9g of propylene glycol
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Ear Drops
Clear, colourless to pale yellow very slightly viscous liquid
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Chloramphenicol is a broad spectrum bacteriostatic antibiotic. It is
active against a wide range
of Gram-negative and Gram-positive organisms, including _ Salmonella
typhi, Haemophilus _
_influenzae, Neisseria meningitidis, Streptococcus pneumoniae and
Bacteroides fragilis. _It has
antirickettsial and antichlamydial activity. It is indicated for the
topical treatment of bacterial
infection of the external ear caused by pathogens which are sensitive
to it.
Chloramphenicol is indicated in adults and children.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults, Children and the Elderly
Apply 3 - 4 drops into the affected ear 2 - 3 times daily for up to 1
week.
Following administration of ear drops patients should be advised to
lie down with the affected
ear uppermost for a minimum of 10 minutes. After this time cotton wool
may be inserted into
the ear and normal activities resumed.
Infants
Only use if considered essential by the physician.
Method of administration
For topical use
4.3
CONTRAINDICATIONS
• Hypersensitivity to the active substance or to any of the
excipients listed in section 6.1
• If the ear drum is perforated.
• Myelosuppression during previous exposure to chloramphenicol.
• Known personal or family history of blood dyscrasias including
aplastic anaemia
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Avoid use for more than 1 week as this may result in sensitivity to
chloramphenicol or the
emergence of resistant organisms. Where chloramphenicol ear drops are
used on a long term
or intermittent basis, it may be advisable to perform a routine blood
profile before therapy and
at appropriate intervals thereafter to d