Chloramphenicol 5% ear drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Chloramphenicol

Available from:

Martindale Pharmaceuticals Ltd

ATC code:

S02AA01

INN (International Name):

Chloramphenicol

Dosage:

50mg/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: 5014124344013

Patient Information leaflet

6. FURTHER INFORMATION
WHAT CHLORAMPHENICOL EAR DROPS
CONTAIN
The active ingredient is
Chloramphenicol 5% w/v BP.
The other ingredient is Propylene Glycol
(95%).
WHAT CHLORAMPHENICOL EAR DROPS
LOOK LIKE AND CONTENT 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 NUMBERS:
PL 00156/0050
Date of last revision: November 2015
IN THIS LEAFLET:
1. What Chloramphenicol Ear Drops are
and what they are used for
2. Before you use Chloramphenicol Ear
Drops
3. How to use Chloramphenicol Ear
Drops
4. Possible side effects
5. Storing Chloramphenicol Ear Drops
6. Further information
This leaflet contains a summary of
the information available for this
medicine. You should ask your doctor or
pharmacist if you are unsure about any
aspect of this medicine.
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
outer ear.
2. BEFORE YOU USE
CHLORAMPHENICOL EAR DROPS
DO NOT USE CHLORAMPHENICOL EAR
DROPS IF:
• you are allergic (hypersensitive) to
Chloramphenicol, Propylene Glycol or
to any of the other ingredients in this
medicine (see section 6)
• you have a hole in your ear drum.
TAKE SPECIAL CARE WITH
CHLORAMPHENICOL EAR DROPS TELL YOUR DOCTOR IF :
• you are pregnant, trying for a baby or
are breast-feeding.
TAKING OTHER MEDICINES
Please tell your doctor if you are taking
or have recently taken any other
medicines including medicines obtained
without a prescription, herbal and
complementary medicines.
PREGNAN

Summary of Product characteristics

1
NAME OF THE MEDICINAL PRODUCT
Chloramphenicol 5% w/v Ear Drops
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chloramphenicol 5% w/v
Excipient with known effect
1ml contains 0.95g of propylene glycol
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Ear Drops
Clear, colourless to pale yellow vert 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
Posology
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