Chloramphenicol 0.5% eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Chloramphenicol

Available from:

The Boots Company Plc

ATC code:

S01AA01

INN (International Name):

Chloramphenicol

Dosage:

5mg/1ml

Pharmaceutical form:

Eye drops

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11030100

Patient Information leaflet

CHLORAMPHENICOL 0.5% EYE DROPS
WHAT IS IN THIS LEAFLET:
1.
What Chloramphenicol Eye Drops are and what
they are used for
2.
What you need to know before you use
Chloramphenicol Eye Drops
3.
How to use Chloramphenicol Eye Drops
4.
Possible side effects
5.
How to store Chloramphenicol Eye Drops
6.
Contents of the pack and other information
1. WHAT CHLORAMPHENICOL EYE 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 Eye Drops
are used in both adults and children for the
treatment of a wide range of eye infections caused
by bacteria.
2. WHAT YOU NEED TO KNOW BEFORE YOU
USE CHLORAMPHENICOL EYE DROPS
DO NOT USE CHLORAMPHENICOL EYE DROPS IF:
• you are allergic to chloramphenicol or any of
the other ingredients of this medicine listed in
section 6
· you or someone in your family ever had a blood
disorder or bone marrow disease including
anemia (decrease in the number of red blood
cells) when using chloramphenicol in the past.
· you have a family history of “dyscrasias”, a
condition which can cause tiredness, bruising
and an increased risk of infections
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using
Chloramphenicol Eye Drops if
· you have visual disturbances
· you have severe pain in the eye
· you are sensitive to light
· your eye is inflamed and you have a rash on the
scalp or face
· your eye looks cloudy
· your black or coloured part of the eye
looks unusual
· you have a foreign body in the eye
· you have an eye infection that keeps
coming back
· you have glaucoma (raised pressure in the eye)
· you have dry eyes
· you have eye injury or eye surgery
· you are currently using any other eye drops or
eye ointment
TAKE SPECIAL CARE:
• If you develop a new eye infection during this
treatment, you should stop using the drops and
speak to your doctor.
• If you use chloramphenicol eye drops for a long
t

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Chloramphenicol 0.5% Eye Drops
Vistaphenicol Eye Drops.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chloramphenicol 0.5% w/v
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Eye Drops
Clear, colourless to slightly yellow solution
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
superficial
ocular infections caused by pathogens which are sensitive to it.
Chloramphenicol is indicated in adults and children.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults (and the elderly) and children
One or two drops applied to each affected eye up to six times daily or
more
frequently if required. (Severe infections may require one to two
drops every
fifteen to twenty minutes initially, reducing the frequency of
instillation
gradually as the infection is controlled).
Paediatric population
Dosage adjustment may be necessary in newborn infants because of
reduced
systemic elimination due to immature metabolism and the risk of
dose-related
adverse effects. The maximum duration of treatment is 10-14 days.
Method of administration
For topical ocular use.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
•
Myelosuprresssion during previous exposure to chloramphenicol.
•
Known personal or family history of blood dyscrasias including
aplastic anaemia
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Chloramphenicol is absorbed systemically from the eye and toxicity has
been
reported following chronic exposure.
Bone marrow hypoplasia, including aplastic anaemia and death, has been
reported following topical use of ch