This information is intended for use by health professionals

1. Name of the medicinal product

Chloramphenicol Ear Drops BP 5% w/v

2. Qualitative and quantitative composition

Chloramphenicol BP 5% w/v

3. Pharmaceutical form

Ear Drops

4. Clinical particulars
4.1 Therapeutic indications

For the treatment of bacterial infection of the external ear.

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.

4.3 Contraindications

Hypersensitivity to the drug or Propylene Glycol or if the ear drum is perforated.

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.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6. Pregnancy and lactation

Chloramphenicol crosses the placenta but no problems have been reported with the use of ear drops. As with all drugs in pregnancy and during breast feeding, care should be taken in assessing the risk-benefits.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

May occasionally cause bone marrow hypoplasia, blood dyscrasia or hypersensitivity reactions.

4.9 Overdose

Overdose is unlikely to occur with this preparation.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Chloramphenicol is a broad spectrum antibiotic which acts by interfering with bacterial protein synthesis.

5.2 Pharmacokinetic properties

When used topically systemic absorption is very low.

5.3 Preclinical safety data

There is no pre-clinical safety data of relevance to the prescriber, therefore, none is presented in this section.

6. Pharmaceutical particulars
6.1 List of excipients

Propylene Glycol BP

6.2 Incompatibilities

None specific to this preparation.

6.3 Shelf life

36 months (unopened).

6.4 Special precautions for storage

Store at 2-8°C in a dry dark place. Do not freeze.

6.5 Nature and contents of container

A 10ml low density polyethylene bottle with dropper insert and high density polyethylene tamper evident cap.

6.6 Special precautions for disposal and other handling

None stated.

7. Marketing authorisation holder

Martindale Pharmaceuticals Ltd

Bampton Road

Harold Hill

Romford

RM3 8UG

8. Marketing authorisation number(s)

PL 00156/0050

9. Date of first authorisation/renewal of the authorisation

Date of first authorisation:

6th June 1997

Renewal Date:

2nd February 1998

10. Date of revision of the text

9th July 2001