Chloramphenicol Ear Drops Bp 5% W/V
SUMMARY OF PRODUCT CHARACTERISTICS
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. Contra-indications
Hypersensitivity to the drug or Propylene Glycol or if the ear drum is perforated.
4.4. Special Warnings and Special 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. Interactions 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.
None stated.
7 MARKETING AUTHORISATION HOLDER
Martindale Pharmaceuticals Ltd
Bampton Road
Harold Hill
Romford
RM3 8UG
8. MARKETING AUTHORISATION NUMBER(S)
PL 00156/0050
THE
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
Date of first authorisation: 6th June 1997 Renewal Date: 2nd February 1998
10. DATE OF (PARTIAL) REVISION OF THE TEXT
9th July 2001