Drugs List

Therapeutic Indications

Uses

Bacterial infection in otitis externa.

Administration

For auricular use.

Contraindications

Perforated tympanic membrane

Hypersensitivity to propylene glycol

Precautions and Warnings

Infants: use only if considered essential by the physician.

Pregnancy (see Pregnancy section).

Breastfeeding (see Lactation section).

Avoid use for more than 1 week as this may result in superinfection with non-susceptible organisms or sensitivity to chloramphenicol.

Contains propylene glycol: may cause irritation.

Pregnancy and Lactation

Pregnancy

Chloramphenicol crosses the placenta, but when used topically as ear drops systemic circulation is very low and no known problems have been reported. However, caution is advised.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use with caution during breastfeeding.
When used topically systemic absorption is very low. Chloramphenicol is secreted in the breast milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Hypersensitivity reactions
Bone marrow hypoplasia
Blood dyscrasias

Presentation

Ear drops containing chloramphenicol 5% w/v
Ear drops containing chloramphenicol 10% w/v

Drugs List

Therapeutic Indications

Uses

Bacterial infection in otitis externa.

Dosage

Following administration, it is advisable to lie down with affected ear uppermost for at least 10 minutes. Cotton wool may then be inserted into the ear and normal activities resumed.

Adults

Children

Administration

For auricular use.

Contraindications

Perforated tympanic membrane

Hypersensitivity to propylene glycol

Precautions and Warnings

Infants: use only if considered essential by the physician.

Pregnancy (see Pregnancy section).

Breastfeeding (see Lactation section).

Avoid use for more than 1 week as this may result in superinfection with non-susceptible organisms or sensitivity to chloramphenicol.

Contains propylene glycol: may cause irritation.

Pregnancy and Lactation

Pregnancy

Chloramphenicol crosses the placenta, but when used topically as ear drops systemic circulation is very low and no known problems have been reported. However, caution is advised.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use with caution during breastfeeding.
When used topically systemic absorption is very low. Chloramphenicol is secreted in the breast milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Effects on Ability to Drive and Operate Machinery

None known

Counselling

Advise patient to lie down for 10 minutes following application with the affected ear uppermost.

Side Effects

Hypersensitivity reactions
Bone marrow hypoplasia
Blood dyscrasias

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet (https://www.toxbase.org/).

Shelf Life and Storage

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

Further Information

Last Full Review Date: January 2011

Reference Sources

Summary of Product Characteristics: Chloramphenicol ear drops BP 5% w/v. Martindale Pharmaceuticals Ltd. Revised July 2001.

Summary of Product Characteristics: Chloramphenicol ear drops BP 10% w/v. Martindale Pharmaceuticals Ltd. Revised July 2001.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 16 August 2017