Drugs List

Therapeutic Indications

Uses

Otitis externa - infective

Contraindications

None known

Precautions and Warnings

Children under 12 years
Perforated tympanic membrane

Advise impaired alertness may affect ability to drive or operate machinery
Advise patient to stop treatment and see GP if ear pain occurs
Advise patient to stop treatment and see GP if hearing becomes impaired
Avoid contact with eyes
Discontinue if first occurrence or worsening of hearing disturbances
Do not use for more than seven days
Consult doctor if no improvement is seen within 48 hours of treatment

Pregnancy and Lactation

Pregnancy

Acetic acid ear spray is considered safe for use in pregnancy.

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 to 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

Acetic acid ear spray is considered safe for use in breastfeeding.

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

Burning sensation (local)
Stinging (transient)

Presentation

Liquid for auricular use containing acetic acid

Drugs List

Therapeutic Indications

Uses

Otitis externa - infective

Dosage

Before use, depress actuator 6 to 10 times until a fine spray is produced. If spray has not been used for over one week depress actuator once or twice to clear the pump chamber before use in the ear.

Adults

Elderly

Children

Contraindications

None known

Precautions and Warnings

Children under 12 years
Perforated tympanic membrane

Advise impaired alertness may affect ability to drive or operate machinery
Advise patient to stop treatment and see GP if ear pain occurs
Advise patient to stop treatment and see GP if hearing becomes impaired
Avoid contact with eyes
Discontinue if first occurrence or worsening of hearing disturbances
Do not use for more than seven days
Consult doctor if no improvement is seen within 48 hours of treatment

Pregnancy and Lactation

Pregnancy

Acetic acid ear spray is considered safe for use in pregnancy.

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 to 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

Acetic acid ear spray is considered safe for use in breastfeeding.

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

Burning sensation (local)
Stinging (transient)

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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: January 2017

Reference Sources

Summary of Product Characteristics: EarCalm Spray. Forest Laboratories UK Limited. Revised July 2015.