Drugs List

Therapeutic Indications

Uses

Otitis externa - infective

Contraindications

Children under 2 years
Perforated tympanic membrane

Precautions and Warnings

Breastfeeding
Pregnancy

Avoid contact with eyes
If no improvement after 7 days: initiate appropriate antimicrobial therapy
Long term use may cause adrenal suppression
May interfere with thyroid function tests
Discontinue if irritation or sensitisation occur
Length of treatment should not exceed 10 days

Not for use in primary bacterial, viral or fungal infections of the outer ear.

Topical application of clioquinol may lead to a marked increase in protein-bound iodine affecting the results of thyroid function tests for protein bound iodine, radioactive iodine and butanol-extractable iodine. Other thyroid function tests such as the T3 resin sponge test or T4 determination are not affected.

The ferric chloride test of phenylketonuria may yield a false-positive result when clioquinol is present in the urine. The product should not, therefore, be allowed to come into contact with the conjunctiva.

Pregnancy and Lactation

Pregnancy

Caution is advised in pregnancy.

The manufacturer notes that there is inadequate evidence of safety in human pregnancy.

In animals, topical administration of corticosteroids can cause abnormalities of foetal development including cleft palate and intrauterine growth retardation. There may, therefore, be a very small risk of such effects in the human foetus.

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

Caution is advised in pregnancy.

The manufacturer notes that use in lactating mothers should only be at the doctor's discretion. It is not known whether the active substances pass into breast milk after topical administration.

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)
Discolouration of hair
Hypersensitivity reactions
Irritation (localised)
Itching sensation (local)
Rash

Presentation

Ear drops containing flumetasone pivalate and clioquinol

Drugs List

Therapeutic Indications

Uses

Otitis externa - infective

Dosage

Adults

Elderly

Children

Contraindications

Children under 2 years
Perforated tympanic membrane

Precautions and Warnings

Breastfeeding
Pregnancy

Avoid contact with eyes
If no improvement after 7 days: initiate appropriate antimicrobial therapy
Long term use may cause adrenal suppression
May interfere with thyroid function tests
Discontinue if irritation or sensitisation occur
Length of treatment should not exceed 10 days

Not for use in primary bacterial, viral or fungal infections of the outer ear.

Topical application of clioquinol may lead to a marked increase in protein-bound iodine affecting the results of thyroid function tests for protein bound iodine, radioactive iodine and butanol-extractable iodine. Other thyroid function tests such as the T3 resin sponge test or T4 determination are not affected.

The ferric chloride test of phenylketonuria may yield a false-positive result when clioquinol is present in the urine. The product should not, therefore, be allowed to come into contact with the conjunctiva.

Pregnancy and Lactation

Pregnancy

Caution is advised in pregnancy.

The manufacturer notes that there is inadequate evidence of safety in human pregnancy.

In animals, topical administration of corticosteroids can cause abnormalities of foetal development including cleft palate and intrauterine growth retardation. There may, therefore, be a very small risk of such effects in the human foetus.

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

Caution is advised in pregnancy.

The manufacturer notes that use in lactating mothers should only be at the doctor's discretion. It is not known whether the active substances pass into breast milk after topical administration.

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)
Discolouration of hair
Hypersensitivity reactions
Irritation (localised)
Itching sensation (local)
Rash

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: July 2013

Reference Sources

British National Formulary, 65th Edition (March - September 2013) Pharmaceutical Press, London.

BNF for Children (2012-2013) Pharmaceutical Press, London.

Summary of Product Characteristics: Locorten-Vioform Ear Drops. Amdipharm Mercury COmpany Limited. Revised June 2006.