Drugs List

Therapeutic Indications

Uses

For the treatment of eczema and infection of the outer ear (otitis externa).
For prophylaxis against otitis externa following trauma.
For post - operative local use in surgery to infected mastoid cavities.

Administration

The area should be cleaned before the drops are administered either directly into the affected ear(s) or via a wick medicated with the ear drops.

Contraindications

Known or suspected perforation of the ear drum.

Precautions and Warnings

Pregnancy ( see Pregnancy section )
Breastfeeding ( see Lactation section )

In infants there is a theoretical risk that sufficient steroid may be absorbed to cause adrenal suppression.

Avoid long term continuous use. Skin sensitisation and emergence of resistant organisms may occur.

Cross sensitivity with other aminoglycosides may occur.

Discontinue if irritation, sensitisation or super-infection occur.

In severe infections, topical use should be supplemented with appropriate systemic antibiotic treatment.

Serious adverse reactions including neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic gentamicin therapy. Although these effects have not been reported following topical otic use of gentamicin, caution is advised when used concomitantly with systemic aminoglycosides.

There have been reports of cases of an increased risk of ototoxicity with aminoglycosides administered to patients with mitochondrial mutations, including cases where the patient's aminoglycoside serum levels were within the recommended range. No cases were identified with topical preparations, however there is a potential risk with gentamicin and other aminoglycosides administered at the site of toxicity.

Avoid application to open wounds or damaged skin as systemic absorption can cause irreversible partial or total deafness. This effect is enhanced in patients with renal or hepatic impairment and the elderly.

Before prescribing always check the condition of the ear drum. If the integrity of the ear drum cannot be guaranteed, do not use.

Direct contact of gentamicin with the middle and inner ear can result in irreversible toxic effects and any benefits need to be considered against the risk of infection itself causing hearing loss.

.

Pregnancy and Lactation

Pregnancy

Gentamicin with hydrocortisone should be used with caution during pregnancy

Topical administration of any corticosteroid to pregnant animals can cause abnormalities of foetal development. Schaefer concludes that aminoglycosides may be administered locally because systemic absorption is minimal by these routes. Gentamicin with hydrocortisone should therefore only be used in pregnancy when considered essential by the physician, after careful assessment of the potential risks and benefits.

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 at ( https://www.toxbase.org/ ) or if this is unavailable at the backup site ( https://www.TOXBASEbackup.org/ ).

Licensed in pregnancy? - No

Animal data - High doses of gentamicin have been linked to nephrotoxicity in foetal rats.

Crosses placenta? - Yes

Effects on foetus - High doses of gentamicin could possibly led to nephrotoxicity.

Lactation

Gentamicin with hydrocortisone can be used during lactation but with caution.

Lactmed states that maternal use of an ear drop or eye drop that contains gentamicin presents little or no risk for the nursing infant.

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

Drug excreted in breast milk? - Small amounts of gentamicin excreted into breast milk. Trace amounts of hydrocortisone excreted into breast milk.

Considered suitable or recommended by manufacturer? - No

Drug substance licensed in infants? - Yes

Side Effects

Hearing loss
Super infections
Stinging
Itching
Burning sensation
Irritation

Presentation

Ear drops containing 0.3% gentamicin base ( as gentamicin sulfate ) and 1% hydrocortisone acetate.

Drugs List

Therapeutic Indications

Uses

For the treatment of eczema and infection of the outer ear (otitis externa).
For prophylaxis against otitis externa following trauma.
For post - operative local use in surgery to infected mastoid cavities.

Dosage

Adults

Elderly

Children

Patients with Renal Impairment

Patients with Hepatic Impairment

Additional Dosage Information

Administration

The area should be cleaned before the drops are administered either directly into the affected ear(s) or via a wick medicated with the ear drops.

Contraindications

Known or suspected perforation of the ear drum.

Precautions and Warnings

Pregnancy ( see Pregnancy section )
Breastfeeding ( see Lactation section )

In infants there is a theoretical risk that sufficient steroid may be absorbed to cause adrenal suppression.

Avoid long term continuous use. Skin sensitisation and emergence of resistant organisms may occur.

Cross sensitivity with other aminoglycosides may occur.

Discontinue if irritation, sensitisation or super-infection occur.

In severe infections, topical use should be supplemented with appropriate systemic antibiotic treatment.

Serious adverse reactions including neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic gentamicin therapy. Although these effects have not been reported following topical otic use of gentamicin, caution is advised when used concomitantly with systemic aminoglycosides.

There have been reports of cases of an increased risk of ototoxicity with aminoglycosides administered to patients with mitochondrial mutations, including cases where the patient's aminoglycoside serum levels were within the recommended range. No cases were identified with topical preparations, however there is a potential risk with gentamicin and other aminoglycosides administered at the site of toxicity.

Avoid application to open wounds or damaged skin as systemic absorption can cause irreversible partial or total deafness. This effect is enhanced in patients with renal or hepatic impairment and the elderly.

Before prescribing always check the condition of the ear drum. If the integrity of the ear drum cannot be guaranteed, do not use.

Direct contact of gentamicin with the middle and inner ear can result in irreversible toxic effects and any benefits need to be considered against the risk of infection itself causing hearing loss.

.

Pregnancy and Lactation

Pregnancy

Gentamicin with hydrocortisone should be used with caution during pregnancy

Topical administration of any corticosteroid to pregnant animals can cause abnormalities of foetal development. Schaefer concludes that aminoglycosides may be administered locally because systemic absorption is minimal by these routes. Gentamicin with hydrocortisone should therefore only be used in pregnancy when considered essential by the physician, after careful assessment of the potential risks and benefits.

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 at ( https://www.toxbase.org/ ) or if this is unavailable at the backup site ( https://www.TOXBASEbackup.org/ ).

Licensed in pregnancy? - No

Animal data - High doses of gentamicin have been linked to nephrotoxicity in foetal rats.

Crosses placenta? - Yes

Effects on foetus - High doses of gentamicin could possibly led to nephrotoxicity.

Lactation

Gentamicin with hydrocortisone can be used during lactation but with caution.

Lactmed states that maternal use of an ear drop or eye drop that contains gentamicin presents little or no risk for the nursing infant.

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

Drug excreted in breast milk? - Small amounts of gentamicin excreted into breast milk. Trace amounts of hydrocortisone excreted into breast milk.

Considered suitable or recommended by manufacturer? - No

Drug substance licensed in infants? - Yes

Effects on Ability to Drive and Operate Machinery

No information is available concerning the ability to drive or operate machinery.

Counselling

Advise patient to report any hearing loss or persistent irritation.

Advise patient to discard 4 weeks after first opening (or when the course is complete).

Side Effects

Hearing loss
Super infections
Stinging
Itching
Burning sensation
Irritation

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 ).

Shelf Life and Storage

Store below 25 degrees C.
Do not freeze or mix with other liquids.
Discard contents 4 weeks after opening.

Further Information

Last Full Review Date: May 2011

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 8th edition (2008) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Martindale: The Complete Drug Reference, 35th edition (2007) ed. Sweetman, S. Pharmaceutical Press, London.

Summary of Product Characteristics: Gentisone HC Ear Drops. Amdipharm. Revised December 2010.

LactMed via ToxNet
https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Accessed 18/04/11

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 19 July 2021