Drugs List

Therapeutic Indications

Uses

Otitis externa

Contraindications

Children under 2 years
Breastfeeding
Perforated tympanic membrane
Pregnancy

Precautions and Warnings

Hepatic impairment
Otitis media
Renal impairment

Do not use if tympanostomy tube (grommet) is in situ
Exclude tympanic membrane perforation before initiating treatment
May mask symptoms or signs of infections
Advise visual disturbances may affect ability to drive or operate machinery
Contains hydroxybenzoate
Do not apply to broken or denuded skin
Do not inhale the spray
If visual disturbances occur, perform ophthalmic evaluation
Paediatric patients may be more susceptible to systemic toxicity
Advise patient to report signs of deafness
Discontinue if no improvement occurs within 7 days
Discontinue treatment if skin rash or other allergic reaction occurs
Avoid prolonged use
Continue treatment for at least 2 days after symptoms resolve

Pregnancy and Lactation

Pregnancy

Dexamethasone, neomycin and acetic acid is contraindicated during pregnancy.

The effects of using dexamethasone, neomycin and acetic acid as a combined product during pregnancy are unknown. Use is not recommended by the manufacturer.

Known effects of dexamethasone during pregnancy
Dexamethasone crosses the placenta to the foetus. Leukocytosis has been observed in infants exposed antenatally to dexamethasone. The white blood cell counts returned to normal in about a week. Systemic absorption of dexamethasone may also occur. Foetal abnormalities including cleft palate and intra-uterine growth retardation, have been observed in pregnant animals from topical application, the relevance of this finding to humans however has not been established (Briggs 2015).

Known effects of neomycin during pregnancy
Ototoxicity known to occur with oral, topical and parenteral neomycin has not been reported as an effect in utero however, eighth cranial nerve toxicity in the foetus is known following exposure to kanamycin and streptomycin and may potentially occur with neomycin. No evidence was found in 30 mother-child pairs having 1st trimester exposure to neomycin to suggest a relationship with malformations. It has been concluded that there is no detectable teratogenic risk of structural defects for any of the aminoglycoside antibiotics following a case-control pair analysis for 2nd and 3rd month of gestation (Briggs 2015).

Lactation

Dexamethasone, neomycin and acetic acid is contraindicated during breastfeeding.

The effects of using dexamethasone, neomycin and acetic acid as a combined product during breastfeeding are unknown. Breastfeeding is contraindicated by the manufacturer and a decision should be made whether to cease breastfeeding or stop taking the medication.

Known effects of dexamethasone during breastfeeding
Traces of dexamethasone may be secreted in human milk. It is not likely that the amount in milk would produce clinical effects unless used in high doses over prolonged periods (Hale 2010).

Known effects of neomycin during breastfeeding
No reports of use during human lactation are available although small amounts of gentamicin are excreted in breast milk and absorbed by the nursing infant. It is considered that given the very low oral bioavailability of neomycin, the amount in breast milk would not be clinically significant in the nursing infant. The safety of neomycin with regard to ototoxicity has not been established during breast feeding and it should be used with caution (Hale 2014).

Side Effects

Blurred vision
Burning sensation (local)
Contact dermatitis
Hypersensitivity reactions
Irritation (localised)
Itching sensation (local)
Skin sensitivity
Stinging
Visual disturbances

Presentation

Liquid ear spray containing neomycin sulfate with dexamethasone and glacial acetic acid.

Drugs List

Therapeutic Indications

Uses

Otitis externa

Dosage

Adults

Children

Contraindications

Children under 2 years
Breastfeeding
Perforated tympanic membrane
Pregnancy

Precautions and Warnings

Hepatic impairment
Otitis media
Renal impairment

Do not use if tympanostomy tube (grommet) is in situ
Exclude tympanic membrane perforation before initiating treatment
May mask symptoms or signs of infections
Advise visual disturbances may affect ability to drive or operate machinery
Contains hydroxybenzoate
Do not apply to broken or denuded skin
Do not inhale the spray
If visual disturbances occur, perform ophthalmic evaluation
Paediatric patients may be more susceptible to systemic toxicity
Advise patient to report signs of deafness
Discontinue if no improvement occurs within 7 days
Discontinue treatment if skin rash or other allergic reaction occurs
Avoid prolonged use
Continue treatment for at least 2 days after symptoms resolve

Pregnancy and Lactation

Pregnancy

Dexamethasone, neomycin and acetic acid is contraindicated during pregnancy.

The effects of using dexamethasone, neomycin and acetic acid as a combined product during pregnancy are unknown. Use is not recommended by the manufacturer.

Known effects of dexamethasone during pregnancy
Dexamethasone crosses the placenta to the foetus. Leukocytosis has been observed in infants exposed antenatally to dexamethasone. The white blood cell counts returned to normal in about a week. Systemic absorption of dexamethasone may also occur. Foetal abnormalities including cleft palate and intra-uterine growth retardation, have been observed in pregnant animals from topical application, the relevance of this finding to humans however has not been established (Briggs 2015).

Known effects of neomycin during pregnancy
Ototoxicity known to occur with oral, topical and parenteral neomycin has not been reported as an effect in utero however, eighth cranial nerve toxicity in the foetus is known following exposure to kanamycin and streptomycin and may potentially occur with neomycin. No evidence was found in 30 mother-child pairs having 1st trimester exposure to neomycin to suggest a relationship with malformations. It has been concluded that there is no detectable teratogenic risk of structural defects for any of the aminoglycoside antibiotics following a case-control pair analysis for 2nd and 3rd month of gestation (Briggs 2015).

Lactation

Dexamethasone, neomycin and acetic acid is contraindicated during breastfeeding.

The effects of using dexamethasone, neomycin and acetic acid as a combined product during breastfeeding are unknown. Breastfeeding is contraindicated by the manufacturer and a decision should be made whether to cease breastfeeding or stop taking the medication.

Known effects of dexamethasone during breastfeeding
Traces of dexamethasone may be secreted in human milk. It is not likely that the amount in milk would produce clinical effects unless used in high doses over prolonged periods (Hale 2010).

Known effects of neomycin during breastfeeding
No reports of use during human lactation are available although small amounts of gentamicin are excreted in breast milk and absorbed by the nursing infant. It is considered that given the very low oral bioavailability of neomycin, the amount in breast milk would not be clinically significant in the nursing infant. The safety of neomycin with regard to ototoxicity has not been established during breast feeding and it should be used with caution (Hale 2014).

Side Effects

Blurred vision
Burning sensation (local)
Contact dermatitis
Hypersensitivity reactions
Irritation (localised)
Itching sensation (local)
Skin sensitivity
Stinging
Visual disturbances

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: March 2019

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

Summary of Product Characteristics: Otomize Ear Spray, Teva UK Limited. Revised February 2018.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 12 March 2019