Drugs List

Therapeutic Indications

Uses

Otitis externa - infective

Contraindications

Children under 3 years
Suspected tympanic membrane perforation
Uncontrolled systemic infection
Breastfeeding
Perforated tympanic membrane
Pregnancy

Precautions and Warnings

Elderly
Renal impairment

Reduce dose in patients with renal impairment
Not to be used in the immediate pre and post operative period
Avoid contact with eyes
Prolonged topical application may cause sensitisation reactions
Avoid prolonged use
Advise patient not to exceed stated dose
Advise patient to see doctor if symptoms persist for 7 days with treatment

Pregnancy and Lactation

Pregnancy

Neomycin sulfate with polymyxin and hydrocortisone is contraindicated in pregnancy.

Ototoxicity is known to occur with oral, topical and parenteral neomycin but this has not been reported as an effect in utero. 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. 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).

The manufacture notes that use of this product is not recommended.

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

Neomycin sulfate with polymyxin and hydrocortisone is contraindicated in breastfeeding.

No information is available from studies or from case reports in breastfeeding women. The manufacturer notes that use of this product in breastfeeding is not recommended.

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)
Eczematous reactions
Ototoxicity
Stinging

Presentation

Ear drops containing neomycin sulfate, polymyxin and hydrocortisone

Drugs List

Therapeutic Indications

Uses

Otitis externa - infective

Dosage

Adults

Elderly

Children

Additional Dosage Information

Contraindications

Children under 3 years
Suspected tympanic membrane perforation
Uncontrolled systemic infection
Breastfeeding
Perforated tympanic membrane
Pregnancy

Precautions and Warnings

Elderly
Renal impairment

Reduce dose in patients with renal impairment
Not to be used in the immediate pre and post operative period
Avoid contact with eyes
Prolonged topical application may cause sensitisation reactions
Avoid prolonged use
Advise patient not to exceed stated dose
Advise patient to see doctor if symptoms persist for 7 days with treatment

Pregnancy and Lactation

Pregnancy

Neomycin sulfate with polymyxin and hydrocortisone is contraindicated in pregnancy.

Ototoxicity is known to occur with oral, topical and parenteral neomycin but this has not been reported as an effect in utero. 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. 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).

The manufacture notes that use of this product is not recommended.

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

Neomycin sulfate with polymyxin and hydrocortisone is contraindicated in breastfeeding.

No information is available from studies or from case reports in breastfeeding women. The manufacturer notes that use of this product in breastfeeding is not recommended.

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)
Eczematous reactions
Ototoxicity
Stinging

Further Information

Last Full Review Date: March 2017

Reference Sources

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: Otosporin Ear Drops. Phoenix Labs. Revised March 2015.