Drugs List

Therapeutic Indications

Uses

Eye
Short-term treatment of steroid responsive inflammatory conditions of the eye when prophylactic antibiotic treatment is also required, after excluding the presence of viral and fungal disease.

Ear
Otitis externa or other steroid responsive conditions where prophylactic antibiotic treatment is also required.

Nose
Steroid responsive inflammatory conditions where prophylactic antibiotic treatment is also required.

Administration

To be instilled into the eyes, ears or nose.

Contraindications

Viral, fungal, tuberculous or purulent conditions of the eye
Glaucoma
Herpetic keratitis (e.g. dendritic ulcer)
Undiagnosed red eye

Solution contains benzalkonium chloride and is therefore contraindicated for soft contact lens wearers.

Perforated ear-drum

Fungal nasal infection
Fungal infection of the ear

Precautions and Warnings

Treatment with a combined corticosteroid and antibiotic should not continue beyond 7 days if there is no clinical improvement as prolonged use may lead to occult extension of the infection due to the masking effect of the steroid. Prolonged use may also lead to skin sensitisation and the emergence of resistant organisms.

Prolonged use in infants may cause adrenal suppression.

Small children and Infants may be at greater risk of aminoglycoside induced deafness due to systemic absorption if high dose topical treatment is administered.

The medication may cause transient blurring of vision on instillation into the eye. Patients should be warned not to drive or operate hazardous machinery unless vision is clear.

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 have been identified in use with neomycin, however, based on the shared mechanism of action there is the potential for a similar effect with neomycin.

Nasal administration of corticosteroids is not advised if the patient has pulmonary tuberculosis or following nasal surgery (until healing has occurred).

It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. If growth is slowed, referral to a paediatrician should be considered.

Corticosteroid treatment should not be repeated without regular review to exclude raised intraocular pressure, cataract formation or infections.

Corticosteroids may reduce resistance to and aid in the establishment of bacterial, viral and fungal infections and mask the clinical signs of infections, preventing recognition of ineffectiveness of the antibiotic. In these cases, antibiotic therapy is mandatory.

Fungal infection should be suspected in any persistent corneal ulceration where a steroid has been used, or is in use and corticosteroid therapy discontinued if fungal infection confirmed.

Patients should not to wear contact lenses during treatment as they increase the chance of infection.

Pregnancy - safety not established ( see Pregnancy ).

Breastfeeding - safety not established ( see Lactation ).

Pregnancy and Lactation

Pregnancy

The safety of the use of betamethasone and neomycin eye drops in pregnancy has not been established.

Topical administration of corticosteroids to pregnant animals can cause abnormalities in foetal development, including cleft palate, interuterine growth retardation, low birth weight and reduced head circumference at birth. There may be a small risk of such effects in the human foetus.

There is a risk of foetal ototoxicity from aminoglycoside use during 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 14-17 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

The safety of the use of betamethasone and neomycin eye drops in nursing mothers has not been established.

At the time of writing, no reports of the use of betamethasone and neomycin eye drops by a nursing mother have been located.

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

Hypersensitivity reactions
Local irritation
Stinging
Itching sensation
Burning sensation
Dermatitis
Corneal ulceration
Increased intraocular pressure
Optic nerve damage
Reduced visual acuity
Visual field damage
Posterior subcapsular cataracts
Thinning of the ocular globe
Perforation of the ocular globe
Glaucoma
Local irritation
Mydriasis
Ptosis
Epithelial punctate keratitis
Anosmia
Asthma
Epistaxis
Headache
Irritation of nasal mucosa
Light-headedness
Nasal dryness
Nausea
Parosmia
Perforation of nasal septum
Rebound congestion
Sneezing
Taste disturbances
Ulceration of the nasal septum
Urticaria

Systemic effects of corticosteroids, particularly with high doses prescribed for a long period may include:
Growth retardation (children)
Adrenal suppression (infants)
Cushing's syndrome
Cushingoid features

Presentation

Ear, Eye and Nose drops containing betamethasone sodium phosphate 0.105% equivalent to 0.1% betamethasone and neomycin sulfate 0.5% equivalent to 0.385% neomycin base.

Drugs List

Therapeutic Indications

Uses

Eye
Short-term treatment of steroid responsive inflammatory conditions of the eye when prophylactic antibiotic treatment is also required, after excluding the presence of viral and fungal disease.

Ear
Otitis externa or other steroid responsive conditions where prophylactic antibiotic treatment is also required.

Nose
Steroid responsive inflammatory conditions where prophylactic antibiotic treatment is also required.

Dosage

The frequency of dosing depends on the clinical response. If there is no response within 7 days, the drops should be discontinued.

Maximum duration of treatment is 7 days, unless under expert supervision. After prolonged treatment (over 6-8 weeks), the drops should be withdrawn slowly to avoid relapse.

Adults

Elderly

Children

Administration

To be instilled into the eyes, ears or nose.

Contraindications

Viral, fungal, tuberculous or purulent conditions of the eye
Glaucoma
Herpetic keratitis (e.g. dendritic ulcer)
Undiagnosed red eye

Solution contains benzalkonium chloride and is therefore contraindicated for soft contact lens wearers.

Perforated ear-drum

Fungal nasal infection
Fungal infection of the ear

Precautions and Warnings

Treatment with a combined corticosteroid and antibiotic should not continue beyond 7 days if there is no clinical improvement as prolonged use may lead to occult extension of the infection due to the masking effect of the steroid. Prolonged use may also lead to skin sensitisation and the emergence of resistant organisms.

Prolonged use in infants may cause adrenal suppression.

Small children and Infants may be at greater risk of aminoglycoside induced deafness due to systemic absorption if high dose topical treatment is administered.

The medication may cause transient blurring of vision on instillation into the eye. Patients should be warned not to drive or operate hazardous machinery unless vision is clear.

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 have been identified in use with neomycin, however, based on the shared mechanism of action there is the potential for a similar effect with neomycin.

Nasal administration of corticosteroids is not advised if the patient has pulmonary tuberculosis or following nasal surgery (until healing has occurred).

It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. If growth is slowed, referral to a paediatrician should be considered.

Corticosteroid treatment should not be repeated without regular review to exclude raised intraocular pressure, cataract formation or infections.

Corticosteroids may reduce resistance to and aid in the establishment of bacterial, viral and fungal infections and mask the clinical signs of infections, preventing recognition of ineffectiveness of the antibiotic. In these cases, antibiotic therapy is mandatory.

Fungal infection should be suspected in any persistent corneal ulceration where a steroid has been used, or is in use and corticosteroid therapy discontinued if fungal infection confirmed.

Patients should not to wear contact lenses during treatment as they increase the chance of infection.

Pregnancy - safety not established ( see Pregnancy ).

Breastfeeding - safety not established ( see Lactation ).

Pregnancy and Lactation

Pregnancy

The safety of the use of betamethasone and neomycin eye drops in pregnancy has not been established.

Topical administration of corticosteroids to pregnant animals can cause abnormalities in foetal development, including cleft palate, interuterine growth retardation, low birth weight and reduced head circumference at birth. There may be a small risk of such effects in the human foetus.

There is a risk of foetal ototoxicity from aminoglycoside use during 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 14-17 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

The safety of the use of betamethasone and neomycin eye drops in nursing mothers has not been established.

At the time of writing, no reports of the use of betamethasone and neomycin eye drops by a nursing mother have been located.

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

Effects on Ability to Drive and Operate Machinery

The ability to drive or operate machinery may be affected by transient blurring of vision. Patients should be warned not to drive or operate machinery unless vision is clear.

Counselling

The ability to drive or operate machinery may be affected by transient blurring of vision. Advise patient not to drive or operate machinery unless vision is clear.

Side Effects

Hypersensitivity reactions
Local irritation
Stinging
Itching sensation
Burning sensation
Dermatitis
Corneal ulceration
Increased intraocular pressure
Optic nerve damage
Reduced visual acuity
Visual field damage
Posterior subcapsular cataracts
Thinning of the ocular globe
Perforation of the ocular globe
Glaucoma
Local irritation
Mydriasis
Ptosis
Epithelial punctate keratitis
Anosmia
Asthma
Epistaxis
Headache
Irritation of nasal mucosa
Light-headedness
Nasal dryness
Nausea
Parosmia
Perforation of nasal septum
Rebound congestion
Sneezing
Taste disturbances
Ulceration of the nasal septum
Urticaria

Systemic effects of corticosteroids, particularly with high doses prescribed for a long period may include:
Growth retardation (children)
Adrenal suppression (infants)
Cushing's syndrome
Cushingoid features

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.
Replace bottle in carton to protect contents from light.

Further Information

Last Full Review Date: December 2011

Reference Sources

British National Formulary, 62nd Edition (2011) Pharmaceutical Press, London.

BNF for Children (2011-2012) Pharmaceutical Press, London.

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, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

Summary of Product Characteristics: Betnesol-N eye, ear and nose drops. RPH Pharmaceuticals AB. Revised November 2020.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Betamethasone Last revised: July 5, 2011
Last accessed: December 28, 2011