BNF for Children (BNFC) 2018-2019

CORTICOSTEROIDS›CORTICOSTEROID

COMBINATIONS WITH ANTI-INFECTIVES

Betamethasone with neomycin

The properties listed below are those particular to the

combination only. For the properties of the components

please consider, betamethasone p. 691 , neomycin sulfate

p. 690.

lINDICATIONS AND DOSE

Eczematous inflammation in otitis externa

▶TO THE EAR USING EAR DROPS

▶Child:Apply 2 – 3 drops 3 – 4 times a day

lCONTRA-INDICATIONSPatent grommet (although may be

used by specialists, see Ear p. 688 ).perforated tympanic

membrane (although may be used by specialists, see Ear

p. 688 )

lCAUTIONSAvoid prolonged use

lMEDICINAL FORMS

There can be variation in the licensing of different medicines

containing the same drug.

Ear/eye/nose drops solution

EXCIPIENTS:May contain Benzalkonium chloride, disodium edetate

▶Betnesol-N(RPH Pharmaceuticals AB)

Betamethasone (as Betamethasone sodium phosphate) 1 mg per

1 ml, Neomycin sulfate 5 mg per 1 mlBetnesol-N ear/eye/nose

drops| 10 mlP£ 2. 39 DT = £ 2. 39

Dexamethasone with ciprofloxacin

21-Dec-2017

The properties listed below are those particular to the

combination only. For the properties of the components

please consider, ciprofloxacin p. 690.

lINDICATIONS AND DOSE

Acute otitis media in patients with tympanostomy tubes

▶TO THE EAR

▶Child 6 months–17 years:Apply 4 drops twice daily for

7 days

Acute otitis externa

▶TO THE EAR

▶Child 1–17 years:Apply 4 drops twice daily for 7 days

IMPORTANT SAFETY INFORMATION

MHRA/CHM ADVICE: CORTICOSTEROIDS: RARE RISK OF CENTRAL

SEROUS CHORIORETINOPATHY WITH LOCAL AS WELL AS SYSTEMIC

ADMINISTRATION (AUGUST 2017)

See Corticosteroids, general use p. 434.

lCONTRA-INDICATIONSFungal ear infections.viral ear

infections

lCAUTIONSAvoid prolonged use

lSIDE-EFFECTS

▶Common or very commonEar discomfort

▶UncommonEar infection fungal.flushing.irritability.

malaise.otorrhoea.paraesthesia.skin reactions.taste

altered.vomiting

▶Rare or very rareDizziness.headache.hearing

impairment

SIDE-EFFECTS, FURTHER INFORMATIONManufacturer

advises further evaluation of underlying conditions if

otorrhoea persists after a full course, or if at least two

episodes of otorrhoea occur within 6 months.

lPREGNANCYManufacturer advises use only if potential

benefit outweighs risk—no information available.

lBREAST FEEDINGManufacturer advises caution—no

information available.

lPATIENT AND CARER ADVICEManufacturer advises

counselling on administration.

lNATIONAL FUNDING/ACCESS DECISIONS

Scottish Medicines Consortium (SMC) Decisions

TheScottish Medicines Consortiumhas advised (July 2017 )

that dexamethasone with ciprofloxacin (Cilodex®)is

accepted for restricted use within NHS Scotland for the

treatment of acute otitis media in patients with

tympanostomy tubes (AOMT).

lMEDICINAL FORMS

There can be variation in the licensing of different medicines

containing the same drug.

Ear drops

EXCIPIENTS:May contain Benzalkonium chloride, disodium edetate

▶Cilodex(Novartis Pharmaceuticals UK Ltd)

Dexamethasone 1 mg per 1 ml, Ciprofloxacin (as Ciprofloxacin

hydrochloride) 3 mg per 1 mlCilodex ear drops| 5 mlP£ 6. 12

DT = £ 6. 12

Dexamethasone with framycetin

sulfate and gramicidin 21-Dec-2017

The properties listed below are those particular to the

combination only. For the properties of the components

please consider, framycetin sulfate p. 689.

lINDICATIONS AND DOSE

Eczematous inflammation in otitis externa

▶TO THE EAR

▶Child: 2 – 3 drops 3 – 4 times a day

IMPORTANT SAFETY INFORMATION

MHRA/CHM ADVICE: CORTICOSTEROIDS: RARE RISK OF CENTRAL

SEROUS CHORIORETINOPATHY WITH LOCAL AS WELL AS SYSTEMIC

ADMINISTRATION (AUGUST 2017)

See Corticosteroids, general use p. 434.

lLESS SUITABLE FOR PRESCRIBINGSofradex®is less

suitable for prescribing.

lMEDICINAL FORMS

There can be variation in the licensing of different medicines

containing the same drug.

Ear/eye drops solution

EXCIPIENTS:May contain polysorbates

▶Sofradex(Sanofi)

Gramicidin 50 microgram per 1ml, Dexamethasone (as

Dexamethasone sodium metasulfobenzoate) 500 microgram per

1 ml, Framycetin sulfate 5mg per 1 mlSofradex ear/eye drops|

10 mlP£ 7. 50

Dexamethasone with glacial acetic

acid and neomycin sulfate 21-Dec-2017

The properties listed below are those particular to the

combination only. For the properties of the components

please consider, neomycin sulfate p. 690.

lINDICATIONS AND DOSE

Eczematous inflammation in otitis externa

▶TO THE EAR

▶Child 2–17 years:Apply 1 spray 3 times a day

IMPORTANT SAFETY INFORMATION

MHRA/CHM ADVICE: CORTICOSTEROIDS: RARE RISK OF CENTRAL

SEROUS CHORIORETINOPATHY WITH LOCAL AS WELL AS SYSTEMIC

ADMINISTRATION (AUGUST 2017)

See Corticosteroids, general use p. 434.

692 Otitis externa BNFC 2018 – 2019

Ear, nose and oropharynx

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