BNF for Children (BNFC) 2018-2019

Gentamicin with hydrocortisone

21-Dec-2017

lINDICATIONS AND DOSE

Eczematous inflammation in otitis externa

▶TO THE EAR

▶Child:Apply 2 – 4 drops 4 – 5 times a day, (including a

dose at bedtime)

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-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

lSIDE-EFFECTSLocal reaction

lPATIENT AND CARER ADVICE

Medicines for Children leaflet: Gentamicin and hydrocortisone ear

drops for inflammatory ear infectionswww.medicinesforchildren.

org.uk/gentamicin-and-hydrocortisone-ear-drops-

inflammatory-ear-infections

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

▶Gentamicin with hydrocortisone (Non-proprietary)

Gentamicin (as Gentamicin sulfate) 3 mg per 1 ml,

Hydrocortisone acetate 10 mg per 1 mlGentamicin^0.^3 %/

Hydrocortisone acetate 1 % ear drops| 10 mlP£ 26. 19 DT =

£ 26. 19

Neomycin sulfate

lINDICATIONS AND DOSE

Bacterial infection in otitis externa

▶TO THE EAR

▶Child:(consult product literature)

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

lSIDE-EFFECTSLocal reaction

lMEDICINAL FORMS

No licensed medicines listed.

Combinations available:Betamethasone with neomycin,

p. 669 .Dexamethasone with glacial acetic acid and neomycin

sulfate,p. 692 .Hydrocortisone with neomycin and polymyxin

B sulfate,p. 693

ANTIBACTERIALS›QUINOLONES

Ciprofloxacin 26-Apr-2018

lINDICATIONS AND DOSE

Acute otitis externa

▶TO THE EAR

▶Child 1–17 years:Apply 0. 25 mL twice daily for 7 days,

each 0. 25 mL dose contains 0. 5 mg ciprofloxacin

lCAUTIONSKnown (or at risk of) perforated tympanic

membrane

lSIDE-EFFECTS

▶UncommonDermatitis.ear pruritus

lHANDLING AND STORAGEManufacturer advises discard

any ampoules remaining 8 days after opening the pouch.

lPATIENT AND CARER ADVICE

Medicines for Children leaflet: Ciprofloxacin ear drops for ear

infectionswww.medicinesforchildren.org.uk/ciprofloxacin-ear-

drops-ear-infections- 0

lNATIONAL FUNDING/ACCESS DECISIONS

Scottish Medicines Consortium (SMC) Decisions

SMC No. 1320/18

TheScottish Medicines Consortiumhas advised (April 2018 )

that ciprofloxacin ear drops (Cetraxal®) are recommended

for use within NHS Scotland for treatment of acute otitis

externa in adults and children over 1 year with an intact

tympanic membrane, caused by ciprofloxacin susceptible

microorganisms when off-label or unlicensed ciprofloxacin

formulations would otherwise be used.

lMEDICINAL FORMS

There can be variation in the licensing of different medicines

containing the same drug. Forms available from special-order

manufacturers include: ear drops

Ear drops

▶Cetraxal(Aspire Pharma Ltd)

Ciprofloxacin (as Ciprofloxacin hydrochloride) 2 mg per

1mlCetraxal 2 mg/ml ear drops 0. 25 ml unit dose| 15 unit

doseP£ 6. 01

Combinations available:Dexamethasone with ciprofloxacin,

p. 692

ANTIBACTERIALS›OTHER

Chloramphenicol

lDRUG ACTIONChloramphenicol is a potent broad-

spectrum antibiotic.

lINDICATIONS AND DOSE

Bacterial infection in otitis externa

▶TO THE EAR

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

lCAUTIONSAvoid prolonged use

lSIDE-EFFECTSBlood disorder.bone marrow depression

lPATIENT AND CARER ADVICE

Medicines for Children leaflet: Chloramphenicol ear drops for ear

infections (otitis externa)www.medicinesforchildren.org.uk/

chloramphenicol-ear-drops-ear-infections-otitis-externa- 0

lLESS SUITABLE FOR PRESCRIBINGChloramphenicol ear

drops are less suitable for prescribing.

lMEDICINAL FORMS

There can be variation in the licensing of different medicines

containing the same drug.

Ear drops

EXCIPIENTS:May contain Propylene glycol

▶Chloramphenicol (Non-proprietary)

Chloramphenicol 50 mg per 1 mlChloramphenicol 5 % ear drops|

10 mlP£ 63. 69 DT = £ 63. 69

Chloramphenicol 100 mg per 1 mlChloramphenicol 10 % ear drops

| 10 mlP£ 87. 84 DT = £ 87. 84

690 Otitis externa BNFC 2018 – 2019

Ear, nose and oropharynx

12