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Managing acute otitis externa in the pharmacy
Acute otitis externa (AOE) is a common condition. 1 More than 90% of cases are due to bacterial infection, 1 therefore topical antibiotic treatment is an appropriate management option. However, antibiotic resistance is a global catastrophe that is threatening the lives of millions of people worldwide. 2 It is therefore important to consider your role in raising awareness of antibiotic resistance and in infection prevention and control. 3
Learning objectives
This module will help you:
- Refresh your knowledge on the signs, symptoms and predisposing factors of acute otitis externa
- Evaluate suitable treatment options in light of NICE guidelines and the current threat of antibiotic resistance
- Choose and discuss appropriate management options, including self-care advice and treatment
- Prepare for Independent Prescribing or PGD supply scenarios for acute otitis externa
Prescribing information (please refer to the full SmPC before prescribing)
Cetraxal: https://www.medicines.org.uk/emc/product/8847/smpc#gref
Cetraxal (ciprofloxacin) 2mg/ml ear drops solution in a single-dose container
Indication: Acute otitis externa in adults and children older than 1 year with an intact tympanic membrane, caused by ciprofloxacin susceptible microorganisms.
Available strength 0.50 mg ciprofloxacin contained in 0.25ml of solution. See the Summary of Product Characteristics (SmPC) for a full list of excipients. Dosage and method of use:
Adults and children aged one year and older: Instil the contents of a single ampoule into the affected ear twice daily for seven days. Children aged less than one year: Safety and efficacy not established. Method of administration: Warm the ampoule in the hand for several minutes. Patient should lie with affected ear upward and instil drops, pulling on auricle several times. Maintain position for 5 minutes to facilitate penetration. For further administration details, please see SmPC. If otowick/tampon is used for administration, double the first dose to two ampoules. Use immediately after opening the ampoule. Discard any unused contents. No dose adjustment required in those with renal or hepatic impairment. Contraindications: Hypersensitivity to ciprofloxacin, any member of the quinolone class or listed excipients. Special warnings and precautions for use: Not for ophthalmic use, inhalation or injection. Monitor use carefully to determine if other therapy may be required. If after one week of therapy, signs and symptoms persist, re-evaluate further. Safety and efficacy not established under 1 year of age. Weigh benefits against known and unknown risks of prescribing in those under 1. Use with caution if known or suspected perforated tympanic membrane and where there is a risk of perforation. Discontinue use at first appearance of a skin rash or any other sign of hypersensitivity. Some patients taking systemic quinolones have shown moderate to severe skin sensitivity to the sun. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some after the first dose of a systemic quinolone. Serious acute hypersensitivity reactions may require immediate emergency treatment. Overgrowth of non-susceptible organisms may occur from use including bacterial strains, yeast and fungi. If superinfection occurs, treat as appropriate. Interactions with other medicinal products: No interaction studies performed. Due to low plasma levels, systemic interactions unlikely. Recommendation not to use other ear preparations concomitantly. Pregnancy and breast-feeding: Can be used during pregnancy and breast-feeding. Effects on ability to drive and use machines: None or negligible. Side effects: For full list of side effects consult the SmPC. Ear pruritis, headache, application site pain, tinnitus, dizziness, dermatitis. Very rarely with locally applied fluoroquinolones: rash, toxic epidermolysis, exfoliative dermatitis, Stevens-Johnson syndrome, urticaria. MAH: Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom MA number: PL35533/0130. Cost: Per pack of 15 ampoules £6.01 Legal Category: POM. Date reviewed: August 2023 Version number: 1010385675 v 4.0
Prescribing information (please refer to the full SmPC before prescribing)
Cetraxal Plus: https://www.medicines.org.uk/emc/product/9805/smpc#gref
Cetraxal Plus (ciprofloxacin and fluocinolone acetonide) 3mg/ml + 0.25mg/ml ear drops solution in a single-dose container
Indication: Acute otitis externa and acute otitis media in patients with tympanostomy tubes, in adults and children aged 6 months and older, caused by ciprofloxacin susceptible microorganisms. Available strength: 0.75 mg ciprofloxacin and 0.0625 mg of fluocinolone acetonide, contained in 0.25ml of solution. Please refer to the Summary of Product Characteristics (SmPC) for a full list of excipients. Dosage and method of use: Adults, elderly and children aged 6 months and older: Instil the contents of one single-dose container into the affected ear canal every 12 hours for 7 days. Renal/hepatic impairment: no dose adjustment necessary. Warm bottle by holding in hand for several minutes. Lie with affected ear upwards - for patients with otitis externa, pull the auricle several times during instillation. For patients with acute otitis media with tympanostomy tubes, pump the tragus 4 times by pushing inward to facilitate penetration. This position should be maintained for around 1 minute. For further details, please refer to the SmPC. Contraindications: Hypersensitivity to ciprofloxacin, any member of the quinolone class, fluocinolone acetonide or listed excipients. Viral infections of the external ear canal, including varicella and herpes simplex infections and fungal otic infections. Special warnings and precautions for use: Not for ophthalmic use, inhalation or injection. Should not be swallowed. If otorrhea persists after full course of therapy or if two or moreepisodes occur within six months, evaluate further. If after treatment signs and symptoms persist, evaluate further. Discontinue at first appearance of a skin rash or any other sign of hypersensitivity. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some after the first dose of a systemic quinolone. Serious acute hypersensitivity reactions may require immediate emergency treatment. Overgrowth of non-susceptible organisms may occur from use including bacterial strains, yeast and fungi. If superinfection occurs, treat appropriately. Some patients taking systemic quinolones have shown moderate to severe skin sensitivity to the sun. Corticosteroids may reduce resistance to, and aid in, the establishment of bacterial, viral or fungal infections and mask the clinical signs of an infection, ineffectiveness of the antibiotic or suppress hypersensitivity reactions. If patient presents with blurred vision or other visual disturbances, consider referral to ophthalmologist for evaluation of causes e.g. cataract, glaucoma, central serous chorioretinopathy. Safety and efficacy not established in children under 6 months – only use after very careful benefit/risk evaluation. Interactions with other medicinal products: No interaction studies performed. Due to low plasma levels, systemic interactions unlikely. Systemic administration of some quinolones may enhance the effects of warfarin and its derivatives and has been associated with transient serum creatinine elevations in patients receiving concomitant cyclosporine. Recommendation not to use other ear preparations concomitantly; if more than one is needed, administer them apart. Pregnancy and breast-feeding: For full details please refer to the SmPC. Pregnancy – Assess whether benefits of the treatment outweigh the possible risk. Caution when administered to a nursing woman. Effects on ability to drive and use machines: None or negligible. Side effects: For full list of side effects consult SmPC. ‘Very Common’ ‘Common’ and ‘Serious’ side effects included in prescribing information: dysgeusia, ear pain, ear discomfort, ear pruritus. MAH: Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom MA number: PL35533/0133. Cost: Per pack of 15 ampoules £6.01 Legal Category: POM. Date reviewed: August 2023. Version Number: 1010385676 v 4.0
Adverse event reporting
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for the MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Aspire Pharma Ltd on 01730 231148.
This training has been developed and funded by Aspire Pharma and is intended for UK registered healthcare professionals only.
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10103851895 v1.0 September 2023
