OTOSPORIN

Otosporin ear drops are for topical administration into the ear only. Adults Following cleansing and drying of the external auditory meatus and canal as appropriate, three drops should be instilled into the affected ear three or four times daily.

Alternatively, a gauze wick may be introduced into the external auditory canal and kept saturated with the solution; the wick may be left in place for 24 to 48 hours. Treatment should not be continued for more than 7 days without medical supervision.

Soap should not be used for cleansing of the external auditory meatus and canal as it may inactivate the antibiotics. Children Otosporin Ear Drops are suitable for use in children ( 3 years and over) at the same dose as adults. A possibility of increased absorption exists in very young children, thus Otosporin Ear Drops are not recommended in neonates and infants (<3 years).

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The incidence of allergic hypersensitivity reactions to neomycin sulphate in the general population is low. There is, however, an increased incidence of hypersensitivity to neomycin in certain selected groups of patients in dermatological practice, particularly those with venous stasis eczema and ulceration, and chronic otitis externa.

Allergic hypersensitivity reactions following topical application of polymyxin B sulphate and hydrocortisone are rare. Allergic hypersensitivity to neomycin following topical use may manifest itself as an eczematous exacerbation with reddening, scaling, swelling and itching or as a failure of the lesion to heal.

Stinging and burning have occasionally been reported when Otosporin Ear Drops gained access to the middle ear.

Postmarketing Data Immune System Disorders Rare:

Application site hypersensitivity General Disorders and Administration Site Conditions Rare: Headache, application site reaction including: pain, irritation, oedema, burning sensation, rash Skin and Subcutaneous Tissue Disorders Rare: Local exfoliative dermatitis, skin atrophy, telangiectasia , striae, exacerbation of underlying skin conditions, including eczema.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard

). Use in the Elderly As for adults. 4 Special Warnings and Precautions for Use). 4 Special Warnings and Precautions for Use). 3 Contraindications The use of Otosporin Ear Drops is contra-indicated in patients in whom perforation of the tympanic membrane is known or suspected.

Due to the known ototoxic and nephrotoxic potential of neomycin sulphate, the use of Otosporin Ear Drops in large quantities or on large areas for prolonged periods of time is not recommended in circumstances where significant systemic absorption may occur.

The use of Otosporin Ear Drops is contra-indicated in patients who have demonstrated allergic hypersensitivity to any of the components of the preparation or to cross-sensitising substances such as framycetin, kanamycin, gentamicin and other related antibiotics.

The use of Otosporin Ear Drops is contra-indicated in the presence of untreated viral, fungal and tubercular infections. A possibility of increased absorption exists in very young children, thus Otosporin Ear Drops are not recommended in neonates and infants (up to 3years).

In neonates and infants, absorption by immature skin may be enhanced and renal function may be immature. 4 Special warnings and precautions for use Occasionally, delayed hypersensitivity to corticosteriods may occur. Treatment with topical steroid antibiotic combinations should not be continued for more than seven days in the absence of any clinical improvement, since prolonged use may lead to occult extension of infection due to the masking effect of the steroid.

Prolonged use may also lead to skin sensitisation and the emergence of resistant organisms. Following significant systemic absorption, aminoglycosides such as neomycin can cause irreversible ototoxicity; neomycin and polymyxin B sulphate have nephrotoxic potential and polymyxin B sulphate has neurotoxic potential.

All topically active corticosteroids possess the potential to suppress the pituitary-adrenal axis following systemic absorption. Development of adverse systemic effects due to the hydrocortisone component of Otosporin Ear Drops is considered to be unlikely, although the recommended dosage should not be exceeded, particularly in infants.

3 Contra-indications,