OTOMIZE, DEXAMETHASONE/ NEOMYCIN SULFATE/ ACETIC ACID

4). One metered dose (60mg) to be administered directly into each affected ear three times daily. Treatment should be continued until two days after symptoms have disappeared. 3). Method of administration Shake the bottle well before use.

Before first use, press actuator down several times to obtain a fine spray. Each press then delivers one metered dose. Do not inhale the spray. Administer spray directly by gently placing nozzle tip into ear opening and pressing down once on the actuator.

Use within one month of first use. If there is a period of more than one week since last use, press actuator down a few times before using again.

4) Skin and subcutaneous tissue disorders Some patients may experience a transient stinging or burning sensation for the first few days of treatment. Skin sensitisation / hypersensitivity reactions (immediate and delayed) leading to irritation, burning, stinging, itching and dermatitis.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

Product use should be discontinued, and medical advice sought where appropriate, if irritation or rash occurs, or if the condition worsens or does not improve within 7 days. When otitis externa is treated topically with preparations containing aminoglycosides, in patients who have a perforation of the tympanic membrane, there is an increased risk of drug induced deafness.

3). It is important to exclude chronic alternate diagnoses, including chronic otitis media, before treatment is commenced. Treatment with corticosteroid/antibiotic combinations should not be continued for more than 7 days in the absence of any clinical improvement, since prolonged use may lead to occult extension of infections due to the masking effect of the steroid.

In children there is a theoretical risk that sufficient steroid may be absorbed to cause adrenal suppression, with prolonged use increasing this risk of adrenal suppression in children. Prolonged use may also lead to skin sensitisation and the emergence of resistant organisms.

Due to potentially immature renal function in children toxicity may develop, thus caution is warranted when administering neomycin in this age group. Aminoglycoside antibiotics may cause irreversible, partial or total deafness when given systemically or when applied topically to open wounds or damaged skin.

This effect is dose related and is enhanced by renal or hepatic impairment. This possibility should be considered when high doses or prolonged treatment is given to small children. 1555A>G mutation, including cases where the patient’s aminoglycoside serum levels were within the recommended range.

Some cases were associated with a maternal history of deafness and/or mitochondrial mutation. While no cases were identified with neomycin, based on a shared mechanism of action there is the potential for a similar effect with neomycin.

1. The product should not be used in patients where a perforated tympanic membrane has been diagnosed or is suspected or where a tympanostomy tube (grommet) is in situ. The product should not be used in infants and neonates under 2 years of age.