Special Warning : אזהרת שימוש

4.4 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 Dexamethasoneh component of Desoren Ear Drops is considered to be unlikely, although the recommended dosage should not be exceeded, particularly in infants.

Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity from mild to life-threatening. Therefore, it is important to consider its diagnosis in patients who develop diarrhoea during or after antibiotic use. Although this is unlikely to occur with topically applied antibiotics, if prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further.

Dexamethasone may mask the allergic effects produced by any components of Desoren ear drops.

Accidental maladministration, prescription and dispensing errors have been reported.
Desoren ear drops should only be used in the ear and are not suitable for use in the eye.
Particular care should be taken to ensure that the correct formulation has been provided and administered. If ear drops are accidentally introduced into the eye, the eye should be rinsed thoroughly with water.
Desoren ear drops should be kept out of the reach of children.

Prolonged, unsupervised, use should be avoided as it may lead to irreversible partial or total deafness, especially in the elderly and in patients with impaired renal function. In renal impairment the plasma clearance of neomycin is reduced (see Dosage in Renal Impairment).

Use in the immediate pre- and post- operative period is not advised as neomycin may rarely cause neuro-muscular block; because it potentiates skeletal muscle relaxant drugs, it may cause respiratory depression and arrest.

There have been observed cases of an increased risk of ototoxicity with aminoglycosides administered to patients with mitochondrial mutations, particularly the m.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.
These mitochondrial mutations are rare, and the penetrance of this observed effect is unknown.

Desoren Ear Drops contains excipient with known effect: 250 mg of propylene glycol in each 1 ml, which is equivalent to 250 mg/ml.


Effects on Driving

4.7 Effects on ability to drive and use machines

Desoren Ear Drops is not expected to affect the ability to drive or use machines.