Treatment should be discontinued if there are signs of sensitivity to any of its ingredients.
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. Prolonged use may also lead to skin sensitisation and the emergence of resistant organisms.
Corticosteroids
Topical corticosteroids should never be given for an undiagnosed red eye as inappropriate use is potentially blinding (see section 4.3).
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Treatment with corticosteroid preparations should not be repeated or prolonged without regular review to exclude raised intraocular, pressure, cataract formation or unsuspected infections.
Antibiotics
Ototoxicty
Aminoglycosides 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. Although this effect has not been reported following ocular use, the possibility should be considered when high dose topical is given to small children or infants.
Mitochondrial disorders
There have been reported cases of ototoxicity with aminoglycosides administered to patients with mitochondrial mutations, particularly the m.1555A>G mutation, which suggests an increased risk of ototoxicity in these patients, 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. Mitochondrial mutations are rare, and the penetrance of this observed effect is unknown.
Although no cases were identified with topical preparations of neomycin, framycetin or gentamicin, the potential for a similar effect with neomycin and other aminoglycosides administered topically cannot be ruled out.
Paediatric Population
Although it is unlikely that infants will be treated with Sofradex for prolonged periods, there is a risk of adrenal suppression, even without occlusive dressings, after prolonged treatment of these patients with topical steroids.