OTIXAL

025% w/v fluocinolone acetonide) otic solution twice daily for a median duration of 7 days. 025% w/v (n=213). 6%) of which were younger than 3 years of age. Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. In the two trials, no treatment related serious adverse events were reported. 025 % w/v). Adverse events leading to discontinuation were generally associated with otitis (otitis media and acute otitis media, and otitis externa) and conditions associated with otitis (such as rhinitis and streptococcal pharyngitis), and events such as ear pain and otorrhea.

4% (148 / 662) of the children from the two trials reported bilateral ear infection at baseline. 7%). The overall incidence of adverse events was greater in the subgroup of children younger than 3 years. For these children, the incidence of adverse events was similar between treatment groups.

3%) children 3 years and older. 025% w/v otic solution in ear infections. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

025% w/v fluocinolone acetonide). Given the low systemic concentrations of ciprofloxacin and fluocinolone acetonide following topical otic administration of OTIXAL to the human ear, drug- drug interactions at the systemic level are unlikely to occur.

Drug-Lifestyle Interactions OTIXAL has no influence on the ability to drive and use machines. 025% w/v fluocinolone acetonide) is for otic use only. It is not for ophthalmic use, or for oral/injection use. OTIXAL should not be used in children less than 6 months of age.

25 mL) of OTIXAL should be instilled into the affected ear canal twice daily (approximately every 12 hours) for 7 days. This dosing regimen should be used for children of 6 months […]

025% w/v fluocinolone acetonide) is contraindicated in patients with known hypersensitivity to fluocinolone acetonide or other corticosteroids, ciprofloxacin or other quinolones, or to any other ingredient of the formulation. Use of this product is contraindicated in viral infections of the external ear canal, including varicella and herpes simplex infections and fungal otic infections.

025% w/v fluocinolone acetonide) is for otic use only. It is not for ophthalmic use, or for oral/injection use. Immune and Hypersensitivity OTIXAL should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.

Serious acute hypersensitivity reactions may require immediate emergency treatment. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolone therapy.

Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial oedema), airway obstruction, dyspnoea, urticaria, and itching. Sensitization and irritation due to dermal applications of topical corticosteroids have been noted.

Allergic contact dermatitis from topical corticosteroids is usually diagnosed by observing failure to heal rather than clinical exacerbation. If patient fails to recover following 7 days of treatment an appropriate therapy should be instituted.

Neurologic Absorption of topical corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression and the potential for adrenal insufficiency after sudden withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glycosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.