Efficacy and Safety of Ciprofloxacin Plus Fluocinolone in Otitis Media With Tympanostomy Tubes in Pediatric Patients

Abstract

clinicaltrials.gov Identifiers: NCT01395966 and NCT01404611.

Efficacy and safety of fluocinolone acetonide 0.025% otic solution in patients with otic eczema: a randomized, double-blind, placebo-controlled clinical trial

“…These results concur with previous studies demonstrating the good tolerability of fluocinolone acetonide treatment. 17 – 19 In two RCTs, fluocinolone acetonide 0.01% in peanut oil showed a good efficacy response, 20 , 21 although this formulation raised concerns about possible peanut-derived allergies. Multiple single-entity and combination products containing fluocinolone acetonide at 0.01% and 0.025% have been commercialized in different formulations (creams, ointments, oils, ophthalmic solutions).…”

“…Multiple single-entity and combination products containing fluocinolone acetonide at 0.01% and 0.025% have been commercialized in different formulations (creams, ointments, oils, ophthalmic solutions). 16 – 19 The only product specifically indicated for otic eczema and approved by the FDA is an oil formulation of fluocinolone acetonide at 0.01%. In the present study, fluocinolone acetonide was assessed at 0.025% based on previous results reporting the safety and good tolerability of this fluocinolone concentration in combination with antibiotics, 17 , 18 with the hypothesis that 0.025% fluocinolone acetonide would achieve high biological activity and induce a rapid response, at a minimum risk of AEs.…”

“… 16 – 19 The only product specifically indicated for otic eczema and approved by the FDA is an oil formulation of fluocinolone acetonide at 0.01%. In the present study, fluocinolone acetonide was assessed at 0.025% based on previous results reporting the safety and good tolerability of this fluocinolone concentration in combination with antibiotics, 17 , 18 with the hypothesis that 0.025% fluocinolone acetonide would achieve high biological activity and induce a rapid response, at a minimum risk of AEs. In addition, otic solutions can release high local concentrations of the active ingredient within the external auditory canal, 26 thus becoming efficacious alternatives to other formulations, such as ointments or creams.…”

“…[14][15][16] The efficacy and safety of fluocinolone acetonide at 0.01 and 0.025% has been demonstrated when used as a single agent or in combination with antibiotics in different formulations (creams, ointments, oils, or ophthalmic and otic solutions). [16][17][18][19][20][21] The aim of the present study was to evaluate the efficacy and safety of fluocinolone acetonide 0.025% otic solution versus placebo in patients with otic eczema.…”

Pharmacokinetics and Bioequivalence Study of Two Ciprofloxacin Hydrochloride Tablets in Chinese Healthy Volunteers Under Fasting and Fed Conditions: A Randomized, Open-Label, Two-Formulation, Two-Sequence, Two-Period, Single-Dose Crossover Study.

“…In addition to complicated urinary tract infections [5], gastrointestinal infections [6], gonorrhea [7], cipro oxacin was widely used in the therapy of lower respiratory tract infections [8], skin and soft tissue infections [9], sinusitis [10], otitis media [11], sepsis [12], etc. Cipro oxacin exhibits excellent antimicrobial activity against many pathogens, such as some Gram-positive organisms including staphylococci, streptococci, and most of Gram-negative organisms consisting of Hemophilus in uenzae, Escherichia coli, Enterobacter, P. aeruginosa species.…”