A Drug Safety Surveillance Study of a Ciprofloxacin/Dexamethasone Ophthalmic Fixed Combination in Peruvian Population.

摘要: (1) Background: drugs provide a significant benefit for patients who require medical treatment; however, their use implies an intrinsic potential danger, with the possibility of causing unwanted effects. These effects are known as adverse drug reactions (ADRs). Post-marketing safety surveillance detects unknown risks that have not been identified in clinical trials, and it is necessary to monitor marketed medications under real-life practice. Due scarce information about fixed combination ciprofloxacin 0.3%/dexamethasone 0.1% (SDO), we performed study. (2) Methods: A prospective non-controlled study was conducted Peruvian population. total 236 prescribed SDO were included derived from 12 sites. Patients' standardized collected through two phone calls, including demographics, history, prescribing patterns SDO, concomitant medication, ADRs detail. The classified by causality severity, followed outcome measures identify new risk. (3) Results: participated 220 included. 82 ADRs/220 reported after presenting ratio 0.37 ADR/patient. most frequent ADR administration eye irritation (30%). All non-serious, 97.5% (n = 80) mild while 2.5% moderate 2). No cases severe category identified. (4) Conclusion: found population where this conducted.