Version 1
: Received: 23 November 2020 / Approved: 25 November 2020 / Online: 25 November 2020 (08:02:47 CET)
Version 2
: Received: 30 December 2020 / Approved: 5 January 2021 / Online: 5 January 2021 (11:51:06 CET)
Contreras-Salinas, H.; Baiza-Durán, L.M.; Barajas-Hernández, M.; Vázquez-Álvarez, A.O.; Rodríguez-Herrera, L.Y. A Drug Safety Surveillance Study of a Ciprofloxacin/Dexamethasone Ophthalmic Fixed Combination in Peruvian Population. Pharmacy2021, 9, 15.
Contreras-Salinas, H.; Baiza-Durán, L.M.; Barajas-Hernández, M.; Vázquez-Álvarez, A.O.; Rodríguez-Herrera, L.Y. A Drug Safety Surveillance Study of a Ciprofloxacin/Dexamethasone Ophthalmic Fixed Combination in Peruvian Population. Pharmacy 2021, 9, 15.
Contreras-Salinas, H.; Baiza-Durán, L.M.; Barajas-Hernández, M.; Vázquez-Álvarez, A.O.; Rodríguez-Herrera, L.Y. A Drug Safety Surveillance Study of a Ciprofloxacin/Dexamethasone Ophthalmic Fixed Combination in Peruvian Population. Pharmacy2021, 9, 15.
Contreras-Salinas, H.; Baiza-Durán, L.M.; Barajas-Hernández, M.; Vázquez-Álvarez, A.O.; Rodríguez-Herrera, L.Y. A Drug Safety Surveillance Study of a Ciprofloxacin/Dexamethasone Ophthalmic Fixed Combination in Peruvian Population. Pharmacy 2021, 9, 15.
Abstract
(1) Background: drugs provide a significant benefit; however, their use implies an intrinsic potential danger, with the possibility to cause unwanted effects. These effects are known as adverse drug reactions (ADRs). Post-marketing drug 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 to the scarce information about fixed combination of ciprofloxacin 0.3% / dexamethasone 0.1% (SDO), we performed a drug safety surveillance study. (2) Methods: A prospective non-controlled drug safety surveillance study was conducted in Peruvian population. A total of 236 patients prescribed SDO were included derivates from 12 sites. Patients' standardized information was collected through two phone calls, including demographics, medical history, prescribing patterns of SDO, concomitant medication, and ADRs in detail. The ADRs were classified by causality and severity, followed by outcome measures to identify new risk. (3) Results: 236 patients prescribed with SDO participated in the study and 220 were included. A total of 82 ADRs/220 patients were reported after the use of SDO, presenting a ratio 0.37 ADR/patient. The most frequent ADR with SDO administration was eye irritation (30%). The totality of the ADR was classified as non-serious, and the 97.5% (n=80) was classified as mild and 2.5% as moderate (n=2). No cases under the severe category were identified. (4) Conclusion: No new risks were found in the population where this study was conducted.
Keywords
Drug Safety Surveillance, Adverse Drug Reaction, Ophthalmic, Ciprofloxacin, Dexamethasone.
Subject
Medicine and Pharmacology, Ophthalmology
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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