A rational pharmacovigilance safety appraisal of topical pefloxacin 0.3% ophthalmological drops in bacterial conjunctivitis, in global multi-centre tertiary care hospitals
DOI:
https://doi.org/10.18203/2319-2003.ijbcp20221595Keywords:
Pharmacovigilance, Fluoroquinolones, Pefloxacin, Bacterial conjunctivitis, Topical pharmacotherapyAbstract
Background: Pefloxacin is a newer broad-spectrum bactericidal fluoroquinolone antibiotic, with superior antibacterial activity in vivo against pathogenic ocular gram-negative and anaerobic microorganisms and better pharmacokinetic properties. The objective of this clinical research study was the rational pharmacovigilance safety appraisal of topical pefloxacin 0.3% ophthalmological drops in bacterial conjunctivitis, in global multi-centre tertiary care hospitals.
Methods: The 43 bacterial conjunctivitis patients were prescribed topical pefloxacin 0.3% ophthalmological drops, 2 drops in each eye after every 3 hours for 2 days, and 2 drops in each eye after every 6 hours for next 5 days. The pharmacovigilance safety appraisal was performed by monitoring the occurrence of adverse drug reactions, like, transient ocular burning or discomfort, ocular irritation, redness, stinging, pruritis, photophobia, ocular watering and dryness, and recording in Adverse Event Case Report Forms, on days 0, 3, 5, 7, 10, 15, 30, and on further follow-ups.
Results: In this study, the safety assessment showed that only 1 patient had ocular discomfort in the eye. The occurrence of adverse effects was statistically non-significant. Thus, 0.3% pefloxacin ophthalmological drops treatment was safe and tolerable, among all 43 patients.
Conclusions: Therefore, pefloxacin is a safe ocular antibiotic for treating bacterial conjunctivitis, with adequate drug tolerability exhibited by the patients.
Metrics
References
Hazra M. A comparative study on the pharmacovigilance scoring of causality assessment grading and staging of topical pharmacotherapy of ofloxacin 0.3% ophthalmic solution in bacterial conjunctivitis and ofloxacin 0.3% otic solution in otitis externa. Int J Basic Clin Pharmacol. 2022;11:173-80.
Hazra M. A rational pharmacotherapeutic study of comparative safety among topical anti anti-acne 1% nadifloxacin monotherapy, 0.1% adapalene monotherapy, 0.025% tretinoin monotherapy, 1% nadifloxacin and 0.1% adapalene combination therapy and 1% nadifloxacin and 0.025% tretinoin combination therapy, in mild to moderate acne vulgaris, in tertiary care hospitals. Int J Basic Clin Pharmacol. 2019;8(9):1959-5.
Hazra M. A rational pharmacotherapeutic study in pharmacovigilance : a comparative assessment of safety between topical 1% nadifloxacin and 0.1% adapalene combination therapy and topical 1% nadifloxacin and 0.025% tretinoin combination therapy, in mild to moderate acne, in tertiary care hospitals, in India. J Evid Based Med Healthc. 2019;6(35):2366-71.
Hazra M, Geetha M, Somashekhar HS, Murugesh SB. A comparative study on the efficacy of topical 1% nadifloxacin and 0.1% adapalene combination therapy with 1% clindamycin and 0.1% adapalene combination therapy, in mild to moderate acne, in a tertiary care hospital. Indian J Pharmacol. 2014;46(1): S73.
Hazra M. Newer Quinolones: The Novel Pharmacotherapeutics. Hazra M, editor.1st edition. New Delhi, India: AkiNik Publications. 2022.
Yadav S, Parvez N. A comparative evaluation of 0.3% eye drops and in situ forming gel of pefloxacin mesylate in experimentally induced pseudomonas conjunctivitis. Continental J Pharmacol Toxicol Res. 2008;2:1-5.
Brar RK, Jyoti U, Patil RK, Patil HC. Fluoroquinolone antibiotics: an overview. Adesh Univ J Med Sci Res. 2020;2(1):26-30.
Assar S, Nosratabadi R, Azad HK, Masoumi J, Mohamadi M, Hassanshahi G. A review of immunomodulatory effects of fluoroquinolones. Immunol Invest. 2020;1-20.
Mohammed HHH, Abuo-Rahma GEAA, Abbas SH, Abdelhafez ESMN. Current trends and future directions of fluoroquinolones. Curr Med Chem. 2019;26(17):3132-49.
Pradhan S, Prajna NV. Topical fluoroquinolones: current perspectives. DJO. 2015;25:267-71.
Fan KC, Lin J, Yannuzzi NA, Al-Khersan H, Patel NA, Maestre-Mesa J, et al. In vitro susceptibilities of methicillin-susceptible and resistant staphylococci to traditional antibiotics compared to a novel fluoroquinolone. J Ophthalmic Inflamm Infect. 2020;10(1):9.
Pham TDM, Ziora ZM, Blaskovich MAT. Quinolone antibiotics. Medchemcomm. 2019;10(10):1719-39.
Yan A, Bryant EE. Quinolones. In: Stat Pearls. Treasure Island (FL): Stat Pearls Publishing 2020 Jan. Available at: https://www.ncbi.nlm.nih.gov/books/NBK557777/. Accessed on 9 December 2021.
Shankarrao PR, Supriya M, Sugave RV, Patil B, Priyanka K. Formulation and evaluation of in situ gel containing pefloxacin mesylate. World J Pharm Res. 2017;6(07):1236-50.
Kovoor TA, Kim AS, McCulley JP, Cavanagh HD, Jester JV, Bugde AC et al. Evaluation of the corneal effects of topical ophthalmic fluoroquinolones using in vivo Confocal Microscopy. Eye Contact Lens. 2004;30(2):90-4.
Vajpayee RB, Sharma N, Verma B, Vajpayee M, Gupta SK, Satpathy G et al. Topical pefloxacin in bacterial keratitis. Int Ophthalmol. 1998;22:47-51.