A rational pharmacovigilance safety appraisal of topical pefloxacin 0.3% ophthalmological drops in bacterial conjunctivitis, in global multi-centre tertiary care hospitals

Authors

  • Moumita Hazra 1Department of Pharmacology, Mamata Medical College and Hospitals, Khammam, Telangana, India; 2Department of Pharmacology, Rama Medical College Hospital and Research Centre, Kanpur, Uttar Pradesh, India; 3Medical Director, Medical Superintendent, Laboratory Director, Medical Academics and Research Director, Consultant Clinical Pharmacological Physician, Consultant Clinical Pathologist, Consultant Drug Quality and Safety Physician, PharmacoHaemo-Materio-Vigilance Specialist, Dr. Moumita Hazra’s Polyclinic and Diagnostic Centre, Dr. Moumita Hazra’s Academic Centre, Dr. Moumita Hazra’s Educational Centre, Hazra Nursing Home, Howrah, Kolkata, West Bengal, India, World; 4Former Assistant Medical Director, GIOSTAR IRM Institutes, Hospitals and Laboratories, New Delhi, India, USA, World

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20221595

Keywords:

Pharmacovigilance, Fluoroquinolones, Pefloxacin, Bacterial conjunctivitis, Topical pharmacotherapy

Abstract

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.

Author Biography

Moumita Hazra, 1Department of Pharmacology, Mamata Medical College and Hospitals, Khammam, Telangana, India; 2Department of Pharmacology, Rama Medical College Hospital and Research Centre, Kanpur, Uttar Pradesh, India; 3Medical Director, Medical Superintendent, Laboratory Director, Medical Academics and Research Director, Consultant Clinical Pharmacological Physician, Consultant Clinical Pathologist, Consultant Drug Quality and Safety Physician, PharmacoHaemo-Materio-Vigilance Specialist, Dr. Moumita Hazra’s Polyclinic and Diagnostic Centre, Dr. Moumita Hazra’s Academic Centre, Dr. Moumita Hazra’s Educational Centre, Hazra Nursing Home, Howrah, Kolkata, West Bengal, India, World; 4Former Assistant Medical Director, GIOSTAR IRM Institutes, Hospitals and Laboratories, New Delhi, India, USA, World

1Associate Professor, Head of Department In Charge, Department of Pharmacology, Mamata Medical College and Hospitals, Telangana, India;
2Medical Director, Consultant Multi-Specialist Clinical Pharmacological Physician, Consultant Clinical Pathologist, Medical Superintendent, Medical Academics and Clinical Research Director, Dr. Moumita Hazra’s Polyclinic And Diagnostic Centre, Hazra Nursing Home, Hazra Polyclinic And Diagnostic Centre, Dr. Moumita Hazra’s Academic Centre, Dr. Moumita Hazra’s Educational Centre, West Bengal, India, World;
3Consultant Pathologist, Laboratory Supervisor, Mahuya Diagnostic Centre and Doctors’ Chamber, West Bengal, India.

 

 

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Published

2022-07-01

How to Cite

Hazra, M. (2022). A rational pharmacovigilance safety appraisal of topical pefloxacin 0.3% ophthalmological drops in bacterial conjunctivitis, in global multi-centre tertiary care hospitals. International Journal of Basic & Clinical Pharmacology, 11(4), 302–307. https://doi.org/10.18203/2319-2003.ijbcp20221595

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Original Research Articles