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Year : 2015  |  Volume : 5  |  Issue : 2  |  Page : 87-91

A prescription event monitoring study on the utility of garenoxacin, a newer fluoroquinolone in India

Department of Medical Services, Glenmark Pharmaceuticals Ltd., Mumbai, Maharashtra, India

Correspondence Address:
Anoop Hajare
S/O Retd. Prof. L. S. Hajare, H. No. 9 880, Shahabazar, Gulbarga 585 101, Karnataka
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/2229-516X.157151

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Background: Prescription event monitoring (PEM) study is conducted worldwide. The main objective of such study is to monitor the adverse events when a drug is being prescribed in "real life clinical" settings. PEM studies are being looked upon as an essential observational tool of postmarketing surveillance. Garenoxacin, a newer fluoroquinolone offers an excellent spectrum of antimicrobial coverage, which includes Gram-positive, Gram-negative, anaerobes and atypical microorganism. This broad spectrum of activity is attributed to its unique structure. Aim: The aim was to assess the safety profile of garenoxacin in Indian settings. Materials and Methods: A total of 400 doctors across the country participated in the study. Data from 12,498 patients was obtained. Monitoring of each patient was done for any adverse events. Results: As an initial line of therapy garenoxacin was preferred in majority of cases of community-acquired pneumonia (CAP) and acute exacerbations of chronic bronchitis. Adverse events were reported in 159 patients which included 0.5% cases with nausea/vomiting, 0.1% cases with diarrhea. Central nervous system side-effects like drowsiness or dizziness was reported in 0.02% of the cases. All the adverse events were of mild to moderate severity and did not require hospitalization. Conclusion: Garenoxacin a novel desfluoroquinolone appears to be an ideal antimicrobial agent for the treatment of various respiratory tract infections including CAP. With superior safety profile, excellent antimicrobial coverage and a convenient once a day dosing garenoxacin appears to improve the patient compliance.

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