title: A prescription event monitoring study on the utility of garenoxacin, a newer fluoroquinolone in India.
abstract: 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.
  
  
  OBJECTIVE
  The aim was to assess the safety profile of garenoxacin in Indian settings.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Medical Services, Glenmark Pharmaceuticals Ltd., Mumbai, Maharashtra, India.
authors.forename: Anoop
authors.initials: A
authors.lastname: Hajare
authors.affiliation: Department of Medical Services, Glenmark Pharmaceuticals Ltd., Mumbai, Maharashtra, India.
authors.forename: Amandeep
authors.initials: A
authors.lastname: Gupta
authors.affiliation: Department of Medical Services, Glenmark Pharmaceuticals Ltd., Mumbai, Maharashtra, India.
authors.forename: Saiprasad
authors.initials: S
authors.lastname: Patil
authors.affiliation: Department of Medical Services, Glenmark Pharmaceuticals Ltd., Mumbai, Maharashtra, India.
authors.forename: K
authors.initials: K
authors.lastname: Krishnaprasad
authors.affiliation: Department of Medical Services, Glenmark Pharmaceuticals Ltd., Mumbai, Maharashtra, India.
authors.forename: Amit
authors.initials: A
authors.lastname: Bhargava
keywords: Adverse events; garenoxacin; prescription event monitoring; respiratory tract infections; safety