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.

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.

• Authors: Anoop Hajare, Amandeep Gupta, Saiprasad Patil, K Krishnaprasad, Amit Bhargava
• Journal: International journal of applied & basic medical research (Int J Appl Basic Med Res) 2015 May-Aug Vol. 5 Issue 2 Pg. 87-91 ISSN: 2229-516X [Print] India
• PMID: 26097813 (Publication Type: Journal Article)