Factive (Gemifloxacin Mesylate) - Summary

FACTIVE SUMMARY

FACTIVE (gemifloxacin mesylate) is a synthetic broad-spectrum antibacterial agent for oral administration. Gemifloxacin, a compound related to the fluoroquinolone class of antibiotics, is available as the mesylate salt in the sesquihydrate form.

FACTIVE is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below.

Acute bacterial exacerbation of chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.

Community-acquired pneumonia (of mild to moderate severity) caused by Streptococcus pneumoniae (including multi-drug resistant strains [MDRSP]) *, Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Klebsiella pneumoniae **.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of FACTIVE and other antibacterial drugs, FACTIVE should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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NEWS HIGHLIGHTS

Published Studies Related to Factive (Gemifloxacin)

Bioequivalence evaluation of 320 mg gemifloxacin tablets in healthy volunteers. [2007.11]
This study was done to compare the bioavailability of a new tablet formulation of gemifloxacin (gemifloxacin 320 mg/tablet) with that of the reference product (factive 320 mg/tablet). The bioequivalence of a single dose (320 mg) was assessed for gemifloxacin included in the test and reference products by comparing the pharmacokinetic parameters derived from the plasma concentration-time profiles following administration to 24 healthy male volunteers in a balanced, 2-period, 2-sequence, 2-way crossover design.

Gemifloxacin once daily for 7 days compared to amoxicillin/clavulanic acid thrice daily for 10 days for the treatment of community-acquired pneumonia of suspected pneumococcal origin. [2004.08]
CONTEXT: Community-acquired pneumonia (CAP) is common among adults and contributes considerably to morbidity and mortality. OBJECTIVE: To compare the safety and efficacy of gemifloxacin to high-dose amoxicillin/clavulanate for the treatment of CAP of suspected pneumococcal origin... CONCLUSION: Gemifloxacin 320 mg once daily for 7 days was found to be clinically, bacteriologically, and radiologically as effective as 10 days of amoxicillin/clavulanate 1 g/125 mg three times daily for the treatment of suspected pneumococcal CAP.

A randomized, double-blind study comparing 5 days oral gemifloxacin with 7 days oral levofloxacin in patients with acute exacerbation of chronic bronchitis. [2004.08]
OBJECTIVE: To demonstrate that 5 days of treatment with a new fluoroquinolone, gemifloxacin, is at least as effective as 7 days of treatment with levofloxacin in adult patients with acute exacerbation of chronic bronchitis (AECB)... CONCLUSION: The clinical efficacy of gemifloxacin 320 mg once daily for 5 days in AECB was at least as good as levofloxacin 500 mg once daily for 7 days. Fewer withdrawals and superior clinical efficacy at long-term follow-up were also seen with gemifloxacin.

Serum bactericidal activity of gemifloxacin versus clarithromycin against Streptococcus pneumoniae with different susceptibility to quinolones. [2004.02]
The objective of this study was to determine serum bactericidal titers (SBT, the highest dilution of serum showing no growth) and the serum bactericidal activity (SBA, i.e. duration of SBT greater than 1:2) as well as the serum bactericidal rate of gemifloxacin and clarithromycin after single doses in healthy male volunteers against Streptococcus pneumoniae...

Oral gemifloxacin once daily for 5 days compared with sequential therapy with i.v. ceftriaxone/oral cefuroxime (maximum of 10 days) in the treatment of hospitalized patients with acute exacerbations of chronic bronchitis. [2003.03]
In a randomized, open-label, controlled, multicentre study, the clinical and bacteriological efficacy, safety and tolerability of oral gemifloxacin (320 mg once daily, 5 days) was compared with sequential intravenous (i.v.) ceftriaxone (1 g once daily, maximum 3 days) followed by oral cefuroxime axetil (500 mg twice daily, maximum 7 days) in adult hospitalized patients with acute exacerbations of chronic bronchitis (AECB) (n = 274)...

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Clinical Trials Related to Factive (Gemifloxacin)

Efficacy of Combination Therapies for Gonorrhea Treatment [Not yet recruiting]
The purpose of this study is to learn how to better treat gonorrhea infections. Gonorrhea is a sexually transmitted disease (STD) that is usually cured with a single antibiotic. However, some gonorrhea is not cured with a single antibiotic. The study will look at how well treating gonorrhea with 2 antibiotics works. Participants will be assigned to 1 of 2 treatment groups each receiving a combination of 2 antibiotics. Sites in the United States will recruit 500 participants (100 female, 100 heterosexual men, and 50 men who have sex with men). Participants must be 15 to 60 years old, in good health and identified in participating sexually transmitted disease clinics as having uncomplicated cervical or urethral gonorrhea. Procedures include collection of current symptoms, medical and sexual history, sexual orientation, vital signs, height, weight, cervical/urethral cultures and clinical examinations. Volunteers will be involved for about 18 days.

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