Gemifloxacin Mesylate

Sinusitis, Urinary Tract Infection (UTI), Gonorrhea + 3 more

Treatment

7 FDA approvals

13 Active Studies for Gemifloxacin Mesylate

What is Gemifloxacin Mesylate

Gemifloxacin

The Generic name of this drug

Treatment Summary

Gemifloxacin is an antibiotic used to treat acute cases of chronic bronchitis and mild-to-moderate pneumonia. It comes in tablet form and works by blocking the growth of bacteria by targeting their DNA. Gemifloxacin targets both DNA gyrase and topoisomerase IV, two key components in the growth of bacteria.

Factive

is the brand name

image of different drug pills on a surface

Gemifloxacin Mesylate Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Factive

Gemifloxacin

2003

4

Approved as Treatment by the FDA

Gemifloxacin, otherwise known as Factive, is approved by the FDA for 7 uses like Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) and Multidrug resistant Streptococcus pneumoniae infection .

Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB)

Multidrug resistant Streptococcus pneumoniae infection

Bacterial Infections

Bronchitis, Chronic

Community Acquired Pneumonia (CAP)

Pneumococcal Infections

Urinary Tract Infection (UTI)

Effectiveness

How Gemifloxacin Mesylate Affects Patients

Gemifloxacin is an antibiotic used to fight bacteria in the body. This drug works by attaching to an enzyme called DNA gyrase, which is important for bacteria to replicate. It attaches much more strongly to the bacterial version of this enzyme than the human version, which helps it fight bacteria without affecting us. Gemifloxacin can fight both Gram-positive and Gram-negative bacteria.

How Gemifloxacin Mesylate works in the body

Gemifloxacin kills bacteria by preventing them from replicating their DNA. It does this by blocking two enzymes that are needed for the process.

When to interrupt dosage

The measure of Gemifloxacin Mesylate is contingent upon the determined ailment, including Urinary Tract Infection (UTI), Community Acquired Pneumonia (CAP) and bacterial rhinosinusitis. The amount of dosage fluctuates in accordance with the technique of delivery featured in the table beneath.

Condition

Dosage

Administration

Gonorrhea

, 320.0 mg

, Tablet, Oral, Tablet - Oral, Tablet, film coated - Oral, Tablet, film coated

Community Acquired Pneumonia (CAP)

, 320.0 mg

, Tablet, Oral, Tablet - Oral, Tablet, film coated - Oral, Tablet, film coated

Urinary Tract Infection (UTI)

, 320.0 mg

, Tablet, Oral, Tablet - Oral, Tablet, film coated - Oral, Tablet, film coated

Bronchitis, Chronic

, 320.0 mg

, Tablet, Oral, Tablet - Oral, Tablet, film coated - Oral, Tablet, film coated

Pneumococcal Infections

, 320.0 mg

, Tablet, Oral, Tablet - Oral, Tablet, film coated - Oral, Tablet, film coated

Sinusitis

, 320.0 mg

, Tablet, Oral, Tablet - Oral, Tablet, film coated - Oral, Tablet, film coated

Warnings

Gemifloxacin Mesylate Contraindications

Condition

Risk Level

Notes

Pulse Frequency

Do Not Combine

There are 20 known major drug interactions with Gemifloxacin Mesylate.

Common Gemifloxacin Mesylate Drug Interactions

Drug Name

Risk Level

Description

Amiodarone

Major

The risk or severity of QTc prolongation can be increased when Gemifloxacin is combined with Amiodarone.

Amitriptyline

Major

Gemifloxacin may increase the QTc-prolonging activities of Amitriptyline.

Anagrelide

Major

The risk or severity of QTc prolongation can be increased when Gemifloxacin is combined with Anagrelide.

Arsenic trioxide

Major

The risk or severity of QTc prolongation can be increased when Gemifloxacin is combined with Arsenic trioxide.

Artemether

Major

The risk or severity of QTc prolongation can be increased when Gemifloxacin is combined with Artemether.

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Gemifloxacin Mesylate Novel Uses: Which Conditions Have a Clinical Trial Featuring Gemifloxacin Mesylate?

42 active studies are currently exploring the potential of Gemifloxacin Mesylate in treating Gonorrhea, Community Acquired Pneumonia (CAP) and Acute Bacterial Exacerbations of Chronic Bronchitis (ABECB).

Condition

Clinical Trials

Trial Phases

Gonorrhea

0 Actively Recruiting

Urinary Tract Infection (UTI)

6 Actively Recruiting

Phase 1, Phase 3, Phase 4, Phase 2

Community Acquired Pneumonia (CAP)

5 Actively Recruiting

Not Applicable, Phase 1, Phase 3

Sinusitis

0 Actively Recruiting

Bronchitis, Chronic

0 Actively Recruiting

Pneumococcal Infections

0 Actively Recruiting

Gemifloxacin Mesylate Reviews: What are patients saying about Gemifloxacin Mesylate?

5

Patient Review

10/28/2007

Gemifloxacin Mesylate for Pneumonia caused by Bacteria

I was diagnosed with pneumonia in my left lung on Wednesday and given this medication. I started taking it that night and by Saturday, I was up cleaning the house! In my opinion, this medicine worked very quickly and efficiently. I did have a little trouble sleeping, but that was the only side effect I experienced.

3.7

Patient Review

10/20/2009

Gemifloxacin Mesylate for Bacterial Pneumonia caused by Streptococcus pneumoniae

After taking this medication, I developed large hives that covered my body from my jaw to my knees. Two days after stopping the medication, the hives were still there.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about gemifloxacin mesylate

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What generation is Gemifloxacin?

"Gemifloxacin is a fourth generation, oral fluoroquinolone antibiotic. It is used in the therapy of mild-to-moderate respiratory tract infections caused by susceptible organisms."

Answered by AI

What is Factive 320 mg used for?

"It is thought to work by interfering with the ability of bacteria to make DNA. Gemsifloxacin may also be used for purposes not listed in this medication guide.

This medication is used to treat various bacterial infections. It is classified as a quinolone antibiotic. It works by stopping the bacteria's growth. It is believed to work by interrupting the bacteria's ability to create DNA. This medication may also be used for other purposes not mentioned in this guide."

Answered by AI

What is gemifloxacin mesylate?

"Gemifloxacin is an antibiotic drug that inhibits bacterial growth. It is of the fluoroquinolone class of drugs, which are broad-spectrum antibiotics. This drug is indicated for the treatment of bacterial infections of the lungs. However, this class of drugs carries a risk of serious or disabling side effects."

Answered by AI

What is Gemifloxacin for?

"Gemifloxacin is an antibiotic used to treat bronchitis and pneumonia caused by bacterial infections. It belongs to a class of medicines known as quinolone antibiotics. These antibiotics work by killing bacteria or preventing their growth. However, they will not work for colds, flu, or other virus infections."

Answered by AI

Clinical Trials for Gemifloxacin Mesylate

Image of Direct Helpers in Hialeah, United States.

Rifaximin + ORT for Diarrhea

6 - 12
All Sexes
Hialeah, FL

The goal of this clinical trial is to learn how rifaximin 200 mg is processed in the body (pharmacokinetics) in children 6 to 11 years old with acute diarrhea that may be caused by bacteria. It will also learn about the safety and effectiveness of rifaximin when given with oral rehydration therapy (ORT) compared with ORT alone. The main questions it aims to answer are: How does rifaximin 200 mg move through and leave the body in children with acute diarrhea? Is rifaximin safe for children in this age group? Does rifaximin plus ORT help resolve diarrhea faster than ORT alone? Researchers will compare rifaximin plus ORT to ORT alone to see if adding rifaximin improves outcomes. Participants will: Take one rifaximin 200 mg tablet + ORT three times a day for 3 days or receive ORT alone Receive oral rehydration therapy according to the investigator's standard of care Attend up to 4 clinic visits over 5 days and receive 4 follow-up phone calls Provide blood samples on Day 1 and Day 3 for pharmacokinetic testing (rifaximin group only) Provide stool samples to identify bacterial pathogens Keep a diary of stool frequency and consistency to help determine when diarrhea resolves Be monitored for side effects, vital signs, and laboratory changes

Phase 4
Recruiting

Direct Helpers (+4 Sites)

Bausch Health Americas, Inc.

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Image of Children's Healthcare of Atlanta in Atlanta, United States.

Antibiotic Strategies for Pneumonia in Children

12 - 71
All Sexes
Atlanta, GA

The goal of this clinical trial is to determine if a "watch and wait" antibiotic strategy, called Safety Net Antibiotic Prescribing (SNAP), can safely reduce unnecessary antibiotic use while ensuring that children diagnosed with community-acquired pneumonia get better from their illness. The main aims of this study are: * To compare the effectiveness of SNAP versus immediate antibiotic prescribing in children with mild community-acquired pneumonia (CAP) * To identify which patient groups benefit most from the SNAP strategy * To identify factors that shape implementation of each prescribing strategy. Researchers will compare the SNAP strategy (where parents or guardians are instructed to give antibiotics only if their child is not improving after 72 hours, or sooner if they are worsening) to the immediate antibiotic prescribing strategy (where parents or guardians are instructed to give the antibiotics right after their healthcare visit) to see if one strategy is more effective than the other. Participants will be randomly assigned to either the immediate antibiotic group or the SNAP group at enrollment. Participation lasts 14 days with follow-up surveys at 4, 7, and 14 days after enrollment.

Recruiting
Has No Placebo

Children's Healthcare of Atlanta (+3 Sites)

Todd Florin, MD, MSCE

Image of Harbor UCLA Medical Center - Medicine - Infectious Diseases in Torrance, United States.

Optimized Beta-lactam Dosing for Bacterial Infections

18+
All Sexes
Torrance, CA

This is a Phase 4, interventional, multi-center pharmacokinetics (PK) study in up to 200 adult patients who are residing in an ICU. This will compare the abilities of Cystatin C (CysC) and CysC-based estimated Glomerular Filtration Rate (eGFR) equations to characterize the PK profiles of meropenem and cefepime relative to Serum Creatinine (SCR), Serum Creatinine based Equation (SCRE), and iohexol in critically ill patients with suspected or documented AMR Gram-negative infections. We hypothesize that CysC and CysC-based eGFR equations will characterize the PK profiles of meropenem and cefepime at the population and individual levels with greater accuracy and precision than SCR and SCREs. Iohexol will be administered to patients enrolled in the study and serve as the reference indicator of measured Glomerular Filtration Rate (mGFR), which is the gold standard assessment of kidney function. We further hypothesize that the predictive performances of CysC and CysC-based eGFR equations in estimating the PK profiles of meropenem and cefepime at the population and individual levels will be comparable to iohexol. Firstly, population PK (PopPK) modeling will be used to develop meropenem and cefepime PopPK models informed by CysC, CysC-based eGFR equations, SCR, and SCREs (renal function biomarkers), and iohexol clearance. Secondly, model diagnostics will then be used to compare the predictive performances of the renal function biomarkers PopPK models for each antibiotic relative to iohexol PopPK model. Lastly, Monte Carlo simulation (MCS) will be used to design PK/ pharmacodynamics (PD) optimized meropenem and cefepime dosing schemes based on the renal function biomarker PopPK model with the best predictive performance for use in the treatment of critically ill adult patients with suspected or documented AMR Gram-negative infections and varying degrees of renal function. The primary objective of this study is to compare the abilities of renal function biomarkers (CysC, CysC-based eGFR equations, SCR, SCREs) relative to iohexol to characterize the PK profiles of meropenem and cefepime in critically ill adult patients with suspected or documented AMR Gram-negative infections.

Phase 4
Recruiting

Harbor UCLA Medical Center - Medicine - Infectious Diseases (+9 Sites)

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