Gemifloxacin

Table of contents

  • Brand Names
  • Chemistry
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Unlabeled Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Toxicological Effects
  • Drug Interactions
  • Nutrition/Nutraceutical Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics
  • Special Considerations

Brand Names

North America

USA: Factive.

Latin America

Mexico: Factive.

Drug combinations

Chemistry

Gemifloxacin Mesylate: C~18~H~20~FN~5~O~4~ CH~4~O~3~S. Mw: 485.49. (1)(Z)-7-[3-(Aminomethyl)-4-(methoxyimino)-1-pyrrolidinyl]-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-1,8-naphthyridine-3-carboxylic acid monomethanesulfonate; (2)(±)-7-[3-(Aminomethyl)-4-oxo-1-pyrrolidinyl]-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-1,8-naphthyridine-3-carboxylic acid, 7^4^-(Z)-(O-methyloxime), monomethanesulfonate. CAS-204519-65-3 (1998).

Pharmacologic Category

Antibacterials; Quinolones. (ATC-Code: J01MA15).

Mechanism of action

Gemifloxacin is a DNA gyrase inhibitor and also inhibits topoisomerase IV. DNA gyrase required for DNA replication and transcription, DNA repair, recombination, and transposition. Bactericidal.

Therapeutic use

Treatment of acute bacterial exacerbations of chronic bronchitis caused by susceptible Streptococcus pneumoniae, Haemophilus influenzae, H. parainfluenzae, or Moraxella catarrhalis. Treatment of mild-to-moderate community-acquired pneumonia caused by S. pneumoniae (including multidrug-resistant strains), H. influenzae, M. catarrhalis, Mycoplasma pneumoniae, Chlamydophila pneumoniae (formerly Chlamydia pneumoniae), or Klebsiella pneumoniae.

Pregnancy and lactiation implications

Adverse events observed in some animal studies. Gemifloxacin should only be used during pregnancy if safer option not available. Not recommended during lactation.

Unlabeled use

Acute sinusitis.

Contraindications

Hypersensitivity to gemifloxacin, other fluoroquinolones, or any component of the formulation.

Warnings and precautions

Fluoroquinolones associated with development of serious, sometimes fatal, hypoglycemia. Hyperglycemia also associated with use of fluoroquinolones. Severe hypersensitivity reactions, including anaphylaxis, have occurred with quinolone therapy. Use of quinolones has been linked to peripheral neuropathy (rare). Avoid excessive sunlight (may cause moderate-to-severe phototoxicity reactions). Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea and pseudomembranous colitis. Tendon inflammation and/or rupture reported (risk may be increased with concurrent corticosteroids, organ transplant recipients, and in patients >60 years of age). Use with caution in significant bradycardia or acute myocardial ischemia. Some quinolones may exacerbate myasthenia gravis (rare, potentially life-threatening weakness of respiratory muscles may occur). Use with caution in renal impairment, and in rheumatoid arthritis (might increase risk of tendon rupture). Use with caution in individuals at risk of seizures (CNS disorders or concurrent therapy with medications which may lower seizure threshold). Potential for seizures, although very rare, may be increased with concomitant NSAID therapy. Adverse effects (e.g. tendon rupture, QT changes) may be increased in the elderly. Hemolytic reactions may (rarely) occur with quinolone use in latent or actual G6PD deficiency.

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