Quixin (levofloxacin)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved August 2000

Specific Treatments:

Antibacterial agent approved for the treatment of bacterial conjunctivitis

Therapeutic Areas

General Information

Quixin is a sterile topical solution approved for the treatment of bacterial conjunctivitis. Its active ingredient, levofloxacin, is a fluoroquinolone antibacterial agent that is active against a broad spectrum of Gram-positive and Gram-negative pathogens. In addition, due to levofloxacin's solubility, Quixin can be produced with a higher active concentration compared to other ophthalmic fluoroquinolones.

Quixin is administered by drops to the infected eye. Treatment runs for approximately seven days, with drops administered at various time intervals.

Clinical Results

Quixin demonstrated significant efficacy in randomized, double-masked, multicenter controlled trials. Patients were dosed for five days, and clinical cures were confirmed in 79% of patients treated for bacterial conjunctivitis. Microbial outcomes for the same clinical trials demonstrated an eradication rate of 90% for presumed pathogens.

Side Effects

The most frequently reported adverse reactions to Quixin include the following:

  • Transient decreased vision
  • Fever
  • Foreign body sensation
  • Headache
  • Ocular pain or discomfort
  • Photophobia

These events occurred in approximately 1 to 3% of study patients.

Other reported effects included allergic reactions, ocular dryness and ocular itching; these occurred in less than 1% of patients. Additionally, Quixin solution is contraindicated in patients with a history of hypersensitivity to levofloxacin, to other quinolones, or to any other component of the medication.

Mechanism of Action

Levofloxacin is the L-isomer of the racemate, ofloxacin, a quinolone antimicrobial agent. The antibacterial activity of ofloxacin resides primarily in the L-isomer. The mechanism of action of levofloxacin and other fluoroquinolone antimicrobials involves the inhibition of bacterial topoisomerase IV and DNA gyrase (both of which are type II topoisomerases), enzymes required for DNA replication, transcription, repair, and recombination.

Levofloxacin has in vitro activity against a wide range of Gram-negative and Gram-positive microorganisms and is often bactericidal at concentrations equal to or slightly greater than inhibitory concentrations. (from FDA label)

Additional Information

For more information on Quixin, please visit the web site of Santen, Inc.. This site provides information on new products being developed and marketed by Santen.