Home » Drug Information » Recently Approved Drugs » 2000
Medical Areas: Ophthalmology
Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Santen
Approval Status: Approved August 2000
Treatment Area: Antibacterial agent approved for the treatment of bacterial conjunctivitis
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.
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.
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.
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)
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.