Vigamox Information
Vigamox () Description
Vigamox () ® (moxifloxacin HCl ophthalmic solution) 0.5% is a sterile ophthalmic solution. It is an 8-methoxy fluoroquinolone anti-infective for topical ophthalmic use.
1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolol[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid, monohydrochloride.
Moxifloxacin hydrochloride is a slightly yellow to yellow crystalline powder. Each mL of Vigamox () ® solution contains 5.45 mg moxifloxacin hydrochloride equivalent to 5 mg moxifloxacin base.
Vigamox () ® solution is an isotonic solution with an osmolality of approximately 290 mOsm/kg.
Vigamox () Clinical Pharmacology
Moxifloxacin is an 8-methoxy fluoroquinolone with a diazabicyclononyl ring at the C7 position. The antibacterial action of moxifloxacin results from inhibition of the topoisomerase II (DNA gyrase) and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.
The mechanism of action for quinolones, including moxifloxacin, is different from that of macrolides, aminoglycosides, or tetracyclines. Therefore, moxifloxacin may be active against pathogens that are resistant to these antibiotics and these antibiotics may be active against pathogens that are resistant to moxifloxacin. There is no cross-resistance between moxifloxacin and the aforementioned classes of antibiotics. Cross resistance has been observed between systemic moxifloxacin and some other quinolones.
frequency of between 1.8 x 10 to
Moxifloxacin has been shown to be active against most strains of the following microorganisms, both and in clinical infections as described in the section:
*Efficacy for this organism was studied in fewer than 10 infections.
The following data are also available, The safety and effectiveness of Vigamox () ® solution in treating ophthalmological infections due to these microorganisms have not been established in adequate and well-controlled trials.
The following organisms are considered susceptible when evaluated using systemic breakpoints. However, a correlation between the systemic breakpoint and ophthalmological efficacy has not been established. The list of organisms is provided as guidance only in assessing the potential treatment of conjunctival infections. Moxifloxacin exhibits minimal inhibitory concentrations (MICs) of 2 μg/ml or less (systemic susceptible breakpoint) against most (≥ 90%) of strains of the following ocular pathogens.
Vigamox () Clinical Studies
In two randomized, double-masked, multicenter, controlled clinical trials in which patients were dosed 3 times a day for 4 days, Vigamox () ® solution produced clinical cures on day 5-6 in 66% to 69% of patients treated for bacterial conjunctivitis. Microbiological success rates for the eradication of the baseline pathogens ranged from 84% to 94%. Please note that microbiologic eradication does not always correlate with clinical outcome in anti-infective trials.
Vigamox () Indications And Usage
Vigamox () ® solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
*Efficacy for this organism was studied in fewer than 10 infections.
Vigamox () Contraindications
Vigamox () ® solution is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication.
Vigamox () Warnings
NOT FOR INJECTION.
Vigamox () ® solution should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.
In patients receiving systemically administered quinolones, including moxifloxacin, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. If an allergic reaction to moxifloxacin occurs, discontinue use of the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated.
Vigamox () Precautions
As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and, where appropriate, fluorescein staining.
Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.
Avoid contaminating the applicator tip with material from the eye, fingers or other source.
Systemically administered quinolones including moxifloxacin have been associated with hypersensitivity reactions, even following a single dose. Discontinue use immediately and contact your physician at the first sign of a rash or allergic reaction.
Long term studies in animals to determine the carcinogenic potential of moxifloxacin have not been performed. However, in an accelerated study with initiators and promoters, moxifloxacin was not carcinogenic in rats following up to 38 weeks of oral dosing at 500 mg/kg/day (approximately 21,700 times the highest recommended total daily human ophthalmic dose for a 50 kg person, on a mg/kg basis).
Moxifloxacin was not mutagenic in four bacterial strains used in the Ames reversion assay. As with other quinolones, the positive response observed with moxifloxacin in strain TA 102 using the same assay may be due to the inhibition of DNA gyrase. Moxifloxacin was not mutagenic in the CHO/HGPRT mammalian cell gene mutation assay. An equivocal result was obtained in the same assay when v79 cells were used. Moxifloxacin was clastogenic in the v79 chromosome aberration assay, but it did not induce unscheduled DNA synthesis in cultured rat hepatocytes. There was no evidence of genotoxicity in a micronucleus test or a dominant lethal test in mice.
Moxifloxacin had no effect on fertility in male and female rats at oral doses as high as 500 mg/kg/day, approximately 21,700 times the highest recommended total daily human ophthalmic dose. At 500 mg/kg orally there were slight effects on sperm morphology (head-tail separation) in male rats and on the estrous cycle in female rats.
Vigamox () Pediatric Use
The safety and effectiveness of Vigamox () ® solution in infants below 1 year of age have not been established.
There is no evidence that the ophthalmic administration of Vigamox () ® solution has any effect on weight bearing joints, even though oral administration of some quinolones has been shown to cause arthropathy in immature animals.
Vigamox () Geriatric Use
No overall differences in safety and effectiveness have been observed between elderly and younger patients.
Vigamox () Adverse Reactions
The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately 1-6% of patients.
Nonocular adverse events reported at a rate of 1-4% were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis.
Vigamox () Dosage And Administration
Instill one drop in the affected eye 3 times a day for 7 days.
Vigamox () How Supplied
Vigamox () ® solution is supplied as a sterile ophthalmic solution in Alcon's DROP-TAINER® dispensing system consisting of a natural low density polyethylene bottle and dispensing plug and tan polypropylene closure. Tamper evidence is provided with a shrink band around the closure and neck area of the package.
3 mL bottle - 21695-968-03
Rx Only
Manufactured by
Alcon Laboratories, Inc.
Fort Worth, Texas 76134 USA
Licensed to Alcon, Inc. by Bayer HealthCare AG.
U.S. PAT. NO. 4,990,517; 5,607,942; 6,716,830
©2003-2006, 2008 Alcon, Inc.
Repackaged by:
Rebel Distributors Corp
Thousand Oaks, CA 91320
Vigamox () Principal Display Panel
