Rx Item-Vigamox 0.5% Drops 3Ml By Alcon Labs

VIGAMOX - moxifloxacin hydrochloride solution/ drops
Alcon Laboratories, Inc.
DESCRIPTION

VIGAMOX� (moxifloxacin hydrochloride ophthalmic solution) 0.5% is a sterile solution for topical ophthalmic use. Moxifloxacin hydrochloride is an 8-methoxy fluoroquinolone anti-infective, with a diazabicyclononyl ring at the C7 position.
Chemical Name:
1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolol[3,4-b]pyridin-6-yl]-4-oxo-3-quinoline carboxylic 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.

Contains: Active: Moxifloxacin 0.5% (5 mg/mL); Inactives: Boric acid, sodium chloride, and purified water. May also contain hydrochloric acid/sodium hydroxide to adjust pH to approximately 6.8.

VIGAMOX� solution is an isotonic solution with an osmolality of approximately 290 mOsm/kg.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
Moxifloxacin is a member of the fluoroquinolone class of anti-infective drugs
Microbiology
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.

In vitro resistance to moxifloxacin develops via multiple-step mutations. Resistance to moxifloxacin occurs in vitro at a general frequency of between 1.8 x 10-9 to < 1 x 10-11 for Gram-positive bacteria.

Moxifloxacin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section:

Aerobic Gram-positive microorganisms:
Corynebacterium species*
Micrococcus luteus*
Staphylococcus aureus
Staphylococcus epidermidis
Staphylococcus haemolyticus
Staphylococcus hominis
Staphylococcus warneri*
Streptococcus pneumoniae
Streptococcus viridans group

Aerobic Gram-negative microorganisms:
Acinetobacter lwoffii*
Haemophilus influenzae
Haemophilus parainfluenzae*

Other microorganisms:
Chlamydia trachomatis

*Efficacy for this organism was studied in fewer than 10 infections.

The following in vitro data are also available, but their clinical significance in ophthalmic infections is unknown. 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 in vitro 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 in vitro minimal inhibitory concentrations (MICs) of 2 μg/ml or less (systemic susceptible breakpoint) against most (≥ 90%) strains of the following ocular pathogens.

Aerobic Gram-positive microorganisms:
Listeria monocytogenes
Staphylococcus saprophyticus
Streptococcus agalactiae
Streptococcus mitis
Streptococcus pyogenes
Streptococcus Group C, G and F

Aerobic Gram-negative microorganisms:
Acinetobacter baumannii
Acinetobacter calcoaceticus
Citrobacter freundii
Citrobacter koseri
Enterobacter aerogenes
Enterobacter cloacae
Escherichia coli
Klebsiella oxytoca
Klebsiella pneumoniae
Moraxella catarrhalis
Morganella morganii
Neisseria gonorrhoeae
Proteus mirabilis
Proteus vulgaris
Pseudomonas stutzeri

Anaerobic microorganisms:
Clostridium perfringens
Fusobacterium species
Prevotella species
Propionibacterium acnes

Other microorganisms:
Chlamydia pneumoniae
Legionella pneumophila
Mycobacterium avium
Mycobacterium marinum
Mycoplasma pneumoniae
PATIENT COUNSELING INFORMATION

Patients should be advised not to touch the dropper tip to any surface to avoid contaminating the contents.

Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.

Systemically administered quinolones including moxifloxacin have been associated with hypersensitivity reactions, even following a single dose. Patients should be told to discontinue use immediately and contact their physician at the first sign of a rash or allergic reaction.

RX ITEM-Vigamox 0.5% Drops 3Ml By Alcon
NDC 00065-4013-03 UPC/GTIN No.3-00654-01303-7 Mfg.Part No.401303

Vigamox 0.5% Drops 3Ml By Alcon Labs
BRAND: VIGAMOX NDC: 00065-4013-03,65401303 UPC: 3-00654-01303-7,300654013037 Alcon Labs

MOXIFLOXACIN HCL OPHTHALM
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