VIGAMOX

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

Ophthalmic solution containing moxifloxacin 0.5%.

VIGAMOX is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.

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.

Drug-drug interaction studies have not been conducted with VIGAMOX

VIGAMOX (moxifloxacin 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. The chemical name for moxifloxacin hydrochloride is 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolol[3,4b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid, monohydrochloride. The molecular formula for moxifloxacin hydrochloride is C

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 contains

VIGAMOX

In two randomized, double-masked, multicenter, controlled clinical trials in which patients were dosed 3 times a day for 4 days, VIGAMOX

In a randomized, double-masked, multicenter, parallel-group clinical trial of pediatric patients with bacterial conjunctivitis between birth and 31 days of age, patients were dosed with VIGAMOX or another anti-infective agent. Clinical outcomes for the trial demonstrated a clinical cure rate of 80% at Day 9 and a microbiological eradication success rate of 92% at Day 9.

Please note that microbiologic eradication does not always correlate with clinical outcome in anti-infective trials.

VIGAMOX

3 mL in a 4 mL bottle NDC 82667-700-03

Storage: Store at 2°C to 25°C (36°F to 77°F).

Advise patients not to touch the dropper tip to any surface to avoid contaminating the contents.

Advise patients 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. Instruct patients to discontinue use immediately and contact their physician at the first sign of a rash or allergic reaction

NDC 82667-700-03

STERILE

VIGAMOX

(moxifloxacin ophthalmic solution)

3 mL

HARROW