These highlights do not include all the information needed to use VIGAMOX® solution safely and effectively. See full prescribing information for VIGAMOX®.VIGAMOX® (moxifloxacin ophthalmic solution) 0.5% Sterile topical ophthalmic solutionInitial U.S. Approval: 1999

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Overview

What is These highlights do not include all the information needed to use VIGAMOX® solution safely and effectively. See full prescribing information for VIGAMOX®.VIGAMOX® (moxifloxacin ophthalmic solution) 0.5% Sterile topical ophthalmic solutionInitial U.S. Approval: 1999?

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.

Chemical Name:1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolol[3,4b]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:

Inactives:

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

What does These highlights do not include all the information needed to use VIGAMOX® solution safely and effectively. See full prescribing information for VIGAMOX®.VIGAMOX® (moxifloxacin ophthalmic solution) 0.5% Sterile topical ophthalmic solutionInitial U.S. Approval: 1999 look like?

What are the available doses of These highlights do not include all the information needed to use VIGAMOX® solution safely and effectively. See full prescribing information for VIGAMOX®.VIGAMOX® (moxifloxacin ophthalmic solution) 0.5% Sterile topical ophthalmic solutionInitial U.S. Approval: 1999?

4 mL bottle filled with 3 mL sterile ophthalmic solution of moxifloxacin 0.5% ()

What should I talk to my health care provider before I take These highlights do not include all the information needed to use VIGAMOX® solution safely and effectively. See full prescribing information for VIGAMOX®.VIGAMOX® (moxifloxacin ophthalmic solution) 0.5% Sterile topical ophthalmic solutionInitial U.S. Approval: 1999?

How should I use These highlights do not include all the information needed to use VIGAMOX® solution safely and effectively. See full prescribing information for VIGAMOX®.VIGAMOX® (moxifloxacin ophthalmic solution) 0.5% Sterile topical ophthalmic solutionInitial U.S. Approval: 1999?

VIGAMOX® solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:

Corynebacterium

Micrococcus luteus*

Staphylococcus aureus

Staphylococcus epidermidis

Staphylococcus haemolyticus

Staphylococcus hominis

Staphylococcus warneri*

Streptococcus pneumoniae

Streptococcus viridans

Acinetobacter lwoffii*

Haemophilus influenza

Haemophilus parainfluenzae*

Chlamydia trachomatis

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

Instill one drop in the affected eye 3 times a day for 7 days.

What interacts with These highlights do not include all the information needed to use VIGAMOX® solution safely and effectively. See full prescribing information for VIGAMOX®.VIGAMOX® (moxifloxacin ophthalmic solution) 0.5% Sterile topical ophthalmic solutionInitial U.S. Approval: 1999?

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What are the warnings of These highlights do not include all the information needed to use VIGAMOX® solution safely and effectively. See full prescribing information for VIGAMOX®.VIGAMOX® (moxifloxacin ophthalmic solution) 0.5% Sterile topical ophthalmic solutionInitial U.S. Approval: 1999?

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What are the precautions of These highlights do not include all the information needed to use VIGAMOX® solution safely and effectively. See full prescribing information for VIGAMOX®.VIGAMOX® (moxifloxacin ophthalmic solution) 0.5% Sterile topical ophthalmic solutionInitial U.S. Approval: 1999?

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What are the side effects of These highlights do not include all the information needed to use VIGAMOX® solution safely and effectively. See full prescribing information for VIGAMOX®.VIGAMOX® (moxifloxacin ophthalmic solution) 0.5% Sterile topical ophthalmic solutionInitial U.S. Approval: 1999?

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What should I look out for while using These highlights do not include all the information needed to use VIGAMOX® solution safely and effectively. See full prescribing information for VIGAMOX®.VIGAMOX® (moxifloxacin ophthalmic solution) 0.5% Sterile topical ophthalmic solutionInitial U.S. Approval: 1999?

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.

What might happen if I take too much These highlights do not include all the information needed to use VIGAMOX® solution safely and effectively. See full prescribing information for VIGAMOX®.VIGAMOX® (moxifloxacin ophthalmic solution) 0.5% Sterile topical ophthalmic solutionInitial U.S. Approval: 1999?

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How should I store and handle These highlights do not include all the information needed to use VIGAMOX® solution safely and effectively. See full prescribing information for VIGAMOX®.VIGAMOX® (moxifloxacin ophthalmic solution) 0.5% Sterile topical ophthalmic solutionInitial U.S. Approval: 1999?

Unopened vials of gemcitabine for injection, USP are stable until the expiration date indicated on the package when stored at controlled room temperature 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] . Product: 50090-0859NDC: 50090-0859-0 3 mL in a BOTTLE, PLASTIC Product: 50090-0859NDC: 50090-0859-0 3 mL in a BOTTLE, PLASTIC

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Moxifloxacin is a member of the fluoroquinolone class of anti-infective drugs .

Non-Clinical Toxicology

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.

The vasodilating effects of isosorbide mononitrate may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety.

Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination. Dose adjustments of either class of agents may be necessary.

NOT FOR INJECTION. VIGAMOX® solution is for topical ophthalmic use only and should not be injected subconjunctivally or introduced directly into the anterior chamber of the eye.

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.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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