Moxifloxacin 0.5% 3mL - Lupin

Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL — Lupin Pharmaceuticals

Product Overview

Moxifloxacin Ophthalmic Solution USP, 0.5%, is a sterile, topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible organisms.

Product Details

Active Ingredient	Moxifloxacin 0.5%
Dosage Form	Sterile ophthalmic solution
Route	Topical ophthalmic use only
Package Size	3 mL
Manufacturer	Lupin Pharmaceuticals
Brand Name Reference	Vigamox

Indications and Usage

Moxifloxacin ophthalmic solution 0.5% is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of designated microorganisms.

Dosage and Administration

For topical ophthalmic use only. Use according to the prescribing healthcare professional’s instructions and the product’s approved prescribing information.

Warnings and Precautions

• For ophthalmic use only; do not inject or administer orally.
• Serious hypersensitivity reactions, including anaphylaxis, have been reported with systemic quinolones and may occur with topical use.
• Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.
• Patients should be advised to avoid contamination of the dropper tip by contact with the eye, fingers, or other surfaces.

Contraindications

Contraindicated in patients with a history of hypersensitivity to moxifloxacin, other quinolones, or any component of the formulation.

Adverse Reactions

Possible adverse reactions include conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing.

Storage and Handling

Store according to the product labeling. Keep the bottle tightly closed when not in use. Keep out of reach of children.

How Supplied

Sterile moxifloxacin ophthalmic solution USP, 0.5%, supplied in a 3 mL bottle.

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Professional use only.

Clinical information is provided as a general summary. Refer to the full FDA-approved prescribing information for complete indications, dosing, warnings, and storage requirements.

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