Moxifloxacin Ophthalmic Sol USP 0.5%

Alembic Pharmaceuticals Limited

Revision date : 2019-02-26

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Health risk rating 1
Safety risk rating 1
Environmental risk rating 1

General Information

Revision date

2019-02-26

Product name

Moxifloxacin Ophthalmic Sol USP 0.5%

CAS No.

354812-41-2

1.2.1 Relevant identified uses

Moxifloxacin Ophthalmic Sol USP is a topical fluoroquinolone anti-infective indicated

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Company Information

company name

Alembic Pharmaceuticals Limited

GHS Information

Signal word

WARNING

Section 2

SECTION 2: Hazards identification

Fire and Explosion See Section 5 Health: 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. WARNING: Topical Ophthalmic Use Only NOT FOR INJECTION, Moxifloxacin ophthalmic solution USP is for topical ophthalmic use only and should not be injected subconjunctivally or introduced directly into the anterior chamber of the eye. Avoidance of Contact Lens Wear, Patients should be advised not to wear contact lenses if they have signs or Symptoms of bacterial conjunctivitis. Growth of Resistant Organisms with Prolonged Use, as with other anti-infectives, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.

Environmental hazards

No information is available about the potential of this product to produce adverse environmental effects.

Signal word

Danger

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