Label: LEVOFLOXACIN solution
- NDC Code(s): 72888-142-22
- Packager: Advagen Pharma Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 10, 2025
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use LEVOFLOXACIN OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for LEVOFLOXACIN OPHTHALMIC SOLUTION ...
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Table of ContentsTable of Contents
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1 INDICATIONS AND USAGELevofloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Gram-positive bacteria - Corynebacterium ...
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2 DOSAGE AND ADMINISTRATIONDays 1 and 2 - Instill one to two drops in the affected eye(s) every 2 hours while awake, up to 8 times per day. Days 3 through 7 - Instill one to two drops in the affected eye(s) every 4 hours ...
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3 DOSAGE FORMS AND STRENGTHS5 mL white LDPE bottle filled with 5 mL sterile ophthalmic solution of levofloxacin, 0.5%.
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4 CONTRAINDICATIONSLevofloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to levofloxacin, to other quinolones, or to any of the components in this medication.
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5 WARNINGS AND PRECAUTIONS5.1 Hypersensitivity Reactions - In patients receiving systemically administered quinolones, including levofloxacin, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have ...
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6 ADVERSE REACTIONSThe most frequently reported adverse reactions in the overall study population were transient decreased vision, fever, foreign body sensation, headache, transient ocular burning, ocular pain or ...
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8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy - Teratogenic Effects - Levofloxacin at oral doses of 810 mg/kg/day in rats caused decreased fetal body weight and increased fetal mortality. No teratogenic effect was observed when ...
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11 DESCRIPTIONLevofloxacin Ophthalmic Solution, 0.5% is a sterile topical ophthalmic solution. Levofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of Gram-positive and Gram-negative ...
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12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action - Levofloxacin is a member of the fluoroquinolone class of anti-infective drugs. (See - 12.4 Microbiology) 12.2 Pharmacokinetics - Levofloxacin ...
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13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - In a long term carcinogenicity study in rats, levofloxacin exhibited no carcinogenic or tumorigenic potential following daily dietary ...
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14 CLINICAL STUDIESIn randomized, double-masked, multicenter controlled clinical trials where patients were dosed for 5 days, Levofloxacin ophthalmic® demonstrated clinical cures in 79% of patients treated for ...
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16 HOW SUPPLIED/STORAGE HANDLINGLevofloxacin Ophthalmic Solution, 0.5% is a clear light yellow solution supplied in a white LDPE bottle with translucent LDPE nozzle and tan coloured HDPE cap in the following size: 5 mL filled ...
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17 PATIENT COUNSELING INFORMATION17.1 Avoid Contamination of the Product - Advise patients to avoid contaminating the applicator tip with material from the eye, finger, or other source. 17.2 Avoid Contact Lens Wear - Advise ...
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PACKAGE LABEL.PRINCIPAL DISPLAY PANELLevofloxacin Ophthalmic Solution, 0.5% Sterile Ophthalmic Solution - NDC 72888-142-22 - 5 mL Carton Label - Levofloxacin Ophthalmic Solution, 0.5% Sterile Ophthalmic Solution - NDC 72888-142-22 ...
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INGREDIENTS AND APPEARANCEProduct Information