displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Levofloxacin 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 ocular pathogens. Levofloxacin is the pure (-)-(S)-enantiomer of the racemic drug substance, ofloxacin. It is more soluble in water at neutral pH than ofloxacin.
Chemical Name: (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4 benzoxazine-6-carboxylic acid hemihydrate.
Levofloxacin (hemihydrate) is a yellowish-white crystalline powder.
Each mL of Levofloxacin Ophthalmic Solution contains 5.12 mg of levofloxacin hemihydrate equivalent to 5 mg levofloxacin.
Active: Levofloxacin 0.5% (5 mg/mL); Preservative: benzalkonium chloride 0.005%; Inactives: purified water and sodium chloride. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.
Levofloxacin Ophthalmic Solution is isotonic and formulated at pH 6.5 with an osmolality of approximately 300 mOsm/kg. Levofloxacin is a fluorinated 4-quinolone containing a six-member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure.
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Levofloxacin Ophthalmic Solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Levofloxacin 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.
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
The most frequently reported adverse events in the overall study population were transient decreased vision, fever, foreign body sensation, headache, transient ocular burning, ocular pain or discomfort, pharyngitis and photophobia. These events occurred in approximately 1-3% of patients. Other reported reactions occurring in less than 1% of patients included allergic reactions, lid edema, ocular dryness, and ocular itching.
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Days 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 while awake, up to 4 times per day.
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Levofloxacin Ophthalmic Solution 0.5%