Levofloxacin

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

Corynebacterium

Viridans group streptococci*

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

Instill one to two drops in the affected eye(s) every 2 hours while awake, up to 8 times per day.

Instill one to two drops in the affected eye(s) every 4 hours while awake, up to 4 times per day.

5 mL white LDPE bottle filled with 5 mL sterile ophthalmic solution of levofloxacin, 0.5%.

The 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 discomfort, pharyngitis and photophobia. These reactions 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.

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 a fluorinated 4-quinolone containing a six-member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure. 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 light yellow powder.

Each mL of levofloxacin ophthalmic solution, 0.5% contains 5.12 mg of levofloxacin hemihydrate equivalent to 5 mg levofloxacin.

Levofloxacin ophthalmic solution, 0.5% is isotonic and formulated at pH 6.0-6.8 with an osmolality between 285-315 mOsm/kg.