Levofloxacin Solution/ Drops

Levofloxacin Solution/ Drops

Levofloxacin Solution/ Drops Recall

Get an alert when a recall is issued.

Questions & Answers

Side Effects & Adverse Reactions

NOT FOR INJECTION. Levofloxacin Ophthalmic Solution should not be injected subconjunctially, nor should it be introduced directly into the anterior chamber of the eye.

In patients receiving systemic quinolones, 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 levofloxacin occurs, discontinue the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


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


Corynebacterium species*

Staphylococcus aureus

Staphylococcus epidermidis

Streptococcus pneumoniae

Streptococcus (Groups C/F)

Streptococcus (Group G)

Viridans group streptococci


Acinetobacter lwoffii*

Haemophilus influenzae

Serratia marcescens*

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


There is currently no drug history available for this drug.

Other Information

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 neutral pH than ofloxacin.

Structural formula:
Levofloxacin Structural Formula
Levofloxacin Hemihydrate
C18H20FN3O4 ½ H2O Mol Wt 370.38

Chemical Name: (-)-(s)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7Hpyrido [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% ( mg/mL); Preservative: benzalkonium chloride 0.005%;

Inactives: sodium chloride and water for injection. 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. 

Levofloxacin Solution/ Drops Manufacturers

  • Pack Pharmaceuticals, Llc
    Levofloxacin Solution/ Drops [Pack Pharmaceuticals, Llc]
  • Hi-tech Pharmacal Co., Inc.
    Levofloxacin Solution/ Drops [Hi-tech Pharmacal Co., Inc.]

Login To Your Free Account