NOT FOR INJECTION.
QUIXIN® solution should not be injected subconjunctivally, 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.
There is currently no manufacturer warning information available for this drug.
QUIXIN® solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
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|
| AEROBIC GRAM-POSITIVE MICROORGANISMS | AEROBIC GRAM-NEGATIVE MICROORGANISMS |
| Corynebacterium species* | Acinetobacter lwoffii* |
| Staphylococcus aureus | Haemophilus influenzae |
| Staphylococcus epidermidis | Serratia marcescens* |
| Streptococcus pneumoniae | |
| Streptococcus (Groups C/F) | |
| Streptococcus (Group G) | |
| Viridans group streptococci | |
QUIXIN® (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.
| Structural formula |
 |
| levofloxacin hemihydrate |
| C18H20FN3 • 1/2 H2O Mol Wt 370.38 |
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 QUIXIN® contains 5.12 mg of levofloxacin hemihydrate equivalent to 5 mg levofloxacin.
Contains
Active: Levofloxacin 0.5% (5 mg/mL); Preservative: benzalkonium chloride 0.005%; Inactives: sodium chloride and water. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.
QUIXIN® 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.