Levofloxacin Solution Recall
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Questions & Answers
Side Effects & Adverse Reactions
NOT FOR INJECTION.
Levofloxacin ophthalmic 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 legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
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:
AEROBIC GRAM-POSITIVE MICROORGANISMS
Streptococcus (Groups C/F)
Streptococcus (Group G)
Viridans group streptococci
AEROBIC GRAM-NEGATIVE MICROORGANISMS
*Efficacy for this organism was studied in fewer than 10 infections.
There is currently no drug history available for this drug.
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. Its structural formula is:
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: Sodium Chloride and Purified Water. May also contain Sodium Hydroxide and/or Hydrochloric Acid 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.