Levofloxacin Solution

Levofloxacin Solution

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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.

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.

Uses

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

AEROBIC GRAM-POSITIVE MICROORGANISMS

Corynebacterium species*
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae
Streptococcus (Groups C/F)
Streptococcus (Group G)
Viridans group streptococci

AEROBIC GRAM-NEGATIVE MICROORGANISMS

Acinetobacter iwoffii*
Haemophilus influenzae
Serratia marcescens*

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

History

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 at neutral pH than ofloxacin. Its structural formula is:

Structural Formula

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.

Contains:

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.

Levofloxacin Solution Manufacturers


  • Akorn Inc.
    Levofloxacin Solution [Akorn Inc.]
  • Hi-tech Pharmacal Co., Inc.
    Levofloxacin Solution [Hi-tech Pharmacal Co., Inc.]

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