Presentation

Levoxin TS Eye Drops: Each ml contains Levofloxacin Hemihydrate USP 15.37 mg equivalent to Levofloxacin 15 mg.

Description

Levofloxacin is a synthetic, broad-spectrum, third generation fluoroquinolone antibacterial agent. It works by the inhibition of bacterial topoisomerase IV and DNA gyrase enzymes required for DNA replication, transcription, repair, and recombination.

Indications

This drug is indicated for the treatment of corneal ulcer caused by susceptible

strains of the following organisms:

Aerobic Gram-Positive Microorganisms Aerobic Gram-Negative Microorganisms:

Corynebacterium species, Acinetobacter lwoffii, Staphylococcus aureus Haemophilus influenza, Staphylococcus epidermidis, Serratia marcescens, Streptococcus pneumonia, Streptococcus (Groups C/F), Streptococcus (Group G), Viridans group streptococci.

Dosage & Administration

Adults and children 6 year of age and older:

Days 1 through 3: Instill one to two drops in the affected eye(s) every 30 minutes to 2 hours while awake and approximately 4 and 6 hours after retiring.

Day 4 through treatment completion: Instill one to two drops in the affected eye(s) every 1 to 4 hours while awake.

Side Effects

The most common side-effects are transient decreased vision, fever, headache, transient ocular burning, ocular pain or discomfort, pharyngitis, allergic reactions, lid edema, ocular dryness and ocular itching.

Precautions

This drug should not be injected subconjunctially, nor should it be introduced directly into the anterior chamber of the eye. Avoid contaminating the applicator tip with material from the eye, fingers or other source.

Use in Pregnancy & Lactation

Pregnancy Category C. There are no adequate and well-controlled studies of Levofloxacin in pregnant woman. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Levofloxacin has not been measured in human milk. Caution should be exercised when Levofloxacin eye drops is administered to a nursing mother.

Drug Interaction

Specific drug interaction studies have not been conducted with Levofloxacin eye drop. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, and enhance the effects of the oral anticoagulant warfarin and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving systemic cyclosporine concomitantly.

Over Dose

Information not available.

Storage

? Keep out of the reach of children.

? Store in a cool, dry place, away from heat and direct light.

? Do not use more than 4 weeks after opening.

Commercial Pack

Levoxin TS eye drops: Plastic dropper bottle containing 5 ml sterile eye drops.