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Levobac Ophthalmic Solution Levofloxacin 0.5% – 5 ml drop
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It is indicated for the treatment of corneal ulcer caused by susceptible strains of the following bacteria:
- Gram-positive Bacteria: Corynebacterium species, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Viridans group streptococci
- Gram-negative Bacteria: Pseudomonas aeruginosa, Serratia marcescens.
Levofloxacin exerts antibacterial action by inhibiting bacterial topoisomerase IV and DNA gyrase, the enzymes required for DNA replication, transcription repair and recombination. It has in vitro activity against a wide range of gm-ve and gm+ve microorganisms. Levofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of Gram-positive and Gram-negative ocular pathogens.
Dosage & Administration
1.5% ophthalmic solution:
- 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.
0.5% ophthalmic solution:
- Days 1 and 2: Instill one to two drops in the affected eye(s) every 2 hours while awake, up to 8 times per day.
- Days 3 through 7: Instill one to two drops in the affected eye(s) every 4 hours while awake, up to 4 times per day.
Specific drug interaction studies have not been conducted with this drug. 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.
In patients with a history of hypersensitivity to levofloxacin, to other quinolones, or to any of the components in this medication.
The most frequently reported adverse events were headache and a taste disturbance following instillation. Other adverse events included decreased/blurred vision, diarrhea, dyspepsia, fever, infection, instillation site irritation/discomfort, ocular infection, nausea, ocular pain/discomfort, and throat irritation.
Pregnancy & Lactation
Pregnancy Category C. There are no adequate and well controlled studies in pregnant women. Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: Levofloxacin has not been measured in human milk. Caution should be exercised when this drug is administered to a nursing mother.
Precautions & Warnings
Not For Injection. 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.
Prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Patients should be advised not to wear contact lenses if they have signs and symptoms of corneal ulcer. Avoid contaminating the applicator tip with material from the eye, fingers or other source.
Use in Special Populations
Pediatric Use: Safety and effectiveness in children below the age of six years have not been established.
Store in a cool and dry place, away from light. Keep out of reach of children.
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