Generic

Levofloxacin

Indications

Levofloxacin eye drops are indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following bacteria:

• Aerobic Gram-Positive bacteria-
• Corynebacterium species
• Staphylococcus oureus
• Staphylococcus epidermidis
• Streptococcus pneumoniae
• Streptococcus (Groups C/F)
• Streptococcus (Group G)
• Streptococcus virions group
• Aerobic Gram-Negative bacteria-
• Acinetobocter Iwoffii
• Haemophilus influenza
• Serrotia marcescent

Levofloxacin also provides a promising treatment for other ocular infections including- Bacterial corneal ulcers, Blepharitis, Hordeolum & Perioperative conditions.

Pharmacology

Levofloxacin eye drops are a sterile topical ophthalmic solution. It is a synthetic, broad-spectrum, third-generation fluoroquinolone bactericidal antibiotic, which acts against a broad spectrum of Gram-positive & Gram-negative ocular pathogens. It functions by inhibiting bacterial topoisomerase IV and DNA gyrase enzymes required for DNA replication, transcription, repair, and recombination.

Dosage & Administration

0.5% eye drop: Adults and children 1 year of age and older:

Days 1 and 2: Instill 1-2 drops in the affected eye(s) every 2 hours while awake, up to 8 times per day.

Days 3 through 7: Instill 1-2 drops in the affected eye(s) every 4 hours while awake, up to 4 times per day.

1.5% eye drop: Adults and children 6 years 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.

Children <1 year: Safety and effectiveness of Levofloxacin below 1 year of age have not been established.

Interaction

Specific drug interaction studies have not been conducted with levofloxacin eye drops. But 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.

Contraindications

It is contraindicated in patients with a history of hypersensitivity to Levofloxacin, to other quinolones, or to any of the components of this medication

Side Effects

Side effects occurred only approximately 1-3% of patients which may include transient blurred vision, fever, foreign body sensation, headache, transient ocular burning, ocular pain or discomfort, pharyngitis, and photophobia. In less than 1% of patients included allergic reactions, lid edema, ocular dryness, and ocular itching.

Pregnancy & Lactation

Pregnancy Category C. Levofloxacin 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 are administered to a nursing mother.

Precautions & Warnings

Prolonged use may result in the overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy.

Therapeutic Class

4-Quinolone preparations

Storage Conditions

Eye drops should be protected from light, stored in a cool (15°-25° C) and dry place & keep out of reach of children.

Pharmaceutical Name

Eskayef Pharmaceuticals Ltd.