Vofox 0.005

INDICATIONS

Levofloxacin eye drops is 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 ... Read moreLevofloxacin eye drops is 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 viridons group.Aerobic Gram-Negative bacteria: Acinetobocter Iwoffii, Haemophilus influenzae, Serrotia morcescens.Levofloxacin also provides a promising treatment for other ocular infections including- Bacterial corneal ulcer, Blepharitis, Hordeolum & Perioperative condition.Levofloxacin ear drops is indicated for the treatment of Otitis externa, otitis media caused by susceptible strains of the following bacteria: Staphylococcus, Streptococcus, Pneumococcus, Moraxella (Branhamella) catarrhalis, Klebsiellapneumoniae, Enterobacter, Serratia, Haemophilus infuenzae, Pseudomonas aeruginosa, Acinetobacter.

PHARMACOLOGY

Levofloxacin eye drops is a sterile topical ophthalmic solution. It is a synthetic, broad spectrum, third generation fluoroquinolone bactericidal antibiotic, which active 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.

1.5% ear drop: The usual dosage is 6 to 10 drops in the ear twice a day. After applying the ear drops, perform an ear bath for about 10 minutes. The number of doses may be increased or decreased as appropriate depending on the symptoms.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.

SIDE EFFECTS

Side effects occurred only approximately 1-3% of patients that 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 is 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, store in a cool (15°-25° C) and dry place & keep out of reach of children.