Lequin

Composition
Each ml contains Levofloxacin Hemihydrate INN equivalent to Levofloxacin 5 mg.
Pharmacology
Lequin eye drops is a sterile topical ophthalmic solution containing Levofloxacin,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. Levofloxacin is a fluorinated 4-quinolone containing a six-member (pyridobenzoxazine) ring from
positions 1 to 8 of the basic ring structure.
Indications & Usage
It 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
Viridans group streptococci
Aerobic Gram-negative Microorganisms
Acinetobacter Iwoffii
Haemophilus influenzae
Serratia marcescens
Dosage & Administration
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.
Precautions
As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including
fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment
dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and,
where appropriate, fluorescein staining. Patients should be advised not to wear contact lenses if they have signs
and symptoms of bacterial conjunctivitis. Avoid contaminating the applicator tip with material from the eye,
fingers or other source. Systemic quinolones have been associated with hypersensitivity reactions, even
following a single dose. Discontinue use immediately and contact your physician at the first sign of a rash or
allergic reaction. Do not touch dropper tip to any surface to avoid contamination.
Adverse Reaction
The most frequently reported adverse events in the overall study population were transient decreased vision,
fever, foreign body sensation, headache, transient ocular burning, ocular pain or discomfort, pharyngitis and
photophobia. These events occurred in approximately 1-3% of patients. Other reported reactions occurring in
less than 1% of patients included allergic reactions, lid edema, ocular dryness, and ocular itching.
Drug Interactions
Specific drug interaction studies have not been conducted with levofloxacin. 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.
Contraindications
It is contraindicated in patients with a history of hypersensitivity to levofloxacin, to other quinolones, or to any of
the components in this medication.
Use in Pregnancy & Lactation
Teratogenic Effects: Pregnancy Category C. Levofloxacin at oral doses of 810 mg/kg/day in rats, which
corresponds to approximately 7,000 times the highest recommended human ophthalmic dose, caused
decreased fetal body weight and increased fetal mortality. No teratogenic effect was observed when rabbits
were dosed orally as high as 50 mg/kg/day, which corresponds to approximately 400 times the highest
recommended maximum human ophthalmic dose, or when dosed intravenously as high as 25 mg/kg/day,
corresponding to approximately 200 times the highest recommended human ophthalmic dose. There are,
however, 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.
Pediatric Use
Safety and effectiveness in infants below the age of one year have not been established.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
Nursing Mothers
Levofloxacin has not been measured in human milk. Based upon data from ofloxacin, it can be presumed that
levofloxacin is excreted in human milk. Caution should be exercised when levofloxacin is administered to a
nursing mother.