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LYFLOX

LOMEFLOXACIN INN


NAME STRENGTH PACK SIZE DOSAGE FORM
LYFLOX 0.3% W/V 0.3% W/V 5 ML EYE DROP

Lyflox Eye Drops contains Lomefloxacin Hydrochloride INN 0.3% w/v.

Lomefloxacin, a diflurinated quinolone derivative, is a baterial gyrase inhibitor. It is effective against gram-positive and gram-negative bacteria. It interferes with bacterial DNA related processes like initiation, elongation and termination phases of replication, transcription, DNA repairing, recombination, transposition, supercoiling and relaxation of DNA. A-subunit of bacterial enzyme gyrase (topoisomerase II) is the target molecule for quinolones. The formation of a stable complex between the quinolone and the whole gyrase teramer A2B2 leads to impair enzyme functions which ultimately leads to the killing of sensitive bacteria. The acute toxicity of Lomefloxacin following systemic and topical ophthalmic application is low. No clinical studies are available about the efficacy in the cases of infections with chlamydia.

Lyflox Eye Drops is indicated in the bacterial infection of the anterior segment of eye including conjunctivitis, blepharitis, blepharo-conjunctivitis which are due to Lomefloxacin susceptible organisms and staphylococcus aureus induced corneal ulcers.

Adult and child (over 1 year of age): Instill one Drop, 2-3 times daily into the lower conjunctival sac. At the beginning of the treatment, Lyflox Eye Drops should be used more frequently and apply 5 drops within 20 minutes or one drop hourly for 6-10 hours. Treatment should be continued for 7-9 days.

Lyflox Eye Drops is contraindicated in the patient with known hypersensitivity to Lomefloxacin or other quinolones.

Long-term use with antibiotics may enhance development of secondary fungal infections or may support growth of non-susceptible bacteria. Some isolated cases of phototoxicity have been reported after systemic but not after topical ophthalmic use. During treatment with Lomefloxacin intensive exposure to sunlight or UV radiation should be completely avoided.

Local irritation, slight and transient burning immediately after instillation, rarely hypersensitivity effects, allergic reactions, asthma, dysponea, urticarea, erythema, pruritus have been reported after the use of Lomefloxacin eye drops.

Clinical studies on the use of Lomefloxacin eye drops during pregnancy or lactation has not been established. So, the drug should only be used when the benefit outweigh the potential risk for the foetus or the infant. However, animal studies revealed that after systemic use Lomefloxacin at a dose of 20 mg/kg, it passes the placental barrier and is excreted into the maternal milk.

Ophthalmic preparation containing heavy metals, such as Zn & Cu should not be used within 15 minutes of application of Lomefloxacin to avoid reduction of efficacy. Bacteriostatic ophthalmic antibiotics should not be used concomitantly with Lomefloxacin eye drops.

Practically there is no risk of adverse effects due to accidental oral ingestion, since a bottle of 5 ml eye drop solution contains only 15 mg Lomefloxacin. This corresponds to 3.75% of the recommended oral daily dose for adults of 400 mg Lomefloxacin

Store in a cool and dry place away from light. Keep out of reach of children.

Lyflox Eye Drops: 5 ml sterile Eye Drops is available in Dropper Bottle.