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LEVOSINA TS

LEVOFLOXACIN INN


NAME STRENGTH PACK SIZE DOSAGE FORM
LEVOSINA TS 1.5% W/V 1.5% W/V 5 ML EYE DROP

Levosina TS Eye Drops : Each ml contains Levofloxacin Hemihydrate INN equivalent to Levofloxacin 15 mg.

Levofloxacin ophthalmic solution is a synthetic, broad-spectrum, third generation fluoroquinolone antimicrobial agent. It acts by the inhibition of bacterial topoisomerase IV and DNA gyrase enzymes require for DNA replication, transcription, repair and recombination. It is more soluble in water at neutral pH than Ofloxacin.

It is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms. Aerobic gram-positive bacteria: Corynebacterium species, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumonia. Aerobic gram-nagetive bacteria: Acinetobacter lwoffii, Haemophilus influenzae, Serratia marcescens, viridans group streptococci. levofloxacin is also indicated in post-operative ocular infections.

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.

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

Avoid contaminating the applicator tip with material from the eye, fingers or other source. If hypersensitivity reaction occurs, discontinue use immediately and contact your physician at the first sign of rash or allergic 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.

Pregnancy Category C. Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Specific drug interaction studies have not been conducted with Levofloxacin eye drops. However, the systemic administration of some quinolones has been shown to elevate plasma concentration of theophylline, interfere with the metabolism of caffeine and has been associated with transient elevation in serum creatinine level in patients receiving systemic cyclosporine concomitantly.

No information provided.

Store at room temperature (15°-25°C) and dry place protected from light. Do not use more than 30 days after first opening of the bottle. Keep out of the reach of children.

Levosina TS Eye Drops : Each plastic dropper bottle contains 5 ml sterile eye drops.