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Levofloxacin Hemihydrate INN
|NAME||STRENGTH||PACK SIZE||DOSAGE FORM|
|Levosina ED||0.5% w/v||5 ml||Eye drops|
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.
Levosina sterile eye drops: Each ml contains Levofloxacin Hemihydrate USP equivalent to Levofloxacin 5 mg.
Indications And Uses
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.
Dosage And Administration
Adult and Children 1year of age and older: Days 1 & 2: Instill 1-2 drops in the affected eye(s) every 2 hours while awake, up to 8 times per day. Days 3 to 7: Instill 1-2 drops in the affected eye(s) every 4 hours while awake, up to 4 times per day.
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.
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.
Use In Pregnancy Lactation
Pregnancy Category C. Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers Levofloxacin has not been measured in human milk. Caution should be exercised when Levofloxacin is administered to a nursing mother.
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 in a cool, dry place and protected from light. Keep out of reach of children.
It is contraindicated in patients with a history of hypersensitivity to Levofloxacin, to other quinolones or to any components in this medication.
Levosina sterile eye drops: Each plastic dropper bottle contains 5 ml sterile solution.