Lefloxin 0.5% Ophthalmic Solution

Lefloxin 0.5% Ophthalmic Solution

levofloxacin

Manufacturer:

Siam Bheasach

Distributor:

Siam Pharmaceutical
Full Prescribing Info
Contents
Levofloxacin (as hemihydrate).
Description
Each mL contains Levofloxacin hemihydrate equivalent to Levofloxacin 5 mg.
Action
Pharmacology: Pharmacodynamics: Levofloxacin is a Fluoroquinolone anti-infective agent which experts a broad spectrum potent anti-bacterial activity against organisms causing ophthalmological infections, including gram-positive bacteria, gram negative bacteria and anaerobic bacteria. Levofloxacin inhibits DNA synthesis in susceptible organisms via inhibition of type II topoisomerase (DNA gyrase) and topoisomerase IV.
Susceptible strains: Levofloxacin has been shown to be active against gram-positive and gram-negative bacteria such as: Gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus sp., Streptococcus group G, Streptococcus pneumoniae, α-hemolytic streptococci (viridans group), and Corynebacterium spp.
Gram-negative bacteria: Serratia marcescens, Haemophilus influenzae or parainfluenzae, Pseudomonas aeruginosa, Acinetobacter lwoffii, Moraxella sp., Klebsiella sp., Enterobacter sp., and Proteus sp.
Pharmacokinetics: After ocular instillation, Levofloxacin is well maintained in the tear-film.
Indications/Uses
Levofloxacin as the hemihydrates in eye drops is used for the treatment of bacterial blepharitis, dacryocystitis, hordeolum, conjunctivitis, tarsadenitis, keratitis (including corneal ulcer) caused by susceptible strains and aseptic treatment during a perioperative period for ocular surgery.
Dosage/Direction for Use
Adult: Instill 1 to 2 drops a time 3 times daily. The dosage may be adjusted according to the patient's symptoms.
Pediatric: Children ≥ 6 years of age and Adolescents: Refer to adult dosing.
Renal impairment: There are no dosage adjustments. However, dosage adjustment unlikely due to low systemic absorption.
Hepatic impairment: There are no dosage adjustments. However, dosage adjustment unlikely due to low systemic absorption.
Overdosage
After a local overdose with Levofloxacin eye drops, the eyes can be flushed with clean water at room temperature. Moreover, the total amount of levofloxacin in a bottle of eye drops is too small to induce toxic effects after an accidental oral intake.
Contraindications
This drug is contraindicated in patients who are hypersensitive to Levofloxacin, the ingredient of this product or any quinolone antibiotics.
Warnings
(according to Notification of the Ministry of Public Health): Do not use this product if the patient is hypersensitive to Levofloxacin or other quinolones.
If any symptoms such as eyelid redness/swelling, rash, muscle pain, tendiopathy are observed administration should be discontinued and consult the doctor immediately.
Levofloxacin may cause hepatotoxicity or renal toxicity.
Special Precautions
Route of administration: Ophthalmic use only. Not for injection or subconjunctival injection or introduction directly into the anterior chamber.
Prolonged use of levofloxacin may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, Levofloxacin should be discontinued and other appropriate therapy instituted.
Use In Pregnancy & Lactation
Pregnancy category: C.
The safety of this product during pregnancy has not been established. Should be used in pregnant women if the expected therapeutic benefits are judged to outweight the possible risks associated with treatment.
Levofloxacin may be distributed into milk. Caution is advised is ophthalmic levofloxacin is administered in nursing women.
Adverse Reactions
See Table.

Click on icon to see table/diagram/image
Drug Interactions
Specific drug interaction studies have not been conducted to date. However, since some systemic absorption may occur following topical application of Levofloxacin to the eye, the possibility of drug interactions such as those reported with systemic administration of some quinolone anti-infectives (eg. interactions with theophylline, caffeine, oral anticoagulants, cyclosporine) should be considered.
Storage
Store below 30°C, Protect from light.
ATC Classification
S01AE05 - levofloxacin ; Belongs to the class of quinolone antiinfectives. Used in the treatment of eye infections.
Presentation/Packing
Ophth soln 0.5% (clear yellow sterile) x 5 mL x 10's.
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