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Glevo Eye/ Ear Drops
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Otitis Externa
Bacterial infection of external auditory canal
Categorized by time course Acute
Subacute
Chronic
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Common pathogens
isolated from patients with Otitis Externa
Dru gs 1999; 58(3): 509-531
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Common pathogens isolated from
patients with AOM
Dru gs 1999; 58(3): 509-531
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CSOM
(Chronic Suppurative Otitis Media)
CSOM is a perforated tympanic membrane withpersistent drainage from the middle ear.
Defined as chronic otorrhoea (> 6-12 wks)
through a perforated tympanic membrane.
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Microbiology
Most common organisms recovered from
the chronically draining ear are:
Pseudomonas aeruginosa S. aureus
Proteus species
K. pneumoniae
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Bacterial Conjunctivitis
Conjunctivitis :inflammation of conjunctiva
Conjunctiva :thin, translucent, elastic tissuelayer with bulbar & palpebral portions
Bulbar :lines the outer surface of the globe to
the limbus (junction of sclera & cornea)
Palpebral :covers the inside of the eyelids
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Classification of Conjunctivitis
Viral
Infectious Hyperacute
Bacterial Acute
Chronic
Non-infectious Allergic, Toxins/Chemicals, Foreign body, Trauma, Neoplasm
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Levofloxacin 0.5% solution
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Mechanism of Action
It is a bactericidal drug
Acts on bacterial topoisomerase
Inhibits the supercoiling activity of bacterial DNA gyrase,
halting DNA replication.
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Spectrum of Activity
Aerobic gram +ve
Enterococcus fecalis
S. aureus
S. haemolyticus
S. saprophyticus
S. pneumoniae
S. pyogenes
Aerobic gram -ve E.cloacae
E. coli
H.influenzae &
parainfluenzae K. pneumoniae
K.oxytoca
M.catarrhalis
P. vulgaris
P. mirabilis
P. aeruginosa
Salmonella species
Shigella spp
B. pertussis
Acinetobacter spp
Providencia spp
Levofloxacin has been shown to be active against most strains of
microorganisms
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Anaerobic microorganisms
Clostridium perfringens
Bacteroides fragilis
Peptostreptococci
Atypical microorganisms
C. pneumoniae
M. pneumoniae
Others :Mycobacterium tuberculosis
Spectrum of Activity (Contd.)
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Pharmacokinetics
The aqueous solubility of Levofloxacin is 10 times morethan either ofloxacin or ciprofloxacin
Concentration of levofloxacin in human tears at 4 hrs afterdrug administration is almost double that of ofloxacin.
Serum concentrations are 1000 times lower than those
reported after standard oral dosing.
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Indications
Otitis Externa
Acute Otitis Media
Chronic Suppurative Otitis Media (CSOM)
Bacterial Conjunctivitis
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Each 5 ml of Glevo Eye/Ear Drops contains :
Levofloxacin Hemihydrate 0.5% w/v
Non-medicin al ing redients :
Sodium Chloride ( preservative)
Benzalkonium Chloride ( preservative)
1 N Hydrochloric Acid (for pH adjustment.)
Composition / Base of
Glevo Eye/Ear Drops
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Dosage & Administration
Otitis Externa :
Pediatric patients (1-13 yrs) :Five drops instilled into
the affected ear once daily for 7 days.
In adults ( 13 yrs) :Ten drops instilled into the affectedear once daily for 7 days
Acute Otitis Media :
Five drops instilled into the affected ear once or twice
daily for 7-10 days
CSOM : (in patients 12 yrs & older)
Ten drops instilled into the affected ear once or twice
daily for 14 days.
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For Ophthalmic use
Adults & children 1 year of age & older
1-2 drops in the affected eye(s) every 2 hours while
awake (upto 8 times daily) for 2 days, then 1 or 2 drops
every 4 hours while awake (upto 4 times daily) for the
next 5 days.
Dosage & Administration
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Undesirable effects
Eye effects : Transient decrease in vision
Ocular burning
Ocular pain or discomfort
Foreign body sensation
Photophobia
Headache
Ear effects:
Application site reactions Pruritus
Earache
Dizziness
Vertigo
Headache
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Glevo Eye/Ear Drops- Highlights
Levofloxacin is the pure L enantiomer of Ofloxacin
Acts by inhibiting two essential bacterial enzymes, DNA
gyrase & topoisomerase IV
MIC 90values for levofloxacin against most bacteria are
approximately 50% lower than those of Ofloxacin
Expanded activity against Gram positive organismscompared with older generation quinolones, while
retaining excellent activity against Gram negative
pathogens
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Major pathogens involved in eye/ ear diseases are
highly susceptible to levofloxacin.
Achieves several times higher concentrations than
other quinolones in the aqueous humor
Well tolerated due to its limited systemic absorptionafter topical administration.
Glevo Eye/Ear Drops- Highlights
(Contd.)