Glevo Eye- Ear Drops-New

8/13/2019 Glevo Eye- Ear Drops-New

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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.)

Glevo Eye- Ear Drops-New

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