Composition

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TISOL Eye Drops is an effectfrive and safe antibacterial preparation for the management of external ocular bacterial infection viz. (a) bacterial keratitis caused by susceptible strains of P.aeruginosa, Propionibacterium acnes, Serratia marcescens, Staph. aureus, S.epidermidis, Strep.pneumoniae, and (b) conjunctivitis caused by susceptible strains like H.influenzae, P.aeruginosa, S.epidermidis, Strep.pneumoniae,Staph.aureus, etc.

TISOL Eye Drops containing Ofloxacin, is bacterial in action. Like other fluoroquinolones, Ofloxacin inhibits DNA topoisomerase (Type II ), generally referred to as DNA gyrase, in susceptible organisms. DNA gyrase is essential for bacterial DNA replication, repair, recombination, transposition. Inhibition of DNA gyrase results in inhibition of ATP dependent negative supercoiling of DNA, inhibition of ATP independent relaxation of supercoiled DNA, and promotion of double stranded DNA breakage.

The extent of ocular and systemetic absorption of Ofloxacon following topical application to the eye has not been fully elucidated; however serum concentrations achieved following such application to uninflammed eyes are minimal relative to those produced by oral parenteral doses of the drug. Ofloxacin is absorbed through the cornea into aqueous humor following topical application to the eye; the absorption is enhanced in the presence of ocular inflammation and/or epithelial defects Followinf topical application to the eye of 2 drops of a 0.3% solution of Ofloxacin every 30 minutes beginning 4 hours before surgery, in patients undergoing keratoplasty, corneal tissue, aqueous humor, vitreous

humor concentrations at the time of surgery averaged 4.4, 1.3 and 0.4 mcg/ml respectively.

The metabolic fate and elimination characterististics of Ofloxacin following topical application to the eye have not been fully elucidated. Following topical apllication of 1 drop of Ofloxacin 0.3% 4 times daily for 12 doses in healthy individuals, the elimination half-life of the drug in tear film was approximately 226 minutes.

Indications
For the treatment of susceptible organisms induced superficial ocular infections like Conjunctivitis, Keratitis, Keratoconjunctivitis, BLepharitis, Blepharo-conjunctivitis, corneal ulcers, dacryocystitis. Also used for prevention of infection following removal of corneal or conjunctival foreign body, before after ocular surgery; useful for prevention of infection due to N.gonorrhoeae or chlamydia trachomatis.

Precautions & Contraindictions
Oversue or prolonged use might lead to overgrowth of nonsusceptible organisms including fungi;Ofloxacin used should then be discontinued and an alternative therapy be introduced. Safety and efficacy ofOfloxacin Ophthalmic Solution in children younger than 1 year of agec have not been established. The drug should be used during pregnancy only when potential benefits justify the possible risks to the fetus. Tisol Eye Drops is contradicated in persons with known history of hypersensitivity to any fluoroquinolones.

Adverse Reaction
Transient ocular discomfort, redness, stringing, itching, foreign body sensation, blurred vision.

Drug Interactions
Specific drug interaction studies have not been carried out with Ofloxacin Ophthalmic Solution.

Dose & Administration
Recommended dosage regimen for

a. Bacterial Conjunctivitis:
1-2 drops to be instilled into eye every 2-4 hours during first two days; then 1-2 drops to be instilled every 4 hours.

b. Bacterial Corneal Ulcer:
Days 1 & 2:1-2 drops every 1/2 hour while awake. Again while awaken after sleep for 6 hours instill 1-2 drops.
Days 3 through 9:1-2 drops every hour while awake.
Days 9 through completion:1-2 drops every 6 hours.