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Gatsina

Gatifloxacin as Gatifloxacin sesquihydrate INN

NAME STRENGTH PACK SIZE DOSAGE FORM
Gatsina ED 0.3% w/v 5 ml Eye drops

Description

Gatifloxacin is an 8-methoxyfluoroquinolone with a 3-methylpiperazinyl substituent at C-7 which shows antibacterial activity by inhibiting the bacterial enzyme DNA gyrase and topoisomerase IV.

Each ml contains Gatifloxacin Sesquihydrate INN equivalent to Gatifloxacin 3 mg.

Gatsina Sterile Eye Drops is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Aerobic Gram-Positive Bacteria: Cornyebacterium propinquum, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis, Streptococcus pneumoniae. Aerobic Gram-Negative Bacteria: Haemophilus influenza. It is also indicated for the treatment of keratitis, blepharitis, pre- and post-operative treatment.

For bacterial conjunctivitis and blepharitis: Days 1 and 2: Instill 1 drop every two hours in the affected eye(s) while awake, up to 8 times daily. Days 3 to 7: Instill 1 drop up to four times daily while awake. For keratitis: Instill 1 drop every 15 minutes in the affected eye(s) for 4 hours, then 4 times daily upto 10 days. For pre-operatively: Instill 1 drop 4 times/day for 2 days, and then 1 drop every 10 minutes before 1 hour of surgery. For post-operatively: Instill 1 drop 4 times/day for 7 days.

Reported side effects are conjunctival irritation, increased lacrimation, keratitis, and papillary conjunctivitis upon instillation. Other side effects are chemosis, conjunctival hemorrhage, dry eye, eye discharge, eye irritation, eye pain, eyelid edema, headache, red eye, reduced visual acuity and taste disturbance.

Prolonged use with other anti-infectives may result in overgrowth of non-susceptible organisms, including fungi. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis. Avoid contaminating the applicator tip with material from the eye, fingers or other source.

Pregnancy: Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Gatifloxacin should be used during pregnancy only if the benefit justifies the potential risk to the fetus. Lactation: It is not known whether Gatifloxacin is excreted in human milk. So, caution should be exercised when Gatifloxacin is administered to a nursing woman.

There may be an interaction between Gatifloxacin and any of the following: Antacids (containing Aluminum, Calcium, and Magnesium) Digoxin, Probenecid Vitamins (containing Zinc, Calcium, Magnesium, or Iron).

An overdose of this medication is unlikely to threaten life.

Store in a cool and dry place & keep away from light. After one month of the opening of dropper do not use the medicine .

Gatifloxacin 0.3% eye drops is contraindicated in patients with a history of hypersensitivity to Gatifloxacin, to other quinolones, or to any of the components in this medication.

Each plastic dropper bottle contains 5 ml sterile eye drops.